Dabrafenib: Pediatric drug information

For additional information see "Dabrafenib: Drug information" and "Dabrafenib: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Tafinlar

Brand Names: Canada

Tafinlar

Therapeutic Category

Antineoplastic Agent, BRAF Kinase Inhibitor

Dosing: Pediatric

Dosage guidance:

Dosage form information: Dabrafenib is available as tablets for oral suspension and capsules; weight-band dosing is product specific in patients <18 years of age due to product strengths.

Glioma, low grade

Glioma, low grade (LGG) (with BRAF V600E mutation): Note: Use in combination with trametinib and continue therapy until disease progression or unacceptable toxicity. Twice-daily doses should be separated by 12 hours.

Weight-directed dosing: Limited data available: Note: In clinical trial experience, both dosage forms, tablets for oral suspension and capsules, were used based on patient's ability to swallow capsules (Ref).

Children 1 to <12 years: Oral: 2.63 mg/kg/dose every 12 hours; maximum dose: 150 mg/dose (Ref).

Children ≥12 years and Adolescents <18 years: Oral: 2.25 mg/kg/dose every 12 hours; maximum dose: 150 mg/dose (Ref).

Weight-band dosing: Children ≥1 year and Adolescents: Oral:

**Dabrafenib Weight-Band Dosing for Low-Grade Glioma in Children ≥1 Year and Adolescents**
Patient Weight (kg)	Tablets for Oral Suspension	Capsules
8 to <10 kg	20 mg twice daily	N/A
10 to <14 kg	30 mg twice daily	N/A
14 to <18 kg	40 mg twice daily	N/A
18 to <22 kg	50 mg twice daily	N/A
22 to <26 kg	60 mg twice daily	N/A
26 to <30 kg	70 mg twice daily	75 mg twice daily
30 to <34 kg	80 mg twice daily	75 mg twice daily
34 to <38 kg	90 mg twice daily	75 mg twice daily
38 to <42 kg	100 mg twice daily	100 mg twice daily
42 to <46 kg	110 mg twice daily	100 mg twice daily
46 to <51 kg	130 mg twice daily	100 mg twice daily
≥51 kg	150 mg twice daily	150 mg twice daily

Solid tumors, unresectable or metastatic

Solid tumors, unresectable or metastatic (BRAF V600E mutation):

Note: For use in patients who have progressed following prior treatment and have no satisfactory alternative treatment options. Approval for solid tumors is from an accelerated process and subject to change as data evolves. Use in combination with trametinib and continue therapy until disease progression or unacceptable toxicity. Twice-daily doses should be separated by 12 hours.

Weight-directed dosing: Limited data available: Note: In the trial, both dosage forms, tablets for oral suspension and capsules, were used based on patient's ability to swallow capsules (Ref).

Children 1 to <12 years: Oral: 2.63 mg/kg/dose every 12 hours; maximum dose: 150 mg/dose (Ref).

Children ≥12 years and Adolescents <18 years: Oral: 2.25 mg/kg/dose every 12 hours; maximum dose: 150 mg/dose (Ref).

Weight-band dosing:

Children ≥1 year and Adolescents: Oral:

**Dabrafenib Weight-Band Dosing for Solid Tumors (Unresectable or Metastatic) in Children ≥1 Year and Adolescents**
Patient Weight (kg)	Tablets for Oral Suspension	Capsules
8 to <10 kg	20 mg twice daily	N/A
10 to <14 kg	30 mg twice daily	N/A
14 to <18 kg	40 mg twice daily	N/A
18 to <22 kg	50 mg twice daily	N/A
22 to <26 kg	60 mg twice daily	N/A
26 to <30 kg	70 mg twice daily	75 mg twice daily
30 to <34 kg	80 mg twice daily	75 mg twice daily
34 to <38 kg	90 mg twice daily	75 mg twice daily
38 to <42 kg	100 mg twice daily	100 mg twice daily
42 to <46 kg	110 mg twice daily	100 mg twice daily
46 to <51 kg	130 mg twice daily	100 mg twice daily
≥51 kg	150 mg twice daily	150 mg twice daily

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity:

Dose reduction levels: Note: In patients <18 years of age, dosage adjustments are dosage form specific (tablets for oral suspension or capsules).

Tablets for oral suspension:

**Dabrafenib Tablets for Oral Suspension Dosage Level Reductions in Ages 1 to <18 Years**
Patient Weight (Usual Dose)	First Dose Reduction	Second Dose Reduction	Third Dose Reduction
8 to <10 kg (20 mg twice daily)	10 mg twice daily	N/A	N/A
10 to <14 kg (30 mg twice daily)	20 mg twice daily	10 mg twice daily	N/A
14 to <18 kg (40 mg twice daily)	30 mg twice daily	20 mg twice daily	10 mg twice daily
18 to <22 kg (50 mg twice daily)	30 mg twice daily	20 mg twice daily	10 mg twice daily
22 to <26 kg (60 mg twice daily)	40 mg twice daily	30 mg twice daily	20 mg twice daily
26 to <30 kg (70 mg twice daily)	50 mg twice daily	40 mg twice daily	20 mg twice daily
30 to <34 kg (80 mg twice daily)	50 mg twice daily	40 mg twice daily	30 mg twice daily
34 to <38 kg (90 mg twice daily)	60 mg twice daily	50 mg twice daily	30 mg twice daily
38 to <42 kg (100 mg twice daily)	70 mg twice daily	50 mg twice daily	30 mg twice daily
42 to <46 kg (110 mg twice daily)	70 mg twice daily	60 mg twice daily	40 mg twice daily
46 to <51 kg (130 mg twice daily)	90 mg twice daily	70 mg twice daily	40 mg twice daily
≥51 kg (150 mg twice daily)	100 mg twice daily	80 mg twice daily	50 mg twice daily

Capsules:

**Dabrafenib Capsule Dosage Level Reductions in Ages 1 to <18 Years Weighing ≥26 kg**
Patient Weight (Usual Dose)	First Dose Reduction	Second Dose Reduction	Third Dose Reduction	Subsequent Modifications
26 to <38 kg (75 mg twice daily)	50 mg twice daily	Permanently discontinue if unable to tolerate 50 mg twice daily
38 to <51 kg (100 mg twice daily)	75 mg twice daily	50 mg twice daily	Permanently discontinue if unable to tolerate 50 mg twice daily
≥51 kg (150 mg twice daily)	100 mg twice daily	75 mg twice daily	50 mg twice daily	Permanently discontinue if unable to tolerate 50 mg twice daily

**Dabrafenib Capsule Dosage Level Reductions in Ages ≥18 Years**
Usual Dose	First Dose Reduction	Second Dose Reduction	Third Dose Reduction	Subsequent Modifications
150 mg twice daily	100 mg twice daily	75 mg twice daily	50 mg twice daily	Permanently discontinue if unable to tolerate 50 mg twice daily

Dosage adjustments: Note: If using combination therapy with trametinib, other adverse reactions related to trametinib may occur; refer to Trametinib monograph for detailed information.

**Dabrafenib Dosage Modifications for Adverse Reactions in Pediatric Patients ≥1 Year of Age**
Adverse Reactions	Description/Severity	Dabrafenib Dosage Modification
^a LVEF = left ventricular ejection fraction, SCARs = severe cutaneous adverse reactions.
Cardiomyopathy	>20% absolute decrease in LVEF^a from baseline that is below institutional LLN	Interrupt dabrafenib until LVEF^a improves to at least the institutional LLN and absolute decrease to ≤10% (compared to baseline), then resume at the same dose.
Cardiomyopathy	Symptomatic heart failure	Interrupt dabrafenib until LVEF^a improves to at least the institutional LLN and absolute decrease to ≤10% (compared to baseline), then resume at the same dose.
Dermatologic toxicity	Intolerable grade 2 adverse reaction or grade 3 or 4 adverse reaction	Interrupt dabrafenib for up to 3 weeks. If improved, resume dabrafenib at a lower dose. If not improved, permanently discontinue dabrafenib.
Dermatologic toxicity	SCARs^a	Permanently discontinue dabrafenib.
Febrile reactions	Fever of 38°C to 40°C (100.4°F to 104°F), or first symptoms in case of recurrence	Interrupt dabrafenib until fever resolves and then resume at the same or lower dose.
Febrile reactions	Fever >40°C (104°F) and/or fever complicated by rigors, hypotension, dehydration, or kidney failure	Interrupt dabrafenib until febrile reaction resolves for at least 24 hours, then resume at a lower dose or permanently discontinue. Administer antipyretics (as secondary prophylaxis) upon dabrafenib resumption if patient had a prior episode of severe febrile reaction or fever associated with complications. Administer corticosteroids (eg equivalent of prednisone 10 mg daily in adults) for ≥5 days for a second or subsequent pyrexia if temperature does not return to baseline within 3 days of onset of fever, or for fever associated with complications (eg, dehydration, kidney failure, hypotension, severe chills/rigors with no evidence of active infection).
Hemorrhage	Intolerable grade 2 or any grade 3 hemorrhage	Interrupt dabrafenib therapy. If hemorrhage improves to grade 0 or 1, resume dabrafenib at a lower dose. If hemorrhage does not improve following therapy interruption, permanently discontinue dabrafenib.
	Grade 4 first occurrence	Interrupt dabrafenib therapy until improves to grade 0 or 1, then resume at lower dose. If no improvement, permanently discontinue.
	Grade 4 recurrent	Permanently discontinue dabrafenib.
Hyperglycemia		Hyperglycemia may require initiation or optimization of insulin or oral hypoglycemic agent therapy (as clinically indicated).
New primary malignancies	New primary cutaneous malignancy	No dabrafenib dosage modification is necessary.
New primary malignancies	Noncutaneous RAS mutation-positive malignancies	Permanently discontinue dabrafenib.
Ocular toxicity	Uveitis, including iritis and iridocyclitis	Manage symptomatically with local ophthalmic therapy (steroid and mydriatic drops were used in clinical trials) while continuing dabrafenib without dose modification. For iritis, administer ocular treatment. For severe uveitis or mild/moderate uveitis that does not respond to therapy, interrupt dabrafenib and treat as clinically indicated. If improves to grade 0 or 1, resume dabrafenib at the same or lower dose. If not improved, or for persistent grade 2 or higher uveitis of >6 weeks duration, permanently discontinue dabrafenib.
Other toxicities	Intolerable grade 2 or any grade 3 adverse reaction	Interrupt dabrafenib therapy until resolution to ≤ grade 1; then resume dabrafenib at a lower dose. If adverse reaction does not improve, permanently discontinue dabrafenib.
	Grade 4 adverse reaction (first occurrence)	Interrupt dabrafenib until resolution to ≤ grade 1; then resume dabrafenib at a lower dose or permanently discontinue.
	Grade 4 adverse reaction (recurrent)	Permanently discontinue dabrafenib.

Dosing: Kidney Impairment: Pediatric

Children ≥1 year and Adolescents: Oral:

eGFR ≥15 mL/minute/1.73 m²: There are no dosage adjustments provided in the manufacturer's labeling; however, pharmacokinetic differences with eGFR ≥15 mL/minute/1.73 m²are not considered clinically relevant.

eGFR <15 mL/minute/1.73 m²: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

Children ≥1 year and Adolescents: Oral:

Mild impairment (bilirubin ≤ ULN and AST > ULN or bilirubin >1 to 1.5 times ULN and any AST): No dosage adjustment necessary.

Moderate (bilirubin >1.5 to 3 times ULN and any AST) to severe (bilirubin >3 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling (an appropriate dose has not been established); however, hepatic metabolism and biliary excretion are the primary elimination routes for dabrafenib and exposure may be increased in patients with moderate to severe impairment.

Dosing: Adult

(For additional information see "Dabrafenib: Drug information")

Dosage guidance:

Clinical considerations: Confirm BRAF V600 mutation status (in tumor specimens) prior to dabrafenib treatment initiation (as a single agent or in combination with trametinib). Secondary prophylaxis with antipyretics may be required when resuming dabrafenib following a severe febrile drug reaction.

Melanoma, adjuvant treatment, with BRAF V600E or BRAF V600K mutation

Melanoma, adjuvant treatment, with BRAF V600E or BRAF V600K mutation: Oral:

Capsules: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue for up to 1 year in the absence of disease recurrence or unacceptable toxicity (Ref).

Tablets for oral suspension:

**Recommended Weight-Based Dosing for Dabrafenib Tablets for Oral Suspension**
Body weight	Recommended dabrafenib dosage^a
^a In combination with trametinib; continue for up to 1 year in the absence of disease recurrence or unacceptable toxicity (Ref).
38 to <42 kg	100 mg twice daily, approximately every 12 hours
42 to <46 kg	110 mg twice daily, approximately every 12 hours
46 to <51 kg	130 mg twice daily, approximately every 12 hours
≥51 kg	150 mg twice daily, approximately every 12 hours

Melanoma, unresectable or metastatic

Melanoma, unresectable or metastatic

Melanoma, unresectable or metastatic, with BRAF V600E mutation (as a single agent): Oral:

Capsules: 150 mg twice daily, approximately every 12 hours (as a single agent); continue until disease progression or unacceptable toxicity (Ref).

Tablets for oral suspension:

**Recommended Weight-Based Dosing for Dabrafenib Tablets for Oral Suspension**
Body weight	Recommended dabrafenib dosage^a
^a As a single agent; continue until disease progression or unacceptable toxicity (Ref).
38 to <42 kg	100 mg twice daily, approximately every 12 hours
42 to <46 kg	110 mg twice daily, approximately every 12 hours
46 to <51 kg	130 mg twice daily, approximately every 12 hours
≥51 kg	150 mg twice daily, approximately every 12 hours

Melanoma, unresectable or metastatic, with BRAF V600E or BRAF V600K mutation (combination therapy): Oral:

Capsules: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity (Ref).

Tablets for oral suspension:

**Recommended Weight-Based Dosing for Dabrafenib Tablets for Oral Suspension**
Body weight	Recommended dabrafenib dosage^a
^a In combination with trametinib; continue until disease progression or unacceptable toxicity (Ref).
38 to <42 kg	100 mg twice daily, approximately every 12 hours
42 to <46 kg	110 mg twice daily, approximately every 12 hours
46 to <51 kg	130 mg twice daily, approximately every 12 hours
≥51 kg	150 mg twice daily, approximately every 12 hours

Non–small cell lung cancer, metastatic, with BRAF V600E mutation

Non–small cell lung cancer, metastatic, with BRAF V600E mutation: Oral:

Capsules: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity (Ref).

Tablets for oral suspension:

**Recommended Weight-Based Dosing for Dabrafenib Tablets for Oral Suspension**
Body weight	Recommended dabrafenib dosage^a
^a In combination with trametinib; continue until disease progression or unacceptable toxicity (Ref).
38 to <42 kg	100 mg twice daily, approximately every 12 hours
42 to <46 kg	110 mg twice daily, approximately every 12 hours
46 to <51 kg	130 mg twice daily, approximately every 12 hours
≥51 kg	150 mg twice daily, approximately every 12 hours

Solid tumors, unresectable or metastatic, with BRAF V600E mutation

Solid tumors, unresectable or metastatic, with BRAF V600E mutation: Oral:

Capsules: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity (Ref).

Tablets for oral suspension:

**Recommended Weight-Based Dosing for Dabrafenib Tablets for Oral Suspension**
Body weight	Recommended dabrafenib dosage^a
^a In combination with trametinib; continue until disease progression or unacceptable toxicity (Ref).
38 to <42 kg	100 mg twice daily, approximately every 12 hours
42 to <46 kg	110 mg twice daily, approximately every 12 hours
46 to <51 kg	130 mg twice daily, approximately every 12 hours
≥51 kg	150 mg twice daily, approximately every 12 hours

Thyroid cancer, anaplastic, locally advanced or metastatic, with BRAF V600E mutation

Thyroid cancer, anaplastic, locally advanced or metastatic, with BRAF V600E mutation: Oral:

Capsules: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity (Ref).

Tablets for oral suspension:

**Recommended Weight-Based Dosing for Dabrafenib Tablets for Oral Suspension**
Body weight	Recommended dabrafenib dosage^a
^a In combination with trametinib; continue until disease progression or unacceptable toxicity (Ref).
38 to <42 kg	100 mg twice daily, approximately every 12 hours
42 to <46 kg	110 mg twice daily, approximately every 12 hours
46 to <51 kg	130 mg twice daily, approximately every 12 hours
≥51 kg	150 mg twice daily, approximately every 12 hours

Missed or vomited doses: A missed dose may be administered up to 6 hours prior to the next dose; do not administer if <6 hours until the next dose (do not make up for the missed dose). If a dose is vomited, do not administer an additional dose; administer the next dose at its scheduled time.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

eGFR <15 mL/minute/1.73 m²: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

Mild (bilirubin ≤ ULN and AST > ULN or bilirubin >1 to 1.5 times ULN and any AST) impairment: No dosage adjustment necessary.

Moderate (bilirubin >1.5 to 3 times ULN and any AST) to severe (bilirubin >3 to 10 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling (an appropriate dose has not been established); however, hepatic metabolism and biliary excretion are the primary elimination routes for dabrafenib, and exposure may be increased in patients with moderate to severe impairment.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Dermatologic: Alopecia (22%), hyperkeratosis (37%), palmar-plantar erythrodysesthesia (20%), skin rash (17% to 27%), squamous cell carcinoma of skin (7% to 11%), xeroderma (16%)

Endocrine & metabolic: Hyperglycemia (50% to 57%), hyponatremia (8% to 14%), hypophosphatemia (35% to 37%)

Gastrointestinal: Constipation (10% to 11%)

Hematologic & oncologic: Papilloma (27%)

Hepatic: Increased serum alkaline phosphatase (19% to 25%)

Nervous system: Chills (17%), headache (30% to 32%)

Neuromuscular & skeletal: Arthralgia (27% to 31%), back pain (12%), myalgia (11% to 13%)

Respiratory: Cough (12% to 21%)

Miscellaneous: Fever (28% to 33%)

1% to 10%:

Dermatologic: Basal cell carcinoma of skin (4%), bullous rash (<10%), malignant melanoma (new primary: 1%), skin photosensitivity (<10%)

Gastrointestinal: Pancreatitis (<10%)

Hematologic & oncologic: Keratoacanthoma (4%), malignant neoplasm (≤1%)

Nervous system: Dizziness (7%), peripheral neuropathy (<10%)

Ophthalmic: Uveitis (1%)

Renal: Interstitial nephritis (<10%)

Respiratory: Nasopharyngitis (10%)

Miscellaneous: Febrile reaction (serious: 6%)

Frequency not defined: Nervous system: Fatigue

Postmarketing: Hematologic & oncologic: Kaposi sarcoma (Parakh 2016)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to dabrafenib or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiomyopathy: Cardiomyopathy (a decrease in left ventricular ejection fraction [LVEF] ≥10% from baseline and below the institutional lower limit of normal) has occurred with dabrafenib when used in combination with trametinib. Cardiomyopathy resolved in most patients receiving dabrafenib in combination with trametinib following dose adjustments, treatment interruption, and/or permanent discontinuation.

• Dermatologic toxicity: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), may occur when dabrafenib is administered with trametinib and could be life-threatening or fatal. Other serious skin toxicities have also occurred (rare).

• Febrile reactions: Serious febrile reactions and fever (any severity) complicated by hypotension, rigors or chills, dehydration, or kidney failure were observed with dabrafenib (as a single agent therapy or in combination with trametinib). The incidence and severity of fevers were increased when dabrafenib was used in combination with trametinib. Some patients experienced multiple discrete episodes.

• Hemophagocytic lymphohistiocytosis: Hemophagocytic lymphohistiocytosis, a life-threatening immune system reaction, has been reported when dabrafenib is used in combination with trametinib.

• Hemorrhage: Hemorrhage (including major hemorrhage, defined as symptomatic bleeding in a critical area/organ), may occur with dabrafenib (in combination with trametinib). Serious bleeding events (some fatal) included intracranial, cerebral, brainstem, or GI hemorrhage.

• Hyperglycemia: Hyperglycemia may occur in patients with a history of diabetes while on dabrafenib therapy (either as a single agent or in combination with trametinib).

• Malignancy: Cutaneous squamous cell carcinoma (cuSCC) and keratoacanthoma, basal cell carcinoma (BCC), and new primary melanoma were observed during single-agent dabrafenib therapy. When used in combination with trametinib, cuSCCs (including keratoacanthomas), BCC, and new primary melanoma were reported in small percentages of patients. Noncutaneous malignancies were reported in a small percentage of patients with dabrafenib (as a single agent or in combination with trametinib).

• Ocular toxicity: Uveitis, including iritis and iridocyclitis, has been reported with dabrafenib (as a single agent therapy or in combination with trametinib). Retinal pigment epithelial detachments (RPED) were seen in clinical trials when used in combination with trametinib (a known complication of trametinib as a single agent). Detachments may be bilateral and multifocal, and occurred in the central macular area or elsewhere in the retina.

• QT prolongation: QTcF prolongation >60 msec above baseline or to >500 msec was reported (rare), both as a single agent or when used in combination with trametinib.

Special populations:

• Glucose-6-phosphate dehydrogenase deficiency: Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be at risk for hemolytic anemia when administered dabrafenib (contains a sulfonamide moiety).

• Older adults: In studies evaluating dabrafenib (in combination with trametinib) for the management of melanoma, an increased incidence of peripheral edema and anorexia were observed in patients ≥65 years of age when compared to patients <65 years of age.

Other warnings/precautions:

• Appropriate use: Exposing BRAF wild-type cells to BRAF inhibitors such as dabrafenib may result in paradoxical activation of MAP-kinase signaling and increased cell proliferation. Prior to initiating therapy with dabrafenib (as a single agent or in combination with trametinib), confirm BRAF V600E or BRAF V600K mutation status (in tumor specimens) with an approved test. Information on approved tests for detection of BRAF V600 mutations is available at http://www.fda.gov/CompanionDiagnostics.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Tafinlar: 50 mg, 75 mg

Tablet Soluble, Oral, as mesylate:

Tafinlar: 10 mg

Generic Equivalent Available: US

Pricing: US

Capsules (Tafinlar Oral)

50 mg (per each): $122.08

75 mg (per each): $157.33

Tablet,Dispersible (Tafinlar Oral)

10 mg (per each): $24.42

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Tafinlar: 50 mg, 75 mg

Tablet Soluble, Oral, as mesylate:

Tafinlar: 10 mg

Administration: Pediatric

Oral: Administer at least 1 hour before or 2 hours after a meal; doses should be ~12 hours apart. When administered in combination with trametinib, take the once-daily dose of trametinib at the same time each day with either the morning or evening dose of dabrafenib. If vomiting occurs after dose administration, do not repeat or take an additional dose.

Capsules: Do not open, crush, or break capsules.

Tablets for oral suspension: Do not swallow whole, chew, or crush tablets for oral suspension. Place tablets for dose in the provided cup. The volume of water to add depends on number of tablets: ~5 mL if dose is 1 to 4 tablets; ~10 mL if dose is 5 to 15 tablets. Stir with the handle of a teaspoon until tablets are fully dissolved; may take ≥3 minutes to fully dissolve; the suspension will be cloudy white once dissolved. Administer dissolved dose immediately via the dosing cup, or pull into an oral dosing syringe to administer by mouth or feeding tube. If not used within 30 minutes of preparation, discard dose.

Missed doses: A missed dose may be administered up to 6 hours prior to the next dose; do not administer if <6 hours until the next dose (do not make up for the missed dose).

Administration: Adult

Oral: Administer at least 1 hour before or 2 hours after a meal. Doses should be administered ~12 hours apart at approximately the same time(s) each day.

Capsules: Do not open, crush, or break capsules.

Tablets for oral suspension: Do not swallow whole, chew, or crush tablets for oral suspension. Place tablets for dose in the provided cup. The volume of water to add depends on number of tablets: ~5 mL if dose is 1 to 4 tablets; ~10 mL if dose is 5 to 15 tablets. Gently stir with the handle of a teaspoon until tablets are fully dissolved; may take ≥3 minutes to fully dissolve; the suspension will be cloudy white once dissolved. Administer dissolved dose immediately via the dosing cup, or pull into an oral dosing syringe to administer by mouth or feeding tube (≥10 French gauge for 1 to 3 tablets, ≥12 French gauge for 4 to 15 tablets). Following administration, add ~5 mL of water to the empty dosing cup and stir with the handle of a teaspoon to loosen remaining medication residue. Administer medication residue via the dosing cup, or pull into an oral dosing syringe to administer by mouth or feeding tube. If administered via the dosing cup, perform rinsing and administration of medication residue 1 time (if dose is 1 to 4 tablets) or 2 times (if dose is 5 to 15 tablets). If administered via oral syringe or feeding tube, repeat rinsing and administration of medication residue 3 times. Flush feeding tube with drinking water following dose administration. If oral suspension not used within 30 minutes of preparation, discard dose.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Storage/Stability

Capsules: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store and dispense in the original bottle with the desiccant.

Tablets for oral suspension: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store and dispense in the original bottle with the desiccant. Discard suspension if not administered within 30 minutes after preparation.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Tafinlar: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s036,217514s010lbl.pdf#page=46

Use

Indications including pediatric patients:

Treatment (in combination with trametinib) of low-grade glioma (LGG) with a BRAF V600E mutation in pediatric patients who require systemic therapy (FDA approved in ages ≥1 year); treatment (in combination with trametinib) of unresectable or metastatic solid tumors with a BRAF V600E mutation in patients who have progressed following prior treatment and have no satisfactory alternative treatment options (FDA approved in ages ≥1 year and adults). Note: Approval for solid tumors from an accelerated process and subject to change as data evolves.

Indications approved only in adults:

Adjuvant treatment of melanoma (in combination with trametinib) in patients with BRAF V600E or BRAF V600K mutations (as detected by an approved test) and lymph node(s) involvement, following complete resection; treatment of unresectable or metastatic melanoma as single-agent therapy in patients with a BRAF V600E mutation (as detected by an approved test) or in patients with BRAF V600E or BRAF V600K mutations (as detected by an approved test) in combination with trametinib; treatment of metastatic non-small cell lung cancer (NSCLC) in patients with BRAF V600E mutation (as detected by an approved test) in combination with trametinib; treatment of locally advanced or metastatic anaplastic thyroid cancer (ATC) in combination with trametinib in patients with BRAF V600E mutation (as detected by an approved test) and with no satisfactory locoregional treatment options (All indications: FDA approved in adults).

Medication Safety Issues

Sound-alike/look-alike issues:

Dabrafenib may be confused with cobimetinib, dacomitinib, dasatinib, duvelisib, encorafenib, tovorafenib, trametinib, vemurafenib

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

Substrate of BCRP, CYP2C8 (Major with inhibitors), CYP2C8 (Minor with inducers), CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Induces CYP3A4 (Moderate);

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Abemaciclib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Abemaciclib. Risk X: Avoid

Abiraterone Acetate: CYP3A4 Inducers (Moderate) may decrease serum concentration of Abiraterone Acetate. Risk C: Monitor

Acalabrutinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Acalabrutinib. Risk C: Monitor

ALfentanil: CYP3A4 Inducers (Moderate) may decrease serum concentration of ALfentanil. Management: If concomitant use of alfentanil and moderate CYP3A4 inducers is necessary, consider dosage increase of alfentanil until stable drug effects are achieved. Monitor patients for signs of opioid withdrawal. Risk D: Consider Therapy Modification

Alpelisib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Alpelisib. Risk C: Monitor

ALPRAZolam: CYP3A4 Inducers (Moderate) may decrease serum concentration of ALPRAZolam. Risk C: Monitor

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Amisulpride (Oral): May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk C: Monitor

AmLODIPine: CYP3A4 Inducers (Moderate) may decrease serum concentration of AmLODIPine. Risk C: Monitor

Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Antihepaciviral Combination Products: CYP3A4 Inducers (Moderate) may decrease serum concentration of Antihepaciviral Combination Products. Risk X: Avoid

Apremilast: CYP3A4 Inducers (Moderate) may decrease serum concentration of Apremilast. Risk C: Monitor

Aprepitant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Aprepitant. Risk C: Monitor

ARIPiprazole Lauroxil: CYP3A4 Inducers (Moderate) may decrease serum concentration of ARIPiprazole Lauroxil. Risk C: Monitor

ARIPiprazole: CYP3A4 Inducers (Moderate) may decrease serum concentration of ARIPiprazole. Risk C: Monitor

Artemether and Lumefantrine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Artemether and Lumefantrine. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be decreased. Risk C: Monitor

Atogepant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. Risk D: Consider Therapy Modification

Atorvastatin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Atorvastatin. Risk C: Monitor

Atrasentan: CYP3A4 Inducers (Moderate) may decrease serum concentration of Atrasentan. Risk X: Avoid

Avacopan: CYP3A4 Inducers (Moderate) may decrease serum concentration of Avacopan. Risk X: Avoid

Avanafil: CYP3A4 Inducers (Moderate) may decrease serum concentration of Avanafil. Risk X: Avoid

Avapritinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Avapritinib. Risk X: Avoid

Axitinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Axitinib. Management: Concurrent use of axitinib with a moderate CYP3A4 inducer should be avoided when possible. If any such combination is necessary, monitor for reduced axitinib efficacy. Risk D: Consider Therapy Modification

Bedaquiline: Dabrafenib may increase QTc-prolonging effects of Bedaquiline. Dabrafenib may decrease active metabolite exposure of Bedaquiline. Dabrafenib may decrease serum concentration of Bedaquiline. Risk X: Avoid

Belumosudil: CYP3A4 Inducers (Moderate) may decrease serum concentration of Belumosudil. Risk C: Monitor

Benzhydrocodone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Benzhydrocodone. Specifically, the serum concentrations of hydrocodone may be reduced. Risk C: Monitor

Bortezomib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Bortezomib. Risk C: Monitor

Bosutinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Bosutinib. Risk C: Monitor

Brexpiprazole: CYP3A4 Inducers (Moderate) may decrease serum concentration of Brexpiprazole. Risk C: Monitor

Brigatinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Brigatinib. Management: Avoid concurrent use of brigatinib with moderate CYP3A4 inducers when possible. If combined, increase the daily dose of brigatinib in 30 mg increments after 7 days of treatment with the current brigatinib dose, up to maximum of twice the dose. Risk D: Consider Therapy Modification

Buprenorphine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Buprenorphine. Risk C: Monitor

BusPIRone: CYP3A4 Inducers (Moderate) may decrease serum concentration of BusPIRone. Risk C: Monitor

Cabozantinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Cabozantinib. Management: For cabozantinib tablets (Cabometyx), avoid combined use if possible. If combined, increase cabozantinib by 20 mg from previous dose, max 80 mg daily. For cabozantinib capsules (Cometriq), monitor for reduced cabozantinib efficacy if combined. Risk D: Consider Therapy Modification

Calcifediol: CYP3A4 Inducers (Moderate) may decrease serum concentration of Calcifediol. Risk C: Monitor

Calcitriol (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of Calcitriol (Systemic). Risk C: Monitor

Cannabis: CYP3A4 Inducers (Moderate) may decrease serum concentration of Cannabis. More specifically, tetrahydrocannabinol and cannabidiol serum concentrations may be decreased. Risk C: Monitor

Capivasertib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Capivasertib. Risk X: Avoid

Capmatinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Capmatinib. Risk X: Avoid

CarBAMazepine: Dabrafenib may decrease serum concentration of CarBAMazepine. CarBAMazepine may decrease serum concentration of Dabrafenib. Risk C: Monitor

Cariprazine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Cariprazine. Risk X: Avoid

Clarithromycin: Dabrafenib may increase QTc-prolonging effects of Clarithromycin. Dabrafenib may increase active metabolite exposure of Clarithromycin. Clarithromycin may increase serum concentration of Dabrafenib. Dabrafenib may decrease serum concentration of Clarithromycin. Clarithromycin may increase active metabolite exposure of Dabrafenib. Management: If coadministration is unavoidable, monitor for decreased clarithromycin efficacy, increased dabrafenib adverse effects, and QTc interval prolongation and ventricular arrhythmias when these agents are combined. Risk D: Consider Therapy Modification

Clindamycin (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of Clindamycin (Systemic). Risk C: Monitor

Clofazimine: May increase QTc-prolonging effects of Dabrafenib. Clofazimine may increase serum concentration of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

CloZAPine: Dabrafenib may increase QTc-prolonging effects of CloZAPine. Dabrafenib may decrease serum concentration of CloZAPine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Additionally, monitor for decreased clozapine concentrations and efficacy. Risk C: Monitor

Cobicistat: May increase serum concentration of Dabrafenib. Dabrafenib may decrease serum concentration of Cobicistat. Management: Consider alternatives to the combination of dabrafenib and cobicistat. If such a combination cannot be avoided, monitor closely for evidence of dabrafenib-related adverse effects and reduced cobicistat efficacy. Risk D: Consider Therapy Modification

Cobimetinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Cobimetinib. Risk X: Avoid

Codeine: CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Codeine. Risk C: Monitor

Copanlisib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Copanlisib. Risk C: Monitor

Crinecerfont: CYP3A4 Inducers (Moderate) may decrease serum concentration of Crinecerfont. Management: Double the evening dose of crinecerfont and continue the morning dose unchanged during coadministration with moderate CYP3A4 inducers. See full interaction monograph for details. Risk D: Consider Therapy Modification

Crizotinib: Dabrafenib may increase QTc-prolonging effects of Crizotinib. Dabrafenib may decrease serum concentration of Crizotinib. Crizotinib may increase serum concentration of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Additionally, monitor for decreased crizotinib efficacy and increased dabrafenib adverse effects. Risk C: Monitor

CycloSPORINE (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of CycloSPORINE (Systemic). Risk C: Monitor

CYP2C8 Inhibitors (Moderate): May increase serum concentration of Dabrafenib. Risk C: Monitor

CYP2C8 Inhibitors (Strong): May increase serum concentration of Dabrafenib. Management: Consider alternatives to strong CYP2C8 inhibitors in patients being treated with dabrafenib. If such a combination cannot be avoided, monitor closely for evidence of dabrafenib-related adverse effects. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Dabrafenib. Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of Dabrafenib. Management: Consider alternatives to any strong CYP3A4 inhibitor for patients being treated with dabrafenib. If such a combination cannot be avoided, monitor closely for evidence of dabrafenib-related adverse effects. Risk D: Consider Therapy Modification

Daclatasvir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg once daily if used with a moderate CYP3A4 inducer. Risk D: Consider Therapy Modification

Dapsone (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of Dapsone (Systemic). Risk C: Monitor

Daridorexant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Daridorexant. Risk X: Avoid

Dasabuvir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Dasabuvir. Risk X: Avoid

Dasatinib: CYP3A4 Inducers (Moderate) may increase serum concentration of Dasatinib. Risk C: Monitor

Deflazacort: CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Deflazacort. Risk X: Avoid

DexAMETHasone (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of DexAMETHasone (Systemic). Risk C: Monitor

DiazePAM: CYP3A4 Inducers (Moderate) may decrease serum concentration of DiazePAM. Risk C: Monitor

Dienogest: CYP3A4 Inducers (Moderate) may decrease serum concentration of Dienogest. Risk C: Monitor

DilTIAZem: CYP3A4 Inducers (Moderate) may decrease serum concentration of DilTIAZem. Risk C: Monitor

Disopyramide: Dabrafenib may increase QTc-prolonging effects of Disopyramide. Dabrafenib may decrease serum concentration of Disopyramide. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced disopyramide efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Domperidone: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Domperidone. Risk X: Avoid

Doravirine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Doravirine. Risk C: Monitor

DOXOrubicin (Conventional): CYP3A4 Inducers (Moderate) may decrease serum concentration of DOXOrubicin (Conventional). Risk X: Avoid

DroNABinol: CYP3A4 Inducers (Moderate) may decrease serum concentration of DroNABinol. Risk C: Monitor

Dronedarone: Dabrafenib may increase QTc-prolonging effects of Dronedarone. Dabrafenib may decrease serum concentration of Dronedarone. Dronedarone may increase serum concentration of Dabrafenib. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias. Also monitor for decreased dronedarone and increased dabrafenib concentrations. Risk D: Consider Therapy Modification

Duvelisib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Duvelisib. Management: Avoid if possible. If used, on day 12 of combination increase duvelisib from 25 mg twice daily to 40 mg twice daily or from 15 mg twice daily to 25 mg twice daily. Resume prior duvelisib dose 14 days after stopping moderate CYP3A4 inducer. Risk D: Consider Therapy Modification

Dydrogesterone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Dydrogesterone. Risk C: Monitor

Efavirenz: CYP3A4 Inducers (Moderate) may decrease serum concentration of Efavirenz. Risk C: Monitor

Elacestrant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Elacestrant. Risk X: Avoid

Elbasvir and Grazoprevir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Elbasvir and Grazoprevir. Risk X: Avoid

Elexacaftor, Tezacaftor, and Ivacaftor: CYP3A4 Inducers (Moderate) may decrease serum concentration of Elexacaftor, Tezacaftor, and Ivacaftor. Risk C: Monitor

Eliglustat: CYP3A4 Inducers (Moderate) may decrease serum concentration of Eliglustat. Risk C: Monitor

Encorafenib: Dabrafenib may increase QTc-prolonging effects of Encorafenib. Dabrafenib may decrease serum concentration of Encorafenib. Encorafenib may decrease serum concentration of Dabrafenib. Management: Monitor for QTc interval prolongation, ventricular arrhythmias, and reduced encorafenib and dabrafenib concentrations and efficacy when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Ensartinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ensartinib. Risk X: Avoid

Entrectinib: Dabrafenib may increase QTc-prolonging effects of Entrectinib. Dabrafenib may decrease serum concentration of Entrectinib. Risk X: Avoid

Enzalutamide: CYP3A4 Inducers (Moderate) may decrease serum concentration of Enzalutamide. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Enzalutamide. Risk C: Monitor

Erdafitinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Erdafitinib. Management: If a moderate CYP3A4 inducer must be used at the start of erdafitinib, administer erdafitinib at a dose of 9 mg daily. If a moderate CYP3A4 inducer is discontinued, continue erdafitinib at the same dose unless there is evidence of drug toxicity. Risk D: Consider Therapy Modification

Erlotinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Erlotinib. Management: Avoid the combination of erlotinib and strong CYP3A4 inducers whenever possible. If this combination must be used, increase erlotinib dose by 50 mg increments every 2 weeks as tolerated, to a maximum of 450 mg/day. Risk D: Consider Therapy Modification

Estrogen Derivatives: CYP3A4 Inducers (Moderate) may decrease serum concentration of Estrogen Derivatives. Risk C: Monitor

Etoposide Phosphate: CYP3A4 Inducers (Moderate) may decrease serum concentration of Etoposide Phosphate. Risk C: Monitor

Etoposide: CYP3A4 Inducers (Moderate) may decrease serum concentration of Etoposide. Risk C: Monitor

Etravirine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Etravirine. Risk C: Monitor

Everolimus: CYP3A4 Inducers (Moderate) may decrease serum concentration of Everolimus. Risk C: Monitor

Exemestane: CYP3A4 Inducers (Moderate) may decrease serum concentration of Exemestane. Risk C: Monitor

Fedratinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Fedratinib. Risk X: Avoid

Felodipine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Felodipine. Risk C: Monitor

FentaNYL: CYP3A4 Inducers (Moderate) may decrease serum concentration of FentaNYL. Risk C: Monitor

Fexinidazole: May increase QTc-prolonging effects of Dabrafenib. Dabrafenib may decrease serum concentration of Fexinidazole. Risk X: Avoid

Finerenone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Finerenone. Risk X: Avoid

Flibanserin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Flibanserin. Risk X: Avoid

Fluorouracil Products: May increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Fosamprenavir: CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Fosamprenavir. Risk C: Monitor

Fosaprepitant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Fosaprepitant. Specifically, CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite aprepitant. Risk C: Monitor

Fosnetupitant: CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Fosnetupitant. Risk C: Monitor

Fostamatinib: CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Fostamatinib. Risk C: Monitor

Fruquintinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Fruquintinib. Management: Avoid this combination when possible. If combined, continue the same fruquintinib dose, but monitor for reduced fruquintinib efficacy. Risk D: Consider Therapy Modification

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Ganaxolone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ganaxolone. Management: Avoid concomitant use of ganaxolone and moderate CYP3A4 inducers whenever possible. If combined, consider increasing the dose of ganaxolone, but do not exceed the maximum recommended daily dose. Risk D: Consider Therapy Modification

Gefitinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Gefitinib. Risk C: Monitor

Gemigliptin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Gemigliptin. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Gemigliptin. Risk C: Monitor

Gepirone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Gepirone. Risk C: Monitor

Gepotidacin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Gepotidacin. Risk C: Monitor

Glasdegib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Glasdegib. Management: Avoid use of glasdegib and moderate CYP3A4 inducers whenever possible. If combined, increase glasdegib dose from 100 mg daily to 200 mg daily or from 50 mg daily to 100 mg daily. Resume previous glasdegib dose 7 days after discontinuation of the inducer. Risk D: Consider Therapy Modification

Glecaprevir and Pibrentasvir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Glecaprevir and Pibrentasvir. Risk C: Monitor

Grapefruit Juice: May increase serum concentration of Dabrafenib. Risk C: Monitor

GuanFACINE: CYP3A4 Inducers (Moderate) may decrease serum concentration of GuanFACINE. Management: Increase extended-release guanfacine dose by up to double when initiating guanfacine in patients taking CYP3A4 inducers or if initiating a CYP3A4 inducer in a patient already taking extended-release guanfacine. Monitor for reduced guanfacine efficacy. Risk D: Consider Therapy Modification

Haloperidol: May increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Hormonal Contraceptives: CYP3A4 Inducers (Moderate) may decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a moderate CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider Therapy Modification

HYDROcodone: CYP3A4 Inducers (Moderate) may decrease serum concentration of HYDROcodone. Risk C: Monitor

Hydrocortisone (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of Hydrocortisone (Systemic). Risk C: Monitor

Ibrexafungerp: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ibrexafungerp. Risk X: Avoid

Ibrutinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ibrutinib. Risk C: Monitor

Ifosfamide: CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Ifosfamide. CYP3A4 Inducers (Moderate) may increase active metabolite exposure of Ifosfamide. Risk C: Monitor

Imatinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Imatinib. Risk C: Monitor

Indinavir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Indinavir. Management: Consider avoiding the combination of indinavir and moderate CYP3A4 inducers whenever possible due to the risk for decreased indinavir concentrations, reduced efficacy, and development of resistance. If combined, monitor for indinavir treatment failure. Risk D: Consider Therapy Modification

Irinotecan Products: CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Irinotecan Products. Specifically, concentrations of SN-38 may be reduced. Risk C: Monitor

Isavuconazonium Sulfate: CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Isavuconazonium Sulfate. Specifically, CYP3A4 Inducers (Moderate) may decrease isavuconazole serum concentrations. Risk C: Monitor

Isradipine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Isradipine. Risk C: Monitor

Istradefylline: CYP3A4 Inducers (Moderate) may decrease serum concentration of Istradefylline. Risk C: Monitor

Ivabradine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ivabradine. Risk X: Avoid

Ivacaftor: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ivacaftor. Risk C: Monitor

Ixabepilone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ixabepilone. Risk C: Monitor

Ixazomib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ixazomib. Risk C: Monitor

Ketamine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ketamine. Risk C: Monitor

Lapatinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lapatinib. Risk C: Monitor

Larotrectinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Larotrectinib. Management: Double the larotrectinib dose if used together with a moderate CYP3A4 inducer. Following discontinuation of the moderate CYP3A4 inducer, resume the previous dose of larotrectinib after a period of 3 to 5 times the inducer's half-life. Risk D: Consider Therapy Modification

Lazertinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lazertinib. Risk X: Avoid

Lefamulin (Intravenous): CYP3A4 Inducers (Moderate) may decrease serum concentration of Lefamulin (Intravenous). Management: Avoid concomitant use of lefamulin (intravenous) with moderate CYP3A4 inducers unless the benefits outweigh the risks. Risk D: Consider Therapy Modification

Lefamulin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lefamulin. Management: Avoid concomitant use of lefamulin with moderate CYP3A4 inducers unless the benefits outweigh the risks. Risk D: Consider Therapy Modification

Lemborexant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lemborexant. Risk X: Avoid

Lenacapavir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lenacapavir. Risk X: Avoid

Leniolisib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Leniolisib. Risk X: Avoid

Lercanidipine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lercanidipine. Risk C: Monitor

Levamlodipine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Levamlodipine. Risk C: Monitor

Levoketoconazole: Dabrafenib may increase QTc-prolonging effects of Levoketoconazole. Levoketoconazole may increase serum concentration of Dabrafenib. Risk X: Avoid

Levomethadone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Levomethadone. Risk C: Monitor

LinaGLIPtin: CYP3A4 Inducers (Moderate) may decrease serum concentration of LinaGLIPtin. Risk C: Monitor

Lonafarnib: May increase QTc-prolonging effects of Dabrafenib. Dabrafenib may decrease serum concentration of Lonafarnib. Risk X: Avoid

Lorlatinib: CYP3A4 Inducers (Moderate) may increase hepatotoxic effects of Lorlatinib. CYP3A4 Inducers (Moderate) may decrease serum concentration of Lorlatinib. Management: Avoid use of lorlatinib with moderate CYP3A4 inducers. If such a combination must be used, increase lorlatinib to 125 mg daily. Monitor for reduced lorlatinib efficacy and consider closer monitoring of AST, ALT, and bilirubin. Risk D: Consider Therapy Modification

Lovastatin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lovastatin. Risk C: Monitor

Lumacaftor and Ivacaftor: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lumacaftor and Ivacaftor. Risk C: Monitor

Lumacaftor and Ivacaftor: May decrease serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor

Lumateperone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lumateperone. Risk X: Avoid

Lurasidone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Lurasidone. Management: After chronic treatment (7 days or more) with a moderate CYP3A4 inducer, lurasidone dose increases may be needed. Monitor closely for decreased lurasidone effects and increase the lurasidone dose as needed. Risk D: Consider Therapy Modification

Macitentan: CYP3A4 Inducers (Moderate) may decrease serum concentration of Macitentan. Risk C: Monitor

Maraviroc: CYP3A4 Inducers (Moderate) may decrease serum concentration of Maraviroc. Management: Increase maraviroc adult dose to 600 mg twice/day, but only if not receiving a strong CYP3A4 inhibitor. Not recommended for pediatric patients not also receiving a strong CYP3A4 inhibitor. Contraindicated in patients with CrCl less than 30 mL/min. Risk D: Consider Therapy Modification

Maribavir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Maribavir. Risk C: Monitor

Mavacamten: CYP3A4 Inducers (Moderate) may decrease serum concentration of Mavacamten. Risk X: Avoid

Mavorixafor: CYP3A4 Inducers (Moderate) may decrease serum concentration of Mavorixafor. Risk C: Monitor

Mefloquine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Mefloquine. Risk C: Monitor

Meperidine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Meperidine. CYP3A4 Inducers (Moderate) may increase active metabolite exposure of Meperidine. Specifically, concentrations of normeperidine, the CNS stimulating metabolite, may be increased. Risk C: Monitor

Methadone: Dabrafenib may increase QTc-prolonging effects of Methadone. Dabrafenib may decrease serum concentration of Methadone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced methadone efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

MethylPREDNISolone: CYP3A4 Inducers (Moderate) may decrease serum concentration of MethylPREDNISolone. Risk C: Monitor

Mianserin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Mianserin. Risk C: Monitor

Midazolam: CYP3A4 Inducers (Moderate) may decrease serum concentration of Midazolam. Risk C: Monitor

Midostaurin: May increase QTc-prolonging effects of Dabrafenib. Dabrafenib may decrease serum concentration of Midostaurin. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Also monitor for decreased midostaurin efficacy. Risk C: Monitor

MiFEPRIStone: CYP3A4 Inducers (Moderate) may decrease serum concentration of MiFEPRIStone. Management: Avoid combined use in patients treated for Cushing's disease. When used for pregnancy termination, mifepristone efficacy may be reduced and an alternative pregnancy termination procedure may be warranted. Ensure a follow-up assessment after combined use. Risk D: Consider Therapy Modification

Mirodenafil: CYP3A4 Inducers (Moderate) may decrease serum concentration of Mirodenafil. Risk C: Monitor

Mitapivat: CYP3A4 Inducers (Moderate) may decrease serum concentration of Mitapivat. Management: Consider alternatives to this combination when possible. If combined, monitor hemoglobin and titrate mitapivat beyond 50 mg twice daily, if needed, but do not exceed doses of 100 mg twice daily. Risk D: Consider Therapy Modification

Mobocertinib: Dabrafenib may increase QTc-prolonging effects of Mobocertinib. Dabrafenib may decrease active metabolite exposure of Mobocertinib. Dabrafenib may decrease serum concentration of Mobocertinib. Risk X: Avoid

Montelukast: CYP3A4 Inducers (Moderate) may decrease serum concentration of Montelukast. Risk C: Monitor

Naldemedine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Naldemedine. Risk C: Monitor

Naloxegol: CYP3A4 Inducers (Moderate) may decrease serum concentration of Naloxegol. Risk C: Monitor

Neratinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Neratinib. Risk X: Avoid

Netupitant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Netupitant. Risk C: Monitor

Nevirapine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Nevirapine. Risk C: Monitor

NIFEdipine: CYP3A4 Inducers (Moderate) may decrease serum concentration of NIFEdipine. Risk C: Monitor

Nilotinib: Dabrafenib may increase QTc-prolonging effects of Nilotinib. Nilotinib may increase serum concentration of Dabrafenib. Dabrafenib may decrease serum concentration of Nilotinib. Nilotinib may increase active metabolite exposure of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Also monitor for decreased nilotinib efficacy and increased dabrafenib adverse effects. Risk C: Monitor

Nilvadipine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Nilvadipine. Risk C: Monitor

NiMODipine: CYP3A4 Inducers (Moderate) may decrease serum concentration of NiMODipine. Risk C: Monitor

Nirogacestat: CYP3A4 Inducers (Moderate) may decrease serum concentration of Nirogacestat. Risk X: Avoid

Nisoldipine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Nisoldipine. Risk X: Avoid

Olaparib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Olaparib. Risk X: Avoid

Oliceridine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Oliceridine. Risk C: Monitor

Olmutinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Olmutinib. Risk C: Monitor

Olutasidenib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Olutasidenib. Risk X: Avoid

Omaveloxolone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Omaveloxolone. Risk X: Avoid

Ondansetron: May increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Osimertinib: May increase QTc-prolonging effects of Dabrafenib. Dabrafenib may decrease serum concentration of Osimertinib. Management: Monitor for decreased osimertinib efficacy, QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Risk C: Monitor

OxyCODONE: CYP3A4 Inducers (Moderate) may decrease serum concentration of OxyCODONE. Risk C: Monitor

PACLitaxel (Conventional): CYP3A4 Inducers (Moderate) may decrease serum concentration of PACLitaxel (Conventional). Risk C: Monitor

PACLitaxel (Protein Bound): CYP3A4 Inducers (Moderate) may decrease serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor

Pacritinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Pacritinib. Risk C: Monitor

Palbociclib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Palbociclib. Risk C: Monitor

Paliperidone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Paliperidone. Risk C: Monitor

Palovarotene: CYP3A4 Inducers (Moderate) may decrease serum concentration of Palovarotene. Risk X: Avoid

PAZOPanib: Dabrafenib may increase QTc-prolonging effects of PAZOPanib. Dabrafenib may decrease serum concentration of PAZOPanib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced pazopanib efficacy. Risk C: Monitor

Pemigatinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Pemigatinib. Risk X: Avoid

Pentamidine (Systemic): May increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Perampanel: CYP3A4 Inducers (Moderate) may decrease serum concentration of Perampanel. Management: Increase perampanel starting dose to 4 mg/day if used with moderate CYP3A4 inducers. Increase perampanel dose by 2 mg/day no more than once weekly based on response and tolerability. Dose adjustments may be needed if the inducer is discontinued. Risk D: Consider Therapy Modification

Pimavanserin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Pimavanserin. Risk X: Avoid

Pimozide: May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk X: Avoid

Piperaquine: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid

Pirtobrutinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Pirtobrutinib. Management: Avoid concomitant use if possible. If combined, if the current pirtobrutinib dose is 200 mg once daily, increase to 300 mg once daily. If current pirtobrutinib dose is 50 mg or 100 mg once daily, increase the dose by 50 mg. Risk D: Consider Therapy Modification

PONATinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of PONATinib. Risk C: Monitor

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Pralsetinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Pralsetinib. Management: If this combo cannot be avoided, increase pralsetinib dose from 400 mg daily to 600 mg daily; from 300 mg daily to 500 mg daily; and from 200 mg daily to 300 mg daily. Risk D: Consider Therapy Modification

Praziquantel: CYP3A4 Inducers (Moderate) may decrease serum concentration of Praziquantel. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for reduced praziquantel efficacy. If possible, stop the moderate CYP3A4 inducer 2 to 4 weeks before praziquantel initiation. Risk D: Consider Therapy Modification

PrednisoLONE (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of PrednisoLONE (Systemic). Risk C: Monitor

PredniSONE: CYP3A4 Inducers (Moderate) may decrease serum concentration of PredniSONE. Risk C: Monitor

Pretomanid: CYP3A4 Inducers (Moderate) may decrease serum concentration of Pretomanid. Risk X: Avoid

QT-prolonging Agents (Highest Risk): Dabrafenib may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Antidepressants (Moderate Risk): Dabrafenib may increase QTc-prolonging effects of QT-prolonging Antidepressants (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): Dabrafenib may increase QTc-prolonging effects of QT-prolonging Class IC Antiarrhythmics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Kinase Inhibitors (Moderate Risk): May increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Miscellaneous Agents (Moderate Risk): May increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of Dabrafenib. QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of Dabrafenib. Management: Monitor for QTc interval prolongation, ventricular arrhythmias, and dabrafenib adverse effects when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Quinolone Antibiotics (Moderate Risk): May increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): Dabrafenib may increase QTc-prolonging effects of QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk). QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk) may increase serum concentration of Dabrafenib. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of Dabrafenib. QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of Dabrafenib. Management: Consider alternatives to these QT-prolonging strong CYP3A4 inhibitors for patients being treated with dabrafenib. If such a combination cannot be avoided, monitor closely for dabrafenib-related adverse effects, including QTc interval prolongation. Risk D: Consider Therapy Modification

QUEtiapine: Dabrafenib may increase QTc-prolonging effects of QUEtiapine. Dabrafenib may decrease serum concentration of QUEtiapine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced quetiapine efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QuiNIDine: Dabrafenib may increase QTc-prolonging effects of QuiNIDine. Dabrafenib may decrease serum concentration of QuiNIDine. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced quinidine efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QuiNINE: Dabrafenib may increase QTc-prolonging effects of QuiNINE. Dabrafenib may decrease serum concentration of QuiNINE. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced quinine efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Quizartinib: May increase QTc-prolonging effects of Dabrafenib. Dabrafenib may decrease serum concentration of Quizartinib. Risk X: Avoid

Ranolazine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ranolazine. Risk X: Avoid

Regorafenib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Regorafenib. CYP3A4 Inducers (Moderate) may increase active metabolite exposure of Regorafenib. Risk C: Monitor

Repaglinide: CYP3A4 Inducers (Moderate) may decrease serum concentration of Repaglinide. Risk C: Monitor

Repotrectinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Repotrectinib. Risk X: Avoid

Revumenib: Dabrafenib may increase QTc-prolonging effects of Revumenib. Dabrafenib may decrease serum concentration of Revumenib. Dabrafenib may also increase concentrations of the M1 metabolite, which may contribute to the QT-prolonging effect of Revumenib. Risk X: Avoid

Ribociclib: Dabrafenib may increase QTc-prolonging effects of Ribociclib. Ribociclib may increase serum concentration of Dabrafenib. Dabrafenib may decrease serum concentration of Ribociclib. Ribociclib may increase active metabolite exposure of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Also monitor for decreased ribociclib efficacy and increased dabrafenib adverse effects. Risk C: Monitor

Rilpivirine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Rilpivirine. Risk C: Monitor

Rimegepant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Rimegepant. Risk X: Avoid

Ripretinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ripretinib. Management: Avoid this combination if possible. If concomitant use is required, increase ripretinib to 150 mg twice daily. Decrease ripretinib to 150 mg once daily 14 days after stopping a moderate CYP3A4 inducer. Monitor patients for ripretinib response and toxicity Risk D: Consider Therapy Modification

RisperiDONE: Dabrafenib may increase QTc-prolonging effects of RisperiDONE. Dabrafenib may decrease serum concentration of RisperiDONE. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced risperidone efficacy. Risk C: Monitor

Ritlecitinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ritlecitinib. Risk C: Monitor

Roflumilast (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of Roflumilast (Systemic). CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Roflumilast (Systemic). Risk C: Monitor

Rolapitant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Rolapitant. Risk C: Monitor

Samidorphan: CYP3A4 Inducers (Moderate) may decrease serum concentration of Samidorphan. Risk C: Monitor

Selpercatinib: Dabrafenib may increase QTc-prolonging effects of Selpercatinib. Dabrafenib may decrease serum concentration of Selpercatinib. Risk X: Avoid

Selumetinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Selumetinib. Risk X: Avoid

Sertindole: May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk X: Avoid

Sertraline: CYP3A4 Inducers (Moderate) may decrease serum concentration of Sertraline. Risk C: Monitor

Sildenafil: CYP3A4 Inducers (Moderate) may decrease serum concentration of Sildenafil. Risk C: Monitor

Simeprevir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Simeprevir. Risk X: Avoid

Simvastatin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Simvastatin. Risk C: Monitor

Sirolimus (Conventional): CYP3A4 Inducers (Moderate) may decrease serum concentration of Sirolimus (Conventional). Risk C: Monitor

Sirolimus (Protein Bound): CYP3A4 Inducers (Moderate) may decrease serum concentration of Sirolimus (Protein Bound). Risk C: Monitor

Sonidegib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Sonidegib. Risk X: Avoid

SORAfenib: CYP3A4 Inducers (Moderate) may decrease serum concentration of SORAfenib. Risk C: Monitor

Sotorasib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Sotorasib. Risk C: Monitor

Sparsentan: CYP3A4 Inducers (Moderate) may decrease serum concentration of Sparsentan. Risk C: Monitor

SUFentanil: CYP3A4 Inducers (Moderate) may decrease serum concentration of SUFentanil. Risk C: Monitor

SUNItinib: Dabrafenib may increase QTc-prolonging effects of SUNItinib. Dabrafenib may decrease serum concentration of SUNItinib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced sunitinib efficacy. Risk C: Monitor

Suvorexant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Suvorexant. Risk C: Monitor

Suzetrigine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Suzetrigine. Risk X: Avoid

Tacrolimus (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of Tacrolimus (Systemic). Risk C: Monitor

Tadalafil: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tadalafil. Risk C: Monitor

Tamoxifen: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tamoxifen. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Tamoxifen. Risk C: Monitor

Tasimelteon: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tasimelteon. Risk C: Monitor

Tazemetostat: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tazemetostat. Risk X: Avoid

Temsirolimus: CYP3A4 Inducers (Moderate) may decrease serum concentration of Temsirolimus. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Temsirolimus. Specifically, sirolimus concentrations may be decreased. Risk C: Monitor

Teniposide: CYP3A4 Inducers (Moderate) may decrease serum concentration of Teniposide. Risk C: Monitor

Tetrahydrocannabinol and Cannabidiol: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tetrahydrocannabinol and Cannabidiol. Risk C: Monitor

Tetrahydrocannabinol: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tetrahydrocannabinol. Risk C: Monitor

Tezacaftor and Ivacaftor: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tezacaftor and Ivacaftor. Risk C: Monitor

Thioridazine: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid

Thiotepa: CYP3A4 Inducers (Moderate) may increase active metabolite exposure of Thiotepa. CYP3A4 Inducers (Moderate) may decrease serum concentration of Thiotepa. Risk C: Monitor

Ticagrelor: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ticagrelor. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Ticagrelor. Risk C: Monitor

Tivozanib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tivozanib. Risk C: Monitor

Tofacitinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tofacitinib. Risk C: Monitor

Tolvaptan: CYP3A4 Inducers (Moderate) may decrease serum concentration of Tolvaptan. Risk C: Monitor

Toremifene: May increase QTc-prolonging effects of Dabrafenib. Dabrafenib may decrease serum concentration of Toremifene. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced toremifene efficacy. Risk C: Monitor

Trabectedin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Trabectedin. Risk C: Monitor

TraMADol: CYP3A4 Inducers (Moderate) may decrease serum concentration of TraMADol. Risk C: Monitor

Trametinib: May increase adverse/toxic effects of Dabrafenib. Trametinib may increase serum concentration of Dabrafenib. Risk C: Monitor

TraZODone: CYP3A4 Inducers (Moderate) may decrease serum concentration of TraZODone. Risk C: Monitor

Tretinoin (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentration of Tretinoin (Systemic). Risk C: Monitor

Triazolam: CYP3A4 Inducers (Moderate) may decrease serum concentration of Triazolam. Risk C: Monitor

Ubrogepant: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a moderate CYP3A4 inducer. Risk D: Consider Therapy Modification

Ulipristal: CYP3A4 Inducers (Moderate) may decrease serum concentration of Ulipristal. Risk X: Avoid

Upadacitinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Upadacitinib. Risk C: Monitor

Valbenazine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Valbenazine. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Valbenazine. Risk C: Monitor

Vandetanib: Dabrafenib may increase QTc-prolonging effects of Vandetanib. Dabrafenib may decrease serum concentration of Vandetanib. Dabrafenib may increase active metabolite exposure of Vandetanib. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and changes in vandetanib efficacy or toxicity. Risk D: Consider Therapy Modification

Vanzacaftor, Tezacaftor, and Deutivacaftor: CYP3A4 Inducers (Moderate) may decrease serum concentration of Vanzacaftor, Tezacaftor, and Deutivacaftor. Risk X: Avoid

Velpatasvir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Velpatasvir. Risk X: Avoid

Vemurafenib: Dabrafenib may increase QTc-prolonging effects of Vemurafenib. Dabrafenib may decrease serum concentration of Vemurafenib. Management: Monitor for decreased vemurafenib efficacy, QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Risk C: Monitor

Venetoclax: CYP3A4 Inducers (Moderate) may decrease serum concentration of Venetoclax. Risk X: Avoid

Verapamil: CYP3A4 Inducers (Moderate) may decrease serum concentration of Verapamil. Risk C: Monitor

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vilazodone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Vilazodone. Risk C: Monitor

VinCRIStine: CYP3A4 Inducers (Moderate) may decrease serum concentration of VinCRIStine. Risk C: Monitor

Vitamin K Antagonists: CYP2C9 Inducers (Weak) may decrease serum concentration of Vitamin K Antagonists. Risk C: Monitor

Voclosporin: CYP3A4 Inducers (Moderate) may decrease serum concentration of Voclosporin. Risk X: Avoid

Vonoprazan: CYP3A4 Inducers (Moderate) may decrease serum concentration of Vonoprazan. Risk X: Avoid

Vorapaxar: CYP3A4 Inducers (Moderate) may decrease serum concentration of Vorapaxar. Risk X: Avoid

Vortioxetine: CYP3A4 Inducers (Moderate) may decrease serum concentration of Vortioxetine. Risk C: Monitor

Voxelotor: CYP3A4 Inducers (Moderate) may decrease serum concentration of Voxelotor. Management: Avoid concomitant use of voxelotor and moderate CYP3A4 inducers. If unavoidable, increase the voxelotor dose to 2,000 mg once daily. For children ages 4 to less than 12 years, weight-based dose adjustments are required. See full monograph for details. Risk D: Consider Therapy Modification

Voxilaprevir: CYP3A4 Inducers (Moderate) may decrease serum concentration of Voxilaprevir. Risk X: Avoid

Zaleplon: CYP3A4 Inducers (Moderate) may decrease serum concentration of Zaleplon. Risk C: Monitor

Zanubrutinib: CYP3A4 Inducers (Moderate) may decrease serum concentration of Zanubrutinib. Management: Avoid this combination if possible. If coadministration of zanubrutinib and a moderate CYP3A4 inducer is required, increase the zanubrutinib dose to 320 mg twice daily. Risk D: Consider Therapy Modification

Zolpidem: CYP3A4 Inducers (Moderate) may decrease serum concentration of Zolpidem. Risk C: Monitor

Zopiclone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Zopiclone. Risk C: Monitor

Zuranolone: CYP3A4 Inducers (Moderate) may decrease serum concentration of Zuranolone. Risk X: Avoid

Food Interactions

Administration of capsules with a high-fat meal (~1,000 calories; 58 to 75 grams of fat, 58 g of carbohydrates, 33 g of protein) decreased C_maxand AUC by 51% and 31%, respectively, and delayed median T_maxby 3.6 hours (compared to a fasted state). Management: Administer 1 hour before or 2 hours after a meal.

Reproductive Considerations

Verify pregnancy status prior to treatment initiation in patients who could become pregnant. Dabrafenib may cause hormonal contraceptives to be ineffective. Patients who could become pregnant should use a highly effective nonhormonal contraceptive during dabrafenib therapy and for 2 weeks after the last dabrafenib dose. Males (including those with vasectomies) with pregnant partners or partners who could become pregnant should use condoms during dabrafenib treatment and for 2 weeks after the last dabrafenib dose.

Pregnancy Considerations

Based on its mechanism of action and on findings in animal reproduction studies, in utero exposure to dabrafenib may cause fetal harm.

Monitoring Parameters

BRAF V600K or V600E mutation status (prior to treatment); serum glucose at baseline and as clinically necessary (particularly in patients with preexisting diabetes mellitus or hyperglycemia); electrolytes; renal function. Verify pregnancy status prior to treatment initiation (in patients who could become pregnant). Perform dermatologic evaluations prior to initiation, every 2 months during therapy, and for up to 6 months following discontinuation to assess for new cutaneous malignancies. Monitor for febrile drug reactions and signs/symptoms of infections; monitor serum creatinine and other evidence of renal function during and after serious fever. Monitor for signs/symptoms of uveitis (eg, eye pain, photophobia, vision changes). Monitor for signs/symptoms of hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, new or worsening dermatologic toxicity (including severe cutaneous adverse reactions), and for noncutaneous malignancies.

For patients receiving combination therapy with trametinib: Hepatic function; CBC (baseline and periodically during therapy); assess left ventricular ejection fraction (by echocardiogram or multigated acquisition [MUGA] scan) at baseline, 1 month after therapy initiation, and then at 2- to 3-month intervals. Monitor for signs/symptoms of hemorrhage, venous thromboembolism, and interstitial lung disease. Monitor for signs/symptoms of retinal pigment epithelial detachment or retinal vein occlusion; promptly (within 24 hours) refer patients for ophthalmological evaluations if loss of vision or other visual disturbances occur; ophthalmic exams (including retinal evaluation) should be performed periodically during treatment with combination therapy.

Monitor adherence.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Dabrafenib selectively inhibits some mutated forms of the protein kinase B-raf (BRAF). BRAF V600 mutations result in constitutive activation of the BRAF pathway; through BRAF inhibition, dabrafenib inhibits tumor cell growth. The combination of dabrafenib and trametinib allows for greater inhibition of the MAPK pathway, resulting in BRAF V600 melanoma cell death (Flaherty 2012). Dabrafenib plus trametinib has been reported to synergistically inhibit cell growth in lung cancer cell lines which are BRAF V600E-mutant (Planchard 2016). Induction of EGFR-mediated MAPK pathway reactivation in the setting of BRAF-mutant colorectal cancer has been identified as a mechanism of intrinsic resistance to BRAF inhibitors.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Decreased when capsules are administered with a high-fat meal (~1,000 calories; 58 to 75 grams of fat, 58 grams carbohydrates, and 33 grams protein).

Distribution: 70.3 L.

Protein binding: 99.7% to plasma proteins.

Metabolism: Hepatic via CYP2C8 and CYP3A4 to hydroxy-dabrafenib (active) which is further metabolized via CYP3A4 oxidation to carboxy-dabrafenib. Carboxy-dabrafenib is decarboxylated to form desmethyl-dabrafenib (active). Desmethyl-dabrafenib is further metabolized via CYP3A4 to oxidative metabolites.

Bioavailability: Capsules: 95%; Tablets for oral suspension: 76%.

Half-life elimination: Parent drug: 8 hours; Hydroxy-dabrafenib (active metabolite): 10 hours; Desmethyl-dabrafenib (active metabolite): 21 to 22 hours; Carboxy-dabrafenib (21 to 22 hours).

Time to peak: Median: 2 hours; delayed by 3.6 hours with a high-fat meal (~1,000 calories; 58 to 75 grams of fat, 58 grams carbohydrates, and 33 grams protein).

Excretion: Feces (71%); urine (23%; metabolites only).

Clearance: 17 L/hour (single dose); 34.4 L/hour (after 2 weeks of twice-daily dosing).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Patients with moderate (bilirubin >1.5 to 3 times ULN and any AST) or severe (bilirubin >3 to 10 times ULN and any AST) hepatic impairment may have increased dabrafenib exposure.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Tafinlar;
(AR) Argentina: Tafinlar;
(AT) Austria: Tafinlar;
(BE) Belgium: Tafinlar;
(BG) Bulgaria: Tafinlar;
(BR) Brazil: Tafinlar;
(CH) Switzerland: Tafinlar;
(CL) Chile: Tafinlar;
(CO) Colombia: Tafinlar;
(CZ) Czech Republic: Tafinlar;
(DE) Germany: Tafinlar;
(EC) Ecuador: Tafinlar;
(EE) Estonia: Tafinlar;
(EG) Egypt: Tafinlar;
(ES) Spain: Tafinlar;
(FI) Finland: Tafinlar;
(FR) France: Tafinlar;
(GB) United Kingdom: Tafinlar;
(GR) Greece: Tafinlar;
(HK) Hong Kong: Tafinlar;
(HR) Croatia: Tafinlar;
(HU) Hungary: Tafinlar;
(IE) Ireland: Finlee | Tafinlar;
(IN) India: Rafinlar;
(IT) Italy: Tafinlar;
(JO) Jordan: Tafinlar;
(JP) Japan: Tafinlar;
(KR) Korea, Republic of: Rafinlar;
(LT) Lithuania: Tafinlar;
(LV) Latvia: Tafinlar;
(MX) Mexico: Tafinlar;
(NL) Netherlands: Tafinlar;
(NO) Norway: Tafinlar;
(NZ) New Zealand: Tafinlar;
(PH) Philippines: Tafinlar;
(PL) Poland: Tafinlar;
(PT) Portugal: Tafinlar;
(QA) Qatar: Tafinlar;
(RO) Romania: Tafinlar;
(RU) Russian Federation: Rafinlar | Tafinlar;
(SE) Sweden: Tafinlar;
(SG) Singapore: Tafinlar;
(SI) Slovenia: Tafinlar;
(SK) Slovakia: Tafinlar;
(SR) Suriname: Tafinlar;
(TH) Thailand: Tafinlar;
(TN) Tunisia: Tafinlar;
(TR) Turkey: Tafinlar;
(TW) Taiwan: Tafinlar;
(UA) Ukraine: Tafinlar;
(UY) Uruguay: Tafinlar;
(ZA) South Africa: Tafinlar

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Mekinist (trametinib) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; May 2023.
Ovesen JL, Sammons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
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Refer to manufacturer's labeling.
Robert C, Grob JJ, Stroyakovskiy D, et al. Five-year outcomes with dabrafenib plus trametinib in metastatic melanoma. N Engl J Med. 2019;381(7):626-636. doi:10.1056/NEJMoa1904059 [PubMed 31166680]
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Tafinlar (dabrafenib) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2025.
Tafinlar (dabrafenib) [product monograph]. Montreal, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; January 2024.
Tafinlar (dabrafenib) [product monograph]. Montreal, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; May 2024.
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Topic 139458 Version 108.0

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Dabrafenib: Pediatric drug information