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Isavuconazole (isavuconazonium sulfate): Drug information

Isavuconazole (isavuconazonium sulfate): Drug information
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Brand Names: US
  • Cresemba
Brand Names: Canada
  • Cresemba
Pharmacologic Category
  • Antifungal Agent, Azole Derivative;
  • Antifungal Agent, Oral;
  • Antifungal Agent, Parenteral
Dosing: Adult

Note: Dosage expressed as milligrams of isavuconazonium sulfate; switching between the IV and oral formulations of isavuconazonium sulfate is acceptable; for maintenance dosing, it is not necessary to restart dosing with the initial dose regimen when switching between formulations.

Aspergillosis, invasive

Aspergillosis, invasive:

IV, Oral: Initial: 372 mg (isavuconazole 200 mg) every 8 hours for 6 doses; Maintenance: 372 mg (isavuconazole 200 mg) once daily (Ref). Start maintenance dose 12 to 24 hours after the last loading dose.

Duration of therapy: Minimum of 6 to 12 weeks, although duration is highly dependent on degree/duration of immunosuppression, disease site, and evidence of disease improvement (Ref).

Candidiasis

Candidiasis:

Esophageal, fluconazole-refractory disease (alternative agent) (off-label use): Oral: 744 mg (isavuconazole 400 mg) as a single dose, then 186 mg (isavuconazole 100 mg) once daily for 14 to 28 days or 744 mg (isavuconazole 400 mg) once weekly for 4 weeks (Ref).

Cryptococcal meningitis

Cryptococcal meningitis (alternative agent) (off-label use):

Consolidation: Oral: 372 mg (isavuconazole 200 mg) once daily for 8 weeks (Ref).

Maintenance (suppression): Oral: 372 mg (isavuconazole 200 mg) once daily for ~12 months depending on immune status (Ref).

Mucormycosis, invasive

Mucormycosis, invasive: IV, Oral: Initial: 372 mg (isavuconazole 200 mg) every 8 hours for 6 doses; Maintenance: 372 mg (isavuconazole 200 mg) once daily (Ref). Start maintenance dose 12 to 24 hours after the last loading dose.

Prophylaxis against invasive fungal infections

Prophylaxis against invasive fungal infections (alternative agent) (off-label use):

Hematology malignancy or hematopoietic cell transplant:

IV, Oral: Initial: 372 mg (isavuconazole 200 mg) every 8 hours for 6 doses; Maintenance: 372 mg (isavuconazole 200 mg) once daily (Ref).

Duration of therapy: Varies based on degree and duration of immunosuppression (Ref).

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

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (Ref).

Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed: No supplemental dose or dosage adjustment necessary (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (highly protein bound): No dosage adjustment necessary (Ref).

CRRT: Not significantly dialyzable given high degree of protein binding (Ref). No initial dosage adjustment necessary; however, lower (and sometimes subtherapeutic) concentrations have been reported in critically ill patients receiving renal replacement therapy; monitor patient closely and utilize therapeutic drug monitoring if available (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Not significantly dialyzable given high degree of protein binding. No initial dosage adjustment necessary; however, potential adsorption to PIRRT equipment has been reported; monitor patient closely and utilize therapeutic drug monitoring if available (Ref).

Dosing: Liver Impairment: Adult

Mild or moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Isavuconazole (isavuconazonium sulfate): Pediatric drug information")

Dosage guidance:

Dosing: Dosage expressed as milligrams of isavuconazonium sulfate; 372 mg isavuconazonium sulfate = 200 mg isavuconazole. Dosing is presented as weight-directed doses (mg isavuconazonium sulfate/kg) and fixed doses (mg isavuconazonium sulfate); use caution.

Clinical considerations: Switching between the IV and oral formulations of isavuconazonium sulfate is acceptable; the same dose and frequency can be used; additional loading doses are NOT necessary.

Aspergillosis, invasive

Aspergillosis, invasive: Note: Minimum duration of therapy is 6 to 12 weeks; duration should be individualized depending on degree and duration of immunosuppression, disease site, and evidence of improvement (Ref).

Intravenous:

Children <3 years: Initial (loading doses): IV: 15 mg isavuconazonium sulfate/kg/dose every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 15 mg isavuconazonium sulfate/kg/dose every 24 hours; maximum dose: 372 mg isavuconazonium sulfate/dose.

Children ≥3 years and Adolescents <18 years: IV: Initial (loading doses): 10 mg isavuconazonium sulfate/kg/dose every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 10 mg isavuconazonium sulfate/kg/dose every 24 hours; maximum dose: 372 mg isavuconazonium sulfate/dose.

Adolescents ≥18 years: IV: Initial (loading doses): 372 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 372 mg isavuconazonium sulfate every 24 hours.

Oral:

Children ≥6 years and Adolescents <18 years:

16 to <18 kg: Oral: Initial (loading doses): 149 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 149 mg isavuconazonium sulfate every 24 hours.

18 to <25 kg: Oral: Initial (loading doses): 223.5 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 223.5 mg isavuconazonium sulfate every 24 hours.

25 to <32 kg: Oral: Initial (loading doses): 298 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 298 mg isavuconazonium sulfate every 24 hours.

≥32 kg: Oral: Initial (loading doses): 372 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 372 mg isavuconazonium sulfate every 24 hours.

Adolescents ≥18 years: Oral: Initial (loading doses): 372 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 372 mg isavuconazonium sulfate every 24 hours.

Candidiasis, esophageal

Candidiasis, esophageal (alternative agent): Limited data available: Multiple regimens reported: Patients with HIV: Adolescents: Oral: 744 mg isavuconazonium sulfate as a single dose, followed by 186 mg isavuconazonium sulfate every 24 hours or 372 mg isavuconazonium sulfate as a single dose, followed by 93 mg isavuconazonium sulfate every 24 hours or 744 mg isavuconazonium sulfate once weekly; treat for 14 to 21 days (Ref).

Mucormycosis, invasive

Mucormycosis, invasive: Note: Treatment duration is highly individualized depending on degree and duration of immunosuppression, disease site, clinical resolution, and improvement on imaging studies; typically weeks to months or longer (Ref).

Intravenous:

Children <3 years: Initial (loading doses): IV: 15 mg isavuconazonium sulfate/kg/dose every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 15 mg isavuconazonium sulfate/kg/dose every 24 hours; maximum dose: 372 mg isavuconazonium sulfate/dose.

Children ≥3 years and Adolescents <18 years: IV: Initial (loading doses): 10 mg isavuconazonium sulfate/kg/dose every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 10 mg isavuconazonium sulfate/kg/dose every 24 hours; maximum dose: 372 mg isavuconazonium sulfate/dose.

Adolescents ≥18 years: IV: Initial (loading doses): 372 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 372 mg isavuconazonium sulfate every 24 hours.

Oral:

Children ≥6 years and Adolescents <18 years:

16 to <18 kg: Oral: Initial (loading doses): 149 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 149 mg isavuconazonium sulfate every 24 hours.

18 to <25 kg: Oral: Initial (loading doses): 223.5 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 223.5 mg isavuconazonium sulfate every 24 hours.

25 to <32 kg: Oral: Initial (loading doses): 298 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 298 mg isavuconazonium sulfate every 24 hours.

≥32 kg: Oral: Initial (loading doses): 372 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 372 mg isavuconazonium sulfate every 24 hours.

Adolescents ≥18 years: Oral: Initial (loading doses): 372 mg isavuconazonium sulfate every 8 hours for 6 doses; maintenance (begin 12 to 24 hours after last loading dose): 372 mg isavuconazonium sulfate every 24 hours.

Dosing: Kidney Impairment: Pediatric

Altered kidney function: Children and Adolescents: No dosage adjustment necessary in any degree of kidney impairment; less than 1% is eliminated by the kidney.

Hemodialysis: Children and Adolescents: Not readily dialyzable; no dosage adjustment necessary.

Dosing: Liver Impairment: Pediatric

Children and Adolescents:

Mild or moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use only when benefits outweigh risks; monitor closely.

Adverse Reactions

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

>10%:

Cardiovascular: Peripheral edema (15%)

Dermatologic: Pruritus (children, adolescents, and adults: 8% to 13%), skin rash (children, adolescents, and adults: 9% to 14%)

Endocrine & metabolic: Hypokalemia (19%)

Gastrointestinal: Abdominal pain (children, adolescents, and adults: 17% to 23%), constipation (14%), diarrhea (children, adolescents, and adults: 24% to 26%), nausea (children and adolescents: 13%; adults: 28%), vomiting (children, adolescents, and adults: 21% to 25%)

Hepatic: Increased liver enzymes (children, adolescents, and adults: 17% to 18%)

Nervous system: Fatigue (11%), headache (children, adolescents, and adults: 12% to 17%), insomnia (11%)

Respiratory: Dyspnea (17%)

1% to 10%:

Cardiovascular: Atrial fibrillation (<5%), atrial flutter (<5%), bradycardia (<5%), chest pain (9%), ECG changes (reduced QT interval) (<5%), hypotension (8%), palpitations (<5%), premature ventricular contractions (<5%), supraventricular extrasystole (<5%), supraventricular tachycardia (<5%), syncope (<5%), thrombophlebitis (<5%)

Dermatologic: Alopecia (<5%), dermatitis (<5%), erythema of skin (<5%), exfoliative dermatitis (<5%), urticaria (<5%)

Endocrine & metabolic: Hypoalbuminemia (<5%), hypoglycemia (<5%), hypomagnesemia (5%), hyponatremia (<5%)

Gastrointestinal: Abdominal distention (<5%), cholecystitis (<5%), cholelithiasis (<5%), decreased appetite (9%), dysgeusia (<5%), dyspepsia (6%), gastritis (<5%), gingivitis (<5%), stomatitis (<5%)

Genitourinary: Hematuria (<5%), proteinuria (<5%)

Hematologic & oncologic: Agranulocytosis (<5%), leukopenia (<5%), pancytopenia (<5%), petechia (<5%)

Hepatic: Hepatic failure (<5%), hepatitis (<5%), hepatomegaly (<5%), increased serum alanine aminotransferase (>3 × ULN: ≤4%; >10 × ULN: ≤1%), increased serum aspartate aminotransferase (>3 × ULN: ≤4%; >10 × ULN: ≤1%)

Hypersensitivity: Hypersensitivity reaction (<5%)

Local: Injection-site reaction (6%)

Nervous system: Anxiety (8%), chills (<5%), confusion (<5%), delirium (9%), depression (<5%), drowsiness (<5%), encephalopathy (<5%), falling (<5%), hallucination (<5%), hypoesthesia (<5%), malaise (<5%), migraine (<5%), paresthesia (<5%), peripheral neuropathy (<5%), seizure (<5%), stupor (<5%), tremor (<5%), vertigo (<5%)

Neuromuscular & skeletal: Back pain (10%), myositis (<5%), neck pain (<5%), ostealgia (<5%)

Ophthalmic: Optic neuropathy (<5%)

Otic: Tinnitus (<5%)

Renal: Kidney failure (10%)

Respiratory: Acute respiratory failure (7%), bronchospasm (<5%), tachypnea (<5%)

Frequency not defined:

Gastrointestinal: Cholestasis

Hepatic: Increased serum alkaline phosphatase, increased serum bilirubin

Renal: Acute kidney injury

Respiratory: Cough

Postmarketing: Hypersensitivity: Anaphylaxis, infusion-related reaction

Contraindications

Hypersensitivity to isavuconazonium sulfate (eg, isavuconazole) or any component of the formulation; concurrent use of strong CYP3A4 inhibitors (eg, ketoconazole, high-dose ritonavir [400 mg every 12 hours]); concurrent use of strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John’s wort, long-acting barbiturates); familial short QT syndrome.

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

Canadian labeling: Additional contraindications (not in US labeling): Concurrent use of moderate CYP3A4/5 inducers (eg, efavirenz, etravirine).

Warnings/Precautions

Concerns related to adverse effects:

• Hepatic effects: Severe reactions (hepatic failure [including fatalities], hepatitis, and cholestasis) have been reported in patients with serious underlying medical conditions (eg, hematologic malignancy). Other reactions (elevations in AST, ALT, alkaline phosphatase and total bilirubin) have also been reported; these elevations are generally reversible and do not require discontinuation of therapy. Monitor liver function tests at baseline and periodically during therapy. If abnormal liver function tests develop, monitor closely for development of severe hepatic reactions. Discontinue therapy if clinical signs and symptoms of liver disease develop.

• Hypersensitivity: Anaphylactic reactions, with fatal outcome, have been reported with isavuconazonium sulfate. Discontinue isavuconazonium sulfate if a patient experiences an anaphylactic reaction. Serious hypersensitivity (eg, anaphylaxis) and severe skin reactions (eg, Stevens-Johnson syndrome) have been reported with other azole antifungal agents. Discontinue if a severe skin reaction occurs. There is no information regarding cross-sensitivity between isavuconazonium sulfate and other azoles. Use with caution in patients with hypersensitivity reactions to other azoles.

Disease-related concerns:

• Hepatic impairment: Use with caution and monitor for adverse effects in patients with severe hepatic impairment (Child-Pugh class C).

Dosage form specific issues:

• Drug particulates: Following dilution for IV infusion, may form precipitate from the insoluble isavuconazole. Use an infusion set with an in-line filter (pore size 0.2 to 1.2 micron) for IV administration.

• Infusion-related reactions: Infusion reactions (eg, hypotension, dizziness, chills, dyspnea, paresthesia and hypoesthesia) have been reported during IV administration. Discontinue the infusion if these reactions occur.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

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

Capsule, Oral, as sulfate:

Cresemba: 74.5 mg, 186 mg [contains disodium edta]

Solution Reconstituted, Intravenous, as sulfate [preservative free]:

Cresemba: 372 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Capsules (Cresemba Oral)

74.5 mg (per each): $55.68

186 mg (per each): $138.90

Solution (reconstituted) (Cresemba Intravenous)

372 mg (per each): $473.26

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:

Cresemba: 100 mg [contains disodium edta]

Solution Reconstituted, Intravenous:

Cresemba: 200 mg (1 ea)

Administration: Adult

IV: Infuse over a minimum of 1 hour; must be administered via an infusion set with an in-line filter (pore size 0.2 to 1.2 micron). Flush line with NS or D5W before and after infusion. Do not administer as an IV bolus injection. Do not mix or infuse with other medications.

NG tube: Administer within 1 hour of reconstitution. Once dose administered, flush nasogastric tube with three 5 mL rinses of water. Do not administer intact capsules through an NG tube.

Oral: Administer with or without food. The manufacturer recommends to swallow capsules whole; do not chew, crush, dissolve, or open. Administration of isavuconazonium sulfate by opening capsules and mixing contents with saline or tube feed formulations for administration via enteral feeding tubes has resulted in comparable isavuconazole concentrations to IV administration and intact capsule formulations. If capsules are opened, consider assessing serum concentrations to ensure absorption (Ref).

Administration: Pediatric

IV: Infuse over a minimum of 1 hour; must be administered via an infusion set with an in-line filter (pore size 0.2 to 1.2 micron). Flush line with NS or D5W before and after infusion. Do not administer as an IV bolus injection. Do not mix or infuse with other medications.

Oral: Administer with or without food. The manufacturer recommends swallowing capsules whole and states not to chew, crush, dissolve, or open capsules, and recommends using the parenteral product enterally for patients who cannot swallow capsules. However, oral administration of isavuconazonium sulfate by opening capsules and mixing contents with an acidic beverage or soft food (eg, yogurt) has resulted in comparable isavuconazole concentrations to IV administration and administration of intact capsule formulations. If capsules are opened, consider assessing serum concentrations to ensure absorption (Ref).

Feeding tube administration:

Using parenteral formulation: Administer via nasogastric (NG) tube using an appropriate syringe within 1 hour of reconstitution. Once dose administered, flush NG tube with three 5 mL rinses of water.

Using capsules: Isavuconazonium sulfate administration via enteral feeding tubes (eg, gastrostomy tube, gastrojejunostomy [GJ] tube) has been described; open capsules and mix contents with water, saline, or tube feed formulations (eg, 372 mg isavuconazonium sulfate in 10 mL saline). In some cases, isavuconazole concentrations were found to be comparable to those achieved with IV administration; however, in one pharmacokinetic study, opening capsules resulted in lower concentrations compared to IV administration. The manufacturer recommends against using capsules for feeding tube administration; parenteral formulation is preferred. If capsules opened and administered via enteral tube, assess serum concentrations to ensure absorption (Ref).

Use: Labeled Indications

Aspergillosis: Treatment of invasive aspergillosis in adults and pediatric patients ≥1 year of age (injection) or adults and pediatric patients ≥6 years of age and ≥16 kg (capsule).

Mucormycosis: Treatment of invasive mucormycosis in adults and pediatric patients ≥1 year of age (injection) or adults and pediatric patients ≥6 years of age and ≥16 kg (capsule).

Use: Off-Label: Adult

Candidiasis, esophageal, fluconazole-refractory disease; Cryptococcal meningitis; Prophylaxis against invasive fungal infections

Metabolism/Transport Effects

Substrate of CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP3A4 (Moderate), MATE1/2-K, OCT1, OCT2, P-glycoprotein; Induces CYP2B6 (Weak);

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.

Abemaciclib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Abemaciclib. Management: Monitor for increased abemaciclib toxicities if combined with moderate CYP3A4 inhibitors. Consider reducing the abemaciclib dose in 50 mg decrements if necessary. Risk C: Monitor

Acalabrutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Acalabrutinib. Management: Reduce acalabrutinib dose to 100 mg once daily with concurrent use of a moderate CYP3A4 inhibitor. Monitor patient closely for both acalabrutinib response and evidence of adverse effects with any concurrent use. Risk D: Consider Therapy Modification

Acrivastine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Acrivastine. Risk C: Monitor

Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Afatinib. Management: If combined, administer the P-gp inhibitor simultaneously with, or after, the dose of afatinib. Monitor closely for signs and symptoms of afatinib toxicity and if the combination is not tolerated, reduce the afatinib dose by 10 mg. Risk D: Consider Therapy Modification

ALfentanil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of ALfentanil. Management: If use of alfentanil and moderate CYP3A4 inhibitors is necessary, consider dosage reduction of alfentanil until stable drug effects are achieved. Frequently monitor patients for respiratory depression and sedation when these agents are combined. Risk D: Consider Therapy Modification

Alfuzosin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Alfuzosin. Risk C: Monitor

Aliskiren: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Aliskiren. Risk C: Monitor

Alitretinoin (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Alitretinoin (Systemic). Risk C: Monitor

ALPRAZolam: CYP3A4 Inhibitors (Moderate) may increase serum concentration of ALPRAZolam. Management: Consider alternatives to this combination when possible. If combined, consider an alprazolam dose reduction and monitor for increased alprazolam effects and toxicities (eg, sedation, lethargy). Risk D: Consider Therapy Modification

Amiodarone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Amiodarone. Risk C: Monitor

AmLODIPine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of AmLODIPine. Risk C: Monitor

Apixaban: Inhibitors of CYP3A4 (Moderate) and P-glycoprotein may increase serum concentration of Apixaban. Risk C: Monitor

Aprepitant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Aprepitant. Risk X: Avoid

ARIPiprazole Lauroxil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of ARIPiprazole Lauroxil. Risk C: Monitor

ARIPiprazole: CYP3A4 Inhibitors (Moderate) may increase serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy, indication, or dosage form. Consult full interaction monograph for specific recommendations. Risk C: Monitor

Atogepant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Atogepant. Risk C: Monitor

Atorvastatin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Atorvastatin. Risk C: Monitor

Avacopan: May increase serum concentration of Isavuconazonium Sulfate. Isavuconazonium Sulfate may increase serum concentration of Avacopan. Risk C: Monitor

Avanafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Avanafil. Management: The maximum avanafil dose is 50 mg per 24-hour period when used together with a moderate CYP3A4 inhibitor. Patients receiving such a combination should also be monitored more closely for evidence of adverse effects (eg, hypotension, syncope, priapism). Risk D: Consider Therapy Modification

Avapritinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Avapritinib. Management: Avoid use of moderate CYP3A4 inhibitors with avapritinib. If this combination cannot be avoided, reduce the avapritinib dose to 100 mg daily for the treatment of GIST or to 50 mg daily for the treatment of advanced systemic mastocytosis. Risk D: Consider Therapy Modification

Axitinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Axitinib. Risk C: Monitor

Barnidipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Barnidipine. Risk C: Monitor

Bedaquiline: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Bedaquiline. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Bedaquiline. Risk C: Monitor

Benidipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Benidipine. Risk C: Monitor

Benzhydrocodone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Benzhydrocodone. Specifically, the concentration of hydrocodone may be increased. Risk C: Monitor

Beta-Acetyldigoxin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Beta-Acetyldigoxin. Risk C: Monitor

Bilastine: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Bilastine. Risk X: Avoid

Blonanserin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Blonanserin. Risk C: Monitor

Bortezomib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Bortezomib. Risk C: Monitor

Bosutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Bosutinib. Risk X: Avoid

Brexpiprazole: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Brexpiprazole. Management: The brexpiprazole dose should be reduced to 25% of usual if used together with both a moderate CYP3A4 inhibitor and a strong or moderate CYP2D6 inhibitor, or if a moderate CYP3A4 inhibitor is used in a CYP2D6 poor metabolizer. Risk C: Monitor

Brigatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Brigatinib. Management: Avoid concurrent use of brigatinib with moderate CYP3A4 inhibitors when possible. If such a combination cannot be avoided, reduce the dose of brigatinib by approximately 40% (ie, from 180 mg to 120 mg, from 120 mg to 90 mg, or from 90 mg to 60 mg). Risk D: Consider Therapy Modification

Bromocriptine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Bromocriptine. Management: The bromocriptine dose should not exceed 1.6 mg daily with use of a moderate CYP3A4 inhibitor. The Cycloset brand specifically recommends this dose limitation, but other bromocriptine products do not make such specific recommendations. Risk D: Consider Therapy Modification

Budesonide (Oral Inhalation): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor

Budesonide (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Budesonide (Systemic). Management: Avoid the concomitant use of CYP3A4 inhibitors and oral budesonide. If patients receive both budesonide and CYP3A4 inhibitors, they should be closely monitored for signs and symptoms of corticosteroid excess. Risk D: Consider Therapy Modification

Budesonide (Topical): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Budesonide (Topical). Risk X: Avoid

Buprenorphine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Buprenorphine. Risk C: Monitor

BuPROPion: CYP2B6 Inducers (Weak) may decrease serum concentration of BuPROPion. Risk C: Monitor

BusPIRone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of BusPIRone. Risk C: Monitor

Cabozantinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cabozantinib. Risk C: Monitor

Cannabis: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cannabis. More specifically, tetrahydrocannabinol and cannabidiol serum concentrations may be increased. Risk C: Monitor

Capivasertib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Capivasertib. Management: If capivasertib is combined with moderate CYP3A4 inhibitors, reduce the capivasertib dose to 320 mg twice daily for 4 days, followed by 3 days off. Monitor patients closely for adverse reactions. Risk D: Consider Therapy Modification

Cariprazine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cariprazine. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Cariprazine. Management: Cariprazine dose adjustments are recommended and depend upon whether a patient is initiating a moderate CYP3A4 inhibitor or cariprazine, as well as cariprazine indication. See full mono for details. Some non-US labels contraindicate this combination. Risk D: Consider Therapy Modification

Celiprolol: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Celiprolol. Risk C: Monitor

Cilostazol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cilostazol. Management: Decrease the dose of cilostazol to 50 mg twice daily when combined with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Cisapride: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cisapride. Management: Consider alternatives to this combination. Prescribing information for some moderate CYP3A4 inhibitors state coadministration with cisapride is contraindicated, while some others recommend monitoring and dose titration. Risk D: Consider Therapy Modification

Clindamycin (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Clindamycin (Systemic). Risk C: Monitor

Clofarabine: OCT2 Inhibitors may increase serum concentration of Clofarabine. Risk C: Monitor

Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor

CloZAPine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of CloZAPine. Risk C: Monitor

Cobimetinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cobimetinib. Management: Avoid this combination when possible. If concurrent short term (14 days or less) use cannot be avoided, reduce the cobimetinib dose from 60 mg to 20 mg daily. Avoid concomitant use in patients already receiving reduced cobimetinib doses. Risk D: Consider Therapy Modification

Codeine: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Codeine. Risk C: Monitor

Colchicine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Colchicine. Management: Avoidance, dose reduction, or increased monitoring for colchicine toxicity may be needed and will depend on brand, indication for colchicine use, renal/hepatic function, and use of a P-gp inhibitor. See full monograph for details. Risk D: Consider Therapy Modification

Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: This combination is often contraindicated, but combined use may be permitted with dose adjustment and monitoring. Recommendations vary based on brand, indication, use of CYP3A4 inhibitors, and hepatic/renal function. See interaction monograph for details. Risk D: Consider Therapy Modification

Conivaptan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Conivaptan. Risk C: Monitor

Copanlisib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Copanlisib. Risk C: Monitor

Crizotinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Crizotinib. Risk C: Monitor

CycloSPORINE (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of CycloSPORINE (Systemic). Risk C: Monitor

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

CYP3A4 Inducers (Strong): May decrease active metabolite exposure of Isavuconazonium Sulfate. Specifically, CYP3A4 Inducers (Strong) may decrease isavuconazole serum concentrations. Risk X: Avoid

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

CYP3A4 Inhibitors (Strong): May increase active metabolite exposure of Isavuconazonium Sulfate. Specifically, CYP3A4 Inhibitors (Strong) may increase isavuconazole serum concentrations. Risk X: Avoid

Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase active metabolite exposure of Dabigatran Etexilate. Risk C: Monitor

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

Dalfampridine: OCT2 Inhibitors may increase serum concentration of Dalfampridine. Management: Consider alternatives to this combination. Carefully weigh the risk of seizures against the benefit of combining OCT2 inhibitors with dalfampridine. Risk D: Consider Therapy Modification

Dapoxetine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Dapoxetine. Management: The dose of dapoxetine should be limited to 30 mg per day when used together with a moderate inhibitor of CYP3A4. Risk D: Consider Therapy Modification

Daridorexant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Daridorexant. Management: Limit the daridorexant dose to 25 mg, no more than once per night, when combined with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Darifenacin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Darifenacin. Risk C: Monitor

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

Deflazacort: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Deflazacort. Management: Administer one third of the recommended deflazacort dose when used together with a strong or moderate CYP3A4 inhibitor. Risk D: Consider Therapy Modification

Delamanid: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Delamanid. Risk C: Monitor

DexAMETHasone (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of DexAMETHasone (Systemic). Risk C: Monitor

DiazePAM: CYP3A4 Inhibitors (Moderate) may increase serum concentration of DiazePAM. Risk C: Monitor

Diazoxide Choline: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Diazoxide Choline. Risk C: Monitor

Dichlorphenamide: Antifungal Agents (Azole Derivatives, Systemic) may increase hypokalemic effects of Dichlorphenamide. Risk C: Monitor

Dienogest: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Dienogest. Risk C: Monitor

Digitoxin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Digitoxin. Risk C: Monitor

Digoxin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Digoxin. Management: Measure digoxin serum concentrations before initiating treatment with these P-glycoprotein (P-gp) inhibitors. Reduce digoxin concentrations by either reducing the digoxin dose by 15% to 30% or by modifying the dosing frequency. Risk D: Consider Therapy Modification

DilTIAZem: CYP3A4 Inhibitors (Moderate) may increase serum concentration of DilTIAZem. Risk C: Monitor

Disopyramide: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Disopyramide. Risk C: Monitor

DOCEtaxel: CYP3A4 Inhibitors (Moderate) may increase serum concentration of DOCEtaxel. Risk C: Monitor

Dofetilide: MATE1/2-K Inhibitors may increase serum concentration of Dofetilide. Risk X: Avoid

Domperidone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Domperidone. Risk X: Avoid

DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of DOXOrubicin (Conventional). Risk X: Avoid

DOXOrubicin (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of DOXOrubicin (Liposomal). Risk C: Monitor

DroNABinol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of DroNABinol. Risk C: Monitor

Dronedarone: May increase serum concentration of Isavuconazonium Sulfate. Isavuconazonium Sulfate may increase serum concentration of Dronedarone. Risk C: Monitor

Ebastine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ebastine. Risk C: Monitor

Edoxaban: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Edoxaban. Risk C: Monitor

Elacestrant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Elacestrant. Risk X: Avoid

Elbasvir and Grazoprevir: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Elbasvir and Grazoprevir. Risk C: Monitor

Eletriptan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Eletriptan. Risk X: Avoid

Elexacaftor, Tezacaftor, and Ivacaftor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Elexacaftor, Tezacaftor, and Ivacaftor. Management: When combined with moderate CYP3A4 inhibitors, elexacaftor/tezacaftor/ivacaftor should be given in the morning, every other day. Ivacaftor alone should be given in the morning, every other day on alternate days. Risk D: Consider Therapy Modification

Eliglustat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Eliglustat. Management: Reduce eliglustat dose to 84 mg daily in CYP2D6 EMs when used with moderate CYP3A4 inhibitors. Avoid use of moderate CYP3A4 inhibitors in CYP2D6 IMs or PMs. Use in CYP2D6 EMs or IMs also taking strong or moderate CYP2D6 inhibitors is contraindicated. Risk D: Consider Therapy Modification

Enasidenib: May decrease serum concentration of Antifungal Agents (Azole Derivatives, Systemic). Risk X: Avoid

Ensartinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ensartinib. Risk X: Avoid

Ensartinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Ensartinib. Risk X: Avoid

Entrectinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Entrectinib. Management: Avoid moderate CYP3A4 inhibitors if possible. If needed, reduce entrectinib dose to 50 mg/day if starting dose 200 mg; to 100 mg/day if starting dose 300 mg; to 200 mg if starting dose 400 mg or 600 mg. Risk D: Consider Therapy Modification

Eplerenone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Eplerenone. Management: If coadministered with moderate CYP3A4 inhibitors, the max dose of eplerenone is 25 mg daily if used for heart failure; if used for hypertension initiate eplerenone 25 mg daily, titrate to max 25 mg twice daily. Risk D: Consider Therapy Modification

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates). Risk C: Monitor

Erlotinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Erlotinib. Risk C: Monitor

Erythromycin (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Erythromycin (Systemic). Risk C: Monitor

Eszopiclone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Eszopiclone. Risk C: Monitor

Etoposide Phosphate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Etoposide Phosphate. Risk C: Monitor

Etoposide: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Etoposide. Risk C: Monitor

Etravirine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Etravirine. Risk C: Monitor

Everolimus: Inhibitors of CYP3A4 (Moderate) and P-glycoprotein may increase serum concentration of Everolimus. Management: Afinitor: For TSC-associated SEGA or TSC-associated seizures reduce everolimus dose 50%. For other Afinitor indications, reduce everolimus dose to 2.5 mg/day, increase to 5 mg/day if tolerated. Zortress: Monitor for increased everolimus concentrations. Risk D: Consider Therapy Modification

Fedratinib: May increase serum concentration of Isavuconazonium Sulfate. Isavuconazonium Sulfate may increase serum concentration of Fedratinib. Risk C: Monitor

Felodipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Felodipine. Risk C: Monitor

FentaNYL: CYP3A4 Inhibitors (Moderate) may increase serum concentration of FentaNYL. Management: Consider fentanyl dose reductions when combined with a moderate CYP3A4 inhibitor. Monitor for respiratory depression and sedation. Upon discontinuation of a CYP3A4 inhibitor, consider a fentanyl dose increase; monitor for signs and symptoms of withdrawal. Risk D: Consider Therapy Modification

Fexinidazole: CYP3A4 Inhibitors (Moderate) may decrease active metabolite exposure of Fexinidazole. Management: Avoid use of fexinidazole and moderate CYP3A4 inhibitors when possible. If combined, monitor for reduced fexinidazole efficacy. Risk D: Consider Therapy Modification

Finerenone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Finerenone. Risk C: Monitor

Flibanserin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Flibanserin. Management: Use of flibanserin with moderate CYP3A4 inhibitors is contraindicated. If starting flibanserin, start 2 weeks after the last dose of the CYP3A4 inhibitor. If starting a CYP3A4 inhibitor, start 2 days after the last dose of flibanserin. Risk X: Avoid

Flucloxacillin: May decrease serum concentration of Isavuconazonium Sulfate. Risk C: Monitor

Fluticasone (Nasal): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fluticasone (Nasal). Risk C: Monitor

Fluticasone (Oral Inhalation): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fluticasone (Oral Inhalation). Risk C: Monitor

Fosamprenavir: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fosamprenavir. Risk C: Monitor

Fosaprepitant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fosaprepitant. Risk X: Avoid

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

Futibatinib: Inhibitors of CYP3A4 (Moderate) and P-glycoprotein may increase serum concentration of Futibatinib. Risk C: Monitor

Gepirone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Gepirone. Management: Reduce the gepirone dose by 50% if combined with moderate CYP3A4 inhibitors. Monitor for QTc interval prolongation with combined use. Risk D: Consider Therapy Modification

Gepotidacin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Gepotidacin. Risk C: Monitor

Gilteritinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Gilteritinib. Risk C: Monitor

Glasdegib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Glasdegib. Risk C: Monitor

Glecaprevir and Pibrentasvir: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Glecaprevir and Pibrentasvir. Risk C: Monitor

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

GuanFACINE: CYP3A4 Inhibitors (Moderate) may increase serum concentration of GuanFACINE. Management: Reduce the extended-release guanfacine dose 50% when combined with a moderate CYP3A4 inhibitor. Monitor for increased guanfacine toxicities when these agents are combined. Risk D: Consider Therapy Modification

Halofantrine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Halofantrine. Risk C: Monitor

HYDROcodone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of HYDROcodone. Risk C: Monitor

Ibrutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ibrutinib. Management: When treating B-cell malignancies, decrease ibrutinib to 280 mg daily when combined with moderate CYP3A4 inhibitors. When treating graft versus host disease, monitor patients closely and reduce the ibrutinib dose as needed based on adverse reactions. Risk D: Consider Therapy Modification

Ifosfamide: CYP3A4 Inhibitors (Moderate) may increase adverse/toxic effects of Ifosfamide. CYP3A4 Inhibitors (Moderate) may decrease active metabolite exposure of Ifosfamide. Risk C: Monitor

Iloperidone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Iloperidone. Risk C: Monitor

Irinotecan Products: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Irinotecan Products. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Irinotecan Products. Specifically, the serum concentration of SN-38 may be increased. Risk C: Monitor

Isradipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Isradipine. Risk C: Monitor

Itraconazole: May increase serum concentration of Isavuconazonium Sulfate. Risk X: Avoid

Ivabradine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ivabradine. Risk X: Avoid

Ivacaftor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ivacaftor. Management: Ivacaftor dose reductions may be required; consult full drug interaction monograph content for age- and weight-specific dosage recommendations. Risk D: Consider Therapy Modification

Ivosidenib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ivosidenib. Management: Avoid use of moderate CYP3A4 inhibitors with ivosidenib whenever possible. If combined, monitor for increased ivosidenib toxicities, including QTc prolongation. Risk D: Consider Therapy Modification

Ixabepilone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ixabepilone. Risk C: Monitor

Lapatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lapatinib. Risk C: Monitor

Lapatinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Lapatinib. Risk C: Monitor

Larotrectinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Larotrectinib. Risk C: Monitor

Larotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Larotrectinib. Risk C: Monitor

Lefamulin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Lefamulin. Management: Avoid concomitant use of lefamulin tablets with P-glycoprotein/ABCB1 inhibitors. If concomitant use is required, monitor for lefamulin adverse effects. Risk D: Consider Therapy Modification

Lemborexant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lemborexant. Risk X: Avoid

Leniolisib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Leniolisib. Risk C: Monitor

Lercanidipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lercanidipine. Risk C: Monitor

Levamlodipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Levamlodipine. Risk C: Monitor

Levomethadone: Isavuconazonium Sulfate may decrease serum concentration of Levomethadone. Risk C: Monitor

Levomilnacipran: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Levomilnacipran. Risk C: Monitor

Lidocaine (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lidocaine (Systemic). CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Lidocaine (Systemic). Specifically, concentrations of monoethylglycinexylidide (MEGX) may be increased. Risk C: Monitor

Lomitapide: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lomitapide. Risk X: Avoid

Lopinavir: May increase active metabolite exposure of Isavuconazonium Sulfate. Specifically, lopinavir/ritonavir may increase isavuconazole serum concentrations. Isavuconazonium Sulfate may decrease serum concentration of Lopinavir. Management: Consider alternatives to this combination. If coadministered, use caution and monitor for increased isavuconazonium effects and toxicities as well as reduced concentrations and effects of lopinavir/ritonavir. Risk D: Consider Therapy Modification

Lovastatin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lovastatin. Risk C: Monitor

Lumateperone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lumateperone. Management: Limit the lumateperone dose to 21 mg once daily when used with a moderate CYP3A4 inhibitor. Risk D: Consider Therapy Modification

Lurasidone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lurasidone. Management: Reduce the lurasidone dose by half when initiating therapy with a moderate CYP3A4 inhibitor. If initiating lurasidone in a patient already receiving a moderate CYP3A4 inhibitor, start lurasidone at 20 mg/day with a max dose of 80 mg/day. Risk D: Consider Therapy Modification

Lurbinectedin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lurbinectedin. Management: Avoid concomitant use of lurbinectedin and moderate CYP3A4 inhibitors when possible. If combined, reduce the lurbinectedin dose by 50%. Risk D: Consider Therapy Modification

Macitentan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Macitentan. Risk C: Monitor

Manidipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Manidipine. Risk C: Monitor

Maraviroc: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Maraviroc. Risk C: Monitor

Mavacamten: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mavacamten. Management: Start mavacamten at 5 mg/day if stable on a moderate CYP3A4 inhibitor, and reduce the mavacamten dose by one dose level if initiating a moderate CYP3A4 inhibitor. Avoid initiating moderate CYP3A4 inhibitors in patients on mavacamten 2.5 mg/day. Risk D: Consider Therapy Modification

Mavorixafor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mavorixafor. Risk C: Monitor

Meperidine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Meperidine. Risk C: Monitor

MetFORMIN: MATE1/2-K Inhibitors may increase serum concentration of MetFORMIN. Risk C: Monitor

Methadone: Isavuconazonium Sulfate may decrease serum concentration of Methadone. Risk C: Monitor

MethylPREDNISolone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of MethylPREDNISolone. Risk C: Monitor

Methysergide: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Methysergide. Risk X: Avoid

Midazolam: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Midazolam. Management: Avoid concomitant use of nasal midazolam and moderate CYP3A4 inhibitors. Consider alternatives to use with oral midazolam whenever possible and consider using lower midazolam doses. Monitor patients for sedation and respiratory depression if combined. Risk D: Consider Therapy Modification

Midostaurin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Midostaurin. Risk C: Monitor

Mirodenafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mirodenafil. Risk C: Monitor

Mitapivat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mitapivat. Management: When coadministered with moderate CYP3A4 inhibitors, doses of mitapivat should not exceed 20 mg twice daily. Additionally, patients should be monitored for changes in hemoglobin response and increased mitapivat adverse effects. Risk D: Consider Therapy Modification

Mizolastine: Antifungal Agents (Azole Derivatives, Systemic) may increase serum concentration of Mizolastine. Risk X: Avoid

Mobocertinib: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Mobocertinib. CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mobocertinib. Management: Avoid use of moderate CYP3A4 inhibitors with mobocertinib when possible. If combined, the mobocertinib dose should be reduced by approximately 50% (ie, from 160 mg to 80 mg, 120 mg to 40 mg, or 80 mg to 40 mg). Monitor QTc interval closely. Risk D: Consider Therapy Modification

Morphine (Systemic): P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Morphine (Systemic). Risk C: Monitor

Mycophenolate: Isavuconazonium Sulfate may increase serum concentration of Mycophenolate. Risk C: Monitor

Nadolol: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Nadolol. Risk C: Monitor

Naldemedine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Naldemedine. Risk C: Monitor

Naldemedine: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Naldemedine. Risk C: Monitor

Nalfurafine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Nalfurafine. Risk C: Monitor

Naloxegol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Naloxegol. Management: The use of naloxegol and moderate CYP3A4 inhibitors should be avoided. If concurrent use is unavoidable, reduce naloxegol dose to 12.5 mg once daily and monitor for signs of opiate withdrawal (eg, hyperhidrosis, chills, diarrhea, anxiety, irritability). Risk D: Consider Therapy Modification

Neratinib: Inhibitors of CYP3A4 (Moderate) and P-glycoprotein may increase serum concentration of Neratinib. Risk X: Avoid

NIFEdipine (Topical): CYP3A4 Inhibitors (Moderate) may increase serum concentration of NIFEdipine (Topical). Risk C: Monitor

NIFEdipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of NIFEdipine. Risk C: Monitor

NiMODipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of NiMODipine. Risk C: Monitor

Nintedanib: Inhibitors of CYP3A4 (Moderate) and P-glycoprotein may increase serum concentration of Nintedanib. Risk C: Monitor

Nirmatrelvir and Ritonavir: Isavuconazonium Sulfate may increase serum concentration of Nirmatrelvir and Ritonavir. Nirmatrelvir and Ritonavir may increase serum concentration of Isavuconazonium Sulfate. Risk C: Monitor

Nirogacestat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Nirogacestat. Risk X: Avoid

Nisoldipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Nisoldipine. Risk X: Avoid

Nitrendipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Nitrendipine. Risk C: Monitor

Olaparib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Olaparib. Management: Avoid use of moderate CYP3A4 inhibitors with olaparib, if possible. If such concurrent use cannot be avoided, the dose of olaparib tablets should be reduced to 150 mg twice daily and the dose of olaparib capsules should be reduced to 200 mg twice daily. Risk D: Consider Therapy Modification

Oliceridine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Oliceridine. Risk C: Monitor

Olmutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Olmutinib. Risk C: Monitor

Omaveloxolone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Omaveloxolone. Management: Avoid this combination if possible. If coadministration is required, decrease the omaveloxolone dose to 100 mg daily and monitor closely for adverse reactions. If adverse reactions occur, decrease omaveloxolone to 50 mg daily. Risk D: Consider Therapy Modification

OxyCODONE: CYP3A4 Inhibitors (Moderate) may increase serum concentration of OxyCODONE. Serum concentrations of the active metabolite Oxymorphone may also be increased. Risk C: Monitor

PACLitaxel (Conventional): CYP3A4 Inhibitors (Moderate) may increase serum concentration of PACLitaxel (Conventional). Risk C: Monitor

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

Pacritinib: Isavuconazonium Sulfate may increase serum concentration of Pacritinib. Pacritinib may decrease serum concentration of Isavuconazonium Sulfate. Risk C: Monitor

Palbociclib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Palbociclib. Risk C: Monitor

Palovarotene: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Palovarotene. Management: Avoid concomitant use of palovarotene and moderate CYP3A4 inhibitors when possible. If combined, decrease palovarotene dose by 50% as described in the full interaction monograph. Monitor for palovarotene toxicities when combined. Risk D: Consider Therapy Modification

Panobinostat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Panobinostat. Risk C: Monitor

PAZOPanib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of PAZOPanib. Risk X: Avoid

Pemigatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pemigatinib. Management: If combined use cannot be avoided, reduce the pemigatinib dose from 13.5 mg daily to 9 mg daily, or from 9 mg daily to 4.5 mg daily. Resume prior pemigatinib dose after stopping the moderate inhibitor once 3 half-lives of the inhibitor has passed. Risk D: Consider Therapy Modification

Pexidartinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pexidartinib. Management: If combined use cannot be avoided, pexidartinib dose should be reduced as follows: reduce pexidartinib doses of 500 mg or 375 mg daily to 125 mg twice daily; reduce pexidartinib 250 mg daily to 125 mg once daily. Risk D: Consider Therapy Modification

Phenobarbital-Primidone: May decrease active metabolite exposure of Isavuconazonium Sulfate. Specifically, isavuconazole serum concentrations may be reduced. Risk X: Avoid

Pimavanserin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pimavanserin. Risk C: Monitor

Pimecrolimus: CYP3A4 Inhibitors (Moderate) may decrease metabolism of Pimecrolimus. Risk C: Monitor

Pimozide: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pimozide. Risk X: Avoid

Piperaquine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Piperaquine. Risk C: Monitor

Pirtobrutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pirtobrutinib. Risk C: Monitor

PONATinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of PONATinib. Risk C: Monitor

Pralsetinib: Inhibitors of CYP3A4 (Moderate) and P-glycoprotein may increase serum concentration of Pralsetinib. Management: If this combo cannot be avoided, decrease pralsetinib dose from 400 mg daily to 300 mg daily; from 300 mg daily to 200 mg daily; and from 200 mg daily to 100 mg daily. Risk D: Consider Therapy Modification

Prazepam: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Prazepam. Risk C: Monitor

Praziquantel: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Praziquantel. Risk C: Monitor

QUEtiapine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of QUEtiapine. Risk C: Monitor

Quinidine (Non-Therapeutic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Quinidine (Non-Therapeutic). Risk C: Monitor

QuiNIDine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of QuiNIDine. Risk C: Monitor

QuiNINE: CYP3A4 Inhibitors (Moderate) may increase serum concentration of QuiNINE. Risk C: Monitor

Ranolazine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ranolazine. Management: Limit the ranolazine dose to a maximum of 500 mg twice daily in patients concurrently receiving moderate CYP3A4 inhibitors. Monitor for increased ranolazine effects and toxicities during concomitant use. Risk D: Consider Therapy Modification

Red Yeast Rice: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Red Yeast Rice. Risk C: Monitor

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

Relugolix, Estradiol, and Norethindrone: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Relugolix, Estradiol, and Norethindrone. Management: Avoid use of relugolix/estradiol/norethindrone with P-glycoprotein (P-gp) inhibitors. If concomitant use is unavoidable, relugolix/estradiol/norethindrone should be administered at least 6 hours before the P-gp inhibitor. Risk D: Consider Therapy Modification

Relugolix: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Relugolix. Management: Avoid coadministration of relugolix with oral P-gp inhibitors whenever possible. If combined, take relugolix at least 6 hours prior to the P-gp inhibitor and monitor patients more frequently for adverse reactions. Risk D: Consider Therapy Modification

Repotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Repotrectinib. Risk X: Avoid

Ribociclib: Isavuconazonium Sulfate may increase serum concentration of Ribociclib. Ribociclib may increase serum concentration of Isavuconazonium Sulfate. Risk C: Monitor

Rifabutin: Isavuconazonium Sulfate may increase serum concentration of Rifabutin. Rifabutin may decrease serum concentration of Isavuconazonium Sulfate. Risk C: Monitor

RifAXIMin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of RifAXIMin. Risk C: Monitor

Rimegepant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Rimegepant. Management: If taking rimegepant for the acute treatment of migraine, avoid a second dose of rimegepant within 48 hours when used concomitantly with moderate CYP3A4 inhibitors. No dose adjustment needed if using rimegepant for prevention of episodic migraine. Risk D: Consider Therapy Modification

Rimegepant: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Rimegepant. Management: Avoid administration of another dose of rimegepant within 48 hours if given concomitantly with a P-glycoprotein (P-gp) inhibitor. Risk D: Consider Therapy Modification

Riociguat: Inhibitors of CYP3A4 (Moderate) and P-glycoprotein may increase serum concentration of Riociguat. Risk C: Monitor

RisperiDONE: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of RisperiDONE. Risk C: Monitor

Rivaroxaban: Inhibitors of CYP3A4 (Moderate) and P-glycoprotein may increase serum concentration of Rivaroxaban. Management: No action is needed in patients with normal renal function. Do not use this combination in patients with estimated creatinine clearance 15 to 80 mL/min unless prospective benefits outweigh the risks. Risk D: Consider Therapy Modification

Roflumilast-Containing Products: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Roflumilast-Containing Products. Risk C: Monitor

RomiDEPsin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of RomiDEPsin. Risk C: Monitor

Rupatadine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Rupatadine. Risk C: Monitor

Ruxolitinib (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ruxolitinib (Systemic). Risk C: Monitor

Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may decrease therapeutic effects of Saccharomyces boulardii. Risk X: Avoid

Salmeterol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Salmeterol. Risk C: Monitor

SAXagliptin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of SAXagliptin. Risk C: Monitor

Selpercatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Selpercatinib. Management: Avoid combination if possible. If use is necessary, reduce selpercatinib dose as follows: from 120 mg twice/day to 80 mg twice/day, or from 160 mg twice/day to 120 mg twice/day. Risk D: Consider Therapy Modification

Selumetinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Selumetinib. Management: Avoid concomitant use when possible. If combined, selumetinib dose reductions are recommended and vary based on body surface area and selumetinib dose. For details, see the full drug interaction monograph or selumetinib prescribing information. Risk D: Consider Therapy Modification

Sertindole: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sertindole. Risk X: Avoid

Sildenafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sildenafil. Risk C: Monitor

Silodosin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Silodosin. Risk C: Monitor

Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Silodosin. Risk C: Monitor

Simeprevir: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Simeprevir. Risk X: Avoid

Simvastatin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Simvastatin. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Simvastatin. Risk C: Monitor

Sirolimus (Conventional): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sirolimus (Conventional). Management: Monitor for increased serum concentrations of sirolimus if combined with a moderate CYP3A4 inhibitor. Lower initial sirolimus doses or sirolimus dose reductions will likely be required. Risk D: Consider Therapy Modification

Sirolimus (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Sirolimus (Conventional). Management: Avoid concurrent use of sirolimus with P-glycoprotein (P-gp) inhibitors when possible and alternative agents with lesser interaction potential with sirolimus should be considered. Monitor for increased sirolimus concentrations/toxicity if combined. Risk D: Consider Therapy Modification

Sirolimus (Protein Bound): P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Sirolimus (Protein Bound). Risk X: Avoid

Solifenacin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Solifenacin. Risk C: Monitor

Sonidegib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sonidegib. Management: Avoid concomitant use of sonidegib and moderate CYP3A4 inhibitors when possible. When concomitant use cannot be avoided, limit CYP3A4 inhibitor use to less than 14 days and monitor for sonidegib toxicity (particularly musculoskeletal adverse reactions). Risk D: Consider Therapy Modification

Sparsentan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sparsentan. Risk C: Monitor

St John's Wort: May decrease active metabolite exposure of Isavuconazonium Sulfate. Specifically, St Johns Wort may decrease isavuconazole serum concentrations. Risk X: Avoid

SUFentanil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of SUFentanil. Risk C: Monitor

SUNItinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of SUNItinib. Risk C: Monitor

Suvorexant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Suvorexant. Management: The recommended dose of suvorexant is 5 mg daily in patients receiving a moderate CYP3A4 inhibitor. The dose can be increased to 10 mg daily (maximum dose) if necessary for efficacy. Risk D: Consider Therapy Modification

Suzetrigine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Suzetrigine. Management: Reduce suzetrigine dose as follows: initiate with 100 mg for 1 dose; then 12 hours after first dose, give 50 mg every 12 hours for doses 2, 3, and 4; then 50 mg every 24 hours for dose 5 and thereafter. Risk D: Consider Therapy Modification

Tacrolimus (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor

Tacrolimus (Topical): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tacrolimus (Topical). Risk C: Monitor

Tadalafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tadalafil. Risk C: Monitor

Talazoparib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Talazoparib. Risk C: Monitor

Tamsulosin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tamsulosin. Risk C: Monitor

Tazemetostat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tazemetostat. Management: Avoid when possible. If combined, reduce tazemetostat dose from 800 mg twice daily to 400 mg twice daily, from 600 mg twice daily to 400 mg in AM and 200 mg in PM, or from 400 mg twice daily to 200 mg twice daily. Risk D: Consider Therapy Modification

Temsirolimus: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Temsirolimus. Specifically, concentrations of sirolimus may be increased. Risk C: Monitor

Teniposide: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Teniposide. Risk C: Monitor

Tenofovir Disoproxil Fumarate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor

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

Tetrahydrocannabinol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tetrahydrocannabinol. Risk C: Monitor

Tezacaftor and Ivacaftor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tezacaftor and Ivacaftor. Management: If combined with moderate CYP3A4 inhibitors, give tezacaftor/ivacaftor in the morning, every other day; give ivacaftor in the morning, every other day on alternate days. Tezacaftor/ivacaftor dose depends on age and weight; see full Lexi-Interact monograph Risk D: Consider Therapy Modification

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

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

Tilidine: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Tilidine. CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tilidine. Risk C: Monitor

Tofacitinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tofacitinib. Risk C: Monitor

Tolterodine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tolterodine. Risk C: Monitor

Tolvaptan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tolvaptan. Management: Avoid this combination with Samsca brand of tolvaptan. Reduce dose for Jynarque brand: 90 mg AM and 30 mg PM, reduce to 45 mg AM and 15 mg PM; 60 mg AM and 30 mg PM, reduce to 30 mg AM and 15 mg PM; 45 mg AM and 15 mg PM, reduce to 15 mg AM and PM. Risk D: Consider Therapy Modification

Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Topotecan. Risk X: Avoid

Toremifene: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Toremifene. Risk C: Monitor

Trabectedin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Trabectedin. Risk C: Monitor

TraMADol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of TraMADol. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of TraMADol. Risk C: Monitor

TraZODone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of TraZODone. Risk C: Monitor

Tretinoin (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tretinoin (Systemic). Risk C: Monitor

Triamcinolone (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Triamcinolone (Systemic). Risk C: Monitor

Triazolam: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Triazolam. Management: Consider triazolam dose reduction in patients receiving concomitant moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Ubrogepant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and avoid a second dose for 24 hours when used with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Ubrogepant: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a P-gp inhibitor. Risk D: Consider Therapy Modification

Udenafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Udenafil. Risk C: Monitor

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

Vamorolone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vamorolone. Risk C: Monitor

Vanzacaftor, Tezacaftor, and Deutivacaftor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vanzacaftor, Tezacaftor, and Deutivacaftor. Management: Age- and weight-specific dose reductions of vanzacaftor, tezacaftor, and deutivacaftor are recommended. Please see full Interact monograph or labeling for details. Risk D: Consider Therapy Modification

Vardenafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vardenafil. Management: Limit Levitra (vardenafil) dose to a single 5 mg dose within a 24-hour period if combined with moderate CYP3A4 inhibitors. Avoid concomitant use of Staxyn (vardenafil) and moderate CYP3A4 inhibitors. Combined use is contraindicated outside of the US. Risk D: Consider Therapy Modification

Vemurafenib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vemurafenib. Risk C: Monitor

Venetoclax: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients requiring concomitant treatment with moderate CYP3A4 inhibitors. Resume the previous venetoclax dose 2 to 3 days after discontinuation of moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Verapamil: Isavuconazonium Sulfate may increase serum concentration of Verapamil. Verapamil may increase serum concentration of Isavuconazonium Sulfate. Risk C: Monitor

Vilazodone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vilazodone. Risk C: Monitor

VinBLAStine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of VinBLAStine. Risk C: Monitor

VinCRIStine: Isavuconazonium Sulfate may increase serum concentration of VinCRIStine. Risk X: Avoid

Vindesine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vindesine. Risk C: Monitor

Vinflunine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vinflunine. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Vinflunine. Risk C: Monitor

Voclosporin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Voclosporin. Management: Decrease the voclosporin dose to 15.8 mg in the morning and 7.9 mg in the evening when combined with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Vorapaxar: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vorapaxar. Risk C: Monitor

Zanubrutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Zanubrutinib. Management: Decrease the zanubrutinib dose to 80 mg twice daily during coadministration with a moderate CYP3A4 inhibitor. Further dose adjustments may be required for zanubrutinib toxicities, refer to prescribing information for details. Risk D: Consider Therapy Modification

Zopiclone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Zopiclone. Risk C: Monitor

Zuranolone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Zuranolone. Risk C: Monitor

Reproductive Considerations

Evaluate pregnancy status prior to use; patients who could become pregnant should use effective contraception during therapy and for 28 days after the last isavuconazonium sulfate dose.

Pregnancy Considerations

Based on data from animal reproduction studies, in utero exposure to isavuconazonium sulfate may cause fetal harm.

Breastfeeding Considerations

It is not known if isavuconazonium sulfate is present breast milk.

The manufacturer recommends breastfeeding be discontinued during maternal isavuconazonium sulfate therapy.

Monitoring Parameters

Hypersensitivity reactions with initial doses, LFTs (eg AST, ALT, alkaline phosphatase, total bilirubin) at baseline and periodically during therapy. Infusion-related reactions (eg hypotension, dyspnea, chills, dizziness, paresthesias, hypoesthesia) during IV infusion.

Routine therapeutic drug monitoring is not recommended; consider assessing serum drug concentrations if there is concern for toxicity, therapeutic failure, or possibility of impaired drug absorption (Adamsick 2019; Andes 2018; McCreary 2020; MSG-ERC [Johnson 2020]; Schmitt-Hoffman 2009).

Reference Range

Optimal drug concentrations have not been established; however, most adult patients achieve levels >1 mg/L with standard dosing regimens; an upper limit associated with toxicity has not been determined (Andes 2018; Desai 2017).

Mechanism of Action

Isavuconazonium sulfate is a prodrug that is rapidly hydrolyzed in the blood to active isavuconazole. Isavuconazole inhibits the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14-alpha-demethylase. This enzyme is responsible for the conversion of lanosterol to ergosterol. An accumulation of methylated sterol precursors and a depletion of ergosterol within the fungal cell membrane weakens the membrane structure and function.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vss: Isavuconazole: IV: ~450 L.

Protein binding: Isavuconazole: >99% (primarily to albumin).

Metabolism: Isavuconazonium sulfate (prodrug) is rapidly hydrolyzed in the blood by esterases to active isavuconazole and an inactive cleavage product. Isavuconazole is metabolized by CYP3A4, CYP 3A5, and UGT.

Bioavailability: Oral: Isavuconazole: 98%.

Half-life elimination: IV: Isavuconazole: 130 hours.

Time to peak: Isavuconazole:

IV: Children and Adolescents: Median range: 1.07 to 1.08 hours (range: 1.02 to 1.35 hours) (Arrieta 2021).

Oral:

Children ≥6 years and Adolescents: Median range: 3.98 to 4 hours (range: 1.98 to 8.03 hours) (Arrieta 2021).

Adults: 2 to 3 hours.

Excretion: Urine (<1% as unchanged isavuconazole); feces (33% as unchanged isavuconazole) (Townsend 2018).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Patients with mild and moderate hepatic impairment had 40% and 48% lower isavuconazole Cl values, respectively, compared with healthy subjects, resulting in 64% and 84% increased drug exposure, respectively. In addition, patients with moderate hepatic impairment had 30% lower Cmax, compared with healthy subjects.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Cresemba;
  • (AR) Argentina: Cresemba;
  • (AT) Austria: Cresemba;
  • (AU) Australia: Cresemba;
  • (BE) Belgium: Cresemba;
  • (BG) Bulgaria: Cresemba;
  • (BR) Brazil: Cresemba;
  • (CH) Switzerland: Cresemba;
  • (CL) Chile: Cresemba;
  • (CO) Colombia: Cresemba;
  • (CZ) Czech Republic: Cresemba;
  • (DE) Germany: Cresemba;
  • (EC) Ecuador: Cresemba;
  • (EE) Estonia: Cresemba;
  • (ES) Spain: Cresemba;
  • (FI) Finland: Cresemba;
  • (FR) France: Cresemba;
  • (GB) United Kingdom: Cresemba;
  • (GR) Greece: Cresemba;
  • (HU) Hungary: Cresemba;
  • (IE) Ireland: Cresemba;
  • (IN) India: Cresemba | Isavufic | Isuvaz;
  • (IT) Italy: Cresemba;
  • (JO) Jordan: Cresemba;
  • (JP) Japan: Cresemba;
  • (KR) Korea, Republic of: Cresemba;
  • (LT) Lithuania: Cresemba;
  • (LU) Luxembourg: Cresemba;
  • (LV) Latvia: Cresemba;
  • (MX) Mexico: Cresemba;
  • (MY) Malaysia: Cresemba;
  • (NL) Netherlands: Cresemba;
  • (NO) Norway: Cresemba;
  • (PE) Peru: Cresemba;
  • (PR) Puerto Rico: Cresemba;
  • (PT) Portugal: Cresemba;
  • (QA) Qatar: Cresemba;
  • (RO) Romania: Cresemba;
  • (RU) Russian Federation: Cresemba;
  • (SA) Saudi Arabia: Cresemba;
  • (SE) Sweden: Cresemba;
  • (SG) Singapore: Cresemba;
  • (SI) Slovenia: Cresemba;
  • (SK) Slovakia: Cresemba;
  • (TW) Taiwan: Cresemba
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