Version July 2025
Chronic myeloid leukemia, Philadelphia chromosome positive (Ph+), chronic phase, newly diagnosed: Oral: 80 mg once daily or 40 mg twice daily; continue as long as clinical benefit is observed or until unacceptable toxicity occurs (Ref).
Chronic myeloid leukemia, Philadelphia chromosome positive (Ph+), chronic phase, previously treated: Oral: 80 mg once daily or 40 mg twice daily; continue as long as clinical benefit is observed or until unacceptable toxicity occurs (Ref).
Chronic myeloid leukemia, Philadelphia chromosome positive, chronic phase, with T315I mutation: Oral: 200 mg twice daily; continue as long as clinical benefit is observed or until unacceptable toxicity occurs (Ref).
Missed dose: If a once-daily dose is missed by more than ~12 hours, skip the missed dose and administer the next dose as scheduled. If a twice-daily dose is missed by more than ~6 hours, skip the missed dose and administer the next dose as scheduled.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
eGFR 15 to 89 mL/minute/1.73 m2 (not requiring dialysis): No dosage adjustment is necessary.
Patients requiring dialysis: There are no dosage adjustments provided in the manufacturer's labeling.
No dosage adjustment is necessary.
|
Dose reduction |
Dose for Ph+ chronic phase CML (newly diagnosed or previously treated) |
Dose for Ph+ chronic phase CML with the T315I mutation |
|---|---|---|
|
a CML = Chronic myeloid leukemia. | ||
|
Initial (usual) dose |
80 mg once daily or 40 mg twice daily |
200 mg twice daily |
|
First dose reduction |
40 mg once daily or 20 mg twice daily |
160 mg twice daily |
|
Subsequent dose reduction |
Permanently discontinue asciminib if unable to tolerate 40 mg once daily or 20 mg twice daily. |
Permanently discontinue asciminib if unable to tolerate 160 mg twice daily. |
|
Adverse reaction |
Severity |
Dosage modification |
|---|---|---|
|
Hematologic toxicity | ||
|
Neutropenia and/or thrombocytopenia |
ANC <1,000/mm3 and/or platelets <50,000/mm3 |
Withhold asciminib until ANC is ≥1,000 mm3 and/or platelets are ≥50,000/mm3. Resolution within 2 weeks: Resume asciminib at the same (starting) dose. Resolution after >2 weeks: Resume asciminib at a reduced dose. Recurrent severe neutropenia and/or thrombocytopenia: Withhold asciminib until ANC is ≥1,000 mm3 and/or platelets are ≥50,000/mm3, then resume asciminib at a reduced dose. |
|
Nonhematologic toxicity | ||
|
Cardiovascular toxicity (including ischemic cardiac and CNS conditions, arterial thrombotic and embolic conditions, heart failure, and arrhythmia) |
Any |
Initiate appropriate treatment as clinically indicated. |
|
≥ Grade 3 |
Withhold asciminib until recovery to ≤ grade 1, then resume at a reduced dose. If not resolved, permanently discontinue asciminib. | |
|
GI (ie, pancreatic) toxicity |
Asymptomatic amylase and/or lipase elevation >2 × ULN |
Withhold asciminib until resolved to <1.5 × ULN, then resume at a reduced dose. If not resolved, permanently discontinue asciminib and evaluate for pancreatitis. If amylase and/or lipase elevation >2 × ULN recurs (at the reduced dose), permanently discontinue asciminib. |
|
Amylase and lipase elevations with concomitant abdominal symptoms |
Temporarily withhold asciminib and evaluate as clinically necessary to exclude pancreatitis. | |
|
Hypersensitivity reactions |
Any |
Initiate appropriate treatment as clinically indicated. |
|
≥ Grade 3 |
Withhold asciminib until recovery to ≤ grade 1, then resume at a reduced dose. If not resolved, permanently discontinue asciminib. | |
|
Hypertension |
Any |
Monitor and manage with standard antihypertensive therapy as clinically indicated. |
|
≥ Grade 3 |
Withhold asciminib until recovery to ≤ grade 1, then resume at a reduced dose. If not resolved, permanently discontinue asciminib. | |
|
Other adverse reactions |
≥ Grade 3 |
Withhold asciminib until recovery to ≤ grade 1, then resume at a reduced dose. If not resolved, permanently discontinue asciminib. |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults receiving either 40 mg twice daily or 80 mg once daily dosing.
>10%:
Cardiovascular: Hypertension (≤14%), increased serum creatine kinase (30%)
Dermatologic: Skin rash (18% to 19%)
Endocrine & metabolic: Decreased serum calcium (corrected: 16% to 42%), decreased serum phosphate (18%), decreased serum potassium (11%), hypercholesterolemia (12% to 34%), increased serum triglycerides (20% to 44%), increased uric acid (21% to 33%)
Gastrointestinal: Abdominal pain (14%), diarrhea (13% to 16%), increased serum amylase (13%), increased serum lipase (15% to 37%), nausea (≤12%; grades 3/4: <1%)
Hematologic & oncologic: Decreased hemoglobin (24% to 37%; grades 3/4: 2% to 3%; including anemia), decreased neutrophils (43% to 46%; grades 3/4: 12% to 22%; including neutropenia), decreased platelet count (46% to 48%; grades 3/4: 12% to 24%; including thrombocytopenia), leukopenia (54%; grades 3/4: 5%), lymphocytopenia (20% to 71%; grades 3/4: 3%)
Hepatic: Increased serum alanine aminotransferase (26% to 27%), increased serum alkaline phosphatase (13% to 25%), increased serum aspartate aminotransferase (21%), increased serum bilirubin (12%)
Hypersensitivity: Hypersensitivity reaction
Nervous system: Fatigue (18% to 20%), headache (14% to 21%)
Neuromuscular & skeletal: Arthralgia (≤13%), musculoskeletal pain (24% to 25%)
Renal: Increased serum creatinine (15%)
Respiratory: Upper respiratory tract infection (15% to 26%)
1% to 10%:
Cardiovascular: Cardiac arrhythmia (<10%), edema (<10%), heart failure (<10%), palpitations (<10%), prolonged QT interval on ECG (<10%)
Dermatologic: Pruritus (<10%), urticaria (<10%)
Endocrine & metabolic: Hypothyroidism (<10%)
Gastrointestinal: Constipation (<10%), decreased appetite (<10%), pancreatitis (<10%), vomiting (<10%)
Genitourinary: Urinary tract infection (<10%)
Hematologic & oncologic: Febrile neutropenia (<10%), hemorrhage (<10%)
Infection: Influenza (<10%)
Nervous system: Dizziness (<10%), peripheral neuropathy (<10%)
Ophthalmic: Blurred vision (<10%), dry eye syndrome (<10%)
Respiratory: Cough (<10%), dyspnea (<10%), lower respiratory tract infection (<10%), pleural effusion (<10%), pneumonia (<10%)
Miscellaneous: Fever (<10%)
Frequency not defined: Cardiovascular: Cardiovascular toxicity (arterial thromboembolism, cerebral ischemia, ischemic heart disease, thromboembolic disease)
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to asciminib or any component of the formulation.
Concerns related to adverse effects:
• Bone marrow suppression: Thrombocytopenia, neutropenia, and anemia have occurred with asciminib, including grade 3 and 4 events. The median time to first occurrence of grade 3 or 4 thrombocytopenia, neutropenia, or anemia was 6 weeks (range: 0.1 to 64 weeks), 7 weeks (range: 0.1 to 180 weeks), or 22 weeks (range: 0.1 to 207 weeks), respectively.
• Cardiovascular toxicity: Cardiovascular toxicity, including ischemic cardiac and CNS conditions, arterial thrombotic and embolic conditions, and heart failure, has been reported (including fatalities). Grade 3 and 4 cardiovascular toxicity has occurred, as well as cases of grade 3 and 4 cardiac failure. In most cases, cardiovascular toxicity occurred in patients with preexisting cardiovascular conditions or risk factors, and/or prior exposure to multiple tyrosine kinase inhibitors. Arrhythmia (including QTc prolongation) has been reported, including grade 3 or 4 events.
• GI toxicity: Pancreatitis has been reported with asciminib, including cases of grade 3 pancreatitis. Lipase and amylase elevations occurred in nearly one-fifth of patients; grade 3 and 4 pancreatic enzyme elevations also were reported.
• Hypersensitivity: Hypersensitivity reactions were reported in almost one-third of patients, including rare grade 3 or 4 events. Reactions included rash, edema, and bronchospasm.
• Hypertension: Hypertension has occurred with asciminib, including grade 3 and 4 hypertension. The median time to first occurrence of grade 3 or 4 hypertension was 32 weeks (range: 0.1 to 365 weeks).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Scemblix: 20 mg, 40 mg, 100 mg
No
Tablets (Scemblix Oral)
20 mg (per each): $447.30
40 mg (per each): $447.30
100 mg (per each): $447.30
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Scemblix: 20 mg, 40 mg
Asciminib is available through specialty pharmacies/distributors and various specialty institutions or accounts. Examples from the manufacturer may be found at https://www.scemblix-hcp.com/sites/scemblix_hcp_com/files/documents/scemblix-specialty-pharmacy-network-flashcard-digital.pdf.
Oral: Administer on an empty stomach; avoid food for at least 2 hours before and 1 hour after asciminib administration. If administering once daily, administer at approximately the same time each day; if administering twice daily, administer approximately every 12 hours. Swallow tablets whole; do not break, crush, or chew.
This medication is not on the NIOSH (2024) list; however, it may meet the criteria for a hazardous drug. Asciminib may cause reproductive toxicity, teratogenicity, and has a structural or toxicity profile similar to existing hazardous agents.
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.
Chronic myeloid leukemia, Philadelphia chromosome positive, chronic phase:
Treatment of newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase in adults.
Treatment of previously treated Ph+ CML in chronic phase in adults.
Treatment of Ph+ CML in chronic phase with the T315I mutation in adults.
Asciminib may be confused with abciximab, abemaciclib, afatinib, alectinib, alpelisib, avapritinib, axitinib, bosutinib, dasatinib, imatinib, nilotinib, ponatinib.
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).
Substrate of BCRP, 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; Inhibits CYP2C8 (Weak), CYP2C9 (Moderate), CYP3A4 (Weak);
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.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Alitretinoin (Systemic): CYP2C9 Inhibitors (Moderate) may increase serum concentration of Alitretinoin (Systemic). Management: Consider reducing the alitretinoin dose to 10 mg when used together with moderate CYP2C9 inhibitors. Monitor for increased alitretinoin effects/toxicities if combined with a moderate CYP2C9 inhibitor. Risk D: Consider Therapy Modification
ALPRAZolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of ALPRAZolam. Risk C: Monitor
Androgens: Hypertension-Associated Agents may increase hypertensive effects of Androgens. Risk C: Monitor
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Atorvastatin: Asciminib may increase serum concentration of Atorvastatin. Risk X: Avoid
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors): Asciminib may increase serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Cannabis: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Cannabis. More specifically, tetrahydrocannabinol serum concentrations may be increased. Risk C: Monitor
CarBAMazepine: CYP3A4 Inhibitors (Weak) may increase serum concentration of CarBAMazepine. Risk C: Monitor
Carvedilol: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Carvedilol. Specifically, concentrations of the S-carvedilol enantiomer may be increased. Risk C: Monitor
Celecoxib: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Celecoxib. Risk C: Monitor
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CycloSPORINE (Systemic): CYP3A4 Inhibitors (Weak) may increase serum concentration of CycloSPORINE (Systemic). Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of Asciminib. Risk C: Monitor
Daprodustat: CYP2C8 Inhibitors (Weak) may increase serum concentration of Daprodustat. Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Deuruxolitinib: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Deuruxolitinib. Risk X: Avoid
Diclofenac (Systemic): CYP2C9 Inhibitors (Moderate) may increase serum concentration of Diclofenac (Systemic). Risk C: Monitor
Dofetilide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Dofetilide. Risk C: Monitor
DroNABinol: CYP2C9 Inhibitors (Moderate) may increase serum concentration of DroNABinol. Risk C: Monitor
Erdafitinib: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Erdafitinib. Management: Avoid concomitant use of erdafitinib and moderate CYP2C9 inhibitors when possible. If combined, monitor closely for erdafitinib adverse reactions and consider dose modifications accordingly. Risk D: Consider Therapy Modification
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Etravirine: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Etravirine. Risk C: Monitor
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Finerenone: CYP3A4 Inhibitors (Weak) may increase serum concentration of Finerenone. Risk C: Monitor
Flibanserin: CYP3A4 Inhibitors (Weak) may increase serum concentration of Flibanserin. Risk C: Monitor
Flurbiprofen (Systemic): CYP2C9 Inhibitors (Moderate) may increase serum concentration of Flurbiprofen (Systemic). Risk C: Monitor
Fluvastatin: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Fluvastatin. Management: Fluvastatin should be used at the lowest effective dose and should not exceed 20 mg twice daily when combined with moderate CYP2C9 inhibitors. Avoid coadministration of fluvastatin extended-release tablets with moderate CYP2C9 inhibitors. Risk D: Consider Therapy Modification
Fosphenytoin-Phenytoin: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor
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
Imatinib: May increase serum concentration of Asciminib. Risk C: Monitor
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Itraconazole: May decrease serum concentration of Asciminib. Specifically, the hydroxypropyl-beta-cyclodextrin contained in oral itraconazole solution may decrease asciminib concentrations. Risk X: Avoid
Ixabepilone: CYP3A4 Inhibitors (Weak) may increase serum concentration of Ixabepilone. Risk C: Monitor
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Lemborexant: CYP3A4 Inhibitors (Weak) may increase serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Lomitapide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Risk D: Consider Therapy Modification
Lornoxicam: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Lornoxicam. Risk C: Monitor
Losartan: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Losartan. CYP2C9 Inhibitors (Moderate) may decrease active metabolite exposure of Losartan. Risk C: Monitor
Meloxicam: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Meloxicam. Risk C: Monitor
Methadone: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Methadone. Risk C: Monitor
Midazolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of Midazolam. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nateglinide: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Nateglinide. Risk C: Monitor
NiMODipine: CYP3A4 Inhibitors (Weak) may increase serum concentration of NiMODipine. Risk C: Monitor
OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors): Asciminib may increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Asciminib may increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Parecoxib: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Parecoxib. Specifically, serum concentrations of the active moiety valdecoxib may be increased. Management: Use the lowest effective dose of parecoxib and consider a dose reduction in patients taking moderate CYP2C9 inhibitors. Risk D: Consider Therapy Modification
PHENobarbital: CYP2C9 Inhibitors (Moderate) may increase serum concentration of PHENobarbital. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pimozide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Pimozide. Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ramelteon: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Ramelteon. Risk C: Monitor
Repaglinide: CYP2C8 Inhibitors (Weak) may increase serum concentration of Repaglinide. Risk C: Monitor
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Rosuvastatin: Asciminib may increase serum concentration of Rosuvastatin. Risk X: Avoid
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Seladelpar: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Seladelpar. Risk C: Monitor
Simvastatin: CYP3A4 Inhibitors (Weak) may increase serum concentration of Simvastatin. CYP3A4 Inhibitors (Weak) may increase active metabolite exposure of Simvastatin. Risk C: Monitor
Siponimod: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Siponimod. Risk C: Monitor
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sirolimus (Conventional): CYP3A4 Inhibitors (Weak) may increase serum concentration of Sirolimus (Conventional). Risk C: Monitor
Sirolimus (Protein Bound): CYP3A4 Inhibitors (Weak) may increase serum concentration of Sirolimus (Protein Bound). Management: Reduce the dose of protein bound sirolimus to 56 mg/m2 when used concomitantly with a weak CYP3A4 inhibitor. Risk D: Consider Therapy Modification
Solriamfetol: May increase hypertensive effects of Hypertension-Associated Agents. Risk C: Monitor
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Sulfonylureas: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Sulfonylureas. Risk C: Monitor
Tacrolimus (Systemic): CYP3A4 Inhibitors (Weak) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tetrahydrocannabinol and Cannabidiol: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Tetrahydrocannabinol and Cannabidiol. Specifically, concentrations of tetrahydrocannabinol may be increased. Risk C: Monitor
Tetrahydrocannabinol: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Tetrahydrocannabinol. Risk C: Monitor
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Torsemide: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Torsemide. Risk C: Monitor
Triazolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of Triazolam. Risk C: Monitor
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Ubrogepant: CYP3A4 Inhibitors (Weak) may increase serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (given at least 2 hours later if needed) of ubrogepant should be limited to 50 mg. Risk D: Consider Therapy Modification
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Vitamin K Antagonists: CYP2C9 Inhibitors (Moderate) may increase serum concentration of Vitamin K Antagonists. Risk C: Monitor
Voriconazole: Asciminib may increase serum concentration of Voriconazole. Voriconazole may increase serum concentration of Asciminib. Risk C: Monitor
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
The AUC and Cmax of asciminib decreased by 62% and 68%, respectively, with a high-fat meal (1,000 calories, 50% fat) and by 30% and 35%, respectively, with a low-fat meal (400 calories, 25% fat) compared to the fasted state. Management: Administer on an empty stomach.
Verify pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 1 week after the last asciminib dose.
Changes in menstrual patterns have been reported with tyrosine kinase inhibitor (TKI) therapy (Yu 2019).
Based on the mechanism of action, TKIs have the potential to adversely affect fertility by acting on receptors in the ovaries or testis, primarily when administered prior to puberty in males. Although there are cases showing difficulty conceiving, successful pregnancies have also been reported. Fertility data related to long-term TKI use are limited. Recommendations are available for fertility preservation prior to TKI treatment (ASCO [Oktay 2018]; Madabhavi 2019; Rambhatla 2021).
Patients planning to become pregnant but currently receiving a TKI should minimize the risk of first trimester exposure (Rambhatla 2021). Discontinuing TKI therapy for chronic myeloid leukemia can be considered if the patient is eligible for a tumor-free remission, allowing a washout period before attempting to conceive (Baccarani 2019; ELN [Hochhaus 2020]; Madabhavi 2019). Because the time to conception can be highly variable, treatment may also be discontinued at the first positive pregnancy test, prior to organogenesis in select patients (Abruzzese 2020).
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to asciminib may cause fetal harm.
Treatment of chronic myeloid leukemia in pregnant patients should be individualized based on gestational age, hematologic parameters, and clinical condition at presentation. If pregnancy is detected in the first trimester in patients already on a tyrosine kinase inhibitor (TKI), treatment should be discontinued as soon as pregnancy is confirmed. Treatments other than a TKI are recommended in pregnant patients not eligible for a tumor-free remission. If a TKI is needed, use of agents other than asciminib may be considered after the first trimester. Close maternal and fetal monitoring is recommended (Abruzzese 2020; BSH [Smith 2020]; ELN [Hochhaus 2020]; Madabhavi 2019).
The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy. The guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team) approach (ESMO [Peccatori 2013]).
A long-term observational research study is collecting information about the diagnosis and treatment of cancer during pregnancy. For additional information about the pregnancy and cancer registry or to become a participant, contact Cooper Health (1-877-635-4499).
It is not known if asciminib is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 1 week after the last asciminib dose. Patients diagnosed with chronic myeloid leukemia requiring a tyrosine kinase inhibitor may consider short-term breastfeeding for the first 2 to 5 days postpartum to provide the benefits of colostrum to the newborn prior to starting or restarting therapy (Abruzzese 2020; Madabhavi 2019).
CBC every 2 weeks for the first 3 months and monthly thereafter or as clinically necessary; serum lipase and amylase levels monthly during treatment or as clinically necessary (monitor more frequently in patients with a history of pancreatitis). Verify pregnancy status prior to use in patients who could become pregnant. Monitor BP. Monitor for signs/symptoms of hypersensitivity reactions, myelosuppression, cardiovascular toxicity (in patients with a history of cardiovascular risk factors), and pancreatic toxicity (monitor more frequently in patients with a history of pancreatitis). Monitor adherence.
Additional cardiovascular monitoring: Comprehensive assessment prior to treatment including a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking; repeat assessment every 3 months for the first year and then every 6 to 12 months thereafter (ASCO [Armenian 2017], ESC [Lyon 2022]). ECG at baseline. Consider baseline echocardiography in all patients; repeat every 3 months for high- and very high-risk patients (ESC [Lyon 2022]).
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.
Asciminib potently inhibits ABL1 kinase activity of the BCR-ABL1 fusion protein via allosteric binding to the ABL myristoyl pocket; it is a STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor (Réa 2021). Asciminib demonstrated activity against wild-type BCR-ABL1 and several mutant forms (including T315I).
Distribution: Vdss: 151 L.
Protein binding: 97% to plasma proteins (in vitro).
Metabolism: Primarily hepatic via CYP3A4-mediated oxidation, and UGT2B7- and UGT2B17-mediated glucuronidation.
Half-life elimination: 5.5 hours (40 mg twice daily and 80 mg once daily doses); 9 hours (200 mg twice daily dose).
Time to peak: Median: 2.5 hours (range: 2 to 3 hours).
Excretion: Feces (80%; 57% as unchanged drug); urine (11%; 2.5% as unchanged drug). Asciminib is eliminated via biliary secretion via breast cancer–resistant protein.
Clearance: 6.7 L/hour (40 mg twice daily and 80 mg once daily doses); 4.1 L/hour (200 mg twice daily dose).
