Asciminib Dosage

Medically reviewed by Drugs.com. Last updated on Mar 13, 2024.

Usual Adult Dose for Chronic Myelogenous Leukemia

Philadelphia chromosome-positive chronic myeloid leukemia I chronic phase (Ph+ CML-CP)

Ph+ CML-CP Previously Treated with 2 or More TKIs (tyrosine kinase inhibitors):
Recommended dose: 80 mg orally once a day OR 40 mg orally every 12 hours
Duration of therapy: Continue as long as clinical benefit is observed or until unacceptable toxicity occurs

Ph+ CML-CP with the T315I Mutation:
Recommended dose:: 200 mg orally every 12 hours

Comments:

• This drug is approved under accelerated approval based on major molecular response; continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials
• For recommended dosage modifications for the management of adverse reactions; see Dose Adjustments.

Uses:

• Treatment of Ph+ CML in CP, previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
• Treatment of Ph+ CML in CP with the T315I mutation

Renal Dose Adjustments

Mild to severe renal impairment (eGFR 15 to 89 mL/min/1.73 m2): No adjustment recommended
ESRD (eGFR less than 15 mL/min/1.73 m2) Data not available

Liver Dose Adjustments

Mild to severe hepatic impairment: No adjustment recommended

Dose Adjustments

Dose Reductions for Adverse Reactions:

Ph+ CML-CP Previously treated with 2 or more TKIs:

• FIRST REDUCTION: 40 mg once a day OR 20 mg twice a day
• SUBSEQUENT REDUCTION: Permanently discontinue in patients unable to tolerate reduced dose

Ph+ CML-CP with T315I Mutation:

• FIRST REDUCTION: 160 mg twice a day
• SUBSEQUENT REDUCTION: Permanently discontinue in patients unable to tolerate reduced dose

THROMBOCYTOPENIA and/or NEUTROPENIA: Absolute Neutrophil Count (ANC) less than 1 x 10(9)/L and or Platelets (PLT) less than 50 x 10(9)/L:

• WITHHOLD therapy until resolved to ANC of 1 x 10(9)/L or greater and/or PLT of 50 x 10(9)/L or greater
• If resolved within 2 weeks: Resume at starting dose
• If resolved after more than 2 weeks: Resume at reduced dose

For recurrent severe thrombocytopenia and/or neutropenia, hold until resolved ANC is 1 x 10(9)/L or greater and PLT is 50 x 10(9)/L or greater, then resume at reduced dose

ASYMPTOMATIC AMYLASE and/or LIPASE ELEVATION: Elevation greater than 2 x ULN:

• WITHHOLD until resolved to less than 1.5 x ULN
• If resolved, restart at reduced dose; if event recurs at reduced dose, permanently discontinue
• If not resolved, permanently discontinue; perform diagnostic tests to exclude pancreatitis

NON-HEMATOLOGIC ADVERSE REACTIONS: Grade 3 or higher:

• WITHHOLD until recovery to Grade 1 or less
• If resolved, resume at reduced dose
• If not resolved, permanently discontinue

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally without food; avoid consuming food for 2 hours before and 1 hour after dosing.
• Once-daily doses should be taken at the same time each day; twice-daily doses should be taken at approximately 12-hour intervals.
• Tablets should be swallowed whole; do not break, crush, or chew tablets.

MISSED DOSE:

• Once-daily regimen: If a dose is missed by more than approximately 12 hours, skip the dose and take the next dose as scheduled
• Twice-daily regimen: If a dose is missed by more than approximately 6 hours, skip the dose and take the next dose as scheduled

Storage requirements:

• Dispense and store in the original container to protect from moisture
• Store at 20C to 25C (68F to 77F), with excursions permitted between 15C and 30C (59F and 86F)

General:

• This drug is approved under accelerated approval based on major molecular response; continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Monitoring:

• Obtain complete blood counts (CBC) every 2 weeks for the first 3 months, then monthly thereafter, or as clinically indicated; monitor for signs and symptoms of myelosuppression.
• Obtain serum lipase and amylase levels monthly, or as clinically indicated; monitor for signs and symptoms of pancreatic toxicity, especially in patients with a history of pancreatitis.
• Monitor blood pressure.
• Monitor for hypersensitivity reactions.
• Monitor for patients with cardiovascular risk factors for worsening or new cardiovascular signs and symptoms.

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
• Patients should be advised to report signs and symptoms of infection, bleeding, pancreatitis, hypersensitivity, hypertension, or cardiovascular toxicity.
• Women of childbearing potential should understand the potential risk to fetus if this drug is used during pregnancy; women should be advised to use effective contraception during treatment and for 1 week after the last dose.
• Women should not breastfeed during treatment and for 1 week after the last dose.
• Patients should be advised that this drug may interact with other medications and alter the effects of this drug; patients should be advised to report all medication use including over the counter and herbal supplements, to their healthcare provider.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer