Pricing
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All price changes →Indications & Uses
Ascimib is indicated for:
Pharmacology
Asciminib is an ABL/BCR-ABL1 tyrosine kinase inhibitor. It blocks the ABL1 kinase activity of the BCRABL1 fusion protein by binding to the ABL myristoyl pocket. In studies done in vitro and in animal models of CML, asciminib was active against wild-type BCR-ABL1 and against several mutant forms of the kinase, including the T315I mutation.
Steady-state exposure to asciminib (AUC and Cmax) rises slightly more than dose proportionally across the dose range of 10 to 200 mg (0.25 to 5 times the recommended 80 mg daily dosage), given once or twice daily. Pharmacokinetic parameters are shown as geometric mean (CV%) unless otherwise stated.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Recommended dosage in patients with Ph+ CML-CP, previously treated with two or more TKIs: the dose of Asciminib is 80 mg taken orally once daily at approximately the same time each day, or 40 mg twice daily at approximately 12-hour intervals. Take it by mouth without food. Avoid eating for at least 2 hours before and 1 hour after taking Asciminib. Continue treatment as long as clinical benefit is seen or until unacceptable toxicity occurs.
Recommended dosage in patients with Ph+ CML-CP with the T315I mutation: the dose of Asciminib is 200 mg taken orally twice daily at approximately 12-hour intervals. Again, take it without food, and avoid eating for at least 2 hours before and 1 hour after the dose.
Missed dose: on the once daily dosage regimen, if a dose of Asciminib is missed by more than approximately 12 hours, skip that dose and take the next one as scheduled. On the twice daily dosage regimens, if a dose is missed by more than approximately 6 hours, skip it and take the next dose as scheduled.
Dosage modifications: the recommended dosage reductions of Asciminib for adverse reactions are as follows. For patients with CP-CML previously treated with two or more TKIs, the reduced dosage is 40 mg once daily or 20 mg twice daily. Permanently discontinue Asciminib in patients who can't tolerate 40 mg once daily or 20 mg twice daily. For patients with Ph+ CML-CP with the T315I mutation, the reduced dosage is 160 mg twice daily, and Asciminib should be permanently discontinued in patients who can't tolerate 160 mg twice daily.
Side Effects
Asciminib can cause several clinically significant side effects: myelosuppression, pancreatic toxicity, hypertension, hypersensitivity and cardiovascular toxicity. Other sections of the labeling discuss each of these in more detail.
Cautions & Contraindications
Warnings & Precautions
Myelosuppression Thrombocytopenia, neutropenia and anemia have occurred in patients receiving Asciminib. Thrombocytopenia occurred in 98 of 356 (28%) patients. Grade 3 thrombocytopenia was reported in 24 (7%) patients and Grade 4 in 42 (12%). Among the patients with Grade 3 or 4 thrombocytopenia, the median time to the first event was 6 weeks (range, 0.1 to 64 weeks). Of the 98 patients with thrombocytopenia, 7 (2%) stopped the medicine permanently because of this reaction, and in 45 (13%) it was withheld temporarily. Pancreatic Toxicity Pancreatitis occurred in 9 of 356 (2.5%) patients, and it was Grade 3 in 4 (1.1%) of them. All the cases were in the Phase I study (X2101). Of the 9 patients with pancreatitis, two (0.6%) stopped permanently, and in 4 (1.1%) the medicine was withheld temporarily because of the reaction. Asymptomatic elevation of serum lipase and amylase occurred in 76 of 356 (21%) patients. Grade 3 elevations occurred in 36 (10%) patients and Grade 4 in 8 (2.2%). Of the 76 patients with raised pancreatic enzymes, 7 (2%) stopped permanently because of the reaction. Hypertension Hypertension occurred in 66 of 356 (19%) patients. Grade 3 hypertension was reported in 31 (9%) patients and Grade 4 in 1 (0.3%). Among those with Grade 3 or 4 hypertension, the median time to the first event was 14 weeks (range, 0.1 to 156 weeks). Of the 66 patients with hypertension, the medicine was withheld temporarily in 3 (0.8%) because of the reaction. Hypersensitivity Hypersensitivity occurred in 113 of 356 (32%) patients, and Grade 3 or 4 hypersensitivity was reported in 6 (1.7%). The reactions included rash, edema and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity and start appropriate treatment as clinically indicated. For Grade 3 or higher hypersensitivity, withhold the medicine temporarily, reduce the dose, or stop it permanently, depending on whether the hypersensitivity persists. Cardiovascular Toxicity Cardiovascular toxicity (including ischemic cardiac and CNS conditions, and arterial thrombotic and embolic conditions) occurred in 46 (13%) of 356 patients, and cardiac failure in 8 (2.2%). Grade 3 cardiovascular toxicity was reported in 12 (3.4%) patients, and Grade 3 cardiac failure in 4 (1.1%). Grade 4 cardiovascular toxicity occurred in 2 (0.6%) patients, and fatalities occurred in 3 (0.8%). Asciminib was stopped permanently in 3 (0.8%) patients because of cardiovascular toxicity and in 1 (0.3%) patient because of cardiac failure. The cardiovascular toxicity occurred in patients with pre-existing cardiovascular conditions or risk factors, and/or prior exposure to multiple TKIs. Embryo-Fetal Toxicity Based on animal studies and its mechanism of action, Asciminib can cause fetal harm when given to a pregnant woman. In animal reproduction studies, pregnant rats and rabbits given the medicine during organogenesis had adverse developmental outcomes, including embryo-fetal mortality and malformations. This happened at maternal exposures (AUC) equivalent to or less than those in patients at the recommended doses. Advise pregnant women and females of reproductive potential about the potential risk to a fetus if the medicine is used during pregnancy, or if the patient becomes pregnant while taking it. Verify the pregnancy status of females of reproductive potential before starting treatment. These patients should use effective contraception during treatment and for 1 week after the last dose.
Pregnancy & Breastfeeding
Pregnancy: Animal studies and the way Asciminib works suggest it can harm the embryo and fetus if a pregnant woman takes it. There are no data on its use in pregnant women, so a risk linked to the medicine can't be assessed. Lactation: No data exist on whether Asciminib or its metabolites pass into human milk, what effect they have on a breastfed child, or whether milk production changes. Because the breastfed child could have serious adverse reactions, women are advised not to breastfeed during treatment and for 1 week after the last dose. Females and Males of Reproductive Potential: Animal studies point to the same concern, which is harm to the embryo and fetus when a pregnant woman takes the medicine. Pregnancy Testing: Check the pregnancy status of females of reproductive potential before starting treatment. Contraception: Females of reproductive potential should use effective contraception during treatment with Asciminib and for 1 week after the last dose. Infertility Females: Findings in animals suggest the medicine may impair fertility in females of reproductive potential. Whether this effect on fertility can be reversed is unknown.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Asciminib hasn't been shown to be safe or effective in children, as its safety and efficacy in pediatric patients have not been established.
Geriatric Use: In patients aged 65 years or older, no differences in safety or efficacy of Asciminib were seen when compared with younger patients. There were not enough patients aged 75 years or older to say whether differences exist in safety or efficacy.
Storage
Keep Asciminib at or below 25°C, in a cool and dry place. Protect it from light, and keep it out of the reach of children.
Drug Interactions
Common questions about Ascimib 40 mg
What is Ascimib 40 mg Tablet?
Ascimib 40 mg Tablet is a medicine that contains Asciminib. It is made by Everest Pharmaceuticals Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Ascimib used for?
Ascimib is used for: Cancer.
What are the side effects of Ascimib?
Asciminib can cause several clinically significant side effects: myelosuppression, pancreatic toxicity, hypertension, hypersensitivity and cardiovascular toxicity. Other sections of the labeling discuss each of these in more detail.
Can I take Ascimib during pregnancy or while breastfeeding?
Pregnancy: Animal studies and the way Asciminib works suggest it can harm the embryo and fetus if a pregnant woman takes it. There are no data on its use in pregnant women, so a risk linked to the medicine can't be assessed. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Ascimib?
Keep Asciminib at or below 25°C, in a cool and dry place. Protect it from light, and keep it out of the reach of children.
Can I take other medicines with Ascimib?
Some medicines can interact with Asciminib, for example: Itraconazole. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Ascimib is already among the lowest-priced brands of Asciminib at this strength.
Do I need a prescription for Ascimib?
Ascimib is a prescription (Rx) medicine. Take it as your doctor advises.