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Other brands with the same active ingredient
These brands contain the same active ingredient (Dasatinib). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Mabic-20 is indicated for:
Pharmacology
At nanomolar concentrations, Dasatinib inhibits these kinases: BCR-ABL, the SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2 and PDGFRβ. Modeling studies predict that Dasatinib binds to several conformations of the ABL kinase. In vitro, it was active in leukemic cell lines representing both imatinib mesylate-sensitive and resistant disease. It slowed the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines that overexpress BCR-ABL. Under the conditions of the assays, Dasatinib could overcome Imatinib resistance caused by BCR-ABL kinase domain mutations, by activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and by overexpression of the multi-drug resistance gene.
Absorption: After oral use, the maximum plasma concentrations (Cmax) of Dasatinib are seen between 0.5 hours and 6 hours (Tmax).
Food Effect: A high-fat meal raised the mean AUC of Dasatinib by 14% after a single 100 mg dose. That meal contained 985 kcal in total. The calories came 52% from fat, 34% from carbohydrates and 14% from protein.
Distribution: The apparent volume of distribution is 2505 (CV% 93%). In vitro, about 96% of Dasatinib was bound to human plasma proteins, and about 93% of its active metabolite. This did not change with concentration over the range of 100 ng/ml to 500 ng/ml. In vitro, Dasatinib is a P-gp substrate.
Elemination: The mean terminal half-life of Dasatinib is 3 hours to 5 hours. The mean apparent oral clearance is 363.8 l/hr (CV% 81.3%).
Metabolism: Dasatinib is metabolized in humans, mainly by CYP3A4. CYP3A4 is also the main enzyme that forms the active metabolite. Flavin-containing monooxygenase 3 (FMO-3) and uridine diphosphate-glucuronosyltransferase (UGT) enzymes take part in forming Dasatinib metabolites too. The active metabolite is equipotent to Dasatinib, but its exposure is only about 5% of the AUC of Dasatinib. It is unlikely to play a major role in the observed pharmacology of the drug. Dasatinib also has several other inactive oxidative metabolites.
Excretion: Elimination is mainly through the feces. After a single radiolabeled oral dose of Dasatinib, 4% of the administered radioactivity was recovered in the urine and 85% in the feces within 10 days. Unchanged Dasatinib made up 0.1% of the administered dose in the urine and 19% in the feces. The rest of the dose was metabolites.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage of Dasatinib in adult patients: For chronic phase CML in adults, the recommended starting dose of Dasatinib is 100 mg taken by mouth once daily. For accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults, the recommended starting dose is 140 mg taken by mouth once daily. Tablets should be swallowed whole and should not be crushed, cut, or chewed. Patients who take a crushed tablet absorb less of the medicine than those who swallow an intact tablet. Dasatinib can be taken with or without a meal, either in the morning or in the evening.
Dosage of Dasatinib in pediatric patients: For children with CML or Ph+ ALL, the recommended starting dose for pediatric patients is based on body weight, as shown in the chart below. The recommended dose should be taken by mouth once daily, with or without food. The dose should be recalculated every 3 months according to changes in body weight, or more often if needed.
Body weight 10 kg to less than 20 kg: daily dose 40 mg.
Body weight 20 kg to less than 30 kg: daily dose 60 mg.
Body weight 30 kg to less than 45 kg: daily dose 70 mg.
Body weight at least 45 kg: daily dose 100 mg.
Pediatric use: The safety profile of Dasatinib in pediatric subjects was comparable to that reported in studies of adult subjects with chronic phase CML. Bone growth and development in pediatric patients should be monitored.
Side Effects
Dasatinib can cause myelosuppression (suppression of blood cell production), bleeding-related events, fluid retention, cardiovascular events, pulmonary arterial hypertension, QT prolongation, severe skin reactions, tumour lysis syndrome, and effects on growth and development in children.
Cautions & Contraindications
Warnings & Precautions
Myelosuppression: Treatment with Dasaren is associated with severe (NCI CTCAE Grade 3 or 4) thrombocytopenia, neutropenia, and anemia. These occur earlier and more often in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML. In patients with chronic phase CML, complete blood counts (CBCs) should be performed every 2 weeks for 12 weeks, then every 3 months thereafter, or as clinically indicated. In patients with advanced phase CML or Ph+ ALL, CBCs should be performed weekly for the first 2 months and then monthly thereafter, or as clinically indicated. Myelosuppression is generally reversible and is usually managed by withholding Dasaren temporarily and/or reducing the dose. Bleeding-Related Events: Dasaren can cause serious and fatal bleeding. Concomitant medications that inhibit platelet function, or anticoagulants, may increase the risk of hemorrhage. Fluid Retention: Dasaren may cause fluid retention. Fluid retention events were typically managed by supportive care measures, which may include diuretics or short courses of steroids. Severe pleural effusion may require thoracentesis and oxygen therapy. Dose reduction or treatment interruption should be considered. Cardiovascular Events: Dasaren can cause cardiac dysfunction. Patients should be monitored for signs or symptoms consistent with cardiac dysfunction and treated appropriately. Pulmonary Arterial Hypertension: Dasaren may increase the risk of developing pulmonary arterial hypertension (PAH) in adult and pediatric patients. This may occur at any time after starting treatment, including after more than 1 year of treatment. Manifestations include dyspnea, fatigue, hypoxia, and fluid retention. PAH may be reversible on discontinuation of Dasaren. Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease before starting Dasaren and during treatment. If PAH is confirmed, Dasaren should be permanently discontinued. QT Prolongation: Dasaren may increase the risk of QTc prolongation in patients, including those with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking antiarrhythmic medicines or other medicinal products that lead to QT prolongation, and those who have received cumulative high-dose anthracycline therapy. Hypokalemia or hypomagnesemia should be corrected before and during Dasaren administration. Severe Dermatologic Reactions: Cases of severe mucocutaneous dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported in patients treated with Dasaren. In patients who experience a severe mucocutaneous reaction during treatment, Dasaren should be discontinued permanently if no other etiology can be identified. Tumor Lysis Syndrome: Tumor lysis syndrome has been reported in patients with resistance to prior Imatinib therapy, primarily in advanced phase disease. Because of the potential for tumor lysis syndrome, adequate hydration should be maintained, uric acid levels should be corrected before starting therapy with Dasaren, and electrolyte levels should be monitored. Patients with advanced stage disease and/or a high tumor burden may be at increased risk and should be monitored more frequently.
Contraindications
Dasatinib should not be given to anyone who is known to be allergic (hypersensitive) to Dasatinib or to any other ingredient in the preparation.
Pregnancy & Breastfeeding
Dasatinib may harm an unborn baby if taken during pregnancy. Women who are able to become pregnant should use effective contraception to avoid pregnancy while on Dasatinib and for 30 days after the last dose. Breastfeeding is not recommended during treatment with Dasatinib and for 2 weeks after the last dose.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Experience with Dasatinib overdose in clinical studies is limited to a few isolated cases. The highest reported overdose was 280 mg per day for 1 week, in two patients. Both developed severe myelosuppression and bleeding. Because Dasatinib is linked with severe myelosuppression, anyone who takes more than the recommended dose should be watched closely for myelosuppression and given appropriate supportive treatment.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Dasatinib below 30°C in a dry place, and protect it from light. Keep it out of the reach of children.
Drug Interactions
Common questions about Mabic-20 20 mg
What is Mabic-20 20 mg Tablet?
Mabic-20 20 mg Tablet is a medicine that contains Dasatinib. It is made by Genvio Pharma Ltd. It belongs to the Targeted Cancer Therapy group of medicines.
What is Mabic-20 used for?
Mabic-20 is used for: Cancer.
What are the side effects of Mabic-20?
Dasatinib can cause myelosuppression (suppression of blood cell production), bleeding-related events, fluid retention, cardiovascular events, pulmonary arterial hypertension, QT prolongation, severe skin reactions, tumour lysis syndrome, and effects on growth and development in children.
Can I take Mabic-20 during pregnancy or while breastfeeding?
Dasatinib may harm an unborn baby if taken during pregnancy. Women who are able to become pregnant should use effective contraception to avoid pregnancy while on Dasatinib and for 30 days after the last dose. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Mabic-20?
Experience with Dasatinib overdose in clinical studies is limited to a few isolated cases. The highest reported overdose was 280 mg per day for 1 week, in two patients. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Mabic-20?
Keep Dasatinib below 30°C in a dry place, and protect it from light. Keep it out of the reach of children.
Can I take other medicines with Mabic-20?
Some medicines can interact with Dasatinib, for example: Vonoprazan + Amoxicillin + Clarithromycin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Mabic-20?
Mabic-20 is a prescription (Rx) medicine. Take it as your doctor advises.