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Dasatab 100

Form: Tablet

Strength: 100mg

Generic Name: Dasatinib

Company: Eskayef Pharmaceuticals Ltd.

MRP:৳ 400.0   (Box=10)

Per Piece: ৳ 40.00  

Is Antibiotic: No

Indications

Dasatab 100 is used to treat adults with:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
  • Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to previous treatments, including Imatinib.
  • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior treatments.

Dasatab 100 is also used to treat children 1 year of age and older with Ph+ CML in chronic phase and newly diagnosed Ph+ ALL in combination with chemotherapy.

Pharmacology

Dasatab 100 works by blocking certain proteins (kinases) that cause cancer cell growth. These include BCR-ABL, SRC family, c-KIT, EPHA2, and PDGFRβ. Dasatab 100 is effective against leukemic cell lines, especially in cases where Imatinib treatment has failed. Dasatab 100 can also overcome resistance caused by mutations in the BCR-ABL gene and other alternative signaling pathways.

Absorption: Dasatab 100 reaches peak levels in the blood between 0.5 to 6 hours after taking Dasatab 100 orally. A high-fat meal can increase its concentration by 14%.

Distribution: Dasatab 100 binds strongly to plasma proteins (about 96%) and has a large volume of distribution.

Elimination: Dasatab 100 has a half-life of 3 to 5 hours and is mostly cleared from the body by the liver.

Metabolism: Dasatab 100 is mainly metabolized by CYP3A4, and its active metabolite contributes to about 5% of its effects.

Excretion: Dasatab 100 is mostly eliminated through the feces, with a small amount in urine.

Dosage & Administration

For Adults: The usual dose for chronic phase CML is 100 mg once daily. For advanced phases of CML or Ph+ ALL, the dose is 140 mg once daily. The tablets should not be crushed or chewed.

For Children: The dose depends on body weight and should be taken once daily with or without food:

  • 10 to less than 20 kg: 40 mg
  • 20 to less than 30 kg: 60 mg
  • 30 to less than 45 kg: 70 mg
  • 45 kg or more: 100 mg

The dose should be recalculated every 3 months based on weight changes.

Interaction

Strong CYP3A4 Inhibitors: These may increase Dasatinib levels, increasing the risk of side effects. They should be avoided, or the dose should be reduced.

Strong CYP3A4 Inducers: These may lower Dasatinib levels, reducing its effectiveness. Alternative medications with less enzyme-inducing effects should be used.

Gastric Acid Reducing Agents: Medications like H2 blockers and proton pump inhibitors may lower Dasatinib levels. They should not be used together. Antacids should be taken at least 2 hours before or after Dasatinib.

Contraindications

Dasatab 100 should not be used by patients who are allergic to Dasatab 100 or any of its ingredients.

Side Effects

Dasatab 100 may cause myelosuppression (low blood cell counts), bleeding, fluid retention, cardiovascular issues, pulmonary hypertension, QT prolongation, skin reactions, tumor lysis syndrome, and effects on growth in children.

Pregnancy & Lactation

Dasatab 100 can harm the fetus if used during pregnancy. Women should avoid pregnancy and use contraception during treatment and for 30 days after stopping Dasatab 100. Breastfeeding should also be avoided during treatment and for 2 weeks afterward.

Precautions & Warnings

Myelosuppression: Dasatab 100 may cause low blood cell counts, especially in advanced phases of CML or Ph+ ALL. Regular blood tests are necessary.

Bleeding: Dasatab 100 can cause serious bleeding. Medications that affect platelets or blood clotting may increase this risk.

Fluid Retention: Dasatab 100 may cause swelling, which can be managed with medication or other treatments. Severe cases may need further intervention.

Cardiovascular Issues: Dasatab 100 can affect the heart, so patients should be monitored for signs of heart problems.

Pulmonary Hypertension: Dasatab 100 may cause lung-related issues. Discontinuation of the drug may reverse these effects.

QT Prolongation: Dasatab 100 may affect heart rhythms. Conditions like low potassium should be corrected before starting treatment.

Severe Skin Reactions: Dasatab 100 may cause severe skin reactions. If this happens, the drug should be stopped immediately.

Tumor Lysis Syndrome: Dasatab 100 can lead to tumor lysis syndrome, especially in advanced stages. Proper hydration and monitoring are necessary.

Overdose Effects

Overdose may lead to severe myelosuppression and bleeding. If more than the recommended dose is taken, the patient should be monitored closely for these effects and receive appropriate treatment.

Therapeutic Class

Dasatab 100 belongs to the class of targeted cancer therapies.

Storage Conditions

Store below 30°C, away from light and moisture, and out of the reach of children.

Similar Brands of Dasatinib (Tablet – 100mg)

Brand Name Form Strength Company MRP (৳)
Dasanix Tablet 100mg Beacon Pharmaceuticals Ltd. 400.0
Mabic-100 Tablet 100mg Genvio Pharma Ltd. 400.0
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