Dasinib

Dasatinib Monohydrate INN.

Composition: Each film coated tablet contains Dasatinib 100 mg as Dasatinib Monohydrate INN.

Indications: Dasatinib is indicated for the treatment of adult patients with

· Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

· Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib.

· Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

Dasatinib is indicated for the treatment of pediatric patients 1 year of age and older with

· Ph+ CML in chronic phase.

· Newly diagnosed Ph+ ALL in combination with chemotherapy.

Dosage and Administration:

Dosage of Dasatinib in Adult Patients: The recommended starting dosage of Dasatinib for chronic phase CML in adults is 100 mg administered orally once daily. The recommended starting dosage of Dasatinib for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults is 140 mg administered orally once daily. Tablets should not be crushed, cut, or chewed; they should be swallowed whole. The exposure in patients receiving a crushed tablet is lower than in those swallowing 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: With CML, or Ph+ ALL: The recommended starting dosage for pediatrics is based on body weight as shown in Table. The recommended dose should be administered orally once daily with or without food. The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary.

Table: Dosage of Dasatinib for Pediatric Patients^a

^aFor pediatric patients with Ph+ALL, begin Dasatinib therapy on or before day 15 of induction chemotherapy, when diagnosis is confirmed and continue for 2 years.

^bTablet dosing is not recommended for patients weighing less than 10 kg.

Or, as directed by the registered physician.

Use in Pregnancy and Lactation: Dasatinib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to avoid pregnancy, which may include the use of effective contraceptive methods, during treatment with Dasatinib and for 30 days after the final dose. Women should be advised that breastfeeding is not recommended during treatment with Dasatinib and for 2 weeks after the final dose.

Packing: Each box contains 20 tablets in Alu-Alu blister pack.