Sprycel 140mg Tablets| Dasatinib | MHP

1. SPRYCEL 70MG DESCRIPTION Sprycel 70mg Sprycel 70mg is a second-generation receptor Tyrosine kinase inhibitor. Which binds to Abl with less stringent conformational needed so it exhibits increased effectiveness compared to Imatinib even though with less selectivity. Unlike most RTK inhibitors, Sprycel 70mg linked the active conformation of Bcr-Abl. Is required to treat patients with some Imatinib resistant forms of CML Sprycel 70mg tablet which used as prescription drug under the guidance of doctor.

2. INDICATION Sprycel 70mg Sprycel 70mg is used for the treatment for Chronic Myeloid Leukaemia: Recently diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase. Severe, increased, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Sprycel 70mg tablet is used for the treatment for Acute Lymphoblastic Leukaemia: Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy

3. MECHANISM OF ACTION Sprycel 70mg Sprycel 70mg is used for the treatment for Chronic Myeloid Leukaemia: Recently diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase. Severe, increased, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Sprycel 70mg tablet is used for the treatment for Acute Lymphoblastic Leukaemia: Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. Sprycel 70mg

4. PROPERTIES Brand :Sprycel Ingredients : Dasatinib Strength : 70mg Manufactured : BMS India Pvt ltd Package : 60 tablets PHARMACOKINETICS Plasma protein binding is 96% volume of distribution 2505 L Extensively metabolized in humans, mainly by the cytochrome P450 enzyme 3A4. Dasatinib excreted through the feces. Half-life is 3-5 hours DOSAGE MANAGEMENT Sprycel 70mg

5. • Newly diagnosed: The prescribed dose for Chronic Myeloid Leukaemia is starting 100 mg PO qDay (morning or evening). The drug will be raised to 140 mg qDay if insufficient response. • The prescribed dose for Advanced CML is starting 140 mg PO qDay. The drug will increase to 180 mg qDay if insufficient reactions • The prescribed dose for Acute Lymphoblastic Leukaemia is starting 140 mg PO qDay. The drug will increase to 180 mg PO qDay if insufficient reactions PRECAUTIONS Sprycel 70mg • When combination with chemotherapy the paediatric patients with Ph+ ALL treated, execute CBCs prior to initial of each block of chemotherapy and as clinically indicated; during consolidation blocks of chemotherapy, do CBCs every 2 days until recovery • During treatment with Sprycel will causes Myelosuppression includes serious thrombocytopenia, neutropenia and Anemia may develop; may manage by dose interruption, dose reduction, or stopping of treatment; hematopoietic growth factor has been used with resistant myelosuppression. • Sprycel 70mg will occur Hypokalaemia, hypomagnesemia, congenital QT interval prolongation, hepatic impairment • Use with caution the drug Sprycel 70mg tablet in patients who have or may develop prolongation of QT interval.

6. SIDE EFFECTS • Dyspnea • Anorexia • Arthralgia • Asthenia • Constipation • Dizziness • Musculoskeletal pain • Febrile neutropenia • Thrombocytopenia • Mucosal inflammation • Anemia • Skin rash • Infection • Nausea • Diarrhea • Headache • Haemorrhage • Fatigue • Pyrexia PREGNANCY Pregnancy category D: Sprycel 70mg will resulted in fetal harm during pregnancy. Discuss with pregnant woman of the possible risk to a foetus. LACTATION Avoid breast feeding during Sprycel treatment. STORAGE Stored at 20°C – 25°C

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