Product Description:

• SPRYCEL is a kinase inhibitor indicated for the treatment of
• newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
• adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
• adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
• pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
• pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

How to use:

• Chronic phase CML in adults: 100 mg once daily.
• Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults: 140 mg once daily.
• Chronic phase CML and ALL in pediatrics: starting dose based on body weight.
• Administer orally, with or without a meal. Do not crush, cut, or chew tablets.

Caution & Warnings:

• Myelosuppression and Bleeding Events
• Fluid Retention
• Cardiovascular Toxicity
• Pulmonary Arterial Hypertension (PAH)
• QT Prolongation
• Severe Dermatologic Reactions
• Tumor Lysis Syndrome
• Empyo-Fetal Toxicity
• Effects on Growth and Development in Pediatric Patients

Adverse Reactions:

• Most common adverse reactions (≥15%) in patients receiving SPRYCEL as single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.
• Most common adverse reactions (≥30%) in pediatric patients receiving SPRYCEL in combination with chemotherapy included mucositis, fepile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infections (bacterial, viral and fungal), hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.

Ingredients:

• Dasatinib 50mg.