Ponaxen 45 (Ponatinib) 45 mg Tablets

Indicated for the treatment of adult patients with:

• 🔹 Chronic Myeloid Leukemia (CML): in chronic phase, accelerated phase, or blast phase in patients resistant or intolerant to prior therapy.
• 🔹 Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL): in patients for whom other tyrosine kinase inhibitors are not suitable or have failed.
• 🔹 T315I mutation: in patients with confirmed BCR-ABL T315I mutation.

Packaging: 45 mg tablets.

⚠️ ADMINISTRATION PROTOCOL:

• Standard Dose: 45 mg orally once daily.
• Dose Adjustment: The dose may be reduced by the treating physician depending on treatment response and safety considerations.
• Food Intake: Can be taken with or without food.
• Administration: Swallow the tablet whole with water.
• Note: Treatment should be initiated and monitored by a hematologist or oncologist experienced in leukemia therapy.

• Hypersensitivity to Ponatinib or any component of the product.
• Pregnancy and breastfeeding.
• Pediatric use under 18 years of age is not established.
• Use with caution in patients with cardiovascular disease, hypertension, hepatic impairment, pancreatitis, or thrombotic risk.

Common and clinically important adverse reactions include:

• 🩸 Cardiovascular/Vascular: Hypertension, thrombosis, vascular occlusion, heart failure.
• 📉 Gastrointestinal: Nausea, abdominal pain, constipation or diarrhea, elevated pancreatic enzymes.
• 🦠 Blood: Anemia, thrombocytopenia, neutropenia.
• ⚠️ Liver/Pancreas: Hepatotoxicity, pancreatitis, increased lipase levels.
• 💢 General: Rash, headache, weakness, fatigue.