Description

1. Product Overview: Ponaxen 15 is a potent targeted anticancer formulation of Ponatinib Hydrochloride INN 15 mg, designed for the treatment of specific types of chronic myeloid leukemia and acute lymphoblastic leukemia.
2. Composition: Active Ingredient: Ponatinib Hydrochloride INN 15 mg | Dosage Form: Tablet
3. Pharmacological Class: Tyrosine Kinase Inhibitor (TKI) | Pan-BCR-ABL Inhibitor
4. Mechanism of Action: Ponatinib inhibits the BCR-ABL tyrosine kinase, including the T315I mutation, which is resistant to other TKIs. It blocks the signaling pathways that drive the overproduction of abnormal white blood cells.
5. Indications: Chronic Myeloid Leukemia (CML) | Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) | T315I-positive CML or Ph+ ALL
6. Dosage & Administration: As prescribed by oncologist | Oral use | May be taken with or without food | Swallow tablets whole
7. Clinical Benefits: Effective against T315I mutation-positive leukemia | Targeted therapy approach | Delays disease progression | Oral dosing convenience
8. Contraindications: Hypersensitivity to Ponatinib or any component
9. Precautions: Monitor for arterial occlusion and thromboembolism | Risk of hepatotoxicity and heart failure | Monitor for hypertension and pancreatitis | Regular blood counts required
10. Drug Interactions: Strong CYP3A inhibitors may increase drug levels | Gastric acid-reducing agents may decrease absorption
11. Special Populations: Pregnancy contraindicated due to fetal risk | Lactation not recommended | Use with caution in patients with pre-existing cardiovascular risk
12. Adverse Effects: Hypertension | Rash | Abdominal pain | Fatigue | Headache | Dry skin
13. Storage Conditions: Store below 30°C | Protect from light and moisture | Keep out of reach of children
14. Packaging: Tablet in blister pack
15. Manufacturer: Everest Pharmaceutical Ltd.