1. Product Overview: Ponaxen 45® is a third-generation tyrosine kinase inhibitor containing Ponatinib, used for the treatment of resistant or intolerant chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia.

2. Composition: Ponatinib INN 45 mg | Dosage Form: Tablet

3. Pharmacological Class: Tyrosine Kinase Inhibitor (BCR-ABL Inhibitor)

4. Mechanism of Action: Ponatinib inhibits BCR-ABL tyrosine kinase, including T315I mutation variants, thereby blocking proliferation and survival of malignant hematopoietic cells.

5. Indications: Chronic myeloid leukemia (CML) | Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) | Resistant or intolerant CML cases

6. Dosage & Administration: As directed by oncology specialist only | Oral use | Once daily | Tablet should be swallowed whole with water

7. Clinical Benefits: Controls resistant blood cancers | Inhibits abnormal cancer cell growth | Improves disease control in TKI-resistant cases | Supports long-term cancer management

8. Contraindications: Hypersensitivity to Ponatinib or any component of the formulation

9. Precautions: Risk of arterial thrombosis and cardiovascular events | Regular monitoring of blood pressure and cardiac status required | Use cautiously in patients with cardiovascular risk factors

10. Drug Interactions: May interact with strong CYP3A inhibitors or inducers | Caution with anticoagulants and antihypertensive agents

11. Special Populations: Not recommended during pregnancy and lactation unless clearly necessary | Elderly use under strict medical supervision

12. Adverse Effects: Hypertension | Rash | Fatigue | Abdominal pain | Thrombosis risk | Liver enzyme elevation | Headache

13. Storage Conditions: Store below 30°C | Protect from light and moisture | Keep out of reach of children

14. Packaging: Tablet blister pack

15. Manufacturer: Everest Pharmaceutical Ltd.