1. Product Overview: Niranib® is a PARP (poly ADP-ribose polymerase) inhibitor containing Niraparib, used as maintenance therapy in certain ovarian and related gynecological cancers after response to chemotherapy.

2. Composition: Niraparib Tosylate Monohydrate equivalent to Niraparib 100 mg | Dosage Form: Capsule

3. Pharmacological Class: PARP Inhibitor (Antineoplastic Agent)

4. Mechanism of Action: Niraparib inhibits PARP enzymes involved in DNA repair, leading to accumulation of DNA damage in cancer cells and resulting in cell death, particularly in tumor cells with deficient DNA repair mechanisms.

5. Indications: Maintenance treatment of recurrent or advanced ovarian cancer | Fallopian tube cancer | Primary peritoneal cancer | BRCA-mutated and non-BRCA cancers (as per indication)

6. Dosage & Administration: As directed by oncology specialist only | Oral use | Once daily at the same time each day | Capsule should be swallowed whole

7. Clinical Benefits: Delays disease progression | Improves progression-free survival | Reduces risk of cancer recurrence | Maintains response after chemotherapy

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

9. Precautions: Risk of bone marrow suppression (anemia, thrombocytopenia) | Regular blood count monitoring required | Use cautiously in cardiovascular conditions | Avoid during pregnancy

10. Drug Interactions: May interact with drugs affecting bone marrow function | Caution with anticoagulants due to bleeding risk

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

12. Adverse Effects: Anemia | Thrombocytopenia | Fatigue | Nausea | Constipation | Decreased appetite | Hypertension

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

14. Packaging: Capsule blister pack

15. Manufacturer: Everest Pharmaceutical Ltd.