Description

1. Product Overview: Osimert is a tablet formulation of Osimertinib INN 80 mg, a third-generation EGFR tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations, including T790M mutation.
2. Composition: Active Ingredient: Osimertinib INN 80 mg | Dosage Form: Tablet
3. Pharmacological Class: EGFR (Epidermal Growth Factor Receptor) Tyrosine Kinase Inhibitor
4. Mechanism of Action: Osimertinib selectively and irreversibly inhibits EGFR mutations, including T790M resistance mutation, leading to inhibition of cancer cell signaling pathways, reduced tumor growth, and apoptosis of cancer cells.
5. Indications: EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) | T790M mutation-positive NSCLC
6. Dosage & Administration: As prescribed by oncologist | Oral use | Once daily dose | Can be taken with or without food
7. Clinical Benefits: Targets EGFR mutations selectively | Effective in resistant NSCLC cases | Slows disease progression | Improves survival outcomes
8. Contraindications: Hypersensitivity to Osimertinib or any component
9. Precautions: Monitor lung, liver, and heart function | Risk of interstitial lung disease | Use under specialist supervision
10. Drug Interactions: CYP3A4 inducers (rifampicin, carbamazepine) may reduce effectiveness | CYP3A inhibitors may increase exposure
11. Special Populations: Pregnancy contraindicated | Lactation not recommended | Dose adjustment may be required in hepatic impairment
12. Adverse Effects: Diarrhea | Rash | Dry skin | Fatigue | Reduced appetite
13. Storage Conditions: Store below 30°C | Protect from moisture and light | Keep out of reach of children
14. Packaging: Tablet in blister pack
15. Manufacturer: Everest Pharmaceutical Ltd.