Osicent (Osimertinib) 80 mg Tablets

Indicated for the treatment of adult patients with metastatic NSCLC:

• 🔹 First-line treatment: Patients whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
• 🔹 Second-line treatment: Patients with EGFR T790M mutation-positive NSCLC (detected after progression on prior EGFR TKI therapy).
• 🔹 Adjuvant therapy: After tumor resection in patients with EGFR mutation-positive NSCLC.

Packaging: 80 mg tablets.

⚠️ ADMINISTRATION PROTOCOL:

• Recommended Dose: 80 mg orally once daily.
• Timing: Take at the same time each day, with or without food.
• Administration: Swallow the tablet whole with water. Do not crush, split, or chew.
• For Difficulty Swallowing: The tablet can be dispersed in 50 mL of non-carbonated water (stir until dispersed, do not crush) and swallowed immediately.

• Hypersensitivity to Osimertinib.
• Pregnancy and breastfeeding (embryo-fetal toxicity).
• History of Interstitial Lung Disease (ILD) or drug-induced pneumonitis.
• Concomitant use with St. John's Wort.

Common adverse reactions include:

• 🩸 Cardiac/Labs: QT interval prolongation, decreased leukocytes/platelets.
• 📉 Dermatologic: Rash, dry skin, paronychia (nail infection/inflammation), pruritus.
• 🌀 Respiratory/GI: Diarrhea, stomatitis, interstitial lung disease (ILD) — requires immediate medical attention.
• Patients should monitor for nail changes and skin rash regularly.