Osimertinib

COMPOSITION:

Each film-coated LuciOsim tablet contains: Osimertinib……………………………80mg

INDICATIONS:

The treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA- approved test and the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.

WARNINGS AND PRECAUTIONS:

1. Interstitial Lung Disease (ILD)/Pneumonitis: Permanently discontinue LuciOsim in patients diagnosed with ILD/Pneumonitis.

2. QTc interval Prolongation: Monitor electrocardiograms and electrolytes in patients who have a history or predisposition for QTc prolongation, or those who are taking medications that are known to prolong the QTc interval. Withhold then restart at a reduced does or permanently discontinue LuciOsim.

3. Cardiomyopathy: Conduct cardiac monitoring, including left ventricular ejection fraction(LVEF) assessment in patients with cardiac risk factors.

4. Keratitis: Promptly refer patients with signs and symptoms of keratitis to an ophthalmologist for evaluation.

5. Erythema Multiforme and Stevens-Johnson Syndrome: Withhold LuciOsim if erythema multiforme major (EMM) or Stevens-Johnson Syndrome (SJS) is suspected and permanently discontinue if confirmed.

6. Embryo-Fetal Toxicity: LuciOsim can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with LuciOsim and for 6 weeks after final dose. Advise males to use effective contraception for 4 months, after the last does of LuciOsim.

ADVERSE REACTIONS:

Most common adverse reaction(≥ 20%) are diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue and decreased appetite

DOSAGE:

Recommended dosage: 80mg orally once daily, with or without food.

PRESENTATION:

Tablets: 80mg, Bottle of 30 Tablets,

STORAGE:

Store at 20°C to 25°C (77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].