Osimert 80 mg Tablets

Osimert 80 mg Tablets contains Osimertinib, a third-generation tyrosine kinase inhibitor (TKI) targeting specific mutations of the epidermal growth factor receptor (EGFR). It is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy.

Dosage and Administration:

The recommended dosage is 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity occurs.

Common Side Effects:

Patients may experience side effects such as diarrhea, rash, dry skin, and nail toxicity. It’s important to monitor for serious adverse reactions, including interstitial lung disease/pneumonitis, QT interval prolongation, and cardiomyopathy.

Precautions:

• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for respiratory symptoms indicative of ILD/pneumonitis. Discontinue Osimertinib if ILD/pneumonitis is confirmed.
• QT Interval Prolongation: Monitor electrocardiograms and electrolytes in patients with a history or predisposition for QTc prolongation. Adjust dosage or discontinue Osimertinib as necessary.
• Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before treatment and periodically thereafter. Discontinue Osimertinib if cardiomyopathy is confirmed.

Use in Specific Populations:

• Pregnancy: Osimertinib can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 6 weeks after the final dose.
• Lactation: Advise lactating women not to breastfeed during treatment and for 2 weeks after the final dose.

Drug Interactions:

Avoid concomitant use with strong CYP3A4 inhibitors or inducers, as they may alter Osimertinib plasma concentrations.

Packaging:

Osimert 80 mg Tablets are available in bottles containing 30 tablets each.

Manufacturer: Everest Laboratories

Note: This medication should be used under the supervision of a qualified healthcare professional. Patients are advised to discuss potential risks and benefits with their healthcare provider before starting treatment.