Tagrix 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 locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has 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. If a dose is missed, it should not be made up, and the next dose should be taken as scheduled.
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 Tagrix 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 Tagrix as necessary.
- Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before treatment and periodically thereafter. Discontinue Tagrix if cardiomyopathy is confirmed.
Use in Specific Populations:
- Pregnancy: Tagrix 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 Tagrix plasma concentrations.
Packaging:
Tagrix 80 mg Tablets are available in boxes containing 30 tablets in Alu-Alu blister packs.
Manufacturer:
Beacon Pharmaceuticals Limited
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.
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