Brand name: Sotokras
Composition:
Each tablet contains:
Sotorasib……………………………………….120mg
Indication:
• SOTOKRAS is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Dosage:
• The usual dose in adults is 960 mg, administered orally once daily, and treatment lasts until disease progression or unacceptable toxicity occurs.
• Recommended dosage: 960 mg orally once daily or follow the doctor’s advice.
• Swallow tablets whole with or without food.
Contraindications:
• Allergic to the drug active substance or any excipients.
Warning:
• Hepatotoxicity: Monitor liver function tests every 3 weeks for the first 3 months of treatment then once monthly as clinically indicated. Withhold, reduce dose, or permanently discontinue SOTOKRAS based on the severity.
• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening pulmonary symptoms. Immediately withhold SOTOKRAS FULL PRESCRIBING INFORMATION: CONTENTS for suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/Pneumonitis are identified.
Adverse effects:
• The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. The most common laboratory (≥ 25%) were decreased lymphocytes, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.
Dosage form: Yellow tablets.
Expiry date：24 months after date of manufacture.
Packaging: 56 tablets per bottle.
Storage:
• Preservation method:20-25° C at room temperature.
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