Brand name: Sotokras
Composition:
Each tablet contains:
Osimertinib……………………………………….80mg
Indication:
OSIMITIB is a kinase inhibitor indicated for:
• as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
• The first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
• The treatment of adult 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.
Dosage:
• Adjuvant treatment of early-stage NSCLC: 80mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years.
• Metastatic NSCLC: 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.
Contraindications: None.
Warning:
• Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 3.7% of patients. Permanently discontinue OSIMITIB in patients diagnosed with ILD/Pneumonitis.
• 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 dose or permanently discontinue OSIMITIB.
• Cardiomyopathy: Occurred in 3% of patients. Conduct cardiac monitoring, including left ventricular ejection fraction (LVEF) assessment in patients with cardiac risk factors.
• Keratitis: Promptly refer patients with signs and symptoms of keratitis to an ophthalmologist for evaluation.
• Erythema Multiforme and Stevens-Johnson syndrome: Withhold OSIMITIB if erythema multiforme major (EMM) or Stevens-Johnson syndrome (SJS) is suspected and permanently discontinue if confirmed.
• Cutaneous Vasculitis: Withhold OSIMITIB if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation based on severity.
• Embryo-Fetal Toxicity: OSIMITIB can cause fetal harm. Consult your doctor for details.
Adverse effects:
• Most common (>20%) adverse reactions, including laboratory abnormalities were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough.
Dosage form: Yellow tablets.
Expiry date：24 months after date of manufacture.
Packaging: 30 tablets per bottle.
Storage:
• Store in a cool and dry place below 30 ° C, protect from light. Keep out of the reach of children.
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Do not self-diagnose or treat any medical condition based solely on the information on this website. If you have any questions or concerns about a medication, please talk to your doctor or pharmacist.
