Brand name: BRIGANIE
Composition:
Each tablet contains:
Brigatinib INN equivalent to Brigatinib………………………….90mg
Indications:
BRIGANIE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Dosage:
• 90mg orally once daily for the first 7 days; then increase to 180mg orally once daily. May be taken with or without food.
Contraindications:
• Pregnant and lactating women.
• Concomitant use with moderate or strong CYP3A4 inducers.
Warnings:
• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening respiratory symptoms, particularly during the first week of treatment. Withhold BRIGANIE for new or worsening respiratory symptoms and promptly evaluate for ILD/pneumonitis. Upon recovery, either dose reduce or permanently discontinue BRIGANIE.
• Hypertension: Monitor blood pressure after 2 weeks and then at least monthly during treatment. For severe hypertension, withhold BRIGANIE, then reduce dose or permanently discontinue.
• Bradycardia: Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold BRIGANIE, then reduce dose or permanently discontinue.
• Visual Disturbance: Advise patients to report visual symptoms. Withhold BRIGANIE and obtain ophthalmologic evaluation, then reduce dose or permanently discontinue BRIGANIE.
• Creatine Phosphokinase (CPK) Elevation: Monitor CPK levels regularly during treatment. Based on the severity and with muscle pain or weakness, withhold BRIGANIE, then resume or reduce dose.
• Pancreatic Enzymes Elevation: Monitor lipase and amylase levels regularly during treatment. Based on the severity, withhold BRIGANIE, then resume or reduce dose.
• Hepatotoxicity: Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin levels regularly during treatment. Based on severity, withhold dose, then resume at lower level.
• Hyperglycemia: Assess fasting serum glucose prior to starting BRIGANIE and regularly during treatment. If not adequately controlled with optimal medical management, withhold BRIGANIE, then consider dose reduction or permanently discontinue, based on severity.
• Photosensitivity: Advise patients to limit sun exposure. Based on severity withhold BRIGANIE, then resume at the same dose, reduce the dose, or permanently discontinue.
• Embryo-Fetal Toxicity: Can cause fetal harm. Consult your doctor for details
Adverse Effects:
• The most common adverse reactions (≥25%) with BRIGANIE were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.
Dosage form: Yellow tablet.
Expiry date: 24 months after date of manufacture.
Packaging: 30 tablets per bottle.
Storage:
• Store in original packaging 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.
