Vizimpro is the brand name for dacomitinib, an EGFR tyrosine kinase inhibitor. If you’re asking for the “package insert” (the official US prescribing information), I can either point you to the official sources or summarize the labeling. Which would you prefer? In the meantime, here are the best places to get the current, official labeling:
- DailyMed (US labeling): DailyMed hosts the current Vizimpro/dacomitinib prescribing information. You can search for “dacomitinib” or “Vizimpro” on DailyMed to open the latest labeling in PDF or HTML.
- Drugs@FDA (FDA labeling): The FDA’s Drugs@FDA database links to the current labeling for Vizimpro. It provides the official prescribing information and PDFs of the labeling.
- Pfizer product page: The manufacturer’s Vizimpro page often hosts the labeling or provides links to the official labeling (FDA/DailyMed).
If you’d like, I can summarize the key sections of the current Vizimpro labeling (indication, dosing, contraindications, warnings/precautions, adverse effects, drug interactions, pregnancy/breastfeeding, and monitoring) or pull out specific details (for example, the exact dosing adjustments or warning language). Just tell me which sections you want.
A brief high-level summary (for orientation only, not a substitute for the full label):
- Indication: Vizimpro is indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations (first-line setting in the US labeling).
- Dosage: Typical starting dose is 45 mg once daily by mouth; continue until disease progression or intolerable toxicity. Dose reductions are allowed (e.g., to 30 mg, then 15 mg) for adverse events.
- Key safety/warnings: Interstitial lung disease/pneumonitis; serious infections; ocular toxicity (e.g., keratitis/eye disorders); severe diarrhea and dehydration; stomatitis; rash; electrolyte disturbances; QT interval prolongation; wound healing complications; hepatotoxicity.
- Drug interactions: Avoid concomitant strong CYP3A inhibitors (they can raise dacomitinib exposure); be cautious with inducers; monitor when coadministered.
- Special populations: Pregnancy should be avoided if possible; use effective contraception; discuss risks if pregnancy occurs. Lactation and pediatric use considerations are included in the labeling.
- Monitoring: Regular lab tests (LFTs, electrolytes), ECG monitoring if indicated, assessment for ILD symptoms, ocular assessments for eye-related events, and evaluation of adverse effects like diarrhea and rash.
If you want, tell me:
- Do you want just the official PDF/URL, or a detailed, section-by-section summary?
- Do you prefer a US-only labeling summary, or also EU/other regions?