Do you want the EU Summary of Product Characteristics (SPC) for Tagrisso (osimertinib) or another country’s labeling (e.g., US labeling)? I can give you a concise summary or provide the full official text and link.
Here’s a quick, high-level overview (EU-style SPC) to give you the gist:
- What it is: Tagrisso is osimertinib, a 3rd-generation EGFR tyrosine kinase inhibitor used for NSCLC with activating EGFR mutations.
- Indications (EU): for adults with EGFR-mutated NSCLC. The SPC also covers use in specific EGFR mutation contexts (e.g., T790M-positive disease after prior EGFR-TKI therapy) and other regional approvals; exact wording is in the official SPC.
- Dose and administration: 80 mg taken orally once daily, with or without food. Continue until disease progression or unacceptable toxicity.
- Common adverse reactions: rash, diarrhea, dry skin, nausea, decreased appetite, fatigue. Other potential issues include stomatitis, and more serious risks.
- Key warnings/precautions: risk of interstitial lung disease/pneumonitis, cardiomyopathy and QT prolongation, ocular/eye effects, severe skin reactions, hepatotoxicity, and potential for fetal harm (pregnancy).
- Drug interactions: avoid or exercise caution with strong CYP3A inhibitors or inducers. If coadministration is unavoidable, dose adjustments or avoidance may be required per the SPC.
- Monitoring: baseline and periodic liver function, QT interval monitoring as indicated, watch for respiratory symptoms suggestive of ILD, and assess for other serious adverse events.
- Pregnancy and contraception: not recommended; use effective contraception during treatment and for a period after the last dose.
- Where to get the official SP C: the EU SPC is published by the EMA. You can search for “Tagrisso Summary of Product Characteristics” on the EMA website (medicines.ema.europa.eu) or ask me for the exact current link.
Would you like:
- a more detailed, section-by-section summary (indications, dosing, contraindications, warnings, adverse effects, interactions, pregnancy), or
- the full official SPC text, or
- the US labeling instead?
If you tell me which region you need and how detailed you want it, I’ll tailor the answer.