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osimertinib

Tagrisso · ATC code L01XE

Key facts
Active substance
osimertinib
Drug class
ALK inhibitor
ATC code
L01XE
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
TAGRISSO 40 mg film-coated tablets / TAGRISSO 80 mg film-coated tablets
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-27

Key facts

Osimertinib is an EGFR tyrosine kinase inhibitor (Tagrisso). It is used in EGFR-mutated non-small cell lung cancer (NSCLC): adjuvant, after chemoradiation, or in advanced disease.

What it is used for

  • Adjuvant after complete resection of stage IB-IIIA NSCLC with exon 19 deletion or L858R mutation
  • Locally advanced, unresectable EGFR-mutated NSCLC not progressing after platinum-based chemoradiation
  • First-line advanced or metastatic NSCLC with activating EGFR mutations
  • Advanced or metastatic T790M-positive NSCLC
  • First-line in combination with pemetrexed and platinum-based chemotherapy

Dosing

  • 80 mg once daily, as monotherapy or with pemetrexed and platinum-based chemotherapy
  • With or without food at the same time each day
  • If dose reduction is needed: 40 mg once daily
  • Missed dose: make it up unless the next dose is due within 12 hours
  • Adjuvant until recurrence or unacceptable toxicity; dose modifications for adverse reactions are in the full text

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Concomitant St. John's Wort

Important warnings

  • EGFR mutation status determined by a validated test
  • Interstitial lung disease/pneumonitis: permanently discontinue
  • QTc greater than 500 msec: withhold, then restart at a reduced dose
  • Stevens-Johnson syndrome and toxic epidermal necrolysis
  • Keratitis: prompt referral to an ophthalmology specialist
  • Elderly or low body weight (<50 kg) patients: higher risk of severe adverse events

Side effects

  • Most common: diarrhoea (46%), rash (45%), paronychia (33%), dry skin (31%), stomatitis (23%)
  • Mostly Grade 1 or 2
  • Interstitial lung disease, keratitis, QTc prolongation

Interactions

  • Strong CYP3A4 inducers can decrease osimertinib exposure; St. John's Wort contraindicated
  • Osimertinib may increase exposure of BCRP and P-gp substrates
  • CYP3A4 inhibitors and omeprazole had no clinically relevant effect

Pregnancy and breastfeeding

  • Should not be used during pregnancy; may cause foetal harm
  • Contraception after treatment for at least 2 months (females) and 4 months (males)

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • TagrissoAstraZeneca AB · EMEA/H/C/004124

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Tagrisso
Liechtenstein
Tagrisso
Norway
Tagrisso

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

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Sources

  1. European Medicines Agency. Tagrisso – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L01XE.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.