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alectinib

Alecensa · ATC code L01ED03

Also known as: Alektinib

Key facts
Active substance
alectinib
ATC code
L01ED03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Alecensa 150 mg hard capsules
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-28

Key facts

Alectinib is an ALK tyrosine kinase inhibitor used to treat ALK-positive non-small cell lung cancer (NSCLC) in adults (Alecensa, hard capsules).

What it is used for

  • Adjuvant monotherapy after complete tumour resection in adults with ALK-positive NSCLC at high risk of recurrence.
  • First-line treatment of adults with ALK-positive advanced NSCLC.
  • Treatment of adults with ALK-positive advanced NSCLC previously treated with crizotinib.

Dosing

  • ALK-positive status must be established with a validated assay before starting treatment.
  • Recommended dose: 600 mg (four 150 mg capsules) twice daily with food (total daily dose 1200 mg).
  • Severe hepatic impairment (Child-Pugh C): starting dose 450 mg twice daily with food.
  • Adjuvant treatment: until recurrence, unacceptable toxicity or for 2 years; advanced NSCLC: until progression or unacceptable toxicity.
  • For adverse reactions, reduce in steps of 150 mg twice daily (450 mg, then 300 mg twice daily); permanently discontinue if 300 mg twice daily is not tolerated. Detailed modifications: see the full text.
  • A missed dose can be made up unless the next dose is due within 6 hours; do not take two doses at once.

Contraindications

  • Hypersensitivity to alectinib or any excipient.

Important warnings

  • Interstitial lung disease/pneumonitis: interrupt immediately and permanently discontinue if no other cause is identified.
  • Hepatotoxicity: monitor ALT, AST and total bilirubin at baseline, every 2 weeks during the first 3 months, then periodically.
  • Severe myalgia and CPK elevation: assess CPK every two weeks for the first month; patients should report unexplained muscle pain.
  • Symptomatic bradycardia can occur; monitor heart rate and blood pressure.
  • Haemolytic anaemia and gastrointestinal perforation have been reported.
  • Photosensitivity: avoid prolonged sun exposure during treatment and for at least 7 days afterwards; use sunscreen with SPF ≥50.

Side effects

  • Most common (≥ 20 %): constipation, myalgia, oedema, increased bilirubin, increased AST, anaemia, rash and increased ALT.
  • Serious: interstitial lung disease/pneumonitis, drug-induced liver injury, bradycardia, haemolytic anaemia, gastrointestinal perforation.

Interactions

  • Strong CYP3A inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's Wort) or strong CYP3A inhibitors (e.g. ritonavir, ketoconazole, itraconazole, voriconazole, posaconazole, grapefruit): no dose adjustment, but appropriate monitoring.
  • Alectinib may increase plasma levels of P-gp substrates (e.g. digoxin, dabigatran etexilate) and BCRP substrates (e.g. methotrexate); monitoring is recommended.
  • Proton pump inhibitors and other medicines that raise gastric pH require no dose adjustment.

Pregnancy and breastfeeding

  • Alectinib may cause foetal harm. Women of childbearing potential must use highly effective contraception during treatment and for at least 5 weeks after the last dose; men with partners of childbearing potential for at least 3 months after the last dose.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

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)

  • AlecensaRoche Registration GmbH · EMEA/H/C/004164

Source: European Medicines Agency (EMA), product information

Turkey

  • AlecensaROCHE MÜSTAHZARLARI SAN.A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

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

EMA – Article 57 product data (EU/EEA), 2026-10-29

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

Other substances in the same group

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Sources

  1. European Medicines Agency. Alecensa – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.