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selpercatinib

Retsevmo · ATC code L01EX22

Also known as: Selperkatinib

Key facts
Active substance
selpercatinib
ATC code
L01EX22
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Retsevmo 40 mg hard capsules / Retsevmo 80 mg hard capsules · Retsevmo 40 mg film-coated tablets / Retsevmo 80 mg film-coated tablets / Retsevmo 120 mg film-coated tablets
Marketing authorisation holder
Eli Lilly Nederland B.V.
Information as of
2026-10-29

Key facts

Selpercatinib (Retsevmo, hard capsules and film-coated tablets) is a selective RET kinase inhibitor. It is used for advanced tumours with a RET fusion or RET mutation.

What it is used for

  • Adults: advanced RET fusion-positive non-small cell lung cancer not previously treated with a RET inhibitor.
  • Adults and children 2 years and older: advanced RET fusion-positive radioactive iodine-refractory thyroid cancer; advanced RET-mutant medullary thyroid cancer.
  • Adults and children 2 years and older: advanced RET fusion-positive solid tumours when other options provide limited benefit or are exhausted.
  • Confirm the RET fusion or mutation with a validated test before starting.

Dosing

  • 12 years and older, by body weight: less than 50 kg 120 mg twice daily; 50 kg or greater 160 mg twice daily (capsules and tablets).
  • Children 2 to less than 12 years: dose by body surface area; see the full text.
  • Reduce the dose if strong CYP3A and/or P-gp inhibitors must be co-administered; dose modifications for adverse reactions in the full text.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Interstitial lung disease/pneumonitis, sometimes fatal; withhold and investigate respiratory symptoms.
  • Increased ALT/AST; monitor liver tests.
  • Hypertension: control blood pressure before starting and monitor it.
  • QT prolongation: QTcF ≤470 ms and normal electrolytes before starting; ECG after 1 week and at least monthly for the first 6 months.
  • Tumour lysis syndrome, and epiphysiolysis of the femoral head in children.

Side effects

  • Very common: urinary tract infections, pneumonia, hypothyroidism, decreased appetite, headache, dizziness, QT prolongation, hypertension, haemorrhage, diarrhoea, dry mouth, abdominal pain, constipation, nausea, vomiting, rash, oedema, fatigue, increased transaminases.
  • Most common serious ADRs: pneumonia (5.3%), haemorrhage (2.4%), abdominal pain (2.1%).

Interactions

  • Strong CYP3A inhibitors (e.g. itraconazole) increase exposure; reduce the dose.
  • Strong CYP3A4 inducers (e.g. rifampicin) decrease exposure.
  • Proton pump inhibitors (e.g. omeprazole) reduce exposure when taken fasting, but not when taken with food.
  • Inhibits MATE1; increases in creatinine may occur.

Pregnancy and breastfeeding

  • Not recommended during pregnancy unless the benefit justifies the risk.
  • Highly effective contraception in women and effective contraception in men during and for at least one week after treatment.

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)

  • RetsevmoEli Lilly Nederland B.V. · EMEA/H/C/005375

Source: European Medicines Agency (EMA), product information

Turkey

  • TanstrıveLİLLY İLAÇ TİC. LTD. ŞTİ. · 8 register entries

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

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

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. Retsevmo – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/retsevmo-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 2026-10-29 · 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.