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abemaciclib

Verzenios · ATC code L01EF03

Key facts
Active substance
abemaciclib
ATC code
L01EF03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Verzenios 50 mg film-coated tablets / Verzenios 100 mg film-coated tablets / Verzenios 150 mg film-coated tablets
Marketing authorisation holder
Eli Lilly Nederland B.V.
Information as of
2026-10-27

Key facts

Abemaciclib is a CDK4/6 inhibitor used to treat HR-positive, HER2-negative breast cancer in combination with endocrine therapy.

What it is used for

  • Adjuvant treatment of adults with HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence, combined with endocrine therapy
  • Women with HR-positive, HER2-negative locally advanced or metastatic breast cancer, combined with an aromatase inhibitor or fulvestrant
  • In pre- or perimenopausal women, endocrine therapy is combined with an LHRH agonist

Dosing

  • Recommended dose: 150 mg twice daily with endocrine therapy
  • Early breast cancer: taken continuously for two years, or until recurrence or unacceptable toxicity
  • Advanced/metastatic breast cancer: continued while there is clinical benefit or until unacceptable toxicity
  • Dose reductions for adverse reactions: 100 mg twice daily, then 50 mg twice daily
  • After vomiting or a missed dose, no extra dose; the next dose is taken at the scheduled time
  • Dose reduction if strong CYP3A4 inhibitors must be co-administered; further schemes in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Neutropenia: dose modification for Grade 3 or 4; fatal neutropenic sepsis in < 1 % of patients with metastatic breast cancer
  • Infections, including lung infection without neutropenia, occurred more often than with endocrine therapy alone
  • Venous thromboembolism: monitoring for deep vein thrombosis and pulmonary embolism
  • Diarrhoea: antidiarrhoeal agents such as loperamide at the first sign of loose stools
  • Complete blood counts before starting and regularly during treatment

Side effects

  • Most common: diarrhoea, infections, neutropenia, leukopenia, anaemia, fatigue, nausea, vomiting, alopecia, decreased appetite
  • Others: thrombocytopenia, febrile neutropenia, headache, dysgeusia, dizziness
  • Serious: venous thromboembolism, ILD/pneumonitis

Interactions

  • Abemaciclib is primarily metabolised by CYP3A4
  • Strong CYP3A4 inhibitors (e.g. clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole) should be avoided; if needed, the dose is reduced
  • Grapefruit and grapefruit juice should be avoided

Pregnancy and breastfeeding

  • Not recommended during pregnancy; women of childbearing potential should use highly effective contraception during treatment and for at least 3 weeks after
  • Patients should not breast-feed during treatment

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)

  • VerzeniosEli Lilly Nederland B.V. · EMEA/H/C/004302

Source: European Medicines Agency (EMA), product information

Turkey

  • YularebLİLLY İLAÇ TİC. LTD. ŞTİ. · 9 register entries

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

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

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?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Verzenios – 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/verzenios-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 2026-10-27 · 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.