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venetoclax

Venclyxto · ATC code L01XX52

Key facts
Active substance
venetoclax
ATC code
L01XX52
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Venclyxto 10 mg film-coated tablets / Venclyxto 50 mg film-coated tablets / Venclyxto 100 mg film-coated tablets
Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Information as of
2026-10-27

Key facts

Venetoclax (Venclyxto) is an oral BCL-2 inhibitor. It is used in adults with chronic lymphocytic leukaemia (CLL) and with newly diagnosed acute myeloid leukaemia (AML).

What it is used for

  • Previously untreated CLL: with acalabrutinib (with or without obinutuzumab), with obinutuzumab, or with ibrutinib
  • Previously treated CLL: in combination with rituximab
  • CLL monotherapy with 17p deletion/TP53 mutation, or after failure of chemoimmunotherapy and a B-cell receptor pathway inhibitor
  • Newly diagnosed AML ineligible for intensive chemotherapy, with a hypomethylating agent

Dosing

  • CLL: start 20 mg once daily for 7 days, increased gradually over 5 weeks to 400 mg daily
  • CLL combinations: duration and timing depend on partner (e.g. 14 cycles with acalabrutinib); details in the full text
  • AML: ramp-up over the first days to 400 mg daily from day 3, with azacitidine or decitabine
  • Dose titration, hydration and laboratory monitoring are used to prevent tumour lysis syndrome
  • Dose modifications for interactions and haematologic toxicity per the full product information

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • CLL: strong CYP3A inhibitors at initiation and during dose titration
  • Preparations containing St. John's wort

Important warnings

  • Tumour lysis syndrome, including fatal events and renal failure requiring dialysis; electrolyte changes as early as 6 to 8 hours after the first dose
  • Risk assessment and prophylaxis (hydration, anti-hyperuricaemics) for all patients
  • Neutropenia and serious infections

Side effects

  • Combination therapy (≥20%): diarrhoea, neutropenia, nausea, upper respiratory tract infection, fatigue, vomiting
  • Monotherapy: neutropenia, diarrhoea, nausea, anaemia, fatigue
  • Serious: pneumonia, febrile neutropenia, sepsis, tumour lysis syndrome

Interactions

  • Strong CYP3A inhibitors (e.g. ketoconazole, ritonavir, posaconazole) markedly increase venetoclax exposure
  • Effect on hormonal contraceptives unknown; add a barrier method

Pregnancy and breastfeeding

  • May harm the foetus; women must use highly effective contraception during and for 30 days after 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)

  • VenclyxtoAbbVie Deutschland GmbH & Co. KG · EMEA/H/C/004106

Source: European Medicines Agency (EMA), product information

Turkey

  • VenclyxtoABBVİE TIBBİ İLAÇLAR SAN. VE TİC. LTD. ŞTİ. · 7 register entries

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

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

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. Venclyxto – 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/venclyxto-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.