cladribine
Litak, Mavenclad · ATC code L01BB04
Also known as: Cladribin · Brand names: Litak, Mavenclad, Leuject, Leustatin, Ocladra
- Key facts
- Active substance
- cladribine
- Drug class
- Purine analogue
- ATC code
- L01BB04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- LITAK 2 mg/ml solution for injection · MAVENCLAD 10 mg tablets
- Marketing authorisation holder
- Lipomed GmbH, Merck Europe B.V.
- Information as of
- 2026-10-27
Key facts
Cladribine is a purine nucleoside analogue with antineoplastic and immunosuppressive activity. It is used as an injection (LITAK) for hairy cell leukaemia and as tablets (MAVENCLAD) for highly active relapsing multiple sclerosis.
What it is used for
- LITAK: hairy cell leukaemia
- MAVENCLAD: adults with highly active relapsing multiple sclerosis as defined by clinical or imaging features
Dosing
- LITAK: a single course of 0.14 mg/kg body weight daily by subcutaneous bolus injection for 5 consecutive days
- LITAK: contraindicated in moderate to severe renal (creatinine clearance ≤50 ml/min) or hepatic impairment and under 18 years
- MAVENCLAD: cumulative dose 3.5 mg/kg over 2 years, as one course of 1.75 mg/kg per year
- MAVENCLAD: each course has 2 treatment weeks at the start of the first and second month; 10 mg or 20 mg daily by body weight on 4 or 5 days
- MAVENCLAD: lymphocytes normal before year 1 and at least 800 cells/mm³ before year 2; year 2 may be delayed up to 6 months
- MAVENCLAD: no further treatment needed in years 3 and 4; weight-based dose tables in the full text
Contraindications
- Hypersensitivity to the active substance or any excipient
- Pregnancy and breast-feeding
- LITAK: patients under 18 years; concomitant other myelosuppressive medicines
- MAVENCLAD: HIV infection, active chronic infection (tuberculosis or hepatitis), active malignancy
- MAVENCLAD: initiation in immunocompromised patients; moderate or severe renal impairment (creatinine clearance <60 mL/min)
Important warnings
- Myelo- and immunosuppression, long-lasting lymphocytopenia and opportunistic infections; close monitoring
- Serious, sometimes fatal infections; exclude HIV, active tuberculosis and hepatitis before starting (MAVENCLAD)
- MAVENCLAD: lymphocyte counts before years 1 and 2 and 2 and 6 months after the start of each treatment year
- LITAK: irradiated cellular blood products to prevent transfusion-related GVHD
- Progressive multifocal leukoencephalopathy (PML)
Side effects
- LITAK (hairy cell leukaemia): very common myelosuppression with severe neutropenia, thrombocytopenia and anaemia, severe immunosuppression/lymphopenia, infections and fever
- MAVENCLAD: most clinically relevant are lymphopenia (25.6%) and herpes zoster (3.0%)
- MAVENCLAD common: oral herpes, rash, alopecia, decreased neutrophil count, hypersensitivity
Interactions
- LITAK: not with other myelosuppressive medicines; other nucleoside analogues not advisable; corticosteroids increase the risk of severe infections
- MAVENCLAD: separate other oral medicines by at least 3 hours on dosing days
- MAVENCLAD: initiation contraindicated during immunosuppressive or myelosuppressive therapy (e.g. methotrexate, cyclophosphamide, cyclosporine, azathioprine, chronic corticosteroids)
Pregnancy and breastfeeding
- Contraindicated in pregnancy and breast-feeding; cladribine causes serious birth defects
- Effective contraception during treatment and for at least 6 months after the last dose (MAVENCLAD: men are counselled too)
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.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
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)
Source: European Medicines Agency (EMA), product information
Austria
- LeujectAtnahs Pharma Netherlands B.V. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- LeustatinAtnahs Pharma Netherlands B.V. · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- MavencladMERCK İLAÇ ECZA VE KİMYA TİC. A.Ş. · 6 register entries
- OcladraBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 21 more European countries
- Belgium
- Leustatin
- Bulgaria
- Леуджект
- Croatia
- Leuject
- Czechia
- Leuject
- Finland
- Leuject
- France
- Cladribine Zentiva, Leustatine
- Greece
- Leustatin
- Hungary
- Leuject
- Iceland
- Mavenclad
- Italy
- Leustatin
- Liechtenstein
- Mavenclad
- Lithuania
- Cladribine Zentiva
- Luxembourg
- Leustatin
- Netherlands
- Leustatin
- Norway
- Cladribine Zentiva, Leuject, Mavenclad
- Poland
- Biodribin, Leuject
- Portugal
- Cladribina Generis, Leustatin
- Romania
- Leuject
- Slovenia
- Leuject
- Spain
- Leustatin
- Sweden
- Leuject
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.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Litak – 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/litak-epar-product-information_en.pdf
- European Medicines Agency. Mavenclad – 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/mavenclad-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L01BB.
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.