ritlecitinib
Litfulo · ATC code L04AF08
Also known as: Ritlesitinib
- Key facts
- Active substance
- ritlecitinib
- Drug class
- Immunosuppressive drug
- ATC code
- L04AF08
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Litfulo 50 mg hard capsules
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Information as of
- 2026-10-28
Key facts
Ritlecitinib (Litfulo) is an oral kinase inhibitor (JAK3/TEC) used to treat severe alopecia areata in adults and adolescents aged 12 and older.
What it is used for
- Severe alopecia areata in adults and adolescents 12 years of age and older.
Dosing
- 50 mg once daily by mouth, with or without food; reassess benefit-risk regularly and consider stopping if there is no benefit after 36 weeks.
- Do not start if absolute lymphocyte count < 0.5 × 10³/mm³ or platelets < 100 × 10³/mm³. Check platelets before starting, at 4 weeks and then routinely; discontinue if < 50 × 10³/mm³; interrupt if lymphocytes < 0.5 × 10³/mm³.
- Interrupt for a serious or opportunistic infection until controlled.
- No adjustment in renal impairment (not recommended in end-stage renal disease or renal transplant), Child-Pugh A/B, the elderly or adolescents.
- Missed dose: take as soon as possible unless less than 8 hours before the next dose.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Active serious infections, including tuberculosis.
- Severe hepatic impairment (Child-Pugh C).
- Pregnancy and breast-feeding.
Important warnings
- Use only if no suitable alternatives are available in patients aged 65 and older, with atherosclerotic cardiovascular disease or cardiovascular risk factors (e.g. smoking) and with malignancy risk factors.
- Serious infections (most often appendicitis, COVID-19 including pneumonia, sepsis); weigh risks in chronic or recurrent infection and TB exposure.
- Venous thromboembolism (deep vein thrombosis, pulmonary embolism) has been reported.
- Decreases in platelets and lymphocytes; laboratory monitoring as specified.
Side effects
- Most frequent: diarrhoea (9.2%), acne (6.2%), upper respiratory tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%) and dizziness (2.3%).
- Others: herpes zoster, increased CPK; uncommon decreased platelet and lymphocyte counts, ALT/AST increased ˃ 3 × ULN.
Interactions
- Ritlecitinib is a moderate CYP3A inhibitor (midazolam AUC increased about 2.7-fold): caution with sensitive CYP3A substrates (e.g. quinidine, ciclosporin, dihydroergotamine, ergotamine, pimozide).
- No dose adjustment needed with CYP3A inhibitors or CYP inducers.
Pregnancy and breastfeeding
- Contraindicated in pregnancy and breast-feeding (teratogenic in animals); effective contraception during treatment and for 1 month after the final 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.
Common questions – ask Medelix
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)
- LitfuloPfizer Europe MA EEIG · EMEA/H/C/006025
Source: European Medicines Agency (EMA), product information
Turkey
- LitfuloPFİZER PFE İLAÇLARI 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
- Litfulo
- Liechtenstein
- Litfulo
- Norway
- Litfulo
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
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Litfulo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/litfulo-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AF.
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.