Molecule
Ritlecitinib is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. It is available as capsules for oral use. MedsAcross supplies Ritlecitinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Source: US FDA prescribing information
LITFULO is a kinase inhibitor. Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family by blocking the adenosine triphosphate (ATP) binding site. In cellular settings, ritlecitinib inhibits cytokine induced STAT phosphorylation mediated by JAK3-dependent receptors. Additionally, ritlecitinib inhibits signaling of immune receptors dependent on TEC kinase family members. The relevance of inhibition of specific JAK or TEC family enzymes to therapeutic effectiveness is not currently known.
Source: US FDA prescribing information
• For recommended testing, evaluations and immunizations prior to LITFULO initiation, see Full Prescribing Information. • Recommended dosage is 50 mg orally once daily. • For dosage interruption for certain adverse reactions, see Full Prescribing Information.
Source: US FDA prescribing information
LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients.
Source: US FDA prescribing information
Boxed warning: Increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. LITFULO should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, start treating latent TB prior to use. • Hypersensitivity: Discontinue LITFULO if a clinically significant hypersensitivity reaction occurs. • Hypoglycemia in Patients with Diabetes: Consider increased monitoring of blood glucose, advise diabetic patients to notify their healthcare provider if they develop signs and symptoms of hypoglycemia. • Laboratory Abnormalities: Perform ALC and platelet counts prior to LITFULO initiation. Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections • Malignancy and Lymphoproliferative Disorders • Thromboembolic Events • Hypersensitivity • Laboratory Abnormalities Most common adverse reactions (incidence ≥1%) are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis.
Source: US FDA prescribing information
• Certain CYP3A substrates: Additional monitoring and dose adjustment of CYP3A substrate should be considered. • Certain CYP1A2 substrates: Additional monitoring and dose adjustment of CYP1A2 substrate should be considered. • Certain CYP3A inducers: Coadministration with strong inducers of CYP3A is not recommended.
Source: US FDA prescribing information
Store LITFULO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ritlecitinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Litfulo 50 mg capsuleOral | Pfizer Laboratories | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Ritlecitinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ritlecitinib, including Litfulo.
Yes. The US FDA first approved Ritlecitinib on 23 June 2023, according to Drugs@FDA.
Yes. Ritlecitinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Ritlecitinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ritlecitinib is classified under ATC code L04AF08 (Ritlecitinib).
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