LITFULO

What it is

LITFULO is a hard capsule containing ritlecitinib tosylate, with each capsule containing 80.128 mg of ritlecitinib tosylate, equivalent to 50 mg of ritlecitinib. Ritlecitinib irreversibly and selectively inhibits Janus kinase (JAK) 3 and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family by blocking the adenosine triphosphate (ATP) binding site. This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information.

Approved indications

— Severe alopecia areata (AA) in adults and adolescents 12 years of age and older.

Dosing overview

The recommended dose of LITFULO is 50 mg once daily. LITFULO is to be taken orally once daily with or without food. Capsules should be swallowed whole and should not be crushed, split, or chewed, because these methods of administration have not been studied in clinical trials. Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of alopecia areata. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis, and consideration should be given to discontinuing patients who show no evidence of therapeutic benefit after 36 weeks.

Key safety warnings

Serious infections have been reported in patients receiving ritlecitinib, with the most frequent serious infections being appendicitis, COVID-19 infection (including pneumonia), and sepsis. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ritlecitinib, and treatment should be interrupted if a patient develops a serious or opportunistic infection. Patients should be screened for TB before starting therapy with ritlecitinib, and ritlecitinib must not be given to patients with active TB. Viral reactivations, including cases of herpes virus reactivation (e.g., herpes zoster), have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with ritlecitinib, and monitoring for reactivation of viral hepatitis according to clinical guidelines is recommended during ritlecitinib treatment. Malignancies, including non melanoma skin cancer (NMSC) have been reported in patients receiving ritlecitinib. Limited clinical data are available to assess the potential relationship of exposure to ritlecitinib and the development of malignancies, and long-term safety evaluations are ongoing. Events of venous and arterial thromboembolism, including major adverse cardiovascular events (MACE), have been reported in patients receiving ritlecitinib. Ritlecitinib should be used with caution in patients with known risk factors for thromboembolism. Treatment with ritlecitinib was associated with decreases in lymphocytes and platelets. Prior to initiating treatment with ritlecitinib, absolute lymphocyte count (ALC) and platelet counts should be performed, and treatment with ritlecitinib should not be initiated in patients with an ALC less than 0.5 × 10³/mm³ or a platelet count less than 100 × 10³/mm³.

Contraindications

LITFULO is contraindicated in cases of hypersensitivity to the active substance(s) or to any of the excipients, active serious infections including tuberculosis (TB), severe hepatic impairment, and pregnancy and breast-feeding.

PBS listing

No information regarding PBS listing is provided in the source documents.

Regulatory history

LITFULO received initial approval on 09 July 2024. Two ARTG entries are registered for LITFULO ritlecitinib (as tosylate) 50 mg hard capsules in both blister pack and bottle formats, first listed on 2024-07-09 under licence category RE.