Lucius LuciRit Ritlecitinib 50mg

Product Information

• Product name: LuciRit Ritlecitinib 50mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Ritlecitinib
• Current strength: 50mg
• SKU: LU-ITEM-98
• Site category: alopecia areata, other cancer

Product Summary

LuciRit Ritlecitinib 50mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Ritlecitinib is the active ingredient used for this product page. Public prescribing information for Ritlecitinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Ritlecitinib 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. 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.

Reference Indications

Ritlecitinib 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. Ritlecitinib 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 .

Reference Dosage and Administration

Recommended dosage is 50 mg orally once daily. with or without food .

With this 50mg product, that corresponds to 1 x 50mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See for complete 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. Ritlecitinib should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; start treating latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

Common Adverse Reactions and Monitoring

The safety of Ritlecitinib was evaluated in three randomized, placebo-controlled clinical trials and one long-term trial in subjects with alopecia areata, including alopecia totalis and alopecia universalis, who were 12 years of age and older. A total of 1628 subjects were treated with Ritlecitinib representing 2085 subject-years of exposure. There were 1011 subjects with at least 1 year of exposure to Ritlecitinib. The median age of subjects was 33 years, 105 (11.9%) subjects were 12 to <18 years old and 22 (2.5%) subjects were 65 years of age or older. The majority of subjects were White (70.7%) and female (63.6%).

Drug Interactions and Special Populations

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. Clinically Significant Interactions Affecting Ritlecitinib CYP3A Inducers Clinical Impact Concomitant use of strong CYP3A inducer (e.g., rifampin) may decrease AUC and C max of ritlecitinib , which may result in loss of or reduced clinical response. Intervention Coadministration with strong inducers of CYP3A is not recommended. Lactation : Breastfeeding not recommended. Severe Hepatic Impairment: Not recommended.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Litfulo public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.