Lucius LuciRux Ruxolitinib 20mg

Product Information

• Product name: LuciRux Ruxolitinib 20mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Ruxolitinib
• Current strength: 20mg
• SKU: LU-ITEM-99
• Site category: myelofibrosis, other cancer

Product Summary

LuciRux Ruxolitinib 20mg 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

Ruxolitinib is the active ingredient used for this product page. Public prescribing information for Ruxolitinib 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

Ruxolitinib, a Janus kinase (JAK) inhibitor, inhibits JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

Reference Indications

Ruxolitinib is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Limitations of Use Use of Ruxolitinib in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

Reference Dosage and Administration

Atopic Dermatitis Apply a thin layer of Ruxolitinib topically twice daily to affected areas of up to 20% body surface area.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

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, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death . Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Invasive fungal infections, including cryptococcosis, and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. Avoid use of Ruxolitinib in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt Ruxolitinib until the infection is controlled.

Common Adverse Reactions and Monitoring

No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects 12 to 17 years of age. Pediatric Subjects 2 to 11 Years of Age In a double-blind, vehicle-controlled clinical trial (TRuE-AD3), 130 pediatric subjects 2 to 11 years of age with mild to moderate atopic dermatitis were treated topically with Ruxolitinib twice daily for 8 weeks . The impact of Ruxolitinib on blood cell counts in this population has not been studied. No clinically meaningful differences in safety or effectiveness were observed between adults and pediatric subjects.

Drug Interactions and Special Populations

Drug interaction studies with Ruxolitinib have not been conducted. Ruxolitinib is known to be a substrate for cytochrome P450 3A4 (CYP3A4). Inhibitors of CYP3A4 may increase ruxolitinib systemic concentrations whereas inducers of CYP3A4 may decrease ruxolitinib systemic concentrations . Lactation : Advise not to breastfeed. Pregnant persons exposed to Ruxolitinib and healthcare providers should report Ruxolitinib exposure by calling 1-855-463-3463 or visiting www.Ruxolitinib.pregnancy.incyte.com. Risk Summary Available data from pregnancies reported in clinical trials with Ruxolitinib are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. The background risks of major birth defects and miscarriage for the indicated populations are unknown.

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: OPZELURA 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.