Big Bear UPADX Upadacitinib 15mg

Product Information

• Product name: UPADX Upadacitinib 15mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Upadacitinib
• Current strength: 15mg
• SKU: BB-ITEM-72
• Site category: rheumatoid arthritis, other cancer

Product Summary

UPADX Upadacitinib 15mg is an AISTIKA-listed product supplied by Laos BigBear 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

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

Upadacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression. Upadacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.

Reference Indications

Upadacitinib/Upadacitinib LQ is a Janus kinase (JAK) inhibitor. Upadacitinib is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Upadacitinib is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. Upadacitinib/Upadacitinib LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

Reference Dosage and Administration

Recommended dosage of Upadacitinib is 15 mg once daily. taken orally with or without food .

With this 15mg product, that corresponds to 1 x 15mg 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, and THROMBOSIS SERIOUS INFECTIONS Patients treated with Upadacitinib /Upadacitinib LQ are at increased risk for developing serious infections that may lead to hospitalization or death . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Upadacitinib /Upadacitinib LQ until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before Upadacitinib /Upadacitinib LQ use and during therapy. Treatment for latent infection should be considered prior to Upadacitinib /Upadacitinib LQ use.

Common Adverse Reactions and Monitoring

Patients could advance or switch to Upadacitinib 15 mg from placebo, or be rescued to Upadacitinib from active comparator or placebo from as early as Week 12 depending on the trial design. A total of 2630 patients received at least 1 dose of Upadacitinib 15 mg, of whom 1860 were exposed for at least one year. Four integrated datasets are presented in the Specific Adverse Reaction section: Placebo-controlled Trials: Trials RA-III, RA-IV, and RA-V were integrated to represent safety through 12/14 weeks for placebo (n=1042) and Upadacitinib 15 mg (n=1035).

Drug Interactions and Special Populations

Strong CYP3A4 Inhibitors : See the for dosage modification for patients with atopic dermatitis, ulcerative colitis, and Crohn’s disease. ( 2.13 , 7.1 ) Strong CYP3A4 Inducers : Coadministration of Upadacitinib/Upadacitinib LQ with strong CYP3A4 inducers is not recommended. Food or drink containing grapefruit should be avoided during treatment with Upadacitinib/Upadacitinib LQ. The recommended maintenance dosage is 15 mg once daily . Coadministration of Upadacitinib/Upadacitinib LQ with strong CYP3A4 inducers is not recommended. Lactation : Advise not to breastfeed. Hepatic Impairment : Upadacitinib/Upadacitinib LQ is not recommended in patients with severe hepatic impairment. If Upadacitinib/Upadacitinib LQ exposure occurs during pregnancy, healthcare providers or patients should report the pregnancy by calling 1-800-633-9110.

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: Rinvoq 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.