Big Bear WELIDX Belzutifan 40mg

Product Information

• Product name: WELIDX Belzutifan 40mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Belzutifan
• Current strength: 40mg
• SKU: BB-ITEM-74
• Site category: kidney cancer, other cancer

Product Summary

WELIDX Belzutifan 40mg 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

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

Belzutifan is an inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α). HIF-2α is a transcription factor that plays a role in oxygen sensing by regulating genes that promote adaptation to hypoxia. Under normal oxygen levels, HIF-2α is targeted for ubiquitin-proteasomal degradation by VHL protein. Lack of functional VHL protein results in stabilization and accumulation of HIF-2α.

Reference Indications

Belzutifan is a hypoxia-inducible factor inhibitor indicated: von Hippel-Lindau (VHL) disease for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Advanced Renal Cell Carcinoma (RCC) for treatment of adult patients with advanced renal cell carcinoma (RCC) with a clear cell component following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Reference Dosage and Administration

Recommended dosage of Belzutifan in adult patients is 120 mg administered orally once daily with or without food.

With this 40mg product, that corresponds to 3 x 40mg tablets 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: EMBRYO-FETAL TOXICITY Exposure to Belzutifan during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of Belzutifan. Advise patients of these risks and the need for effective non-hormonal contraception. Belzutifan can render some hormonal contraceptives ineffective . WARNING: EMBRYO-FETAL TOXICITY See for complete boxed warning. Exposure to Belzutifan during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of Belzutifan. Advise patients of these risks and the need for effective non-hormonal contraception. Belzutifan can render some hormonal contraceptives ineffective. ( 5.3 , 7.2 , 8.1 , 8.3 ) Anemia : Monitor for anemia before initiation of and periodically throughout treatment with Belzutifan.

Common Adverse Reactions and Monitoring

Von Hippel-Lindau (VHL) disease LITESPARK-004 The safety of Belzutifan was evaluated in an open-label clinical trial (LITESPARK-004) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney . Patients received Belzutifan 120 mg orally once daily until disease progression or unacceptable toxicity. The median duration of exposure to Belzutifan was 68 weeks (range: 8.4 to 104.7 weeks). Dosage interruptions of Belzutifan due to an adverse reaction occurred in 39% of patients. Dose reductions of Belzutifan due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

Drug Interactions and Special Populations

UGT2B17 or CYP2C19 Inhibitors: Monitor for signs and symptoms of anemia and hypoxia and reduce the dosage of Belzutifan as recommended. ( 2.2 , 7.1 ) 7.1 Effects of Other Drugs on Belzutifan UGT2B17 or CYP2C19 Inhibitors Monitor for anemia and hypoxia and reduce the dosage of Belzutifan as recommended . If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of Belzutifan with CYP3A4 substrates decreases concentrations of CYP3A substrates , which may reduce the efficacy of these substrates. The magnitude of this decrease may be more pronounced in patients who are dual UGT2B17 and CYP2C19 poor metabolizers .

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: WELIREG 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.