Belzutifan (Welireg) is an oral hypoxia-inducible factor inhibitor (HIF-2α inhibitor) that received its first approval for marketing in the United States in 2021.

What are the Indications for Belzutifan (Welireg)?

Primary Indications

Belzutifan is mainly indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease.

The following criteria must be met: the relevant tumors require treatment; the patients have renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET) associated with VHL disease.

Non-emergency surgery situation: the above-mentioned tumors do not require immediate surgical intervention at present.

Dosage Form, Strength and Properties of Belzutifan (Welireg)

Dosage Form and Strength

Tablet: 40 mg.

Description: Blue, oval, film-coated tablets. One side is engraved with "177" and the other side is blank.

Properties and Ingredients

Active Ingredient: Belzutifan.

Chemical Name: 3-[[(1S,2S,3R)-2,3-difluoro-2,3-dihydro-1-hydroxy-7-(methylsulfonyl)-1H-inden-4-yl]oxy]-5-fluorobenzonitrile.

Molecular Formula: C₁₇H₁₂F₃NO₄S.

Properties: White to light brown powder, soluble in acetonitrile, dimethoxyethane and acetone.

Excipients

Tablet Core: Croscarmellose Sodium, Hypromellose Acetate Succinate, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Silicon Dioxide.

Film Coating: FD&C Blue No. 2 Aluminum Lake, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide.

Storage Method of Belzutifan (Welireg)

Storage Conditions

Temperature Requirement: Store at room temperature between 20°C and 25°C (68°F and 77°F). Short-term storage between 15°C and 30°C (59°F and 86°F) is permitted.

Environmental Requirement: Keep the bottle tightly closed, store in a dry place, and protect from direct sunlight and moisture.

Precautions: The desiccant inside the bottle is for moisture absorption and protection, do not ingest it by mistake. Keep the medicine out of the reach of children.

If patients find that the tablets have changed color, become damaged or altered in properties, they should refrain from taking them. Any unused or expired medicine should be properly disposed of in accordance with local regulations and should not be discarded at will.