Belzutifan(Welireg)
Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection
Validity period:
24 months
Reminder: The outer packaging is for reference only, please purchase and use under the guidance of
a
pharmacist. For read by medical and pharmaceutical professionals only.
WELIREG, with the active pharmaceutical ingredient belzutifan, is an orally
administered medication available as 40 mg film-coated tablets. Chemically,
belzutifan is
3-[[(1S,2S,3R)-2,3-Difluoro-2,3-dihydro-1-hydroxy-7-(methylsulfonyl)-1H-inden-4-yl]oxy]-5-fluorobenzonitrile.
It is designed for therapeutic use in adult patients with specific oncological
conditions, including tumors associated with von Hippel-Lindau disease and
certain types of advanced kidney cancer.
The therapeutic effect of belzutifan is derived from its activity as an
inhibitor of hypoxia-inducible factor 2 alpha (HIF-2αα). HIF-2αα is a key
transcription factor that plays a significant role in the body's oxygen-sensing
mechanisms by modulating genes involved in adaptation to hypoxic (low oxygen)
conditions. By targeting and inhibiting HIF-2αα, WELIREG interferes with
cellular pathways that contribute to the growth and progression of certain
cancers.
Generic name
Belzutifan(Welireg)
Alternative Names
Welireg
Indications
1. Von Hippel-Lindau (VHL) disease: For the 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.
2. Advanced Renal
Cell Carcinoma (RCC): For the 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).
Therapeutic Target
Hypoxia-inducible factor 2 alpha (HIF-2 α α).
Active Ingredients
Belzutifan
specifications
40mg*90 tablets/bottle
Description
Belzutifan is an inhibitor of hypoxia-inducible factor-2αα (HIF-2αα). The chemical name is 3-[[(1S,2S,3R)-2,3-Difluoro-2,3-dihydro-1-hydroxy-7-(methylsulfonyl)-1H-inden-4-yl]oxy]-5-fluorobenzonitrile. The molecular formula is C1717H1212F33NO44S, and the molecular weight is 383.34 Daltons. Belzutifan is a white to light brown powder. It is soluble in acetonitrile, dimethoxyethane, and acetone; sparingly soluble in ethyl acetate; very slightly soluble in isopropanol and toluene; and insoluble in water.
WELIREG tablets are supplied as blue, film-coated tablets for oral use containing 40 mg of belzutifan and the following inactive ingredients: croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, mannitol, microcrystalline cellulose, and silicon dioxide. The film coating contains FD&C Blue aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Dosage and Administration
The recommended dosage of WELIREG is 120 mg administered
orally once daily until disease progression or unacceptable toxicity. It should
be taken at the same time each day and may be taken with or without food.
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