CRYSVITA (burosumab-twza) injection
CRYSVITA is a prescription medicine used to treat X-linked hypophosphatemia (XLH). It is not commercially registered or marketed in India, but eligible patients can legally access it through the Named Patient Program (NPP). This pathway allows individuals to import the medication for personal use by obtaining specific regulatory clearance from the CDSCO.
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CRYSVITA (burosumab-twza) injection
It is a prescription medication used to treat X-linked hypophosphatemia (XLH) in adults and children 6 months of age or older. It is also used to treat adults and children 2 years of age or older for FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) when the tumor cannot be located or surgically removed.
CRYSIVTA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for:
• The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
• The treatment of FGF23-related hypophosphatemia in tumorinduced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
Burosumab-twza is a human immunoglobulin G subclass 1 (IgG1), anti-human fibroblast growth factor 23 (FGF23) antibody produced by recombinant DNA technology using Chinese hamster ovary cells. Burosumab-twza is composed of two heavy chain (γ1-chain) molecules and two light chain (κ-chain) molecules. Each heavy chain has an N-linked carbohydrate moiety at asparagine 297
(Asn297).
Burosumab, sold under the brand name Crysvita, is a human monoclonal antibody medication approved 2018 for the treatment of X-linked hypophosphatemia and tumor-induced osteomalacia.
CRYSVITA® (burosumab-twza) injection, for subcutaneous use Initial U.S. Approval: 2018
Drug Name: CRYSVITA
Active Ingredient: burosumab-twza injection
b 12/13/2018
Dosage Forms And Strengths: Injection: 10 mg/mL, 20 mg/mL, or 30 mg/mL in a single-dose vial
Burosumab-twza is a human immunoglobulin G subclass 1 (IgG1), anti-human fibroblast growth factor 23 (FGF23) antibody produced by recombinant DNA technology using Chinese hamster ovary cells. Burosumab-twza is composed of two heavy chain (γ1-chain) molecules and two light chain (κ-chain) molecules. Each heavy chain has an N-linked carbohydrate moiety at asparagine 297
(Asn297).
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Alleviare Life Sciences Pvt. Ltd. (India) serves as a facilitator for medical and pharmaceutical products, commencing its operations in 2005. Headquartered in Delhi, India, Alleviare operates nationwide, providing a range of comprehensive services to patients, doctors, hospitals, and government healthcare facilities.
Our specialization lies in facilitating access to medicines, leveraging our expertise in sourcing and providing documentation assistance for programs such as Named Patient Program, Managed Access Program, and Early Access Program. We take pride in ensuring smooth and efficient access to medications for those who require them.
