ELFABRIO (Pegunigalsidase Alfa-iwxj) Injection

ELFABRIO (pegunigalsidase alfa-iwxj), from Chiesi Global Rare Diseases and Protalix BioTherapeutics, is an enzyme replacement therapy indicated for the long-term treatment of adults with confirmed Fabry disease, an X-linked inherited disorder caused by alpha-galactosidase A deficiency.

Fabry disease results in progressive accumulation of a fatty substance (globotriaosylceramide, Gb3) in cells throughout the body. ELFABRIO supplies an exogenous, PEGylated form of alpha-galactosidase A to help clear the accumulated substrate.

• Hypersensitivity reactions, including anaphylaxis, have occurred — infusions should be administered where such reactions can be managed.
• Infusion-associated reactions are common, particularly during early treatment cycles.
• Common side effects: chills, fatigue, headache, infusion-site reactions, nausea.

What documents are required to import ELFABRIO to India?

ELFABRIO may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered physician/geneticist
• Diagnostic report confirming Fabry disease (enzyme assay/genetic testing)
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription and an import permit, if applicable.

Is ELFABRIO available in India?

ELFABRIO is not commercially marketed in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source ELFABRIO from Chiesi/Protalix’s authorized distribution network and facilitate supply to patients, doctors, and hospitals. ELFABRIO requires cold-chain handling (refrigerated 2-8°C); IPN uses temperature-monitored logistics for every shipment.

For ELFABRIO cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA — May 9, 2023.

What is ELFABRIO used for?

ELFABRIO is an enzyme replacement therapy for adults with confirmed Fabry disease.

Who manufactures ELFABRIO?

ELFABRIO is developed by Chiesi Global Rare Diseases and Protalix BioTherapeutics.

How often is ELFABRIO given?

As an IV infusion once every 2 weeks, dosed at 1 mg/kg, under physician supervision.

How much does ELFABRIO cost in India?

Cost depends on body-weight dosing, sourcing logistics, and quantity — share your prescription with IPN for a quote.