Waylivra (Volanesorsen) Injection

Waylivra (volanesorsen), from Ionis Pharmaceuticals, is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) who are at high risk for pancreatitis, in markets where it holds regulatory approval.

Volanesorsen is an antisense oligonucleotide that reduces the production of apolipoprotein C-III (apoC-III), a protein that inhibits the clearance of triglyceride-rich lipoproteins, thereby lowering severely elevated triglyceride levels in FCS patients.

• Thrombocytopenia (low platelet count) is a significant risk; regular platelet monitoring is required throughout treatment.
• Injection-site reactions are commonly reported.
• Should only be used under specialist supervision with access to regular laboratory monitoring.
• Since this product is not FDA-approved, US patients should discuss its regulatory status with their treating physician before use.

What documents are required to import Waylivra to India?

Waylivra may be imported in the patient’s name only, based on a treating specialist’s recommendation. Required documents include:

• A valid prescription from a registered lipidologist/endocrinologist
• Genetic test report confirming familial chylomicronemia syndrome
• 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 confirmation of sourcing feasibility.

Is Waylivra available in India?

Waylivra is not commercially marketed in India. Availability through the Named Patient Program (NPP) depends on sourcing feasibility from markets where it holds approval.

Indian Pharma Network (IPN) can source Waylivra from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

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

Global Approval Status:

• European Union: Approved by the EMA — May 2019.
• United States: Not FDA-approved.

What is Waylivra used for?

Waylivra lowers severely elevated triglycerides in patients with familial chylomicronemia syndrome, reducing pancreatitis risk.

Who manufactures Waylivra?

Waylivra is developed by Ionis Pharmaceuticals.

Is Waylivra FDA-approved?

No — it is approved by the EMA in the European Union but is not currently FDA-approved.

How much does Waylivra cost in India?

Cost and sourcing feasibility depend on the patient’s specific case — contact IPN to discuss.