Kalydeco (Ivacaftor)

Kalydeco (ivacaftor), from Vertex Pharmaceuticals, is indicated for the treatment of cystic fibrosis (CF) in patients 1 month of age and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data (e.g., certain gating mutations including G551D).

Ivacaftor is a CFTR potentiator. In patients with responsive CFTR mutations, the CFTR protein reaches the cell surface but does not open properly. Ivacaftor helps keep the CFTR channel open longer, improving chloride ion transport across cell membranes and helping to thin the mucus associated with cystic fibrosis.

• Elevated liver enzymes have been reported; liver function tests are recommended before starting and periodically during treatment.
• Cataracts (non-congenital lens opacities) have been reported in pediatric patients; eye examinations are recommended.
• Should be taken with fat-containing food to ensure adequate absorption.
• Common side effects: headache, upper respiratory tract infection, nasal congestion, rash, dizziness.

What documents are required to import Kalydeco to India?

Kalydeco 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 pulmonologist specifying Kalydeco and dose
• CFTR genetic test report confirming an ivacaftor-responsive mutation
• 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 Kalydeco available in India?

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

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

For Kalydeco 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 — January 2012.
• European Union: Approved by the EMA.

What is Kalydeco used for?

Kalydeco treats cystic fibrosis in patients with at least one ivacaftor-responsive CFTR mutation.

Who manufactures Kalydeco?

Kalydeco is manufactured by Vertex Pharmaceuticals.

Does Kalydeco need to be taken with food?

Yes — Kalydeco should be taken with fat-containing food to ensure proper absorption.

How much does Kalydeco cost in India?

Cost depends on monthly quantity and sourcing logistics — share your prescription and genetic test report with IPN for a quote.