Fabhalta

Boxed Warning — Fabhalta: Fabhalta increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. Patients must be vaccinated against these bacteria, or receive antibacterial prophylaxis if not up to date, and are monitored for early signs of infection. Fabhalta is available only through the Fabhalta REMS program.

Fabhalta Warnings and Precautions

• Serious infections: See boxed warning above — vaccination or prophylaxis is required before starting treatment.
• Hemolysis after discontinuation: Patients should be monitored for signs of hemolysis if Fabhalta is stopped.
• Elevated cholesterol: Serum lipid levels should be monitored periodically; cholesterol-lowering treatment may be needed.

How to Access Fabhalta in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Fabhalta to India?

Fabhalta (iptacopan) capsules may be imported in the patient's name only, by patients or government hospitals, in line with India's import regulations for unapproved medicines. The following documentation is required:

• A valid prescription from a qualified hematologist or nephrologist
• The patient's diagnostic reports confirming PNH or IgA nephropathy
• Documentation of vaccination status against encapsulated bacteria, as required by the Fabhalta REMS program
• 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 from the doctor and, if applicable, an import permit.

Is Fabhalta available in India?

Fabhalta (iptacopan capsules) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, Fabhalta is not commercially marketed in India.

However, patients in India can legally access Fabhalta through the Named Patient Program (NPP) — an import provision that allows patients to receive medicines approved in other countries but not yet marketed in India, under a doctor's prescription and proper regulatory documentation.

Fabhalta received US FDA approval in December 2023 for PNH, with a subsequent indication for IgA nephropathy, ensuring full transparency throughout the process.

Fabhalta can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others.

Sourcing & Delivery of Fabhalta

Fabhalta is sourced directly from authorized channels in the country of origin and shipped to India under GDP-compliant logistics to preserve product integrity from dispatch to delivery.

• Storage maintained at 15°C to 30°C throughout transit
• Real-time shipment tracking and delivery updates
• Delivery coordinated directly with the patient, family, or treating hospital

Availability of Fabhalta Across Major Cities in India

Named Patient Program supports access to Fabhalta for patients with PNH or IgA nephropathy across major cities in India, coordinating documentation, sourcing, and delivery with treating specialists.

Mumbai

Patients in Mumbai can access Fabhalta through NPP with support from treating hematologists and nephrologists.

Delhi

In Delhi, NPP coordinates with hospitals and specialty hematology/nephrology clinics to facilitate timely access to Fabhalta.

Bangalore

Bangalore's hematology and nephrology centers work with NPP to support patients requiring Fabhalta.

Chennai

Patients in Chennai can access Fabhalta through NPP, with coordination between treating doctors and the program's regulatory and logistics team.

Hyderabad

Hyderabad's hematology and nephrology centers support diagnosis and access coordination for Fabhalta through NPP.

Kolkata

NPP facilitates access to Fabhalta for patients in Kolkata under the guidance of treating specialists.

Pune

Patients in Pune can access Fabhalta through NPP with prescription-based coordination and delivery support.

Ahmedabad

NPP supports access to Fabhalta for patients in Ahmedabad, working directly with treating specialists.

Kochi

Patients in Kochi and across Kerala can access Fabhalta through NPP's regulated import pathway.

Chandigarh

NPP coordinates access to Fabhalta for patients in Chandigarh and the surrounding region.

Jaipur

Patients in Jaipur can access Fabhalta through NPP with support from treating specialists.

Lucknow

NPP facilitates access to Fabhalta for patients in Lucknow and across Uttar Pradesh.

Bhubaneswar

Patients in Bhubaneswar can access Fabhalta through NPP's coordinated import and delivery process.

Guwahati

NPP supports access to Fabhalta for patients in Guwahati and across the Northeast region.

NPP also supports access for patients in other Indian cities not listed above — contact the team to check availability and timelines for your location.