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Manufacturer / Innovator:
USA
Regulatory Approval:
N/A
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Qfitlia (fitusiran) is an siRNA therapeutic approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years and older with hemophilia A or B, with or without factor VIII or factor IX inhibitors.
Qfitlia works by lowering antithrombin, a natural protein that inhibits blood clotting. By reducing antithrombin levels, Qfitlia helps rebalance clotting in patients with hemophilia, reducing bleeding episodes regardless of whether the patient has developed inhibitors to factor replacement therapy.
Qfitlia is intended for patients with hemophilia A or B who require routine prophylaxis to prevent bleeding episodes, including those who have developed inhibitors that make standard factor replacement therapy less effective.
The recommended dose of Qfitlia is 50 mg administered subcutaneously once every two months, with dose adjustments made to maintain antithrombin activity within a target range of 15% to 35%.
Boxed Warning — Qfitlia: Serious thrombotic events have occurred in patients treated with Qfitlia, particularly those with risk factors for thromboembolism, including persistent antithrombin activity below 15%, use of the 80 mg monthly dose, indwelling venous catheters, and the post-operative setting when bleed management guidelines were not followed. Acute and recurrent gallbladder disease, including cholelithiasis and cholecystitis, has also occurred in Qfitlia-treated patients, some requiring cholecystectomy or experiencing complications such as pancreatitis.
Antithrombin activity should be monitored using an FDA-cleared test, with the goal of maintaining levels within the target range of 15% to 35% to balance efficacy and thrombotic risk.
Liver function tests should be performed at baseline and monitored monthly for at least the first six months of treatment.
Patients should be monitored for signs and symptoms of gallbladder disease throughout treatment.
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.
Qfitlia is manufactured and marketed by Genzyme Corporation, a Sanofi company. It is sourced through authorized distribution channels for patients seeking named-patient import into India.
Patients typically need a valid prescription from a treating hematologist confirming hemophilia A or B diagnosis and inhibitor status. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved therapy for hemophilia prophylaxis, Qfitlia is sourced through authorized channels and imported under GDP-compliant, cold-chain logistics to preserve product quality throughout transit.
NPP sources Qfitlia directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.
Qfitlia requires refrigerated storage at 2°C to 8°C, though it may be kept at room temperature (15°C to 30°C) for up to 3 months if needed. NPP maintains appropriate handling throughout transit.
Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile cold-chain logistics to the patient's city.
Patients across India can access Qfitlia through NPP's regulated import pathway, with hematology specialists in major cities supporting the treatment process.
Leading hospitals in Mumbai support hemophilia care coordination and documentation for Qfitlia access.
Delhi's major hospitals assist patients with prescription support and documentation for Qfitlia.
Bangalore's specialist network offers access coordination for eligible hemophilia patients seeking Qfitlia.
Chennai-based hematology specialists coordinate Qfitlia access alongside comprehensive hemophilia care.
Hyderabad's care institutions support patients pursuing Qfitlia therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Qfitlia.
Pune-based specialists assist with prescription support and Qfitlia treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Qfitlia.
Kochi's specialist units assist patients with the documentation needed for Qfitlia access.
Chandigarh's care centers support Qfitlia treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Qfitlia access process.
Lucknow-based centers assist patients pursuing Qfitlia therapy.
Bhubaneswar's institutions support access to Qfitlia for eligible patients.
Guwahati's specialists help coordinate Qfitlia access for patients across the Northeast.
Patients in other cities across India can also access Qfitlia through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026
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