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Defitelio

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Defitelio

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Defitelio
Generic Name (API): Defibrotide sodium
Dosage Form & Strength: 200 mg / 2.5 ml (80 mg / ml)
Route: Intravenous (IV) infusion
Drug Class: Antithrombotic and profibrinolytic agent

Manufacturer / Innovator:

Ireland

Regulatory Approval:

  • FDA (US)
  • EMA (Europe)
  • TGA (Australia)
  • HC (Health Canada)
  • and others
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  • Medicines sourced from authorized manufacturers with full batch traceability

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  • EU-GDP Compliant Warehousing for secure, quality-controlled global distribution.

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What Is Defitelio Used For?

Defitelio (defibrotide sodium) is a medicine made from small natural DNA-like molecules. It helps protect the tiny blood vessels in the liver and helps keep the body's blood clotting and clot-breaking processes in balance. It is indicated for the treatment of:

  • Adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

Hepatic VOD/SOS is an uncommon but often life-threatening complication of stem-cell transplantation, and Defitelio is the first and only medicine specifically approved for this condition.

Defitelio is a prescription medicine that must be initiated and supervised by a physician experienced in the care of hematopoietic stem-cell transplant patients.

Recommended Dosage

Defitelio is given as an intravenous infusion of 6.25 mg/kg of body weight every 6 hours (a total daily dose of 25 mg/kg), with each dose infused over approximately 2 hours. The calculated dose is diluted in normal saline or 5% dextrose before administration.

Treatment should continue for a minimum of 21 days. If, after 21 days, the signs and symptoms of hepatic VOD have not resolved, treatment is generally continued until VOD resolves or transplant-related mortality occurs, per the treating physician's judgment. The exact dose, duration, and any interruptions for bleeding or hypersensitivity must be individualized by the treating physician according to the full prescribing information.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Defitelio Warnings and Precautions

  • Defitelio may increase the risk of serious or life-threatening bleeding. Patients should report unusual bleeding, easy bruising, blood in urine or stool, severe headache, confusion, slurred speech, or vision changes immediately. Treatment should not begin during significant active bleeding.
  • Defitelio must not be used with systemic anticoagulant or fibrinolytic medicines because combining them can significantly increase bleeding risk. Patients should inform their healthcare provider about all medicines affecting blood clotting before starting Defitelio treatment.
  • Defitelio may cause allergic reactions, including serious anaphylaxis. Patients should inform their doctor about any previous exposure to defibrotide. Healthcare professionals will monitor patients during infusion for signs of an allergic reaction and provide appropriate treatment if necessary.
  • Common effects reported in approximately 1 in 10 patients or more include low blood pressure, diarrhea, vomiting, nausea, and nosebleeds (epistaxis). Patients should inform their healthcare team if these effects become severe, persistent, or concerning during treatment.
  • There is limited information about Defitelio use during pregnancy. Because serious adverse effects, including bleeding, may potentially affect a breastfed infant, breastfeeding is not recommended during treatment. Patients who are pregnant, planning pregnancy, or breastfeeding should discuss this with their doctor.
  • Patients receiving Defitelio require regular monitoring for bleeding and hypersensitivity reactions throughout treatment. Special attention is needed when other medicines affecting blood clotting are used. Defitelio must be prepared, diluted, and administered exactly as directed by trained healthcare professionals.

How to Access Defitelio 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 – 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.

Access This Process Easily via Our App

You can manage the entire process seamlessly through the Named Patient Program App, available on both the Play Store and App Store.

  • Track your medicine request in real-time
  • Upload documents and approvals
  • View quotations and timelines
  • Get status updates at every step

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Documentation & Availability

What documents are required to import DEFITELIO to India?

DEFITELIO (defibrotide sodium) injection may be imported in the patient's name only, by patients or government hospitals. The following documentation is required:

  • A valid prescription from a qualified hematologist/oncologist or transplant physician
  • The patient's diagnostic reports (confirming VOD/SOS diagnosis and post-HSCT status)
  • 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 DEFITELIO available in India?

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

However, patients in India can legally access DEFITELIO through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of an individual patient, on the prescription of their treating physician.

NamedPatientProgram.com (NPP) acts as a facilitator under named patient supply, providing input on:

  • Availability of Defitelio in India and pathways to access it
  • Availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE)
  • Defitelio price in India under the NPP route
  • Sourcing from genuine, reliable channels in the USA, Europe, China, Singapore, Canada, and Australia
  • Ensuring full transparency throughout the process

DEFITELIO 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 — and can facilitate delivery to the patient's treating hospital or bone marrow transplant (BMT) unit. Orders are confirmed only upon receipt of a valid doctor's prescription and, where applicable, an import permit.

Sourcing & Delivery of Defitelio

NamedPatientProgram.com (NPP) can source Defitelio from reliable global manufacturers and qualified pharmaceutical supply channels and facilitate supply to patients, doctors, and hospitals under applicable legal provisions. Defitelio is stable at controlled room temperature and does not require cold-chain refrigeration, but it is still transported and stored under validated, GDP-compliant conditions to protect product integrity.

All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For Defitelio cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability of Defitelio Across Major Cities in India

Patients across India can access Defitelio® through regulated import pathways, with delivery arranged to the treating hospital or transplant unit based on a valid specialist's prescription.

Mumbai: A major hematopoietic stem-cell transplant hub with institutions like Tata Memorial, Mumbai, sees demand for time-critical therapies like Defitelio® in patients developing VOD after HSCT.

Bangalore: With a growing network of BMT-capable multispecialty hospitals, Bangalore supports access to global transplant-supportive treatments through structured import pathways guided by treating specialists.

Delhi: As part of the Delhi NCR region, the city has a strong concentration of bone marrow transplant centers, making it a key location for accessing advanced imported therapies.

Gurgaon: Home to leading hospitals like Medanta, Gurgaon plays an important role in facilitating access to innovative post-transplant care through coordinated pathways.

Noida: With proximity to Delhi and access to top hospitals, Noida patients benefit from streamlined logistics and specialist-driven treatment planning.

Hyderabad: Hyderabad's advanced transplant infrastructure and hematology expertise support patients seeking access to internationally approved VOD therapies.

Chennai: Known for its established medical ecosystem, Chennai attracts patients from across India for complex post-transplant complications and specialized drug access.

Kolkata: A key eastern healthcare hub, Kolkata offers access to advanced hematology and transplant care through leading hospitals and treatment centers.

Ahmedabad: Ahmedabad's expanding healthcare sector and BMT facilities support patients requiring advanced and imported therapies.

Pune: With reputed hospitals and a growing transplant care infrastructure, Pune is an emerging center for access to specialized VOD treatment.

Chandigarh: Serving North India, Chandigarh provides access to advanced medical care through reputed institutions and specialist-led treatment planning.

Jaipur: Jaipur's improving healthcare network enables patients to explore access to innovative post-transplant therapies through structured import processes.

Lucknow: As a major city in North India, Lucknow supports access to advanced hematology treatments through both public and private healthcare institutions.

Indore: Indore is emerging as a regional healthcare hub, offering access to specialized care and modern treatment pathways.

Bhopal: Patients in Bhopal can access advanced hematology treatments through the growing healthcare infrastructure and referral networks.

Nagpur: Nagpur serves as a central hub for patients across Vidarbha, with increasing access to transplant care and specialized therapies.

Surat: Surat's developing healthcare ecosystem supports patients seeking access to global transplant-supportive treatments through coordinated care.

Patna: As a major city in Eastern India, Patna provides growing access to hematology treatment through expanding hospital networks.

Coimbatore: Coimbatore is known for quality healthcare services, offering access to advanced hematology treatments in South India.

Kochi: With modern hospitals and specialist care, Kochi enables patients to explore access to internationally approved VOD therapies.

Note: Access timelines may vary depending on documentation, regulatory approvals, and sourcing logistics.

Access/Buy Defitelio® at Leading Hospitals in India

Defitelio® is typically used in specialized hematopoietic stem-cell transplant settings and can be accessed at leading hospitals across India, where specialists diagnose and manage VOD/SOS and guide patient-specific access pathways.

Major Hospitals with Bone Marrow / Stem-Cell Transplant Units:

Tata Memorial Centre: One of India's premier cancer institutes, Tata Memorial runs a major HSCT program and plays a key role in guiding transplant patients toward advanced supportive therapies like Defitelio®.

AIIMS: As a leading government medical institution, AIIMS operates a bone marrow transplant unit and supports patients requiring access to specialized and emerging treatments for transplant complications.

Christian Medical College (CMC), Vellore: One of India's oldest and most experienced BMT centers, with long-standing expertise in managing VOD/SOS.

Apollo Hospitals: With a nationwide presence, Apollo Hospitals offers hematopoietic stem-cell transplant services and facilitates access to global treatment options through its extensive medical network.

Fortis Healthcare: Fortis hospitals run active bone marrow transplant programs with multidisciplinary teams managing complex transplant-related complications.

Max Healthcare: Max Healthcare is known for its strong hematology and BMT departments, providing access to innovative therapies under expert clinical supervision.

Manipal Hospitals: Manipal Hospitals supports advanced hematology and transplant care through experienced specialists and structured treatment planning across multiple cities.

Medanta – The Medicity: Medanta is a renowned super-specialty hospital where complex post-transplant cases are managed with advanced treatment protocols and global access support.

Kokilaben Dhirubhai Ambani Hospital: A leading private hospital in Mumbai offering bone marrow transplant care and access to advanced global therapies.

BLK-Max Super Speciality Hospital: BLK-Max provides comprehensive bone marrow transplant services and supports patients seeking access to specialized treatment options.

Narayana Health: Narayana Health combines affordability with advanced medical care, offering hematology and BMT services across multiple locations in India.

Amrita Hospital: Amrita Hospital provides high-quality transplant care with a focus on patient-centric treatment and access to modern therapies.

Rajiv Gandhi Cancer Institute: A dedicated cancer care center, RGCI runs a stem-cell transplant program and supports patients through complex post-transplant journeys.

Note: Defitelio® is not stocked for direct purchase but is arranged through compliant import processes and delivered to the hospital for patient-specific treatment.

Written By:

Nitin Goswami
Senior Medical Content Writer

Medically Reviewed By:

Shilpi Banerjee
Registered Pharmacist (M.Pharm)

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