defibrotide
Sign in to saveDefibrotide, sold under the brand name Defitelio, is a mixture of single-stranded oligonucleotides that is purified from the intestinal mucosa of pigs. It is used to treat veno-occlusive disease of the liver of people having had a bone marrow transplant, with different limitations in the US and the European Union. It works by protecting the cells lining blood vessels in the liver and preventing blood clotting; the way it does this is not well understood.
Key facts
- Drug.verifiedrevid
- 447578248
- Drug.Verifiedfields
- changed
- Drug.image_class
- skin-invert-image
- Drug.width
- 200px
- Drug.JAN
- defibrotide sodium
- Drug.USAN
- defibrotide sodium
- Drug.tradename
- Defitelio
- Drug.DailyMedID
- Defibrotide
- Drug.pregnancy_AU
- D
- Drug.routes_of_administration
- Intravenous
- Drug.ATC_prefix
- B01
- Drug.ATC_suffix
- AX01
- Drug.legal_AU
- S4
- Drug.legal_CA
- Rx-only
- Drug.legal_UK
- POM
- Drug.legal_US
- Rx-only
- Drug.legal_EU
- Rx-only
- Drug.legal_status
- Rx-only
via Wikipedia infobox
Medication
- Generic name
- Defibrotide Sodium
- Brand names
- Defitelio
- Drug class
- Other antithrombotic agents
- Active ingredients
- defibrotide
- Route
- Intravenous
- Dosage form
- Injection
- Type
- Human Prescription Drug
- Manufacturer
- Jazz Pharmaceuticals, Inc.
Indications: 1 INDICATIONS AND USAGE DEFITELIO 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). DEFITELIO… (per FDA label)
Clinical Trials
23 registered- PHASE1/PHASE2COMPLETEDMelphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma PatientsSilvio Aime · NCT00406978
- PHASE2COMPLETEDDefibrotide in Treating Patients With Liver Damage Following Peripheral Stem Cell TransplantationDana-Farber Cancer Institute · NCT00003966
- PHASE2/PHASE3COMPLETEDPediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of DefibrotideEuropean Society for Blood and Marrow Transplantation · NCT00272948
- PHASE2WITHDRAWNDefibrotide Prophylaxis of Transplant Associated-Thrombotic Microangiopathy for NeuroblastomaUniversity of California, San Francisco · NCT06182410
- PHASE3COMPLETEDStudy Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric PatientsJazz Pharmaceuticals · NCT02851407
- PHASE2COMPLETEDDefibrotide in Sickle Cell Disease-Related Acute Chest SyndromeNew York Medical College · NCT03805581
~6 min read
Encyclopedic overview
10 sectionsContents
- Medical uses
- Contraindications
- Adverse effects
- Pharmacology
- Chemistry
- History
- Society and culture
- Legal status
- References
- Further reading
Defibrotide, sold under the brand name Defitelio, is a mixture of single-stranded oligonucleotides that is purified from the intestinal mucosa of pigs. It is used to treat veno-occlusive disease of the liver of people having had a bone marrow transplant, with different limitations in the US and the European Union. It works by protecting the cells lining blood vessels in the liver and preventing blood clotting; the way it does this is not well understood.
The most common side effects include abnormally low blood pressure (hypotension), diarrhea, vomiting, nausea and nosebleeds (epistaxis). Serious potential side effects that were identified include bleeding (hemorrhage) and allergic reactions. Defibrotide should not be used in people who are having bleeding complications or who are taking blood thinners or other medicines that reduce the body's ability to form clots. Use of the drug is generally limited by a strong risk of life-threatening bleeding in the brain, eyes, lungs, gastrointestinal tract, urinary tract, and nose. Some people have hypersensitivity reactions.
Excerpted from Wikipedia’s “defibrotide” article, available under the CC BY-SA 4.0 licence.