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Defitelio (Defibrotide Sodium)

Defitelio (Defibrotide Sodium)

Introduction 

Defibrotide sodium induces the release of prostaglandin 12 and reduces the expression of adhesion molecules on endothelial cells, thereby interfering with platelet and leukocyte adhesion to the endothelium. Defibrotide injection is used to treat adults and children with hepatic veno-occlusive disease (VOD; blocked blood vessels inside the liver, also known as sinusoidal obstruction syndrome), who have kidney or lung problems after receiving a hematopoietic stem-cell transplant (HSCT; procedure in which certain blood cells are removed from the body and then returned to the body). Defibrotide injection is in a class of medications called antithrombotic agents. It works by preventing the formation of blood clots. 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.

Defibrotide was approved for medical use in the European Union in October 2013, in the United States in March 2016, and in Australia in July 2020. Defibrotide is the first FDA-approved therapy for the treatment of severe hepatic VOD, a rare and life-threatening liver condition. 

In the European Union defibrotide is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in hematopoietic stem-cell transplantation (HSCT) therapy for adults, adolescents, children, and infants over one month of age. Defibrotide’s mechanism of action is poorly understood. In vitro studies have shown that it protects the endothelium lining blood vessels from damage by fludarabine, a chemotherapy drug, and from a few other insults like serum starvation. It also appears to increase t-PA function and decrease plasminogen activator inhibitor- 1 activity.

Side effects:

  • dizziness
  • diarrhoea
  • vomiting
  • nausea
  • nose bleeding

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • rash
  • hives
  • itching
  • swelling of the face, lips, tongue or throat
  • unusual bleeding or bruising
  • blood in urine or stool
  • headache
  • confusion
  • slurred speech
  • vision changes
  • fever, cough, or other signs of infection

Precautions:

  • Tell your doctor and pharmacist if you are allergic to defibrotide, any other medications, or any of the ingredients in defibrotide injection. Ask your pharmacist for a list of the ingredients.
  • Tell your doctor if you are taking or have received anticoagulants (‘blood thinners’) such as apixaban (Eliquis), dabigatran (Pradaxa), dalteparin (Fragmin), or if you will be receiving medications thrombolytic medications tissue plasminogen activators such as alteplase (Activase), reteplase (Retavase), or tenecteplase (TNKase). Your doctor will probably tell you not to use defibrotide injection if you are taking or using one or more of these medications.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
  • Tell your doctor if you are bleeding anywhere on your body or if you have bleeding problems.
  • Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving, call your doctor. Do not breastfeed while receiving defibrotide injection.

 

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