Defibrotide Injection

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.

Defibrotide injection comes as a solution (liquid) to be injected intravenously (into a vein) over 2 hours by a doctor or nurse in a medical facility. It is usually injected once every 6 hours for 21 days, but may be given for up to 60 days. The length of treatment depends on how well your body responds to the medication and the side effects that you may experience.

Your doctor may need to delay or stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with defibrotide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving defibrotide injection,

• 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), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, rivaroxaban (Xarelto), and warfarin (Coumadin, Jantoven) 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• 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 breast-feeding. If you become pregnant while receiving, call your doctor. Do not breastfeed while receiving defibrotide injection.

Unless your doctor tells you otherwise, continue your normal diet.

• Defibrotide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • dizziness

  • diarrhea

  • 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

• Defibrotide injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to defibrotide injection.

Ask your pharmacist any questions you have about defibrotide injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.