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Drug class: Miscellaneous Coagulation Modifiers

What is Defitelio?

Defitelio increases the breakdown of blood clots. Defitelio treats severe veno-occlusive diseases (VOD) in both adults and children after a stem cell transplant and chemotherapy. When blood vessels within the liver are blocked, it can cause liver damage. Defitelio can be used in other ways not mentioned in the medication guide.

Side effects of Defitelio

If you experience any of the following: hives, itching or skin rash, difficulty breathing, swelling in your lips, face, throat, tongue, and/or mouth,

Defitelio may cause serious side effects. If you experience:

  • Easy bruising and unusual bleeding
  • Blood in urine or stool;
  • Confusion, headaches;
  • Slurred speech and vision problems
  • Feeling lightheadedness as though they might pass out.

If you experience certain side effects, your treatment may be permanently stopped or delayed.

Defitelio can cause the following side effects:

  • Nausea, vomiting, diarrhea;
  • Dizziness;

There may be other side effects. Call your physician if experiencing side effects; otherwise contact FDA at 1-800-FDA-1088 to report them.


Please read all the instructions on the label or package of your medication. Inform your doctors about your allergies and medical conditions. Inform them which medications you are currently using and inform them which they might cause adverse interactions with other substances.

Before you take this drug

If you have an allergy to Defitelio, or:

  • You have bleeding that is active.
  • You should also consider taking a blood-thinning medication such as Warfarin. (Coumadin or Jantoven).
  • Use streptokinase or urokinase to dissolve or treat blood clots.

Tell your doctor if:

  • A bleeding or blood clotting disorder.

It's not clear if Defitelio can harm a baby. Inform your doctor of any pregnancy or plans to get pregnant. It's not clear if defibrotide can pass into breast milk or if nursing babies could be harmed by it. You should tell your doctor that you are breastfeeding a child.

How to take Defitelio?

Defitelio can be injected through an IV into a vein. The IV infusion must be administered slowly and can last up to 2 hours. It is possible that you will be taught how to administer an IV in your home. You should not administer this medication to yourself if you don't know how to inject the medicine and dispose of IV tubes, needles, and other used items. Defitelio can be given for up to 60 days if the symptoms do not improve. Do not alter the instructions on your prescription. Use this medication only as directed. Do not exceed the recommended dose or use it for longer than directed. Defitelio should be mixed with a liquid before use. You should know how to mix the medication and store it properly if you use the injections in your home. Defitelio should not be mixed with any other medicine in the same intravenous line. Your doctor will tell you how to flush your IV after every injection. Do not prepare your injection dose until you are prepared to administer it. If the color of your medicine changes or if it contains particles, do not use it. For new medication, call your pharmacist. Store Defitelio in the fridge after mixing it with a diluteant. Use within 24 hours. If you store it at room temperature, the mixed medicine has to be taken within four hours. This medicine comes in a single-use bottle (vial). Even if some medication is left after injection, throw it away immediately after use.

What happens if I miss the dose?

As soon as possible, take the dose you missed.If your next scheduled dose is due soon, skip any missed ones and resume taking your usual schedule.You should not take extra medication to compensate for a missed dose.

What happens if I overdose?

Reach out immediately if a poison incident arises by dialling 1-800-222-1222 for support, or seek emergency medical attention immediately.

What should be avoided?

If your doctor recommends any restrictions regarding food, beverages or activities for you, be sure to adhere to them.

Interaction with other drug

Defibrotide may also interact with other drugs, such as prescription medicines and herbal remedies. Inform your healthcare providers of all the medicines that you are currently taking and those you plan to start using.