Defibrotide Sodium Solution for injection
What is this medicine?
Defibrotide (dee FYI broe tide) is used to treat blocked, small blood vessels in the liver that can occur after stem cell transplant.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
take medicines that treat or prevent blood clots
an unusual or allergic reaction to defibrotide, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This does not apply.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
certain medicines that treat or prevent blood clots like heparin and alteplase
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine.
You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid alcoholic drinks; they can make you more dizzy.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose
signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert