Defibrotide Injectable Solution

Defibrotide (dee FYI broe tide) is used to treat blocked, small blood vessels in the liver that can occur after stem cell transplant.

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.

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):

• diarrhea
• nausea
• vomiting

Do not take this medicine with any of the following medications:

• certain medicines that treat or prevent blood clots like heparin and alteplase

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.

They need to know if you have any of these conditions:

• bleeding disorders
• 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
• breast-feeding

This does not apply.

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.

This drug is given in a hospital or clinic and will not be stored at home.