defibrotide

What is the most important information I should know about defibrotide?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is defibrotide?

Defibrotide works by increasing the breakdown of clots in the blood.

Defibrotide is used to treat severe veno-occlusive disease (VOD) in adults and children who have undergone chemotherapy and a stem-cell transplant. VOD happens when blood vessels in the liver become blocked, which decreases blood flow and can lead to liver damage.

Defibrotide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving defibrotide?

• you have active bleeding;
• you also take a blood thinner such as warfarin (Coumadin, Jantoven); or
• you use any medication to treat or dissolve blood clots such as streptokinase or urokinase.

To make sure defibrotide is safe for you, tell your doctor if you have:

• a bleeding or blood clotting disorder.

How is defibrotide given?

Defibrotide is injected into a vein through an IV. This medicine must be given slowly, and the IV infusion can last at least 2 hours.

You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Defibrotide is usually given for at least 21 days, to a maximum of 60 days if symptoms have not fully improved.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Defibrotide must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not mix defibrotide with other medicines in the same IV line. Follow your doctor's instructions about flushing your IV line after each injection.

Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while receiving defibrotide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of defibrotide?

• easy bruising, unusual bleeding;
• blood in your urine or stools;
• confusion, headaches;
• vision problems, slurred speech; or
• a light-headed feeling, like you might pass out.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting, diarrhea;
• dizziness; or
• nosebleeds.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect defibrotide?

Other drugs may interact with defibrotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about defibrotide.