Defibrotide

Defibrotide helps to break down blood clots.

Defibrotide is used to treat severe veno-occlusive disease (VOD) in adults and children who have had chemotherapy and a stem-cell transplant. VOD occurs when blood vessels in the liver are blocked, reducing blood flow and potentially causing liver damage.

Defibrotide may also be used for reasons not mentioned in this medication guide.

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.

After mixing defibrotide with a diluent, store in the refrigerator and use within 24 hours.

Mixed medicine must be used within 4 hours if you keep it at room temperature.

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.

Follow all instructions on your medicine label and package. Inform all your healthcare providers about all your medical conditions, allergies, and all medications you are taking.

You should not use defibrotide if you are allergic to it, or if:

• 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.

It is not known whether defibrotide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether defibrotide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, skin rash; difficult breathing; swelling of your face, lips, tongue, or throat.

Defibrotide may cause serious side effects. Call your doctor right away if you have:

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

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

Common side effects of defibrotide may include:

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

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

Usual Adult Dose for Hepatic Veno-Occlusive Disease:

6.25 mg/kg IV every 6 hours given as a constant 2-hour infusionDuration of therapy: Minimum of 21 days; if signs and symptoms of hepatic veno-occlusive disease (VOD) remain after 21 days, continue this drug until resolution of VOD or up to a maximum of 60 days.Comments: Baseline body weight prior to the preparative regimen for hematopoietic stem-cell transplantation (HSCT) should be used to calculate the dose.Use: Treatment of patients with hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following HSCT.

Usual Pediatric Dose for Hepatic Veno-Occlusive Disease:

1 Month or Older:6.25 mg/kg IV every 6 hours given as a constant 2-hour infusionDuration of therapy: Minimum of 21 days; if signs and symptoms of hepatic veno-occlusive disease (VOD) remain after 21 days, continue this drug until resolution of VOD or up to a maximum of 60 days.Comments: Baseline body weight prior to the preparative regimen for hematopoietic stem-cell transplantation (HSCT) should be used to calculate the dose.Use: Treatment of patients with hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following HSCT.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Other drugs may interact with defibrotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform each of your health care providers about all medicines you are currently using and any medicines you begin or stop using.