Defitelio

Defitelio helps by increasing the breakdown of blood clots.

Defitelio 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 get blocked, reducing blood flow and potentially causing liver damage.

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

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

You should not use Defitelio 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 Defitelio is safe for you, tell your doctor if you have:

• a bleeding or blood clotting disorder.

It is not known whether Defitelio 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 notice signs of an allergic reaction: hives, itching, skin rash; trouble breathing; swelling of your face, lips, tongue, or throat.

Defitelio can cause serious side effects. Contact your doctor immediately if you experience:

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

Certain side effects may cause your treatments to be delayed or stopped completely.

Common side effects of Defitelio may include:

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

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

Defitelio 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.

Defitelio 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.

Defitelio 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 Defitelio 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 Defitelio 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.

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. Tell each of your health care providers about all medicines you are currently using and any medicine you begin or stop using.