What is Defibrotide?
Defibrotide increases the breakdown of blood clots. Defibrotide can be used to treat severe venous occlusive disease (VOD) in both adults and children after undergoing chemotherapy or a stem cell transplant. When blood vessels within the liver are blocked, it can cause liver damage. This medication guide does not list all possible uses of defibrotide.
Side effects of Defibrotide
If you experience any of the following: hives, itching or skin rash, difficulty breathing, swelling in your lips, face, throat, or tongue
Defibrotide may cause serious side effects. If you experience:
- Easy bruising and unusual bleeding
- Blood in urine or stool;
- Confusion, headaches;
- If you have vision issues or slurred words,
- Feeling faint. Sensing that one could pass out.
If you experience certain side effects, your treatment may be permanently stopped or delayed. Defibrotide can cause a number of side effects.
- Nausea, vomiting, diarrhea;
- Dizziness;
There may be other side effects. Call your physician if experiencing side effects and report them directly. Otherwise contact FDA at 1-800-FDA-1088.
Warnings
Please read all the instructions on the label or package of your medication. Inform your doctors about your allergies and medical conditions.Also inform them which medications you're currently taking.
Before you take this drug
Defibrotide should be avoided if the user is allergic or:
- You have bleeding that is active.
- You should also consider taking a blood-thinning medication such as Warfarin (Coumadin or Jantoven);
- Use urokinase to dissolve or treat blood clots.
Tell your doctor about any of the following to ensure that defibrotide will not harm you:
- A bleeding or blood clotting disorder.
Defibrotide is unknown to cause harm to an unborn child. Inform your physician immediately if you intend to become pregnant. It is unknown whether defibrotide can pass into breastmilk or whether it can harm nursing babies. You should tell your doctor that you are breastfeeding a child.
How to take Defibrotide?
The IV is used to inject defibrotide into the vein. The IV infusion must be administered slowly and can last up to 2 hours. It is possible that you will be taught how to administer an IV in your home. You should not administer this medication to yourself if you don't know how to inject the medicine and dispose of IV tubes, needles, and other used items. If symptoms do not improve, defibrotide can be given for up to 60 days. Do not alter the instructions on your prescription. Use this medication only as directed. Do not exceed the prescribed dosage or use it for longer than advised. Before using defibrotide, it must first be diluted with liquid. You should know how to mix the medication and store it properly if you use the injections in your home. Defibrotide should not be mixed with any other medicine in the same intravenous line. After each injection, flush your IV according to your doctor's directions. Do not prepare your injection dose until you are prepared to administer it. If the color of your medicine changes or if it contains particles, do not use it. For new medication, call your pharmacist. Store defibrotide in the fridge after mixing it with a diluteant. Use within 24 hours. If you store it at room temperature, the mixed medicine has to be taken within four hours. This medicine comes in a single-use bottle (vial). Even if some medication is left after injection, throw it away immediately after use.
Details on dosage
Adult dose for hepatic venous occlusive disorder:
Infusion of 6.25 mg/kg every six hours as a continuous 2-hour infusion
The duration of treatment is 21 days. If symptoms and signs of hepatic vein occlusion disease (VOD) persist after the 21-day period, you can continue to take this medication until VOD resolves or for a maximum of 60 days.
Comment: The dose should be calculated using the baseline body weight before the preparation regimen for hematopoietic stem-cell transplantation.
Use: Patients with sinusoidal obstruction syndrome, or SOS (hepatic VOD), and renal or pulmonary failure following HSCT.
The usual pediatric dose for hepatic venous occlusive disorder is:
One Month and Older
Infusion of 6.25 mg/kg every six hours as a continuous 2-hour infusion
The duration of treatment is 21 days. If symptoms and signs of hepatic vein occlusion disease (VOD) persist after the 21-day period, you can continue to take this medication until VOD resolves or for a maximum of 60 days.
Comment: The dose should be calculated using the baseline body weight before the preparation regimen for hematopoietic stem-cell transplantation.
Patients with sinusoidal obstruction syndrome, or hepatic VOD (also known as sinusoidal obstruction syndrome), who have renal or pulmonary impairment following HSCT
What happens if I miss the dose?
As soon as possible, take the dose you missed. If your next dose is approaching, skip the missed dose. You should not take extra medication to compensate for a missed dose.
What happens if I overdose?
Dial 1-800-222-1222 immediately in case of poisoning and seek immediate medical advice or seek emergency care as soon as possible.
What should be avoided?
If your doctor recommends any restrictions regarding food, beverages or activities for which to adhere, be sure to comply.
Interaction with other drug
Defibrotide may also interact with other drugs, such as prescription medicines and herbal remedies. Inform your healthcare providers of all the medicines that you are currently taking and those you plan to start using.
