Defitelio

Defitelio is a prescription medication used to treat severe hepatic (liver) veno-occlusive disease (VOD).

This medication is available as a sterile, preservative-free solution for intravenous (IV) infusion by a health care professional. 

Common side effects of Defitelio include abnormally low blood pressure, diarrhea, vomiting, nausea, and nosebleeds.

Defitelio is a prescription medication used to treat severe hepatic (liver) veno-occlusive disease (VOD).

VOD can occur after receiving chemotherapy and hematopoietic stem cell transplantation (HSCT). HSCT is a procedure performed in some patients to treat certain blood or bone marrow cancers.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Jazz Pharmaceuticals, Inc.

Serious side effects have been reported with Defitelio. See the “Defitelio Precautions” section.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take Antithrombotic Agents (medications to treat and prevent blood clots) such as:

• antiplatelets (a type of blood thinner) such as clopidogrel (Plavix), aspirin, prasugrel (Effient), ticagrelor (Brilinta), ticlopidine (Ticlid), abciximab (ReoPro), eptifibatide (Integrilin), tirofiban (Aggrastat), and cilostazol (Pletal)

• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis)
•  thrombolytics (clot dissolvers) such as alteplase (Activase),  tenecteplase (TNKase), anistreplase (Eminase), and reteplase (Retavase)

This is not a complete list of Defitelio drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Defitelio including the following:

• Hemorrhage (bleeding). Tell your healthcare provider right away if you have some or all of the following symptoms of hemorrhage:
  • you may bruise more easily
  • it takes longer than usual for any bleeding to stop
  • unexpected bleeding, or bleeding that lasts a long time, such as:
    • unusual bleeding from the gums
    • nosebleeds that happen often
    • menstrual bleeding or vaginal bleeding that is heavier than normal
  • bleeding that is severe or you cannot control
  • red, pink, or brown urine
  • red or black stools (looks like tar)
  • cough up blood or blood clots
  • vomit blood or your vomit looks like coffee grounds
  • headache
  • confusion
  • slurred speech
  • altered vision

Do not take Defitelio if you:

• are allergic to Defitelio or to any of its ingredients
• are taking anticoagulant (blood thinner) or fibrinolytic medication.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Defitelio, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Defitelio, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Defitelio or to any of its ingredients
• have an active bleed
• are taking anti-thrombotic medications such as blood thinners
• have a surgery planned
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

There is no information regarding the presence of Defitelio in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including bleeding in a breastfed infant, breastfeeding is not recommended during treatment with Defitelio.
 

Infuse Defitelio into a vein over a 2-hour period.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Administer Defitelio 6.25 mg/kg every 6 hours given as a 2-hour intravenous infusion.

The dose your doctor recommends will be based on your weight.

Treat for a minimum of 21 days. If after 21 days signs and symptoms of VOD have not resolved, continue treatment until resolution.

If Defitelio is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.