Class: Supportive Care
Generic Name: Defibrotide sodium
Trade Name: Defitelio®
For which conditions is this drug approved? Defitelio is used to treat severe hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem-cell transplantation (HSCT.) Hepatic VOD is a rare, but life-threatening complication that can occur following chemotherapy and a stem cell transplant as treatment for cancer. Hepatic VOD occurs when some of the veins in the liver become blocked, causing swelling and a decrease in blood flow inside the liver.
What is the mechanism of action? The medicines used before a patient undergoes HSCT can damage the lining in the blood vessels in the liver, leading to clots and obstructions of the veins in the liver. Defitelio is a medicine containing the active substance defibrotide which works by increasing the breakdown of clots in the blood.
How is Defitelio typically given (administered)? Defitelio is administered by intravenous infusion.
What are the most common side effects of treatment with Defitelio?
- Hypotension (low blood pressure)
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What are the more serious side effects or precautions of Defitelio?
- Patients must be monitored for bleeding. Withhold or discontinue Defitelio if significant bleeding occurs.
- Hypersensitivity Reactions. If severe or life threatening allergic reaction occurs, discontinue Defitelio and monitor until signs and symptoms resolve.
What should patients be aware of before or during treatment of Defitelio?
- Patients must see a healthcare provider immediately with any signs or symptoms suggestive of hemorrhage (unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision).
- Ask patients if they have been treated with defibrotide sodium previously. Patients should be instructed on the symptoms and risk of allergic reactions, including anaphylaxis. Seek medical attention immediately if they experience such symptoms.
Last updated on 05/16.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition, or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
DISCLAIMER OF WARRANTIES
CANCERCONNECT.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONNECT.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.
The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.