Why is this medication prescribed?

Defitelio (defibrotide) is prescribed to treat hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), in patients undergoing hematopoietic stem-cell transplantation (HSCT). VOD is a serious complication that occurs when the small veins in the liver become blocked, leading to liver damage and potentially liver failure. Defitelio works by helping to dissolve blood clots in these blocked veins, improving blood flow and reducing liver damage.

How should this medicine be used?

Defitelio (defibrotide) is typically administered as an intravenous infusion. The specific dosage and duration of treatment will be determined by your healthcare provider based on factors such as your weight, overall health, and the severity of your condition.

Here are general guidelines for the use of Defitelio:

• Administration: Defitelio is administered through a vein (intravenously) by a healthcare professional. It is usually given over a period of time, often several hours, depending on the prescribed dosage and treatment plan.
• Dosage: The dosage of Defitelio can vary depending on the individual patient and the specific indication being treated. Your healthcare provider will determine the appropriate dosage for you based on factors such as your weight, medical history, and response to treatment.
• Monitoring: While receiving Defitelio, your healthcare team will closely monitor your condition, including your liver function, blood clotting parameters, and any signs of adverse reactions or side effects.
• Duration: Treatment with Defitelio may continue for several days or weeks, depending on the underlying condition being treated and how well you respond to the medication.
• Follow-up: After completing a course of treatment with Defitelio, your healthcare provider may recommend follow-up appointments to monitor your progress and assess the need for further treatment or supportive care.

It’s essential to follow your healthcare provider’s instructions carefully regarding the use of Defitelio. If you have any questions or concerns about how Defitelio should be used or about your treatment plan in general, don’t hesitate to discuss them with your healthcare provider.

Other uses for this medicine

• Treatment of severe hepatic sinusoidal obstruction syndrome (SOS) unrelated to HSCT.
• Prevention of VOD in patients at high risk undergoing HSCT.
• Treatment of other conditions associated with endothelial cell injury and inflammation, such as thrombotic microangiopathy and graft-versus-host disease (GVHD).

What special precautions should I follow?

As for special precautions when using Defitelio, here are some important points to consider:

• Medical History: Inform your healthcare provider about any medical conditions you have, especially if you have a history of bleeding disorders, liver disease, or kidney disease.
• Medication Interactions: Tell your doctor about all the medications you are currently taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Some medications may interact with Defitelio, potentially affecting its effectiveness or increasing the risk of side effects.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of using Defitelio with your doctor. It’s essential to weigh the potential risks to the fetus or breastfeeding infant against the potential benefits of treatment.
• Allergic Reactions: If you have had an allergic reaction to Defitelio or any of its ingredients in the past, inform your healthcare provider before starting treatment. Allergic reactions to Defitelio can include rash, itching, swelling, dizziness, or difficulty breathing.
• Monitoring: Your doctor will likely monitor your liver function, blood clotting parameters, and other relevant indicators during treatment with Defitelio to ensure its safety and effectiveness.

Always follow your healthcare provider’s instructions carefully when using Defitelio and report any unusual symptoms or side effects promptly.

What special dietary instructions should I follow?

Regarding special dietary instructions for Defitelio, there are typically no specific dietary restrictions associated with its use. However, it’s essential to maintain a balanced and healthy diet as recommended by your healthcare provider to support your overall health and well-being during treatment.

What should I do if I forget a dose?

If you forget to take a dose of Defitelio, contact your healthcare provider or pharmacist for guidance. They can provide instructions on whether to take the missed dose as soon as you remember or to wait until the next scheduled dose. It’s important not to double the dose to make up for a missed one unless instructed to do so by your healthcare provider. Consistent adherence to the prescribed dosing schedule is essential for optimal treatment outcomes.

What side effects can this medication cause?

Defitelio (defibrotide) is generally well-tolerated, but like any medication, it can cause side effects in some people. Common side effects of Defitelio may include:

• Nausea and vomiting: These gastrointestinal symptoms are among the most frequently reported side effects.
• Diarrhea: Some individuals may experience diarrhea while taking Defitelio.
• Low blood pressure (hypotension): Defitelio may cause a decrease in blood pressure in some patients.
• Headache: Headaches are a relatively common side effect of Defitelio treatment.
• Increased liver enzyme levels: Defitelio can sometimes cause elevated liver enzyme levels, which may indicate liver inflammation or damage.
• Bleeding: Defitelio may increase the risk of bleeding, especially in patients with a history of bleeding disorders or those taking other medications that affect blood clotting.
• Allergic reactions: Although rare, some individuals may experience allergic reactions to Defitelio, which can manifest as rash, itching, swelling, dizziness, or difficulty breathing.
• Fatigue: Feeling tired or fatigued is another potential side effect of Defitelio.

It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects not listed here. If you experience any persistent or bothersome side effects while taking Defitelio, contact your healthcare provider for further evaluation and guidance. Additionally, if you develop signs of a severe allergic reaction, such as difficulty breathing or swelling of the face, lips, tongue, or throat, seek immediate medical attention.

What should I know about storage and disposal of this medication?

When it comes to the storage and disposal of Defitelio (defibrotide), here are some important considerations:

• Storage: Defitelio should be stored at room temperature between 20°C to 25°C (68°F to 77°F). Avoid exposing the medication to excessive heat or moisture. Keep Defitelio in its original packaging or container, away from direct sunlight and out of the reach of children and pets.
• Disposal: Unused or expired Defitelio should be disposed of properly according to local regulations or guidelines. Do not flush medications down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist or healthcare provider on the proper disposal method for Defitelio.

In case of emergency/overdose

In case of emergency or overdose of Defitelio, it’s essential to seek immediate medical attention or contact a poison control center (such as the National Poison Control Center in the United States at 1-800-222-1222). Symptoms of an overdose may include severe bleeding, changes in blood pressure, or other adverse reactions. Be prepared to provide information about the amount of medication ingested, as well as any symptoms experienced.

What other information should I know?

• Regular Monitoring: Your healthcare provider may perform regular monitoring of your liver function, blood clotting parameters, and other relevant indicators during treatment with Defitelio to ensure its safety and effectiveness.
• Follow-up Appointments: Attend all scheduled follow-up appointments with your healthcare provider to assess your response to treatment and address any concerns or questions you may have.
• Medication Compliance: It’s important to take Defitelio exactly as prescribed by your healthcare provider. Do not alter the dosage or discontinue treatment without consulting your doctor first.
• Informing Healthcare Providers: Inform all healthcare providers involved in your care, including dentists and pharmacists, about your use of Defitelio. This includes disclosing any other medications, supplements, or herbal products you are taking to avoid potential interactions.

By following these guidelines and staying informed about the proper storage, disposal, and emergency procedures for Defitelio, you can help ensure the safe and effective use of this medication as part of your treatment plan.