Why is this medication prescribed?

Defibrotide injection is prescribed primarily for the treatment of severe hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome, which is a condition that can occur in patients who have undergone hematopoietic stem-cell transplantation (HSCT). VOD is characterized by the blockage of small veins in the liver, leading to liver damage, and can be life-threatening if not treated. Defibrotide helps to protect the endothelial cells lining the blood vessels in the liver and to reduce blood clot formation, thereby improving blood flow and reducing the severity of VOD.

How should this medicine be used?

Here’s a general guideline on how Defibrotide Injection may be used:

• Preparation: The healthcare provider will prepare the medication according to the prescribed dosage. This usually involves diluting the Defibrotide Injection with a compatible infusion solution.
• Administration: The diluted Defibrotide solution is administered intravenously, meaning it’s injected directly into a vein. This is usually done using an intravenous line or catheter. The infusion rate may vary depending on the patient’s condition and tolerance, but it’s typically administered over a specified duration, such as several hours.
• Monitoring: During the infusion, the patient will be closely monitored for any adverse reactions or signs of improvement. Vital signs, such as blood pressure, heart rate, and oxygen saturation, may be monitored regularly.
• Follow-up: After the infusion is completed, the healthcare team will continue to monitor the patient’s response to treatment and may adjust the dosage or administration schedule as needed.

It’s essential for patients to receive Defibrotide Injection under the supervision of a healthcare professional in a clinical setting. Self-administration of this medication is not recommended. If you have any questions or concerns about how Defibrotide Injection is being used, be sure to discuss them with your healthcare provider.

Other uses for this medicine

• Treatment of VOD: Its primary use is for preventing and treating hepatic veno-occlusive disease (VOD) in people who have undergone stem cell transplantation.
• Off-label Uses: While primarily used for VOD, Defibrotide has also been investigated for other conditions such as hepatic sinusoidal obstruction syndrome (SOS) and thrombotic microangiopathy (TMA). However, its efficacy for these conditions may vary and should be determined by a healthcare professional.

What special precautions should I follow?

Special precautions should be observed when using Defibrotide Injection:

• Medical Supervision: Defibrotide Injection should only be administered under the supervision of healthcare professionals experienced in the management of patients undergoing stem cell transplantation or chemotherapy.
• Monitoring: Patients receiving Defibrotide should be closely monitored for signs of adverse reactions, including bleeding, allergic reactions, and liver function abnormalities.
• Contraindications: Defibrotide is contraindicated in patients with known hypersensitivity to the drug or any of its components.
• Bleeding Risk: Due to its antithrombotic properties, Defibrotide may increase the risk of bleeding. Patients with a history of bleeding disorders or those taking anticoagulant medications should be monitored closely.
• Liver Function: Defibrotide may affect liver function, and liver function tests should be monitored regularly during treatment.
• Renal Impairment: Patients with renal impairment may require dosage adjustments or closer monitoring when receiving Defibrotide.
• Pregnancy and Breastfeeding: The safety of Defibrotide use during pregnancy or breastfeeding has not been established. Women who are pregnant or breastfeeding should discuss the risks and benefits of treatment with their healthcare provider.

As with any medication, it’s important to follow your healthcare provider’s instructions carefully and to communicate any concerns or side effects experienced during treatment.

What special dietary instructions should I follow?

Regarding special dietary instructions for Defibrotide Injection, there are typically no specific dietary restrictions associated with its use. However, it’s essential to maintain a balanced and nutritious diet to support overall health during treatment. If you have any concerns or specific dietary needs, it’s advisable to discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

If you forget a dose of Defibrotide Injection, you should contact your healthcare provider or healthcare team for guidance on what to do next. They will provide instructions based on your individual circumstances, which may include rescheduling the missed dose or adjusting the treatment plan accordingly. It’s important not to double the dose to make up for a missed one unless specifically instructed to do so by your healthcare provider.

What side effects can this medication cause?

Defibrotide Injection, like any medication, can cause side effects, although not everyone experiences them. Common side effects may include:

• Bleeding: Defibrotide has antithrombotic properties and may increase the risk of bleeding. This can manifest as nosebleeds, bruising, or prolonged bleeding from minor cuts or injuries.
• Liver Function Abnormalities: Defibrotide may affect liver function, leading to elevated liver enzymes (transaminases) in blood tests. This can indicate liver damage or inflammation.
• Hypersensitivity Reactions: Some individuals may experience allergic reactions to Defibrotide, which can range from mild symptoms such as rash or itching to severe reactions like difficulty breathing (anaphylaxis).
• Nausea and Vomiting: Gastrointestinal symptoms such as nausea, vomiting, or diarrhea may occur in some patients.
• Hypotension: Defibrotide infusion may cause a temporary drop in blood pressure (hypotension), especially during the infusion process.
• Headache: Some individuals may experience headaches as a side effect of Defibrotide treatment.
• Fatigue: Feelings of tiredness or fatigue have been reported by some patients receiving Defibrotide.
• Fever: Low-grade fever or feverish sensations may occur during treatment.
• Shortness of Breath: In rare cases, Defibrotide may cause difficulty breathing or shortness of breath.

It’s essential to report any side effects or adverse reactions experienced during Defibrotide treatment to your healthcare provider promptly. They can provide guidance on managing side effects and may adjust the treatment plan if necessary. Additionally, if you experience severe or concerning symptoms, seek medical attention immediately.

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

When it comes to the storage and disposal of Defibrotide Injection, here are some important points to keep in mind:

• Storage: Defibrotide Injection should be stored according to the manufacturer’s instructions, typically at room temperature away from light and moisture. Avoid freezing the medication. Be sure to keep it out of reach of children and pets.
• Disposal: Unused or expired Defibrotide Injection should be disposed of properly according to local regulations. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your healthcare provider or pharmacist for guidance on safe disposal methods.

In case of emergency/overdose

• Seek Medical Attention: If you suspect an overdose or experience severe symptoms such as excessive bleeding, difficulty breathing, or signs of allergic reaction (e.g., rash, swelling), seek immediate medical attention by calling emergency services or visiting the nearest emergency room.
• Contact Poison Control: You can also contact your local poison control center for guidance on what to do in case of overdose. They can provide instructions on managing the situation and may advise on further steps to take.

What other information should I know?

• Follow Instructions: Always use Defibrotide Injection as directed by your healthcare provider. Do not alter the dosage or frequency of administration without consulting them first.
• Regular Monitoring: During treatment with Defibrotide, you may undergo regular monitoring of liver function, blood clotting parameters, and overall response to treatment. Attend all scheduled appointments and inform your healthcare provider of any concerns or changes in your condition.
• Interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Defibrotide. This includes prescription and over-the-counter medications.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of Defibrotide treatment with your healthcare provider. The safety of Defibrotide during pregnancy and lactation has not been established.
• Storage and Handling: Handle Defibrotide Injection with care, and do not use it if the solution appears discolored or contains particles. Follow proper aseptic techniques when administering the medication to reduce the risk of contamination.

By adhering to these guidelines and staying informed about Defibrotide Injection, you can ensure its safe and effective use as part of your medical treatment.