Defibrotide Intravenous

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For defibrotide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to defibrotide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of defibrotide injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of defibrotide injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving defibrotide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using defibrotide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abciximab
• Acenocoumarol
• Alteplase, Recombinant
• Anagrelide
• Anistreplase
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Bivalirudin
• Certoparin
• Cilostazol
• Clopidogrel
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Dipyridamole
• Edoxaban
• Enoxaparin
• Eptifibatide
• Fondaparinux
• Heparin
• Iloprost
• Lepirudin
• Nadroparin
• Parnaparin
• Phenindione
• Phenprocoumon
• Prasugrel
• Protein C
• Reteplase, Recombinant
• Reviparin
• Rivaroxaban
• Streptokinase
• Sulfinpyrazone
• Tenecteplase
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Treprostinil
• Urokinase
• Vorapaxar
• Warfarin

Using defibrotide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chamomile
• Citalopram
• Desvenlafaxine
• Escitalopram
• Fluoxetine
• Fluvoxamine
• Garlic
• Ginkgo
• Milnacipran
• Papaya
• Paroxetine
• Sertraline
• St John's Wort
• Tan-Shen
• Venlafaxine

Using defibrotide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chondroitin
• Coenzyme Q10
• Curcumin
• Dong Quai
• Ginger
• Vitamin A

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using defibrotide with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use defibrotide, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado

Other Medical Problems

The presence of other medical problems may affect the use of defibrotide. Make sure you tell your doctor if you have any other medical problems, especially:

• Active bleeding—Should not be given in patients with this condition.

• Bleeding problems—Use with caution. May make these conditions worse.

Your doctor will check your or your child's progress closely while you are receiving defibrotide. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it and to check for unwanted effects.

Do not use defibrotide if you are also using alteplase (Activase®) or heparin.

defibrotide may increase your risk of bleeding. Tell your doctor if you or your child has the following symptoms: blood in the urine or stool, changes in vision, confusion, headache, slurred speech, unusual bleeding or bruising.

defibrotide may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving defibrotide.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Black, tarry stools
• bloody nose
• bloody stools
• blurred vision
• chills
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast heartbeat
• fever
• lightheadedness
• rapid, shallow breathing
• sweating
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds

• Chest pain
• cough or hoarseness
• lower back or side pain
• painful or difficult urination
• sneezing
• sore throat
• tightness in the chest
• troubled breathing

• Difficulty with swallowing
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

• Bleeding gums
• coughing up blood
• headache
• increased menstrual flow or vaginal bleeding
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• nausea
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.