Defitelio

Generic name: defibrotide
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by A Ras MD.

What is Defitelio?

Defitelio is a prescription medicine that is used to treat a liver problem called hepatic veno-occlusive disease (VOD) in certain people.

Description

Defibrotide sodium is an oligonucleotide mixture with profibrinolytic properties. The chemical name of defibrotide sodium is polydeoxyribonucleotide, sodium salt. Defibrotide sodium is a polydisperse mixture of predominantly single-stranded (ss) polydeoxyribonucleotide sodium salts derived from porcine intestinal tissue having a mean weighted molecular weight of 13-20 kDa, and a potency of 27-39 and 28-38 biological units per mg as determined by two separate assays measuring the release of a product formed by contact between defibrotide sodium, plasmin and a plasmin substrate. The primary structure of defibrotide sodium is shown below.

DEFITELIO (defibrotide sodium) injection is a clear, light yellow to brown, sterile, preservative-free solution in a single-patient-use vial for intravenous use. Each milliliter of the injection contains 80 mg of defibrotide sodium and 10 mg of Sodium Citrate, USP, in Water for Injection, USP. Hydrochloric Acid, NF, and/or Sodium Hydroxide, NF, may have been used to adjust pH to 6.8-7.8.

Mechanism of Action

The mechanism of action of defibrotide sodium has not been fully elucidated. In vitro, defibrotide sodium enhances the enzymatic activity of plasmin to hydrolyze fibrin clots. Studies evaluating the pharmacological effects of defibrotide sodium on endothelial cells (ECs) were conducted primarily in the human microvascular endothelial cell line. In vitro, defibrotide sodium increased tissue plasminogen activator (t-PA) and thrombomodulin expression, and decreased von Willebrand factor (vWF) and plasminogen activator inhibitor‑1 (PAI-1) expression, thereby reducing EC activation and increasing EC‑mediated fibrinolysis. Defibrotide sodium protected ECs from damage caused by chemotherapy, tumor necrosis factor-α (TNF-α), serum starvation, and perfusion.

Before taking Defitelio, tell your doctor:

If you are allergic to Defitelio; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you have active bleeding.
If you are taking a blood thinner.
If a drug is being used to break up a clot.
If you are breast-feeding. Do not breast-feed while you take Defitelio.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Defitelio with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Defitelio?

Tell all of your health care providers that you take Defitelio. This includes your doctors, nurses, pharmacists, and dentists.
You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
There may be a risk of pregnancy loss (miscarriage) when Defitelio is used during pregnancy. Talk with the doctor.
If you are pregnant or you get pregnant while taking Defitelio, call your doctor right away.

How is Defitelio best taken?

Use Defitelio as ordered by your doctor. Read all information given to you. Follow all instructions closely.

It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

Call your doctor to find out what to do.

What are the side effects of Defitelio that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
Very bad dizziness or passing out.
Very bad headache.
Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.

What are some other side effects of Defitelio?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Diarrhea.
Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Defitelio?

If you need to store Defitelio at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

This product’s label may have been updated. For full prescribing information, please visit LABELS.FDA.GOV.
Distributed by:
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304

SRC: NLM .

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