BeneFIX

BeneFIX is a prescription medicine used to prevent and control bleeding in people with hemophilia B, an inherited bleeding disorder. BeneFIX belongs to a group of drugs called antihemophilic agents which work by replacing clotting factors required to stop bleeding that are missing in people with hemophilia B. 

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of BeneFIX include nausea and injection site pain. 

BeneFIX is a prescription medication used for:

• control and prevention of bleeding episodes in adults with hemophilia B
• perioperative (before and after surgery) use in adults with hemophilia B

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take BeneFIX exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your healthcare provider will tell you how much BeneFIX to use based on your weight, the severity of the factor IX deficiency, the location and extent of bleeding, your clinical condition, age and recovery of factor IX.

Serious side effects have been reported with BeneFIX including:

• Hypersensitivity reactions, including anaphylaxis. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • swelling of the face or lips
  • chest tightness
  • a drop in blood pressure
  • lethargy (sluggishness)
  • nausea
  • vomiting
  • tingling in hands or feet
  • restlessness
  • wheezing
  • difficulty breathing
• Development of proteins that inhibit (stop) the activity of BeneFIX. Your healthcare provider will want to monitor for this development.
• Nephrotic syndrome (kidney damage). Tell your healthcare provider right away if you have some or all of the following symptom:
  • urine with a foamy appearance
  • poor or decreased appetite
  • swelling around the eyes, feet, and ankles, and in the abdomen (stomach area)
  • weight gain from an increase in fluid in the body
• Thromboembolic complications. This is a process of blood clot formation. This can be especially dangerous if a blood clot gets stuck in the leg (deep vein thrombosis), the lungs (pulmonary embolism), or if you have a stroke (clotting of a vessel leading to the brain).

 Do not take BeneFIX if you:

• have a known hypersensitivity (allergic reaction) to BeneFIX or its ingredients
• are allergic to hamsters
• develop disseminated intravascular coagulation (DIC). (DIC is when clotting and bleeding of the blood becomes unbalanced.)
• develop signs of fibrinolysis. (Fibrinolysis is when your blood loses its ability to clot.)

Serious side effects have been reported with BeneFIX. “Drug Precautions” section.

Common side effects of BeneFIX include:

• nausea
• injection site reaction 
• injection site pain
• headache
• dizziness
• rash

This is not a complete list of BeneFIX side effects. Ask your doctor or pharmacist for more information.

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

No BeneFIX drug interactions have been reported, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

BeneFIX falls into category C. No studies have been done in animals, and there are no well-done studies in pregnant women. BeneFIX should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether BeneFIX crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using BeneFIX.

Notify your doctor right away and seek emergency care if you develop signs and symptoms of a hypersensitivity reaction such as fever, hives, rashes, nausea, swelling of face or other body areas, wheezing, hypotension, dizziness, lightheadedness, or loss of consciousness.

Your doctor will monitor your factor IX activity levels.