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.

• Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

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.

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.)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of BeneFIX, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking BeneFIX, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or have had any medical problems
• have any allergies, including allergies to hamsters
• are breastfeeding. It is not known if BeneFIX passes into your milk and if it can harm your baby.
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

Take BeneFIX exactly as prescribed.

BeneFIX is given directly into the vein. BeneFIX should be administered as ordered by your healthcare provider. 

You may have to have blood tests done after getting BeneFIX to be sure that your blood level of factor IX is high enough to clot your blood. Call your healthcare provider right away if your bleeding does not stop after taking BeneFIX.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of BeneFIX at the same time.

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.

If you take too much BeneFIX call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at refrigerated temperature 2° to 8°C (35 to 46°F). Do not freeze.
• You can store the product at room temperature (below 30°C or 86°F) for up to 6 months or until it has reached its expiration date, whichever comes first. 
• If you have taken the product kit labeled for storage in the refrigerator out of the refrigerator and stored it at room temperature (below 30°C or 86°F), then use the product within 6 months from the time you took the product out of the refrigerator or until it has reached its expiration date, whichever comes first.
• Do not use after the expiration date printed on the carton or vial.
• Do not share BeneFIX with other people, even if they have the same symptoms as you do.
• Keep out of reach of children.