Bebulin

Bebulin is a prescription medicine used to prevent and control bleeding in people with hemophilia B, an inherited bleeding disorder. Bebulin belongs to a group of drugs called antihemophilic agents. These 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 Bebulin include decreased blood pressure, itching and redness, fever, and chills.

Bebulin may cause dizziness. Do not drive or operate heavy machinery until you know how Bebulin affects you.

Bebulin is a prescription medication used to control and prevent bleeding episodes in adults with hemophilia.

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

• Baxter Healthcare Corporation

Serious side effects have been reported with Bebulin. See the “Bebulin Precautions” section.

Common side effects of Bebulin include:

• decreased blood pressure
• itching and redness
• fever
• chills

This is not a complete list of Bebulin 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 Bebulin 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 Bebulin including:

• Hypersensitivity reactions, including anaphylaxis. Tell your healthcare provider right away if you have some or all of the following symptoms of a hypersensitivity reaction:
  • 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 Bebulin. 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 symptoms of nephrotic syndrome:
  • 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
• Complications 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 Bebulin if you:

• have a known hypersensitivity (allergic reaction) to Bebulin or its ingredients
• have a known allergy to heparin
• have a history of heparin-induced thrombocytopenia

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 Bebulin, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• have or have had any medical problems
• 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.

Bebulin falls into category C. No studies have been done in animals, and there are no well-done studies in pregnant women. Bebulin 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 Bebulin 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 Bebulin.

Take Bebulin exactly as prescribed.

Bebulin is given directly into the bloodstream. Bebulin should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia B learn to infuse their Bebulin by themselves or with the help of a family member.

You may have to have blood tests done after getting Bebulin 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 Bebulin.

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 2doses of Bebulin at the same time.

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

Your healthcare provider will tell you how much Bebulin 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 Bebulin call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Bebulin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Bebulin at a refrigerated temperature of 2° to 8°C (35° to 46°F). Do not freeze.
• Do not use after the expiration date printed on the carton or vial.
• Do not share Bebulin with other people, even if they have the same symptoms as you do.
• Keep this and all medications out of reach of children.