Bebulin VH

 
Generic Name: factor IX complex (injectable)

Brands: Alphanine SD, Bebulin VH, Benefix, Konyne 80, Mononine, Profilnine SD, Proplex T

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What is the most important information I should know about Bebulin VH?

· Factor IX complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although Bebulin VH is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using Bebulin VH.

· Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from Bebulin VH. Parovovirus B19 may more seriously affect pregnant women and those with poor immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark-colored urine and yellowing of the skin or whites of the eyes may also occur. Contact your doctor if you develop any of these symptoms after treatment with Bebulin VH.

· Carry or wear identification that will alert others that you have hemophilia or another blood clotting disorder in the case of an emergency.

· Tell your doctor and dentist that you have hemophilia or another blood clotting disorder before having surgery or other invasive procedures.

 

What is Bebulin VH?

· Factor IX is a natural protein, normally present in the blood, that helps blood to clot. A lack of this protein causes hemophilia B (Christmas disease). Factor IX complex also contains small amounts of other blood clotting factors.

· Factor IX complex is used to treat or prevent bleeding in people with hemophilia B. Some forms of Bebulin VH may also be used to treat or prevent bleeding in people with factor VII deficiency or inhibitors to factor VIII.

· Factor IX complex may also be used for purposes other than those listed here.

 

What should I discuss with my healthcare provider before using Bebulin VH?

· Do not use Bebulin VH without first talking to your doctor if you have      ·had an unusual or allergic reaction to this medication, a similar medication, a human or animal (mouse or hamster) protein, dyes, additives, or preservatives;     ·hardening of the arteries;     ·severe injury or infection;     ·liver disease; or     ·other bleeding or blood clotting disorders.

· You may not be able to use Bebulin VH or you may require a dosage adjustment or special monitoring during treatment.

· Factor IX complex is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use Bebulin VH without first talking to your doctor if you are pregnant or could become pregnant during treatment.

· It is not known whether Bebulin VH could be harmful to a nursing baby. Do not use Bebulin VH without first talking to your doctor if you are breast-feeding a baby.

 

How should I use Bebulin VH?

· Factor IX complex will be administered by intravenous (into a vein) injection by a healthcare provider.

· Your doctor may want you to have blood tests or other medical evaluations during treatment with factor IX to monitor progress and side effects.

· Carry or wear identification that will alert others that you have hemophilia or another blood clotting disorder in the case of an emergency.

· Your healthcare provider will store Bebulin VH as directed by the manufacturer.

· If you are using Bebulin VH at home, your doctor or healthcare provider will give you detailed instructions on how to administer and store the medication.

 

What happens if I miss a dose?

· Contact your doctor if a dose of factor IX is missed.

 

What happens if I overdose?

· Seek emergency medical attention if an overdose of Bebulin VH is suspected.

 

What should I avoid while using Bebulin VH?

· Tell your doctor and dentist that you have hemophilia or another blood clotting disorder before having surgery or other invasive procedures.

 

What are the possible side effects of Bebulin VH?

· Factor IX complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although Bebulin VH is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using Bebulin VH.

· Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from Bebulin VH. Parovovirus B19 may more seriously affect pregnant women and those with poor immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark-colored urine and yellowing of the skin or whites of the eyes may also occur. Contact your doctor if you develop any of these symptoms after treatment with Bebulin VH.

· If you experience any of the following serious side effects, contact your healthcare provider immediately or seek emergency medical attention:     ·an allergic reaction (shortness of breath; wheezing; tightness of the chest; closing of the throat; hives; swelling of the lips, face, or tongue; hives or rash; dizziness or fainting); or     ·fever;     ·nausea or vomiting;     ·increased heart rate;     ·decreased blood pressure (may result in dizziness or fainting);     ·difficulty breathing, chest pain, or cough; or     ·pain, redness, or swelling at the injection site.

· Other, less serious side effects may be more likely to occur. Continue to use Bebulin VH and talk to your doctor if you experience     ·headache; or     ·flushing.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect Bebulin VH?

· Other drugs that affect bleeding or blood-clotting processes can interact with Bebulin VH resulting in dangerous side effects and/or altered effectiveness. Do not take any other prescription or over-the-counter medicines, including herbal products, without first talking to your doctor during treatment with Bebulin VH.

 

Where can I get more information?

· Your pharmacist has additional information about Bebulin VH written for health professionals that you may read.

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