factor IX complex

Generic Name: factor IX complex (injectable) (FAC tor NINE)
Brand Name: Alphanine SD, Bebulin VH, Benefix, Konyne 80, Mononine, Profilnine SD, Proplex T, ...show all 14 brand names

What is factor IX complex?

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 factor IX complex 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 is the most important information I should know about factor IX complex?

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 factor IX complex 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 factor IX complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from factor IX complex. 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 factor IX complex.

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 should I discuss with my healthcare provider before using factor IX complex?

Do not use factor IX complex 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 factor IX complex 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 factor IX complex without first talking to your doctor if you are pregnant or could become pregnant during treatment.

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

How should I use factor IX complex?

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 factor IX complex as directed by the manufacturer.

If you are using factor IX complex 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 factor IX complex is suspected.

What should I avoid while using factor IX complex?

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

Factor IX complex side effects

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 factor IX complex 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 factor IX complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from factor IX complex. 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 factor IX complex.

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 factor IX complex 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.

Factor IX complex dosing information

Usual Adult Dose for Factor IX Deficiency:

Although the dose of factor IX should be individualized for each patient based on body weight, type of hemorrhage, and desired plasma factor IX concentration, the following formulas may be used as a guide in determining dosage.
Human-derived factor IX:
Dose factor IX (IU) = Body weight (kg) x Desired factor IX increase (% of normal) x 1.0 IU/kg.
Recombinant factor IX:
Dose factor IX (IU) = Body weight (kg) x Desired factor IX increase (% of normal) x 1.2 IU/kg.

The following are suggestions for approximate factor IX levels, typical initial doses, and the average duration of treatment:

Minor (uncomplicated hemarthrosis, superficial muscle, or soft tissue hemorrhage):
20% to 30% desired factor IX level for 1 to 2 days duration.

Moderate (intramuscle or soft tissue with disconnection, mucous membranes, dental extractions, or hematuria hemorrhage):
25% to 50% desired factor IX level until bleeding stops and healing begins (usually 2 to 7 days).

Major (pharynx, retropharynx, retroperitoneum, CNS, or surgery hemorrhage):
40% to 100% desired factor IX level for 7 to 10 days.

Relatively high levels may be maintained by daily or twice daily doses, while the lower effective levels may require injections only once every two to three days. A single dose may be sufficient to stop a minor bleeding episode.

The following are suggested administration rates for the various brands of factor IX complex: Bebulin VH 2 mL/min, Konyne 80 100 IU/min, Profiline SD 10 mL/min, and Proplex T 2 to 3 mL/min.

Usual Adult Dose for Factor VII Deficiency:

(For Proplex T brand only)
Units required to raise blood level percentages = 0.5 unit/kg x body weight (in kg) x desired increase (%of normal)
Repeat dose every 4 to 6 hours as needed.

In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40% to 60% of normal.

What other drugs will affect factor IX complex?

Other drugs that affect bleeding or blood-clotting processes can interact with factor IX complex 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 factor IX complex.

Where can I get more information?

  • Your pharmacist has additional information about factor IX complex written for health professionals that you may read.

What does my medication look like?

Factor IX complex is available with a prescription under the several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 7/1/04 2:10:22 PM.

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