coagulation factor IX

Generic Name: coagulation factor IX (koe AG yoo LAY shun FAK tor NINE)
Brand Name: AlphaNine SD, Alprolix, BeneFIX, Mononine, Rixubis, BeneFIX 250 Int'l Units

What is coagulation factor IX?

Coagulation factor IX is a man-made protein similar to a natural protein in the body that helps the blood to clot.

Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency.

Coagulation factor IX may also be used for purposes not listed in this medication guide.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

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

You should not use this medicine if:

  • you have had an allergic reaction to clotting factor medicine;

  • you have signs of excessive blood clotting; or

  • you are allergic to hamster proteins.

To make sure coagulation factor IX is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • coronary artery disease (hardening of the arteries); or

  • history of heart attack or stroke.

FDA pregnancy category C. It is not known whether coagulation factor IX will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether coagulation factor IX passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Coagulation factor IX is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use coagulation factor IX?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Coagulation factor IX is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Coagulation factor IX is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

The mixture should appear clear and colorless. Do not use the mixed medicine if it has changed colors or has particles in it. Prepare a new kit or call your pharmacist for a new supply of coagulation factor IX.

Gently swirl but do not shake the medicine bottle when mixing or you may ruin the medicine. Use the injection within 3 hours after mixing your dose.

Coagulation factor IX comes with patient instructions for proper mixing and storage. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using coagulation factor IX, you may need frequent blood tests.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any medical care provider who treats you should know that you have a bleeding disorder.

If you store this medicine at home, carefully follow the directions on your medicine label about how to store the powder medicine and the diluent. Some forms of coagulation factor IX can be stored at room temperature, and others should be kept in a refrigerator. Do not freeze. Avoid exposing the medication to sunlight.

Throw away any coagulation factor IX not used before the expiration date on the medicine label.

What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using coagulation factor IX?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Coagulation factor IX side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, tightness in your chest, difficult breathing, fast heartbeats, blue lips, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • swelling in your feet or ankles, weight gain, loss of appetite;

  • fever or chills;

  • continued bleeding after treatment;

  • new or worsened bleeding; or

  • signs of excessive blood clotting--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, or pain, swelling, warmth and redness in one or both legs.

Common side effects may include:

  • nausea;

  • headache;

  • dizziness;

  • altered sense of taste;

  • mild skin rash; or

  • pain, stinging, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Coagulation factor IX dosing information

Usual Adult Dose for Factor IX Deficiency:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.

In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.8 + or - 0.2 IU/dL [range 0.4 to 1.2 IU/dL].

One international unit of Rixubis per kg of body weight increased the circulating activity of factor IX by 0.9 international units/dL.

The following formula may be used as a guide in determining the dose for treatment of bleeding episodes:
Initial dose (number of factor IX IU required) = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/dL per IU/kg)

Control and Prevention of Bleeding Episodes and Perioperative Management:
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days

Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days

Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 100 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Rixubis dosing for Perioperative Management:
Minor
Tooth extraction:
Circulating Factor IX Activity Required: 30 to 60 [% or (IU/dL)]
Dosing Interval: 24 hours
Duration of Therapy: At least 1 day, until healing is achieved

Major
Intracranial, intraabdominal, intrathoracic, joint replacement:
Circulating Factor IX Activity Required: 80 to 100 [% or (IU/dL)]
Dosing Interval: 8 to 24 hours
Duration of Therapy: 7 to 10 days

Rixubis Routine Prophylaxis dose: 40 to 60 international units per kg IV twice weekly

Usual Adult Dose for Hemophilia B:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.

In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.8 + or - 0.2 IU/dL [range 0.4 to 1.2 IU/dL].

One international unit of Rixubis per kg of body weight increased the circulating activity of factor IX by 0.9 international units/dL.

The following formula may be used as a guide in determining the dose for treatment of bleeding episodes:
Initial dose (number of factor IX IU required) = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/dL per IU/kg)

Control and Prevention of Bleeding Episodes and Perioperative Management:
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days

Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days

Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 100 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Rixubis dosing for Perioperative Management:
Minor
Tooth extraction:
Circulating Factor IX Activity Required: 30 to 60 [% or (IU/dL)]
Dosing Interval: 24 hours
Duration of Therapy: At least 1 day, until healing is achieved

Major
Intracranial, intraabdominal, intrathoracic, joint replacement:
Circulating Factor IX Activity Required: 80 to 100 [% or (IU/dL)]
Dosing Interval: 8 to 24 hours
Duration of Therapy: 7 to 10 days

Rixubis Routine Prophylaxis dose: 40 to 60 international units per kg IV twice weekly

Usual Pediatric Dose for Factor IX Deficiency:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.

In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.7 + or - 0.3 IU/dL [range 0.2 to 2.1 IU/dL].

The following formula may be used as a guide in determining the dose for treatment of bleeding episodes:
Initial dose (number of factor IX IU required) = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/dL per IU/kg)

Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days

Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days

Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 100 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Safety and efficacy of Rixubis in pediatric patients have not been established.

Usual Pediatric Dose for Hemophilia B:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.

In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.7 + or - 0.3 IU/dL [range 0.2 to 2.1 IU/dL].

The following formula may be used as a guide in determining the dose for treatment of bleeding episodes:
Initial dose (number of factor IX IU required) = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/dL per IU/kg)

Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days

Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days

Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 100 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Safety and efficacy of Rixubis in pediatric patients have not been established.

What other drugs will affect coagulation factor IX?

Other drugs may interact with coagulation factor IX, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about coagulation factor IX.
  • 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: 2.02. Revision Date: 2014-05-27, 11:44:53 AM.

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