Generic Name: Coagulation Factor IX Brand Name(s): Coagulation Factor IX.

Uses

What is Coagulation Factor IX used for?

Coagulation Factor IX is commonly used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause.

This medication should not be used to reverse the effects of “blood thinners” (e.g., warfarin). Most types of this medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII). If you are using this medication for one of these conditions, consult your doctor or pharmacist to make sure that you are using the right product.

How should I take Coagulation Factor IX?

This medication is given by injection into a vein as directed by your doctor. Dosage is based on your medical condition (e.g., amount and location of bleeding), weight, and response to treatment.

Gently swirl the medication to mix. Do not shake. Some forms of this medication must be completely mixed into the liquid so that the liquid contains no particles. In these cases, do not use the liquid if it contains particles. Other forms of this medication may occasionally contain a few small particles in the vial, even if the medication is mixed correctly. In these cases, the particles will not affect how well the medication works and will be removed by the filter. If you have questions about whether your form of this medication may be used if it contains particles, or if you have other questions about the use of this medication, consult the doctor or pharmacist.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Learn how to store and discard medical supplies safely.

The medication in the vial and the supplies that come with the medication should be used only once. Do not reuse.

Tell your doctor if your condition persists or worsens.

How do I store Coagulation Factor IX?

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 light.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

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

Precautions & warnings

What should I know before using Coagulation Factor IX?

Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other clotting disorders (e.g., disseminated intravascular coagulation-DIC), heart disease (e.g., coronary artery disease), immune system problems, recent surgery/procedure, liver disease.

Before having surgery, tell your doctor or dentist that you are using this medication.

Since this medication is made from human blood, there is a very small chance that you may get infections from it (e.g., viral infections such as hepatitis). It is recommended that you get the appropriate vaccinations (e.g., for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent viral infections. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Coagulation Factor IX during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Coagulation Factor IX. Coagulation Factor IX is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Coagulation Factor IX?

Pain at injection site, chills, tingling, flushing, headache, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling at injection site, fast heartbeat, shortness of breath, signs of kidney problems (such as change in the amount of urine), swelling of the ankles/feet, pain/redness/swelling of arms or legs, new or increased bleeding/bruising.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, trouble breathing, bluish fingers.

This medication is made from human blood. Even though donors are carefully screened and this medication goes through a special manufacturing process, there is a very small chance that you may get infections from the medication (e.g., viral infections such as hepatitis). Tell your doctor right away if you develop any signs of hepatitis/another infection, including fever, persistent sore throat, unusual tiredness, persistent nausea/vomiting, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Coagulation Factor IX?

Some products that may interact with this drug include: drugs that help with clotting (such as aminocaproic acid, tranexamic acid).

Coagulation Factor IX may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Coagulation Factor IX?

Coagulation Factor IX may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Coagulation Factor IX?

Coagulation Factor IX may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Coagulation Factor IX.

What is the dose of Coagulation Factor IX for an adult?

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

What is the dose of Coagulation Factor IX for a child?

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.

How is Coagulation Factor IX available?

Coagulation Factor IX is available in the following dosage forms and strengths:

  • Intravenous powder for injection
  • Intravenous kit

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Coagulation Factor IX, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 30, 2018 | Last Modified: January 30, 2018

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