Generic Name: coagulation factor IX (koh AG yoo LAY shun FAK tor)
Brand names: AlphaNine SD, BeneFIX, Mononine, BeneFIX 250 Int'l Units
What is coagulation factor IX?
Coagulation factor IX is a man-made protein that is 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 VII deficiency.
Coagulation factor IX may also be used for purposes other than those listed here.
What is the most important information I should know about coagulation factor IX?
Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.
Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have liver disease, coronary artery disease (hardening of the arteries), or a history of stroke or heart attack.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition.
What should I discuss with my healthcare provider before using coagulation factor IX?
Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.
Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have:
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether coagulation factor IX passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use coagulation factor IX?
Coagulation factor IX is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home.
Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.
Use each disposable needle only one time. Throw away used needles and syringes in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Coagulation factor IX is a powder medication that must be mixed with a liquid (diluent) before injecting it. Use the injection within 3 hours after mixing your dose.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition. If you store this medication at home, keep the powder medicine in the refrigerator. Do not freeze. Avoid exposing the medication to sunlight. The diluent can be stored at room temperature. You may also coagulation factor IX powder at cool room temperature for up to 6 months.
What happens if I miss a dose?
Contact your doctor if you miss a dose of this medication.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
An overdose of coagulation factor IX is not expected to produce life-threatening symptoms.
What should I avoid while using coagulation factor IX?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using coagulation factor IX.
Coagulation factor IX side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
fever or chills;
continued bleeding after treatment;
feeling like you might pass out;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance; or
swelling in your feet or ankles, weight gain, loss of appetite.
Less serious side effects may be more likely to occur, such as:
headache;
warmth, redness, or tingly feeling under your skin;
nausea, vomiting;
dizziness; or
pain, redness, or swelling 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.
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].
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 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days
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].
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 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days
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].
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 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days
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].
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 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days
What other drugs will affect coagulation factor IX?
There may be other drugs that can interact with coagulation factor IX. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More coagulation factor IX resources
- Coagulation factor IX Side Effects (in more detail)
- Coagulation factor IX Use in Pregnancy & Breastfeeding
- Coagulation factor IX Support Group
- 1 Review for Coagulation factor IX - Add your own review/rating
- AlphaNine SD MedFacts Consumer Leaflet (Wolters Kluwer)
- Alphanine SD Prescribing Information (FDA)
- Alphanine SD Advanced Consumer (Micromedex) - Includes Dosage Information
- BeneFIX Monograph (AHFS DI)
- BeneFIX Prescribing Information (FDA)
- BeneFix MedFacts Consumer Leaflet (Wolters Kluwer)
- Mononine Prescribing Information (FDA)
- Mononine MedFacts Consumer Leaflet (Wolters Kluwer)
Compare coagulation factor IX with other medications
- Factor IX Deficiency
- Hemophilia B
Where can I get more information?
- Your pharmacist can provide more information about coagulation factor IX.
See also: coagulation factor IX side effects (in more detail)
