Coagulation factor IX

Coagulation factor IX is a prescription medication used to replace replace clotting factor (factor IX) that is missing in adults and children at least 12 years of age with hemophilia B. 

Coagulation factor IX belongs to a group of drugs called blood coagulation factors. These work to activate substances in your blood to form clots and decrease bleeding episodes.

This medications comes as an injection to be given into the vein (IV) by a healthcare provider.

The most common side effect of this medication is headache. 

Coagulation factor IX is a medicine used to replace clotting factor (factor IX) that is missing in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents clotting. Your healthcare provider may give you this medication when you have surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Coagulation factor IX may be found in some form under the following brand names:

• Ixinity

Serious side effects have been reported with coagulation factor IX. See the “Drug Precautions” section.

The most common side effect in clinical trials was headache.

This is not a complete list of coagulation factor IX side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take aminocaproic acid.

This is not a complete list of coagulation factor IX drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with coagulation factor IX including the following: 

• Allergic reactions may occur with coagulation factor IX. Call your healthcare provider or get emergency treatment right away if you get any of the following symptoms: rash, hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.
• Development of neutralizing antibodies (inhibitors) to Ixinity. Your doctor will continue to monitor you and your labs.
• Nephrotic syndrome. Nephrotic syndrome is a group of symptoms that include protein in the urine, low blood protein levels, high cholesterol levels, high triglyceride levels, and swelling.
• Blood clots. Call your healthcare provider or get emergency treatment right away if you get any of the following symptoms:
  • ​Changes in skin color (redness)
  • Leg pain
  • Leg swelling (edema)
  • Skin that feels warm to the touch
  • Shortness of breath
  • Chest pain
  • Cough

Do not use coagulation factor IX if you:

• Are allergic to hamsters
• Are allergic to any ingredients in coagulation factor IX

Tell your healthcare provider if you are pregnant or breastfeeding because Ixinity may not be right for you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of coagulation factor IX, there are no specific foods that you must exclude from your diet when receiving this medication. 

You should tell your healthcare provider if you:

• Have or have had any medical problems
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
• Have any allergies, including allergies to hamsters
• Are breastfeeding. It is not known if coagulation factor IX passes into your milk and if it can harm your baby.
• Are pregnant or planning to become pregnant. It is not known if coagulation factor IX may harm your baby.
• Have been told that you have inhibitors to factor IX (because coagulation factor IX may not work for you).

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Coagulation factor IX falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if this medication crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using coagulation factor IX.

Coagulation factor IX comes as an injection to be given into the vein (IV) by a healthcare provider. Coagulation factor IX should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia B learn to infuse coagulation factor IX by themselves or with the help of a family member.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• the severity of your factor IX deficiency
• your weight

Since coagulation factor IX is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.