Coagulation Factor IX (Recombinant), Albumin Fusion Protein

Coagulation Factor IX (Recombinant), Albumin Fusion Protein] is a prescription medication used to treat children and adults with Hemophilia B. 

This medication 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 medication 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 (Recombinant), Albumin Fusion Protein] is a prescription medication used to treat children and adults with Hemophilia B. This medication replaces the 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. 

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

Coagulation Factor IX (Recombinant), Albumin Fusion Protein may be found in some form under the following brand names:

• Idelvion

Serious side effects have been reported with this medication. See the “Drug Precautions” section.

The most common side effect in clinical trials was headache.

This is not a complete list of 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.

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Coagulation Factor IX (recombinant), albumin fusion protein including the following: (listed format)

• 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 this medication. 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 receive Coagulation Factor IX (recombinant), albumin fusion protein if you:

• are allergic to Coagulation Factor IX (recombinant), albumin fusion protein or to any of its ingredients
• are allergic to hamster proteins
• have had life-threatening hypersensitivity reactions to

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 Idelvion, there are no specific foods that you must exclude from your diet when receiving this medication.

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

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. It is not known if this medication will cause harm to your unborn baby. This medication should be given to a pregnant woman only if clearly needed. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Coagulation Factor IX (recombinant), albumin fusion protein 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 Idelvion while breastfeeding. 

Receive this medication exactly as prescribed.

Coagulation Factor IX (recombinant), albumin fusion protein is available as an injection to be given into the vein (IV). 

You will be trained on how to do injections by your healthcare provider or receive your injections at a hemophilia treatment center.

Many people with hemophilia B learn to inject Coagulation Factor IX (recombinant), albumin fusion protein by themselves or with the help of a family member.

Your healthcare provider will tell you how much Coagulation Factor IX (recombinant), albumin fusion protein to use based on your weight, the severity of your hemophilia B, and where you are bleeding.

You may need to have blood tests done after getting Coagulation Factor IX (recombinant), albumin fusion protein to be sure that your blood level of Factor IX is high enough to clot your blood.

Call your healthcare provider right away if your bleeding does not stop after taking this medication. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

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

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