Factor IX Fc Fusion Protein Recombinant (intravenous)

Factor IX fc fusion protein recombinant is a medication that is administered intravenously to control excessive bleeding in patients with hemophilia B.

Overview

Factor IX fc fusion protein recombinant is a medication used to control the excessive bleeding of patients with hemophilia B by helping the blood to clot.

Factor IX is a protein that is naturally produced in the body that causes blood to clot. Factor IX fc fusion protein recombinant is a manufactured protein that mimics the effect of Factor IX on the body. Patients with hemophilia B have an inherited deficiency of Factor IX. This leads to bleeding into joints, tissues, and body cavities spontaneously or in response to trauma.

Factor IX fc fusion protein recombinant is administered intravenously, through an injection, and should be administered by a medical professional. It is possible that a patient can also be trained to administer Factor IX fc fusion protein recombinant to himself or herself via injection.

Factor IX fc fusion protein recombinant is administered either before a surgery, in order to prevent excessive bleeding during surgery, or routinely in order to minimize the frequency and severity of bleeding episodes.

Conditions Treated

  • Hemophilia B (congenital Factor IX deficiency)

Type Of Medicine

  • Blood Coagulation Factor

Side Effects

Like all medications, Factor IX fc fusion protein recombinant can cause unintended side effects as well as the intended effects on the body. You should always talk to your doctor about the possible side effects you might experience and whether the benefits you will derive from the medication are worth the risk of side effects.

Check in with a doctor or medical professional immediately if you experience any of the following side effects:

  • Cough
  • Difficulty breathing
  • Dizziness, faintness, or lightheadedness
  • Pain in chest, groin, or legs
  • Rapid or irregular heartbeat
  • Skin hives, itching, or rash
  • Slurred speech
  • Sudden and severe headache
  • Sudden loss of coordination
  • Sudden shortness of breath
  • Sweating
  • Swelling of the face or eyes
  • Tightness in chest
  • Vision changes

Some side effects are unpleasant, but not dangerous. If you experience any of the following side effects, discuss them with your doctor or medical professional if they are persistent or get worse over time. Your doctor may also be able to help you mitigate some side effects.

  • Burning, itching, or tingling sensations in the mouth
  • Headache
  • Loss of or change to taste
  • Pain in injection site
  • Unusual fatigue

You may experience other side effects that have not been listed here. If you are experiencing any discomfort after being administered your dosage of Factor IX fc fusion protein recombinant, discuss this with your doctor. He or she may be able to help you control the discomfort of certain side effects.

You may also report any side effects that you experience to the FDA at 1-800-FDA-1080.

Dosage

Your doctor or medical professional will determine the proper dosage for you based on your medical history, health, age, intended effects of the medication, and the severity of your condition. Your dosage will be adjusted based upon your reaction to the initial dose. Your doctor will decide what dose is right for you and a medical professional will administer it to you.

Interactions

Make sure that you talk to your doctor about any other medications that you are taking before you are administered your dose of Factor IX fc function protein recombinant. Some drugs may interact with Factor IX fc function protein recombinant in ways that can alter the functioning of one or both drugs.

Some foods, or the use of alcohol or tobacco, can also interact with some drugs. Discuss your alcohol and tobacco use with your doctor to determine if you will need to change your use around the time of your administration of Factor IX fc function protein recombinant. Your doctor will tell you if there are any changes you need to make to your diet before or after receiving your dose(s) of Factor IX fc function protein recombinant.

Follow all the instructions that your doctor or medical professional gives you. If you have questions or do not understand these instructions, ask your doctor.

Warnings

Tell your doctor if you have any allergies. If you have any side effects to Factor IX fc function protein recombinant that might indicate an allergic reaction, tell your doctor or medical professional immediately.

Some medical conditions might affect the way you may use this medicine. It is important that you share your medical history with your doctor. The following conditions are especially important to share with your doctor before receiving a dose of Factor IX fc function protein recombinant:

  • Blood clots
  • Factor IX inhibitors (these may increase your risk of experiencing certain side effects)

Factor IX fc function protein recombinant has been determined to be safe in use of children 12 years of age and older. Children under the age of 12 may respond differently to the medication. They may need an adjustment in their dose to ensure the effectiveness of the medication.

There has not been adequate research to determine whether or not Factor IX fc function protein recombinant is safe for pregnant women. Therefore, pregnant women will need to discuss with their doctors whether or not the benefits of taking Factor IX fc function protein recombinant are worth the risks.

There has not been adequate research to determine whether elderly patients will respond differently to Factor IX fc function protein recombinant than younger adults. There have been no issues reported, but elderly patients should still discuss this risk with their doctors.

Factor IX fc function protein recombinant can cause serious side effects and allergic reactions. Your doctor should monitor you carefully after you have received your first dose of Factor IX fc function protein recombinant.

The use of Factor IX fc function protein recombinant can also increase a patient's risk of blood clotting issues. It is very important that you talk to your doctor immediately if you experience:

  • Chest pain
  • Numbness
  • Shortness of breath
  • Sudden or severe headache
  • Vision or speech issues
  • Weakness

You should also talk to your doctor if using Factor IX fc function protein recombinant does not alleviate your bleeding.

You should not use Factor IX fc function protein recombinant if you have had an extreme allergic reaction to it before.

Storage

You should always store Factor IX fc function protein recombinant in its original packaging in order to protect it from light. Store it in your refrigerator at temperatures of 2-8C (36-46F) and do not allow it to freeze.

Factor IX fc function protein recombinant may be stored at room temperature, up to 30C (86F) for a single period of time up to six months. If you are storing it at room temperature, make sure to record the date that you removed it from the refrigerator. Do not use Factor IX fc function protein recombinant if it has been stored at room temperature for longer than six months. Do not return Factor IX fc function protein recombinant to the refrigerator once it has been stored at room temperature.

Do not use Factor IX fc function protein recombinant if it has reached the expiration date printed on its label.

After reconstituting Factor IX fc function protein recombinant, it may be stored at room temperature for no longer than 3 hours as long as it is protected from direct sunlight. Do not use it if it has been exposed to direct sunlight or if it has been at room temperature for longer than three hours.

Summary

Factor IX fc function protein recombinant is a medication that is used by patients with hemophilia B to reduce the bleeding associated with their condition.

Factor IX fc function protein recombinant is a manufactured version of the protein Factor IX, which is produced in the body and helps cause blood clotting. Patients with hemophilia B experience spontaneous or traumatic bleeding as a result of a deficiency of Factor IX protein.

The use of Factor IX fc function protein recombinant by patients with hemophilia B can help reduce their spontaneous or traumatic bleeding incidents or allow them to undergo surgery without experiencing excessive bleeding.

Side effects and allergic reactions, which can sometimes be severe, are possible with this medication. Discuss these risks with your doctor before receiving the medication. If you experience any of the listed side effects, report them to your doctor or a medical professional.

Talk to your doctor about any allergies you have or medications that you take. Some medications may interact with Factor IX fc function protein recombinant.

It is also important that you talk to your doctor about your medical history and any medical conditions that you have. This is especially important if you have blood clots or Factor IX inhibitors.