Coagulation factor ix recombinant, glycopegylated (Intravenous)

Coagulation factor IX (recombinant), glycoPEGylated injection is used to control bleeding episodes and prevent bleeding during surgery in patients with hemophilia B (congenital Factor IX deficiency).

Factor IX is a protein that the body normally makes. This medicine is a man-made version of that protein designed to mimic the natural factor IX in the body. It helps stop bleeding by allowing the blood to clot in patients with hemophilia B.

This medicine is to be given only by or under the supervision of your doctor or other health care professional.

It is very important that your doctor checks you closely while you or your child are receiving this medicine to ensure it is working properly. Blood and urine tests will be needed to look for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may increase your risk of having blood clotting problems. Tell your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are receiving this medicine.

This medicine may cause a serious kidney problem, called nephrotic syndrome. Check with your doctor right away if you have cloudy or bloody urine, high blood pressure, or swelling of the face, feet, or lower legs.

Call your doctor right away if this medicine does not prevent or stop bleeding as expected.

In deciding to use a medicine, you and your doctor must weigh the risks of taking the medicine against the benefits it provides. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems in children that would limit the use of coagulation factor IX (recombinant), glycoPEGylated injection.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of coagulation factor IX (recombinant), glycoPEGylated injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if interactions might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to hamster protein—Should not be used in patients with this condition.

• Clotting disorders (including disseminated intravascular coagulation, thrombosis) or
• Liver disease—Use with caution. These conditions may increase the risk of developing blood clots.

• Nephrotic syndrome (kidney disease)—Use with caution. May worsen this condition.

• Patients with factor IX inhibitors—May have an increased risk of allergic reactions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may require medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Cough
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• Hives, itching, rash
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Tightness in the chest
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Rebinyn

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

A doctor or other trained health professional will give you this medicine. You may also be trained to administer this medicine yourself. This medicine is given through a needle placed in one of your veins.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.