Factor ix fc fusion protein recombinant (Intravenous)

Factor IX Fc fusion protein recombinant injection is used as an on-demand treatment to control or prevent bleeding episodes, prevent bleeding during surgery, or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital Factor IX deficiency).

Factor IX is a protein that is produced naturally in the body. Alprolix® is a man-made protein designed to mimic the naturally occurring factor IX in the body. It is used to stop bleeding by helping 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 check your and your child's progress closely while you or your child are receiving this medicine to make sure it is working properly. Blood tests will be needed to check 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 or nurse right away if you have a rash, itching skin, difficulty swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in your face, hands, tongue, or throat, or chest pain after you receive the medicine.

Your body can make antibodies (inhibitors) against this medicine, which may stop it from working properly. Your healthcare provider may need to test your blood for these inhibitors from time to time.

This medicine may increase your chance 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, trouble breathing, or numbness or weakness while you are receiving this medicine.

Tell your doctor if this medicine does not prevent or stop bleeding as expected.

Serious kidney problems may occur while using this medicine. Check with your doctor right away if you have blood in the urine, decreased urine output, lower back or side pain, swelling of the feet or lower legs, or unusual tiredness or weakness.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed so far have not shown any specific problems in children that would limit the usefulness of Alprolix® in this age group. However, children younger than 12 years may require a dose adjustment of Alprolix®, as determined by your child's doctor.

Geriatric

Although appropriate studies on how age affects the effects of Alprolix® have not been done in older adults, no specific problems related to this age group have been reported to date.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

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

• Blood clots or a history of medical problems caused by blood clots—Use with caution. These conditions may raise the risk of developing blood clots.

• Patients with factor IX inhibitors—May increase the risk of an allergic reaction.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

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

Rare

• Dizziness, faintness, or lightheadedness when standing up quickly from a lying or sitting position
• fast, irregular, pounding, or racing heartbeat or pulse
• sweating

Incidence not known

• Cough
• difficulty breathing
• hives, itching, or skin rash
• pain in the chest, groin, or legs, especially in the calves
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• tightness or pain in the chest
• vision changes

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. Your health care professional may also be able to tell you how 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

• Headache

Rare

• Burning, itching, numbness, prickling, or tingling feelings in the mouth
• change or loss of taste
• pain in the injection site

Other side effects not listed may also happen 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.

• Alprolix

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

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

This medicine comes with a patient information leaflet. It is very important that you read and follow the instructions carefully. Ask your doctor if you have questions.