Pronunciation:

FAK-tor NINE Fc FUE-zhun PROE-teen ree-KOM-bi-nant

Brand Names:

• Alprolix

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

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 produced to replicate 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.

Before Using This Medicine:

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

Allergies—

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

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Alprolix® in children. However, children younger than 12 years of age may need an adjustment in the dose of Alprolix®, as determined by your child's doctor.

Older adults—

Although appropriate studies on the relationship of age to the effects of Alprolix® have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change 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]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 with 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.

Side Effects of This Medicine:

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

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

Rare

Dizziness, faintness, or lightheadedness when getting up suddenly 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 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. 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 or 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 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.