Pronunciation:

FAK-tor NINE al-BUE-min FUE-zhun PROE-teen ree-KOM-bi-nant

Brand Names:

• Idelvion

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Factor IX albumin fusion protein recombinant injection is used in patients with hemophilia B (congenital Factor IX deficiency) to control or prevent bleeding episodes, or prevent bleeding during surgery.

Factor IX is a protein that is produced naturally in the body. This medicine 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 Idelvion® in children.

Older adults—

Although appropriate studies on the relationship of age to the effects of Idelvion® 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:

• Allergy to hamster protein—Should not be used in patients with these conditions.

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

• Nephrotic syndrome (kidney disorder)—Use with caution. May make this condition worse.

• Patients with factor IX inhibitors—May increased 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 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. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine:

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

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child 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.

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you or your child 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.

Call your doctor right away if you or your child start to have bleeding problems, especially if this medicine has worked well for you before.

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

Cough

fast heartbeat

fever

hives, itching, or rash

hoarseness

irritation

joint pain, stiffness, or swelling

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled breathing or swallowing

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

Dizziness

skin rash, encrusted, scaly, and oozing

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.