Pronunciation:

an-tye-hee-moe-FIL-ik FAK-tor ree-KOM-bin-ant PEG-il-ay-ted - aucl

Brand Names:

• Jivi

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antihemophilic Agent

Uses of This Medicine:

Antihemophilic factor (recombinant) pegylated-aucl injection is used to treat and control bleeding in patients with hemophilia A (congenital Factor VIII deficiency) who have been treated before. It is also used to reduce the number of bleeding episodes in patients when used regularly. Antihemophilic factor (recombinant) pegylated-aucl injection is also used to prevent bleeding during a surgical procedure.

This medicine is available only with your doctor's prescription.

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 have not been performed on the relationship of age to the effects of antihemophilic factor (recombinant) pegylated-aucl injection in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of antihemophilic factor (recombinant) pegylated-aucl injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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 polyethylene glycol (PEG), or mouse or hamster proteins, history of or
• von Willebrand disease (blood clotting disorder)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

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 into one of your veins.

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

Swirl the vial gently to dissolve the powder. Do not shake. Do not use the mixed liquid if it is cloudy or has particles in it.

Inject the mixed liquid right away or you may store it at room temperature for not more than 3 hours. Throw away any unused medicine after 3 hours.

Precautions While Using This Medicine:

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

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

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

Tell your doctor if you have plans to travel. You should bring enough medicine for your treatment during this time.

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 immediately if any of the following side effects occur:

Less common

Fast heartbeat

fever

hives, itching, skin 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:

More common

Cough

headache

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

change or loss of taste

dizziness

feeling of warmth

nausea

stomach pain

trouble sleeping

vomiting

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.