Pronunciation:

an-tee-hee-moe-FIL-ik FAK-tor ATE HUE-man, Von WILL-a-brand FAK-tor HUE-man

Brand Names:

• Alphanate
• Humate-P
• Wilate

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antihemophilic Agent

Uses of This Medicine:

Antihemophilic factor VIII and von Willebrand factor injection is a combination product that is used to treat serious bleeding episodes in patients with a bleeding problem called von Willebrand disease (VWD). The bleeding episode may be related to an injury (trauma) or a surgical procedure. This medicine may also be used to stop bleeding, and to control and prevent bleeding episodes in patients with hemophilia A.

Antihemophilic factor VIII and von Willebrand factor are normally produced in the body. They help clot the blood when an injury occurs. Patients with von Willebrand disease or hemophilia A do not make enough of these substances to prevent bleeding, so this product is given to increase the levels of these substances in the blood.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of antihemophilic factor VIII and von Willebrand factor injection in children with von Willebrand disease, and in teenagers with hemophilia A.

Older adults—

Adequate and well-controlled studies have not been done on the relationship of age to the effects of antihemophilic factor VIII and von Willebrand factor injection in geriatric patients.

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, history of or
• Deep vein thrombosis (blood clot in leg), history of or
• Pulmonary embolism (blood clot in lung), history of or
• Stroke, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed in one of your veins.

This medicine may also be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Make sure you understand all of the instructions before giving yourself an injection.

Your dose may change based on where you are bleeding. Do not use more medicine or use it more often than your doctor tells you to.

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

Inject the mixed liquid right away.

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 tests may be needed to check for unwanted effects.

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

This medicine may cause serious allergic reactions including anaphylaxis. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a cough, difficulty with swallowing, dizziness, a fast heartbeat, trouble breathing, chest tightness, swelling in your face, hands, tongue, or throat, a fever, chills, a runny nose or sneezing, itching or hives, or lightheadedness or faintness after you get the injection.

This medicine may increase your chance of having blood clots. Tell your doctor right away if you or your child have a sudden or severe headache, problems with vision or speech, chest pain, trouble breathing, or numbness or weakness after receiving this medicine.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

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:

More common

Difficulty with breathing or swallowing

dizziness

fast heartbeat

fever

hives or welts, itching, rash

nausea

reddening of the skin, especially around the ears

swelling of the face, throat, or tongue

unusual tiredness or weakness

Incidence not known

Abdominal or stomach pain

blurred vision

cough

headache

nervousness

pounding in the ears

slow or fast heartbeat

tightness in the chest

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.