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Antihemophilic Factor Viii and Von Willebrand Factor Complex (Intravenous Route)

US Brand Names

Description

Antihemophilic Factor VIII and von Willebrand Factor Complex 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 in patients with hemophilia A.

Antihemophilic Factor VIII and von Willebrand Factor Complex 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. This medicine is to be administered only by or under the supervision of your doctor.

Before Using

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Antihemophilic Factor VIII and von Willebrand Factor Complex injection in children 5 to 16 years of age.

Geriatric

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 Complex injection in geriatric patients.

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

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.

Proper Use

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

Precautions

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

This medicine may cause a serious type of allergic reaction called 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 cough; difficulty with swallowing; dizziness; a fast heartbeat; wheezing; shortness of breath; trouble with 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 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.

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

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:

• Difficulty with breathing or swallowing
• Dizziness
• Fast heartbeat
• Fever
• Hives or welts
• Itching
• Nausea
• Reddening of the skin, especially around the ears
• Shortness of breath
• Skin rash
• Swelling of the face, throat, or tongue
• Unusual tiredness or weakness

• Cough
• Tightness in the chest
• Vomiting
• Wheezing

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.

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