Adynovate

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A.

Recombinant antihemophilic factor works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Recombinant antihemophilic factor is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage.

Recombinant antihemophilic factor is not for use in people with von Willebrand disease.

Recombinant antihemophilic factor may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you have ever had a severe allergic reaction to antihemophilic factor, or if you are allergic to mouse, hamster, or beef proteins.

Before using recombinant antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Recombinant antihemophilic factor will not treat von Willebrand disease.

It is not known whether recombinant antihemophilic factor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether recombinant antihemophilic factor passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for:

• On-demand treatment and control of bleeding episodes
• Routine prophylaxis to reduce the frequency of bleeding episodes

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

Dosage Forms And Strengths

ADYNOVATE is a lyophilized powder in single-use vials containing nominally (approximately) 250, 500, 1000, and 2000 International Units (IU, units). The actual factor VIII potency/content is labeled on each ADYNOVATE vial.

The potency assignment employs a factor VIII concentrate standard that is referenced to a WHO (World Health Organization) international standard for factor VIII concentrates and is evaluated by appropriate methodology to ensure accuracy of the results.

ADYNOVATE is supplied in packages comprised of a single-use vial containing nominally (approximately) 250, 500, 1000, or 2000 international units (IU) of factor VIII potency, a diluents vial containing 5 mL of sterile Water for Injection (sWFI), and a BAXJECT II Hi-Flow Needleless Transfer Device. Components not made with natural rubber latex.

Actual factor VIII activity in IU is stated on the label of each ADYNOVATE carton and vial.

Storage And Handling

• Store ADYNOVATE in powder form at 2°to 8°C (36°to 46°F).
• Do not freeze.
• ADYNOVATE may be stored at room temperature not to exceed 30°C (86°F) for a period of up to 1 month not to exceed the expiration date. If stored at room temperature, write the date on the carton when ADYNOVATE is removed from refrigeration.
• After storage at room temperature, do not return the product to the refrigerator.
• Do not use beyond expiration date printed on the carton or vial.
• Store vials in their original box and protect them from extreme exposure to light.
• After reconstitution, do not refrigerate the solution. Use the reconstituted solution immediately or within 3 hours after reconstitution. Discard any remaining solution.

Baxalta US Inc. Westlake Village, CA 91362 USA, U.S. Revised: Nov 2015

Included as part of the PRECAUTIONS section.

Adynovate is an injectable prescription medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in adults and children with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.

• Adynovate is used on-demand to control bleeding in patients with hemophilia A.
• Adynovate may be given to those undergoing surgery.
• Adynovate can reduce the number of bleeding episodes when used regularly (prophylaxis). 

Adynovate is not used to treat von Willebrand disease. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

You should not use Adynovate if you:

• are allergic to mice or hamster protein 
• are allergic to any ingredients in Adynovate or Advate 

Tell your healthcare provider if you are pregnant or breastfeeding because Adynovate may not be right for you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Adynovate, there are no specific foods that you must exclude from your diet when receiving this medication.

If you take too much Adynovate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Adynovate is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic side effects may rarely happen.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Call the doctor right away if the normal dose does not work as well.
• Talk with the doctor before you travel. You will need to bring enough of Adynovate for use during travel.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Adynovate, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Adynovate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Adynovate (antihemophilic factor (recombinant [pegylated])).

Review Date: October 4, 2017