Adynovate

Adynovate is a prescription medication used to control and reduce the number of bleeding episodes in patients with hemophilia A.

Adynovate belongs to a group of drugs called clotting factor replacement treatments. These work by replacing clotting factor that is missing in people with hemophilia.

This medication comes as a dry powder to be mixed into a solution and injected into a vein (IV) by a healthcare provider. Many people with hemophilia A learn to infuse their Adynovate by themselves or with the help of a family member.

Common side effects of Adynovate include headache and nausea.

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.

• Shire US Inc.

Common side effects of Adynovate include headache and nausea.

This is not a complete list of Adynovate side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

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.

Before taking Adynovate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Adynovate or to any of its ingredients
• have or have had any medical problems
• have any allergies, including allergies to mice or hamsters
• are breastfeeding
• are pregnant or plan to become pregnant
• have been told that you have inhibitors to factor VIII (because Adynovate may not work for you)

Tell your doctor about all medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no studies that have been done in humans or animals with Adynovate. It is not known if Adynovate can harm an unborn baby. Adynovate should only be used in pregnant women if it is clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Adynovate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Adynovate.

This medication comes as a dry powder to be mixed into a solution and injected into a vein (IV) by a healthcare provider. Many people with hemophilia A learn to infuse their Adynovate by themselves or with the help of a family member.

Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.

You must carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing Adynovate so that your treatment will work best for you.

You may have to have blood tests done after receiving Adynovate to be sure that your blood level of factor VIII is high enough to clot your blood.

Call your healthcare provider right away if your bleeding does not stop after taking Adynovate.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

Your healthcare provider will tell you how much Adynovate to use based on your weight, level of physical activity, the severity of your hemophilia A, and where you are bleeding.

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.

• Store Adynovate in the refrigerator and do not freeze.
• Adynovate may be stored at room temperature for up to one month. After storage at room temperature, do not return Adynovate back to the refrigerator.
• Do not use beyond the expiration date printed on the carton or vial.
• Store vials in their original box and protect them from extreme exposure to light.
• Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.
• Dispose of all materials, including any leftover reconstituted (after mixing dry product with wet diluent) Adynovate, in an appropriate container.
• Reconstituted product must be used within 3 hours and cannot be stored or refrigerated.
• Keep this and all medicines out of reach of children.