Antihemophilic Factor (Recombinant), Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by IV injection to prevent or control bleeding in people who have hemophilia A.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antihemophilic; coagulation factor

Generic and brand names: factor VIII; antihemophilic factor (recombinant), injection; Adynovate; Kovaltry; Novoeight

What is this medicine used for?

This medicine is given by injection (shots into a vein) to prevent or control bleeding in people who have hemophilia A. This medicine may also be given to people with hemophilia A when they have surgery to prevent bleeding.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had an allergic reaction to any medicine or to hamster proteins.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is usually given by your healthcare provider. You may be able to inject this medicine yourself or with the help of someone at home. Your healthcare provider or a hemophilia center can teach you the proper way to give the shots. If you take this medicine on a regular schedule, do not stop taking this medicine without your healthcare provider's approval.

This medicine is given by IV injection (shots into a vein), usually over 2 to 5 minutes. The number of shots you need depends on where you are bleeding, how severe your bleeding is, and how quickly it stops.

Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you take this medicine on a regular schedule and you miss a dose, contact your healthcare provider. Do not take double doses.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Your body may make antibodies that prevent this medicine from working. Tell your healthcare provider if this medicine does not seem to be working as well as usual. If your bleeding is not controlled after you receive this medicine, contact your healthcare provider right away.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Wear some form of identification stating that you take this medicine (such as a Medic Alert bracelet).

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain; unusual bruising or bleeding; blood in the urine or bowel movement; fast heartbeat; pale, cold skin; severe dizziness or fainting.

Other: Mild headache, swelling or itching at spot where the shot was given, fever.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How do I store this medicine?

Store the medicine without the diluent added to it in the refrigerator. Do not let it freeze. After you add the diluent to the medicine, use it within 4 hours. Do not refrigerate the medicine after you add the diluent. Any medicine left in the vial at the end of your infusion should be discarded, and you should properly dispose of the needle and syringe as well.

Once the medicine is kept at room temperature, it should remain so until injected. Do not put it back in the refrigerator. Do not use the medicine after 12 months from the date you started storing it at room temperature. Do not use it past the specified period of time according to the package instructions. Do not use the medicine after the expiration date printed on the vial. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.