Antihemophilic factor recombinant (Injection)

How to Store and Dispose of This Medicine

• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
• You may also store the medicine at room temperature for short periods of time. Store this medicine as directed by your doctor or the manufacturer. Write the date you removed the medicine from the refrigerator on the carton. If you have already stored this medicine at room temperature, do not return it to the refrigerator. Protect the carton from heat and direct light.
• After you mix the powder with the sterile water, keep the mixture at room temperature. Do not store the mixture in the refrigerator.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have any medical problems.
• This medicine treats only hemophilia A (classic hemophilia). This medicine does not treat other kinds of hemophilia or blood clotting problems.
• Your body may react against Xyntha® and cause the medicine to stop working properly. Check with your doctor right away if you notice that your medicine is not working or is less effective than usual.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• You should carry identification that says you have hemophilia A and what medicine you use. Check with your doctor if you have any questions about what kind of identification to carry.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever
• Lightheadedness, dizziness, or fainting
• Skin rash or itchiness
• Swelling of you face, lips, tongue, or throat
• Trouble breathing
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Cough, runny or stuffy nose, or sore throat
• Headache
• Joint or muscle pain
• Pain, burning, swelling, or a lump under your skin where the needle is placed
• Vomiting

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. Do not use more medicine or use it more often than your doctor tells you to. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Use a new needle and syringe each time you inject your medicine. You must use a plastic syringe. There is one in the package with your medicine.
• Xyntha® injection is available in a prefilled dual-chamber syringe. It must be used within 3 hours after it is mixed or after you remove of the rubber cap from the syringe. You may store the mixed liquid at room temperature before you inject the medicine. Throw away any medicine you do not use after 3 hours.
• Do not use Xyntha® or Advate® injection if the mixed liquid is discolored or has particles in it.
• Advate® injection is a powder that must be mixed with sterile water before you use it. The sterile water should come in the same package with the medicine. Let both the powdered medicine and the sterile water warm up to room temperature before you mix them together. After you mix the powdered medicine with the water, store at room temperature and use it within 3 hours.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Talk to your doctor before you travel. You should bring enough medicine for your treatment when you travel.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

Introduction

Antihemophilic Factor (Recombinant) Plasma/Albumin-Free (an-tee-hee-moe-FIL-ik FAK-tor (re-KOM-bin-ant) PLAZ-ma/al-BYOO-min-free)

Prevents and controls bleeding episodes in people who have hemophilia A (classic hemophilia). Also prevents bleeding problems from happening as often.

Brand Name(s)

Advate, Xyntha