Anti-inhibitor coagulant complex (Injection)

Drugs and Foods to Avoid

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

• Patients who have hemophilia should not take aspirin, because it may increase bleeding.
• Make sure your doctor knows if you are also using coagulation factor VIIa (Novoseven®). Do not use medicines that affect the blood such as aminocaproic acid (Amicar®) or tranexamic acid (Cyklokapron®) for 12 hours after receiving FEIBA NF®.

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
• Blood in the urine or stools
• Chest pain, shortness of breath, or coughing up blood
• Dark-colored urine or pale stools
• Fever or chills
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Sudden or severe headache, problems with vision, speech, or walking
• Swelling of the face, around the eyes, or mouth
• Wheezing, trouble breathing, or chest tightness
• Yellowing of your skin or the whites of your eyes

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

• Back pain
• Headache
• Tiredness

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

Anti-Inhibitor Coagulant Complex (AN-tee in-HIB-i-ter co-AG-yoo-lant kom-plex)

Controls bleeding episodes or bleeding during surgery in patients who have hemophilia A or hemophilia B, disorders in which blood does not form clots normally.

Brand Name(s)

Feiba-VH, Feiba NF

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. 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.
• The medicine must be given by someone trained to give an IV, such as a nurse. You, someone in your family, or a friend can also be taught to give the medicine.
• Before your nurse or caregiver give the medicine, look at the liquid in the bag or syringe, if you see specks or solid pieces, you should not use the medicine. Mix a new dose of the medicine.
• After it is mixed, give the medicine right away. The treatment needs to be done within 1 hour after mixing (if you are using Autoplex®) or within 3 hours (if you are using FEIBA® or FEIBA NF®).
• The medicine needs to be mixed with liquid (sterile water) before it is given. When it is time for your treatment, bring the medicine and sterile water to room temperature. Make sure your nurse or caregiver understand how to mix the powder with the water before giving your medicine.
• If the medicine goes into your veins too fast, it can cause headaches, flushing, or changes in blood pressure and heartbeat. The symptoms will usually go away if you stop the treatment. You may need to give the medicine more slowly. Talk to your caregiver about this.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine

• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
• If needed, you may also store the medicine at room temperature for up to 6 months. 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.
• After you mix the powder with the sterile water, do not store the mixture in the refrigerator. Keep the mixture at room temperature and use it within 3 hours.
• 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.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease (including hepatitis A), heart disease, a virus infection (Parvovirus B19 infection), or a weak immune system.
• This medicine may increase your chance of having blood clots or bleeding, especially in patients with atherosclerosis (hardening of the arteries), a serious injury, a serious blood infection (septicemia), or a history of blood clotting problems, heart attack, or stroke. Patients who stay in bed for a long time because of surgery or illness are also at risk for blood clots. Check with your doctor right away if you suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; lightheadedness or dizziness; or any swelling of your hands, face, or mouth after you have receive 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.
• Stop using this medicine and check with your doctor right away if you have chest pain, cough, fast or slow heartbeat, shortness of breath, trouble with breathing, or wheezing after receiving this medicine.
• Check with your doctor right away if you develop pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
• Check with your doctor right away if you have fever, chills, drowsiness, joint pain, rash, or runny nose.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• Certain components of the packaging material contain dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.