Antihemophilic factor viii human (Injection)

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
• Dark-colored urine or pale stools
• Fever or chills
• Lightheadedness, dizziness, or fainting
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Yellowing of your skin or the whites of your eyes

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

• Change or loss of taste
• Drowsiness, headache, or tiredness
• Mild stomach pain
• Pain, itching, swelling, burning, or a lump under your skin where the needle is placed

Introduction

Antihemophilic Factor VIII Human (an-tee-hee-moe-FIL-ik FAK-tor ATE HUE-man)

Prevents and controls bleeding in people with certain types of bleeding disorders.

Brand Name(s)

Koate-DVI

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.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver problems (such as hepatitis A) or parvovirus infection. Tell your doctor if you have received hepatitis A or hepatitis B vaccine shots.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; lightheadedness or dizziness; or any swelling of your hands, face, or mouth after you receive this medicine.
• It is recommended that you carry an identification (ID) card or letter stating that you have hemophilia A and the type of medicine you are using. If you have any questions about what kind of identification to carry, check with your doctor.
• Check with your doctor right away if you have any symptoms of parvovirus infection: fever, chills, drowsiness, runny nose, and followed by a rash or joint pain.
• Check with your doctor right away if you have 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.
• 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 of 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 manufacture of these medicines. Although the risk is low, talk with your doctor if you have any concerns.
• The stopper of the bottle (vial) contains 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.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

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

Drugs and Foods to Avoid

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