Feiba NF

This section provides information on the proper use of a number of products that contain anti-inhibitor coagulant complex. It may not be specific to Feiba NF. Please read with care.

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

It is very important that your doctor check you closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your chance of having blood clots or bleeding, especially in patients with atherosclerosis (hardening of the arteries), 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.

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.

1. Sjamsoedin LJ, Heijnen L, Mauser-Bunschoten EP, van Geijlswijk JL, van Houwelingen H, van Asten P, Sixma JJ. The effect of Activated Prothrombin-Complex Concentrate (FEIBA) on joint and muscle bleeding in patients with Hemophilia A and antibodies to Factor VIII. N Engl J Med. 1981;305(13): 717-721. 2. Hilgartner MW, Knatterud GL. The use of Factor-Eight-Inhibitor-By-Passing-Activity (FEIBA IMMUNO) product for treatment of bleeding episodes in Hemophiliacs with inhibitors. Blood. 1983;61(1): 36-40. 3. Antunes SV, Tangada S, Stasyshyn O, Mamonov V, Phillips J, Guzman-Becerra N, Grigorian A, Ewenstein B, Wong WY. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2013; DOI 10.1111/hae.12246. 4. Turecek PL, Varadi K, Gritsch H, Auer W, Pichler L, Eder G, Schwarz HP. Factor Xa and prothrombin: mechanism of action of FEIBA. Vox Sanguinis 1999;77 Suppl 1:72-79. 5. Turecek PL, Varadi K, Gritch H, Schwarz HP. FEIBA: Mode of action Haemophilia 2004;10: Suppl. 2:3-9

How Supplied

FEIBA is available in single-dose vials in the following nominal dosage strengths:

Nominal Strength	Color Code	Factor VIII Potency Range	Kit NDC	Sterile Water Volume
500 units	Blue	350-650 units per vial	64193-426-02	10 mL
1000 units	Green	700-1300 units per vial	64193-424-02	20 mL
2500 units	Purple	1750-3250 units per vial	64193-425-02	50 mL

The number of units of factor VIII inhibitor bypassing activity is stated on the label of each vial.

FEIBA is packaged with a suitable volume (10 mL, 20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT II Hi-Flow Needleless Transfer Device, and one Package Insert.

Storage and Handling

• Store at room temperature, not to exceed 25°C (77°F). • Store in the original package in order to protect from light. • Do not freeze.