What is Feiba?

Thromboembolic events have been reported during postmarketing surveillance following infusion of anti-inhibitor coagulant complex, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving anti-inhibitor coagulant complex for signs and symptoms of thromboembolic events .

Anti-inhibitor coagulant complex injection is used to control bleeding episodes or bleeding during surgery in patients with hemophilia A and hemophilia B.

Anti-inhibitor coagulant complex contains substances called coagulation factors (e.g., non-activated Factors II, IX, and X, and activated Factor VII) that are normally produced in the body. These substances are used to stop bleeding of injuries for patients with hemophilia by helping the blood to clot.

This medicine is to be administered only by or under the supervision of your doctor.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

No information is available on the relationship of age to the effects of anti-inhibitor coagulation complex injection in newborn babies. Safety and efficacy have not been established.

No information is available on the relationship of age to the effects of anti-inhibitor coagulation complex injection in geriatric patients. However, it should be used with caution in elderly patients.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aminocaproic Acid
• Coagulation Factor VIIa
• Emicizumab
• Tranexamic Acid

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Atherosclerosis (hardening of the arteries) or
• Blood clotting problems (e.g., venous thrombosis, pulmonary embolism) or history of or
• Heart attack, history of or
• Injury, serious or
• Septicemia (serious blood infection) or
• Stroke, history of—Use with caution. May increase the risk of a blood clot.

• Bleeding problems caused by coagulation factor VIII or coagulation factor IX deficiencies or
• Disseminated intravascular coagulation or DIC (blood clotting problem) or
• Fibrinolysis or
• If your blood clots normally—Should not be used in patients with these conditions.

• Coronary heart disease, history of or
• Liver disease (including hepatitis A) or
• Parvovirus B19 infection or
• Weak immune system—Use with caution. May make these conditions worse.

• Non-hemophilic patients (who have acquired inhibitors against Factors VIII, IX, or XII)—May increased risk for both bleeding and blood clotting problems.

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.