Pronunciation:

AN-tee in-HIB-i-ter co-AG-yoo-lant kom-plex

Brand Names:

• Autoplex T
• Feiba NF
• Feiba-VH

Dosage Forms:

• Powder for Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antihemophilic Agent

Uses of This Medicine:

Anti-inhibitor coagulant complex injection is used to treat, control, prevent, and decrease bleeding episodes or frequency of bleeding during surgery in patients with hemophilia A and hemophilia B.

Anti-inhibitor coagulant complex contains substances called coagulation factors (eg, 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.

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Feiba® injection in babies. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of Feiba® injection in geriatric patients.

Breast-feeding—

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.

Other medicines—

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

Other interactions—

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.

Other medical problems—

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 (eg, 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
• Blood clotting problems (eg, acute thrombosis or embolism) or
• Disseminated intravascular coagulation or DIC (blood clotting problem) or
• Heart attack—Should not be used in patients with these conditions.

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

Proper Use of This Medicine:

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

Precautions While Using This Medicine:

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.

Do not use aminocaproic acid (Amicar®) or tranexamic acid (Cyklokapron®) within 6 to 12 hours after receiving this medicine.

This medicine may increase your chance of having blood clotting problems (eg, venous thrombosis, pulmonary embolism, myocardial infarction, and stroke). Tell your doctor right away if you have anxiety, chest pain or discomfort, confusion, cough, difficulty speaking, dizziness or lightheadedness, double vision, fainting, fast heartbeat, inability to move the arms, legs, or facial muscles, headache, nausea, pain or discomfort in the arms, jaw, back ,or neck, slow speech, sudden trouble breathing, sweating, or vomiting while you are receiving this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you or your child have a rash, itching skin, difficulty with swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in your face, hands, tongue, or throat, or chest pain after you receive the medicine.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jakob disease) to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Pale skin

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain. discomfort, or tightness

cough

difficulty with swallowing

dizziness

fast heartbeat

fever

hives or welts

hoarseness

irritation

itching

joint pain, stiffness, or swelling

nausea

pain in the injection site

pain or discomfort in the arms, jaw, back, or neck

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

skin rash

sweating

swelling of the eyelids, face, lips, hands, or feet

trouble swallowing

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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