Feiba-VH (Intravenous)

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

Anti-inhibitor coagulant complex contains substances known as coagulation factors (for example, non-activated Factors II, IX, and X, and activated Factor VII) that are normally made in the body. These substances help stop bleeding from injuries in patients with hemophilia by assisting the blood to clot.

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

It is very important that your doctor monitors you closely while you are receiving this medicine to ensure 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 risk of blood clotting problems (for example, venous thrombosis, pulmonary embolism, myocardial infarction, and stroke). Notify your doctor immediately if you experience anxiety, chest pain or discomfort, confusion, cough, difficulty speaking, dizziness or lightheadedness, double vision, fainting, fast heartbeat, inability to move your arms, legs, or facial muscles, headache, nausea, pain or discomfort in your 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. Inform your doctor or nurse right away if you or your child develop a rash, itchy skin, difficulty swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling of your face, hands, tongue, or throat, or chest pain after receiving the medicine.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (for example, Creutzfeldt-Jakob disease) to people who have received them, although the risk is low. Both human donors and donated blood are tested for viruses to minimize the transmission risk. Discuss any concerns about this risk with your doctor.

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

In deciding to use a medicine, you and your doctor need to consider the risks against the benefits. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies to determine how Feiba® injection affects babies. Its safety and effectiveness have not been established.

Geriatric

There have not been appropriate studies to determine how Feiba® injection affects older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together despite possible interactions. If you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The following interactions have been selected based on their potential significance and may not include all possibilities.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

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

• Bleeding problems caused by deficiencies in coagulation factor VIII or IX or
• Blood clotting issues (e.g., 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 have an increased risk for both bleeding and blood clotting problems.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if you experience any of these side effects:

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 swallowing
• Dizziness
• Fast heartbeat
• Fever
• Hives or welts
• Hoarseness
• Irritation
• Itching
• Joint pain, stiffness, or swelling
• Nausea
• Pain at 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, consult 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.

In the U.S.

• Autoplex T
• Feiba NF
• Feiba-VH

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

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