Feiba NF (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 called coagulation factors (for example, non-activated Factors II, IX, and X, and activated Factor VII) that are normally produced in the body. These substances help stop bleeding from injuries for patients with hemophilia by aiding the blood to clot.

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

It is very important that your doctor checks 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 chance of having blood clotting problems (for example, venous thrombosis, pulmonary embolism, myocardial infarction, and stroke). Tell your doctor right away 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. Tell your doctor or nurse right away if you or your child have a rash, itchy skin, difficulty swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in 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. 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.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a decision you will make with your doctor. For this medicine, consider the following:

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 if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies on how Feiba® injection affects babies. Safety and effectiveness have not been established.

Geriatric

There have not been enough studies on 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 taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following medicines is usually not recommended, but it may be necessary 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtimes or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell 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 history of or
• Heart attack, history of or
• Serious injury 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 (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, this medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require medical attention.

Check with your doctor or nurse right away 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 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.

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.