Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of Feiba® injection in geriatric patients.
Breastfeeding
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.
Drug Interactions
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
- Fitusiran
- 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
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
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
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.
DRG-20074430
