Anti-inhibitor coagulant complex
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: EMBOLIC and THROMBOTIC EVENTS Thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events. WARNING: EMBOLIC and THROMBOTIC EVENTS See full prescribing information for complete boxed warning. Thromboembolic events have been reported during postmarketing surveillance, particularly following the administration of high doses and/or in patients with thrombotic risk factors.
Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events ( 5.1 , 6.2 ).
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Prepare this dose
Your numbers for anti-inhibitor coagulant complex. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
Preparation and Reconstitution Use aseptic technique throughout the entire reconstitution process. If the patient uses more than one vial per injection, reconstitute each vial according to the following instructions. Allow the vials of FEIBA and Sterile Water for Injection (diluent) to reach room temperature, if refrigerated.
Remove the plastic caps from the concentrate and diluent vials. Wipe the stoppers of both vials with a sterile alcohol swab and allow them to dry prior to use. Open the package of BAXJECT II Hi-Flow device by peeling away the lid completely without touching the inside (Fig. A). Do not remove the device from the package.
Do not touch the clear spike. Place the diluent vial on a flat and solid surface. Turn the package over and insert the clear plastic spike through the diluent stopper by pressing straight down (Fig. B). Grip the BAXJECT II Hi-Flow device package at the edges and pull the package off the device (Fig. C). Do not remove the blue protective cap from the BAXJECT II Hi-Flow device.
Do not touch the purple spike. Turn the system over, so that the diluent vial is on top. Quickly insert the purple spike of the BAXJECT II Hi-Flow device fully into the FEIBA vial. The vacuum will draw the diluent into the FEIBA vial (Fig. D). The connection of the two vials should be done expeditiously to close the open fluid pathway created by the first insertion of the spike to the diluent vial.
Gently swirl (do not shake) the vial until FEIBA is completely dissolved. Make sure that FEIBA has been dissolved completely; otherwise, active material will not pass through the device filter. The reconstituted solution should be inspected visually for particulate matter before administration. The solution should be discarded if it is not clear or is discolored.
After reconstitution of FEIBA is complete, the injection or infusion should begin immediately and must be completed within three hours following reconstitution. Do not refrigerate after reconstitution. Discard unused portion. [See table below.] Figure A Figure B Figure C Figure D
Administration For intravenous injection or intravenous infusion after reconstitution only. Inspect the reconstituted FEIBA solution visually for particulate matter and discoloration prior to administration. The appearance of the solution should be colorless to slightly yellowish. Do not use if particulate matter or discoloration is observed.
Flush venous access lines with isotonic saline prior to and after infusion of FEIBA. Do not administer in the same tubing or container with other medicinal products. Use plastic Luer lock syringes because protein such as FEIBA tends to stick to the surface of all-glass syringes. Remove the blue protective cap from the BAXJECT II Hi-Flow device.
Tightly connect the syringe to the BAXJECT II Hi-Flow device (DO NOT DRAW AIR INTO THE SYRINGE) by turning the syringe in clockwise direction until stop position. Use of a Luer lock syringe is highly recommended to ensure a tight connection between the syringe and the BAXJECT II Hi-Flow device (Fig. E). Invert the system so that the dissolved FEIBA product is on top.
Draw the dissolved product carefully into the syringe by pulling the plunger back slowly to avoid foaming (Fig. F). Ensure that the tight connection between the BAXJECT II Hi-Flow device and the syringe is maintained. Disconnect the syringe. Attach a suitable needle and inject or infuse intravenously at a rate that does not exceed 10 units per kg of body weight per minute.
A syringe pump may be used to control the rate of administration. For a patient with a body weight of 75 kg, this corresponds to an infusion rate up to 15 mL per minute. Figure E Figure F Figure E Figure F
Drug interactions
Check anti-inhibitor coagulant complex against a medication listLabel text (3 paragraphs)
Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used. Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended. ( 7 )
7.1 Concomitant Medications Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with FEIBA. No adequate and well-controlled studies of the combined or sequential use of FEIBA and recombinant factor VIIa antifibrinolytics, or emicizumab have been conducted. Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.
Clinical experience from an emicizumab clinical trial suggests that a potential drug interaction may exist with emicizumab when FEIBA was used as part of a treatment regimen for breakthrough bleeding 6 [see Warnings and Precautions (5.1) ] .
Contraindications
Known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system. Disseminated intravascular coagulation (DIC). Acute thrombosis or embolism (including myocardial infarction). History of anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system. ( 4 ) Disseminated intravascular coagulation (DIC). ( 4 ) Acute thrombosis or embolism (including myocardial infarction). ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for anti-inhibitor coagulant complex. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data with FEIBA use in pregnant women to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with FEIBA. It is also not known whether FEIBA can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. In the U.S. general population, the estimated background risk for major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There is no information available on the effect of FEIBA on labor and delivery.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.