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FEIBA

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Overview

What is FEIBA?

FEIBA (Anti-Inhibitor Coagulant Complex) is a freeze-dried sterile human plasma fraction with factor VIII inhibitor bypassing activity to be reconstituted for intravenous administration. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One unit of activity is defined as that amount of FEIBA that shortens the aPTT of high titer factor VIII inhibitor reference plasma to 50% of the blank value.

FEIBA contains mainly non-activated factors II, IX, and X and mainly activated factor VII. It contains approximately equal unitages of factor VIII inhibitor bypassing activity and prothrombin complex factors. In addition, the preparation contains 1-6 units of factor VIII coagulant antigen (FVIII C:Ag) per mL. The product contains traces of factors of the kinin generating system. It contains no heparin. Reconstituted FEIBA contains 4 mg of trisodium citrate and 8 mg of sodium chloride per mL.

FEIBA is manufactured from large pools of human plasma. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of FEIBA is collected at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) Mini-pools of the plasma are tested and found negative for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT).

To reduce the risk of viral transmission, the manufacturing process of FEIBA includes two dedicated and independent virus removal/inactivation steps namely 35 nm nanofiltration and a vapor heat treatment process. In addition, the DEAE-Sephadex adsorption contributes to the virus safety profile of FEIBA.

In vitro



What does FEIBA look like?



What are the available doses of FEIBA?

FEIBA is available as a lyophilized powder in single-use vials containing nominally 500, 1000, or 2500 units per vial. ()

What should I talk to my health care provider before I take FEIBA?

How should I use FEIBA?

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

For intravenous use after reconstitution only


What interacts with FEIBA?

Sorry No Records found


What are the warnings of FEIBA?

Sorry No Records found


What are the precautions of FEIBA?

Sorry No Records found


What are the side effects of FEIBA?

Sorry No records found


What should I look out for while using FEIBA?

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What might happen if I take too much FEIBA?

Sorry No Records found


How should I store and handle FEIBA?

Store APTIOM tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) How SuppliedFEIBA is available in single-dose vials in the following nominal dosage strengths:The number of units of factor VIII inhibitor bypassing activity is stated on the label of each vial.FEIBA is packaged with a suitable volume (10 mL, 20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT II Hi-Flow Needleless Transfer Device, and one Package Insert.Storage and HandlingHow SuppliedFEIBA is available in single-dose vials in the following nominal dosage strengths:The number of units of factor VIII inhibitor bypassing activity is stated on the label of each vial.FEIBA is packaged with a suitable volume (10 mL, 20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT II Hi-Flow Needleless Transfer Device, and one Package Insert.Storage and HandlingHow SuppliedFEIBA is available in single-dose vials in the following nominal dosage strengths:The number of units of factor VIII inhibitor bypassing activity is stated on the label of each vial.FEIBA is packaged with a suitable volume (10 mL, 20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT II Hi-Flow Needleless Transfer Device, and one Package Insert.Storage and HandlingHow SuppliedFEIBA is available in single-dose vials in the following nominal dosage strengths:The number of units of factor VIII inhibitor bypassing activity is stated on the label of each vial.FEIBA is packaged with a suitable volume (10 mL, 20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT II Hi-Flow Needleless Transfer Device, and one Package Insert.Storage and HandlingHow SuppliedFEIBA is available in single-dose vials in the following nominal dosage strengths:The number of units of factor VIII inhibitor bypassing activity is stated on the label of each vial.FEIBA is packaged with a suitable volume (10 mL, 20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT II Hi-Flow Needleless Transfer Device, and one Package Insert.Storage and Handling


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
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Lidocaine 2.5% and prilocaine 2.5% cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.

Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition

Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see ).

Should lidocaine 2.5% and prilocaine 2.5% cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors [see ].

Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment with FEIBA should be weighed against the potential risk of these thromboembolic events.

Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue the infusion and initiate appropriate diagnostic and therapeutic measures.

The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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