Anti-inhibitor Coagulant Complex
Generic Name: anti-inhibitor coagulant complex
Brand Names:
Feiba
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
1 INDICATIONS AND USAGE FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. 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. FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes. Perioperative management. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Dosage
2 DOSAGE AND ADMINISTRATION For intravenous use after reconstitution only. For intravenous use after reconstitution only ( 2 ) Each vial of FEIBA contains the labeled amount of factor VIII inhibitor bypassing activity in units. ( 2.1 ) Type of Bleeding Dose (unit/kg) Frequency/Duration Control and Prevention of Bleeding 50 - 100 Determined by the type of bleeding episode Perioperative Management 50 - 100 Determined by the type of surgical intervention Routine Prophylaxis 85 Every other day Maximum injection or infusion rate must not exceed 10 units per kg of body weight per minute. ( 2.3 ) 2.1 Dose A guide for dosing FEIBA is provided in Table 1.
Side Effects
6 ADVERSE REACTIONS 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. The most common adverse reactions observed in >5% of subjects were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting. ( 6.1 ) The serious adverse drug reactions are hypersensitivity and thromboembolic events, including stroke, pulmonary embolism, and deep vein thrombosis.
Interactions
7 DRUG INTERACTIONS 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.
Warnings
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. 5 WARNINGS AND PRECAUTIONS FEIBA can cause thromboembolic events following doses above 200 units per kg per day and in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events. ( 5.1 ) Anaphylaxis and severe hypersensitivity reactions may occur. Should symptoms occur, discontinue treatment with FEIBA and administer appropriate treatment. ( 5.2 ) FEIBA is made from human plasma and may contain infectious agents, e.g., viruses, the variant Creutzfeldt-Jacob disease (vCJD) and theoretically, Creutzfeldt-Jacob disease (CJD) agent. 4 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).
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.
Storage
Storage and Handling Store at 36°F to 77°F (2°C to 25°C) Store in the original package in order to protect from light. Do not freeze. Prior to preparation and reconstitution, allow the vials of FEIBA and Sterile Water for Injection (diluent) to reach room temperature, if refrigerated.
Frequently Asked Questions
What is Anti-inhibitor Coagulant Complex used for?▼
1 INDICATIONS AND USAGE FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. 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. FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes. Perioperative management. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
What are the side effects of Anti-inhibitor Coagulant Complex?▼
6 ADVERSE REACTIONS 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. The most common adverse reactions observed in >5% of subjects were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting. ( 6.1 ) The serious adverse drug reactions are hypersensitivity and thromboembolic events, including stroke, pulmonary embolism, and deep vein thrombosis.
Can I take Anti-inhibitor Coagulant Complex during 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.
What are the important warnings for Anti-inhibitor Coagulant Complex?▼
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. 5 WARNINGS AND PRECAUTIONS FEIBA can cause thromboembolic events following doses above 200 units per kg per day and in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events. ( 5.1 ) Anaphylaxis and severe hypersensitivity reactions may occur. Should symptoms occur, discontinue treatment with FEIBA and administer appropriate treatment. ( 5.2 ) FEIBA is made from human plasma and may contain infectious agents, e.g., viruses, the variant Creutzfeldt-Jacob disease (vCJD) and theoretically, Creutzfeldt-Jacob disease (CJD) agent. 4 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).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.