FEIBA
anti-inhibitor coagulant complex · KIT · Takeda Pharmaceuticals America, Inc.
FEIBA is a kit containing anti-inhibitor coagulant complex. Manufactured by Takeda Pharmaceuticals America, Inc..
Key Facts
- Brand Name
- FEIBA
- Generic Name
- anti-inhibitor coagulant complex
- NDC Code (Product)
64193-424- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- BLA101447
- Marketing Start
- 01/31/1986
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to factor VIII or factor IX. ( 1 )
Dosage & Administration
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. Table 1: Dosing Guidelines Dose (unit/kg) Frequency of Doses (hours) Duration of Therapy Control and Prevention of Bleeding Joint Hemorrhage 50 – 100 12 Until pain and acute disabilities are improved. Mucous Membrane Bleeding 50 – 100 6 At least 1 day or until bleeding is resolved. Soft Tissue Hemorrhage (e.g., retroperitoneal bleeding) 100 12 Until resolution of bleed. Other Severe Hemorrhage (e.g., CNS bleeds) 100 6 – 12 Until resolution of bleed. Perioperative Management Preoperative 50 – 100 One time dose Immediately prior to surgery. …
Contraindications
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). 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 )
Drug 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. 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) ] .
Adverse Reactions
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. ( 5.1 , 5.2 , 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safet…
Frequently Asked Questions
What is FEIBA used for?
FEIBA contains anti-inhibitor coagulant complex. It is a kit taken as directed. Consult your doctor for specific uses.
Is FEIBA a controlled substance?
FEIBA is not classified as a controlled substance by the DEA.
What is the generic name for FEIBA?
The generic name for FEIBA is anti-inhibitor coagulant complex. There are no other listed brand versions of anti-inhibitor coagulant complex.
What is the NDC code for FEIBA ?
The NDC (National Drug Code) for FEIBA is 64193-424, listed by Takeda Pharmaceuticals America, Inc..
Other FEIBA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)