Dosing & Uses
Dosage Forms & Strengths
lyophilized powder for reconstitution
- 500 units/vial
- 1000 units/vial
- 2500 units/vial
Hemophilia A & B
Prevention and control of spontaneous hemorrhage or bleeding during surgical interventions in hemophilia patients who have autoantibodies or alloantibodies to coagulation factors; also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors
Prevention and control of bleeding
- Joint hemorrhage: 50 units/kg IV q12hr; may increase to 100 units/kg q12hr; continue until signs of clinical improvement occur; not to exceed 200 mg/kg/day
- Mucous membrane bleed: 50 units/kg IV q6hr, may increase to 100 units/kg q6hr for 2 doses maximum; not to exceed 200 units/kg/day
- Soft tissue hemorrhage: 100 units/kg IV q12hr; not to exceed 200 units/kg/day
- Severe hemorrhage (eg, CNS bleed): 100 units/kg IV q6-12hr; not to exceed 200 units/kg/day unless severity of hemorrhage justifies higher doses
Perioperative management
- Preoperative: 50-100 units/kg IV once immediately prior to surgery
- Postoperative: 50-100 units/kg IV q6-12hr until resolution of bleeding and healing is achieved
Routine prophylaxis
- 85 units/kg IV every other day
Dosage Forms & Strengths
lyophilized powder for reconstitution
- 500 units/vial
- 1000 units/vial
- 2500 units/vial
Hemophilia A & B
Prevention and control of spontaneous hemorrhage or bleeding during surgical interventions in hemophilia patients who have autoantibodies or alloantibodies to coagulation factors; also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors
Prevention and control of bleeding
- Joint hemorrhage: 50 units/kg IV q12hr; may increase to 100 units/kg q12hr; continue until signs of clinical improvement occur; not to exceed 200 mg/kg/day
- Mucous membrane bleed: 50 units/kg IV q6hr, may increase to 100 units/kg q6hr for 2 doses maximum; not to exceed 200 units/kg/day
- Soft tissue hemorrhage: 100 units/kg IV q12hr; not to exceed 200 units/kg/day
- Severe hemorrhage (eg, CNS bleed): 100 units/kg IV q6-12hr; not to exceed 200 units/kg/day unless severity of hemorrhage justifies higher doses
Perioperative management
- Preoperative: 50-100 units/kg IV once immediately prior to surgery
- Postoperative: 50-100 units/kg IV q6-12hr until resolution of bleeding and healing is achieved
Routine prophylaxis
- 85 units/kg IV every other day
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- prothrombin complex concentrate, human
anti-inhibitor coagulant complex increases effects of prothrombin complex concentrate, human by pharmacodynamic synergism. Contraindicated. Coadministration increases risk of thrombosis.
Serious - Use Alternative (2)
- tranexamic acid injection
anti-inhibitor coagulant complex, tranexamic acid injection. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration ma.
tranexamic acid injection, anti-inhibitor coagulant complex. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration ma. - tranexamic acid oral
tranexamic acid oral, anti-inhibitor coagulant complex. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may increase risk for thrombosis.
anti-inhibitor coagulant complex, tranexamic acid oral. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration ma.
Monitor Closely (0)
Minor (0)
Adverse Effects
Frequency Not Defined
Headache
Lethargy
Nausea
Chest discomfort
Chills
Rash
Urticaria
Injection site pain
Fever
Flushing
Hypotension
Myocardial infarction
Tachycardia
Thromboembolic events
Hypersensitivity reactions
Warnings
Black Box Warnings
Thrombotic and thromboembolic events have been reported during post-marketing surveillance following infusion, particularly following the administration of high doses and/or in patients with thrombotic risk factors
Contraindications
Treatment of bleeding occurrences resulting from deficiencies in coagulation factors VIII or IX
DIC
Normal coagulation mechanisms present
Cautions
Neonates (risk of thrombosis and/or hepatitis)
Risk of transmissible infectious disease from human plasma (rare)
Possibility of transient hypofibrinogenemia in children
Administer to pregnant patients only if benefits outweigh risks
Caution in patients with hepatic impairment
Small amounts of factor VIII in the formulation may cause an anamnestic response
Avoid or delay use in patients receiving treatment with antifibrolytic agents
Only use to control bleeding in patients with coagulation deficiencies
Discontinue in case of severe hypersensitivity reactions
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not studied
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Provides activated blood coagulation factors II, VII, IX and X from pooled human plasma
May shorten the activated partial thromboplastin time of plasma containing factor VIII inhibitors
Administration
IV Preparation
Allow vials of drug and diluent to reach room temperature, if refrigerated
Reconstitute with sterile water for injection according to manufacturers directions
After reconstitution, begin injection or infusion immediately; must be completed within 3 hr following reconstitution
Do not refrigerate after reconstitution
Discard unused portion
IV Administration
Slow IV injection or IV infusion; not to exceed 10 U/kg/min
Storage
Store at 36-77ºF (2-25ºC) in original package in order to protect from light
Do not freeze
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Feiba NF intravenous - | 1,750-3,250 unit vial |  | |
| Feiba NF intravenous - | 700-1,300 unit vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
anti-inhibitor coagulant complex intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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