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anti-inhibitor coagulant complex (Feiba NF, Feiba VH Immuno)

 

Classes: Hemostatics; Coagulation Factors

Dosing and uses of Anti-inhibitor coagulant complex (Feiba NF, Feiba VH Immuno)

 

Adult dosage forms and strengths

powder for reconstitution

  • 500 units
  • 1000 units
  • 2500 units

 

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

 

Pediatric dosage forms and strengths

powder for reconstitution

  • 500 units
  • 1000 units
  • 2500 units

 

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

 

Anti-inhibitor coagulant complex (Feiba NF, Feiba VH Immuno) adverse (side) 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 occurences 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 patiehts with hepatic Impairment

Small amounts of factor VIII in the formulationi 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 and 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 of Anti-inhibitor coagulant complex (Feiba NF, Feiba VH Immuno)

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

Warm drug and diluent to room temp

Reconstitute with SWI according to manufacturers directions

Do not refrigerate, use promptly

 

IV Administration

Slow IV injection or IV infusion

Feiba VH/Feiba NF

  • infusion rate not to exceed 2 U/kg/min
  • complete infusion within 3 hr of reconstitution