Drug information of Anti-inhibitor coagulant complex

Provides activated blood coagulation factors II, VII, IX and X from pooled human plasma

Multiple interactions of the components in anti-inhibitor coagulant complex restore the impaired thrombin generation of hemophilia patients with inhibitors. In vitro, anti-inhibitor coagulant complex shortens the activated partial thromboplastin time of plasma containing factor VIII inhibitor.

Anti-inhibitor coagulant complex contains several clotting factors which act at various points in the caogulation cascade to promote thrombosis .

Onset of Action

Peak thrombin generation: Within 15 to 30 minutes

Duration of Action

8 to 12 hours (based on thrombin generation)

Half-Life Elimination

4 to 7 hours (based on thrombin generation)

-Hemorrhage in patients with hemophilia A and B with inhibitors

-Perioperative bleeding management in patients with hemophilia A and B with inhibitors

-Routine prophylaxis of bleeding events in patients with hemophilia A and B with inhibitors

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

-Treatment of bleeding occurrences resulting from deficiencies in coagulation factors VIII or IX

-DIC  (disseminated intravascular coagulation)

-Normal coagulation mechanisms present

-Known anaphylactic or severe hypersensitivity to anti-inhibitor coagulant complex or any component of the formulation, including factors of the kinin generating system;

-acute thrombosis or embolism (including myocardial infarction)

Headache

Lethargy

Nausea

Chest discomfort

Chills

Rash

Urticaria

Injection site pain

Fever

Flushing

Hypotension

Myocardial infarction

Tachycardia

Thromboembolic events

Hypersensitivity reactions

prothrombin complex concentrate, human

tranexamic acid injection

tranexamic acid oral

aminocaproic acid

aprotinin

coagulation factor viia

emicizumab

-Neonates (risk of thrombosis and/or hepatitis)

-Risk of transmissible infectious disease from human plasma (rare)

-Possibility of transient hypofibrinogenemia in children

-Small amounts of factor VIII in the formulation may cause an anamnestic response

-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

- Discontinue in case of severe hypersensitivity reactions

- Only use to control bleeding in patients with coagulation deficiencies

- Avoid or delay use in patients receiving treatment with antifibrolytic agents

-Caution in patients with hepatic impairment

- Administer to pregnant patients only if benefits outweigh risks

Limited outcome information is available from a pregnancy registry following use of anti-inhibitor coagulant complex (human) in pregnant women with acquired hemophilia A . Other products are preferred for the routine prophylaxis of bleeding events in pregnant patients with known hemophilia .However, the use of anti-inhibitor coagulant complex (human) may be considered in select patients with bleeding associated with postpartum acquired hemophilia A (a recombinant product may be preferred) .