Anti-Inhibitor Coagulant Complex

Pronunciation: koe-AG-yoo-lant
Class: Antihemophilic agent

Trade Names

Febia NF
- Injection, lyophilized powder for solution 500 units/vial
- Injection, lyophilized powder for solution 1,000 units/vial
- Injection, lyophilized powder for solution 2,500 units/vial

Pharmacology

Anti-inhibitor coagulant complex is a sterile human plasma fraction with factor VIII inhibitor bypassing activity. In vitro, it shortens the APTT of plasma containing factor VIII inhibitor.

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Pharmacokinetics

Special Populations

Renal Function Impairment

No data available.

Hepatic Function Impairment

No data available.

Indications and Usage

For the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and B patients with inhibitors.

Contraindications

Known normal coagulation mechanism; treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX; patients with significant signs of DIC.

Dosage and Administration

Adults and Children 31 days of age and older Hemorrhage

IV 50 to 100 units/kg at 12-h intervals (max, 100 units/kg per single dose or 200 units/kg per daily dose).

Joint hemorrhage

IV 50 units/kg at 12-h intervals initially; may increase to 100 units/kg at 12-h intervals. Continue until clear signs of clinical improvement appear, such as relief of pain, reduction of swelling, or mobilization of the joint (max, 100 units/kg per single dose or 200 units/kg per daily dose).

Mucous membrane bleeding

IV 50 units/kg initially at 6-h intervals under careful monitoring (visible bleeding site, repeated measurements of the patient's Hct). If hemorrhage does not stop, increase to 100 units/kg at 6-h intervals (max, 100 units/kg per single dose or 200 units/kg per daily dose).

Other severe hemorrhages

IV 100 units/kg at 12-h intervals. Sometimes, anti-inhibitor coagulant complex may be indicated at 6-h intervals until clear clinical improvement is achieved (max, 100 units/kg per single dose or 200 units/kg per daily dose).

Serious soft tissue hemorrhage

IV 100 units/kg at 12-h intervals (max, 100 units/kg per single dose or 200 units/kg per daily dose).

General Advice

• The solution must be given by IV injection or IV drip infusion; the maximum injection or infusion rate must not exceed 2 units/kg/min.
• Give high doses only as long as necessary to stop the bleeding.
• If clinical signs of intravascular coagulation occur (eg, changes in BP or pulse rate, respiratory distress, chest pain, cough), stop the infusion and initiate appropriate diagnostic and therapeutic measures.
• Response to treatment may differ from patient to patient, with no correlation to the patient's inhibitor titer. Response may also vary between different types of hemorrhage (eg, joint hemorrhage vs CNS hemorrhage).
• Certain components of the packaging material contain dry natural rubber latex.
• Do not use antifibrinolytics until 12 h after administration of anti-inhibitor coagulant complex.
• Allow the unopened vials of anti-inhibitor coagulant complex (concentrate) and sterile water for injection (diluent) to reach room temperature (not above 98°F).
• Refer to the manufacturer's prescribing information for preparing anti-inhibitor coagulant complex.
• Do not refrigerate after reconstitution.
• After complete reconstitution of anti-inhibitor coagulant complex, its injection or infusion should be commenced as promptly as practicable, but it must be completed within 3 h following reconstitution.
• Inspect for particulate matter and discoloration after reconstituting the concentrate. The appearance of the solution should be colorless to slightly yellowish and essentially free of visible particulates.
• Plastic luer lock syringes are recommended for use with this product because protein, such as anti-inhibitor coagulant complex, tends to stick to the surface of all-glass syringes.

Storage/Stability

Store at 36° to 46°F. Within the indicated shelf life, the product may be stored at room temperature (not exceeding 77°F) for up to 6 mo. After storage at room temperature, the product must not be returned to the refrigerator. If the product is transferred from the refrigerator to room temperature, it expires at the end of the 6-mo period or at the end of shelf life, whichever comes earliest. Record the date on the package prior to shifting the product to room temperature. Avoid freezing, which may damage the diluent vial.

Drug Interactions

None well documented.

Adverse Reactions

Cardiovascular

Thrombotic and thromboembolic events (eg, DIC, MI, pulmonary embolism [PE], stroke, venous thrombosis); embolism, hypotension (postmarketing).

CNS

Anamnestic responses (20%); hypoaesthesia, hypoaesthesia facial (postmarketing).

Hypersensitivity

Anaphylactic reaction, hypersensitivity (postmarketing).

Miscellaneous

Injection-site pain, urticaria (postmarketing).

Precautions

Warnings Thrombotic and thromboembolic events have been reported during postmarketing surveillance, particularly following the administration of high doses and/or in patients with thrombotic risk factors.

Monitor Monitor for the development of signs and symptoms of DIC, acute coronary ischemia, and other thrombotic and thromboembolic complications. Laboratory indications of DIC are decreased fibrinogen, decreased platelet count, or presence of fibrin-fibrinogen degradation products. Other indications of DIC include significantly prolonged thrombin time, PT, or PTT.

Pregnancy

Category C .

Lactation

Undetermined.

Children

No data are available regarding the use in newborns; use with caution.

Elderly

Use with caution.

Hypersensitivity

Allergic reactions, including severe anaphylactoid reactions, have been reported.

Hepatic Function

Use with caution.

Anamnestic responses

Anamnestic responses with rises in factor VIII inhibitor titer have been observed in 20% of the cases.

Disease transmission

This drug is made from human plasma and may contain infectious agents, such as viruses, that can cause disease (eg, non-A, non-B hepatitis; Creutzfeldt-Jacob disease).

Nonhemophilic patients

Nonhemophilic patients with acquired inhibitors against factors VIII, IX, or XII may have both a bleeding tendency and an increased risk of thrombosis.

Thrombotic events

Thrombotic and thromboembolic events (including DIC, MI, PE, stroke, and venous thrombosis) have been reported, particularly following high doses and/or in patients with thrombotic risk factors. Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of thrombotic events. Use caution when administering to patients with an increased risk of thromboembolic complications (eg, DIC, elderly patients, history of coronary heart disease, liver disease, neonates, postoperative immobilization).

Overdosage

Symptoms

DIC, MI, thromboembolism.

Patient Information

• Discuss the risks and benefits of using this product with patient.
• Encourage patient to consult their health care provider if any of the following occur: dark urine and/or yellowed complexion; drowsiness, chills, and runny nose followed about 2 wk later by a rash and joint pain; poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly.

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