ctivated prothrombin complex concentrates

U.S. BRAND NAMES — Feiba VH

PHARMACOLOGIC CATEGORY
Activated Prothrombin Complex Concentrate (aPCC)
Antihemophilic Agent
Blood Product Derivative

DOSING: ADULTS — Control of bleeding: I.V.:

General dosing guidelines: 50-100 units/kg (maximum 200 units/kg)
Joint hemorrhage: 50 units/kg every 12 hours; may increase to 100 units/kg; continue until signs of clinical improvement occur
Mucous membrane bleeding: 50 units/kg every 6 hours; may increase to 100 units/kg (maximum: 2 administrations/day or 200 units/kg/day)
Soft tissue hemorrhage: 100 units/kg every 12 hours (maximum: 200 units/kg/day)
Other severe hemorrhage: 100 units/kg every 12 hours; may be used every 6 hours if needed; continue until clinical improvement

DOSING: PEDIATRIC — Refer to adult dosing.

(For additional information see "Activated prothrombin complex concentrates (factor VIII inhibitor bypassing activity): Pediatric drug information")

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, powder for reconstitution:
Feiba VH: Each bottle is labeled with Immuno units of factor VIII [heparin free; contains sodium 8 mg/mL; packaging contains natural rubber latex]

DOSAGE FORMS: CONCISE
Injection, powder for reconstitution:
Feiba VH: Each bottle is labeled with Immuno units of factor VIII [heparin free; contains sodium 8 mg/mL]

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — Maximum infusion rate: 2 units/kg/minute. Following reconstitution, complete infusion within 3 hours.

USE — Hemophilia A & B patients with inhibitors who are to undergo surgery or those who are bleeding

USE - UNLABELED / INVESTIGATIONAL — Nonhemophiliac patients with acquired inhibitors with titers >5 Bethesda units (BU) to factors VIII, XI, and XII

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: Blood pressure changes, chest pain, MI, pulse rate changes, thromboembolism

Dermatologic: Rash, urticaria

Hematologic: DIC, fibrin decreased, fibrin split products increased, platelets decreased, PT increased, PTT increased

Respiratory: Cough, respiratory distress

Miscellaneous: Allergic reaction, anamnestic response

CONTRAINDICATIONS — Patients with normal coagulation mechanism

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Thrombotic events: Observe closely for signs and symptoms of intravascular coagulation or thrombosis. High doses have been associated with thrombotic complications, including MI and DIC; single doses should not exceed 100 units/kg and daily doses should not exceed 200 units/kg. Use with caution when administering to patients with liver disease, postoperatively, neonates, or patients at risk of thromboembolic phenomena, disseminated intravascular coagulation or patients with signs of fibrinolysis due to the potential risk of thromboembolic complications.

Disease-related concerns: Hepatic impairment: Use with extreme caution in patients with hepatic impairment.

Dosage form specific issues: Factor VIII: Product contains minute amounts of factor VIII which may cause an anamnestic response. Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer. Latex: Product packaging may contain natural rubber latex.

Other warnings/precautions: Appropriate use: Should only be used to control bleeding in patients with inhibitors resulting from coagulation factor deficiencies. Tests used to control improvement, such as aPTT, whole blood clotting time (WBCT), and thromboelastography (TEG), do not correlate with clinical efficacy. Dosing to normalize these values may result in DIC.

DRUG INTERACTIONS
Antifibrinolytic Agents: May enhance the thrombogenic effect of Anti-inhibitor Coagulant Complex. Risk X: Avoid combination

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Reproduction studies have not been conducted.

LACTATION — Excretion in breast milk unknown/use caution

DIETARY CONSIDERATIONS — Contains sodium 8 mg/mL

MONITORING PARAMETERS — Monitor for control of bleeding; signs and symptoms of DIC (blood pressure changes, pulse rate changes, chest pain/cough, fibrinogen decreased, platelet count decreased, fibrin-fibrinogen degradation products, significantly-prolonged thrombin time, PT, or partial thromboplastin time); hypotension; have epinephrine ready to treat hypersensitivity reactions. Note: Tests used to control efficacy such as aPTT, WBCT, and TEG do not correlate with clinical improvement. Dosing to normalize these values may result in DIC.

CANADIAN BRAND NAMES — Feiba VH Immuno