No

Antihemophilic Agent

Treatment of congenital hemophiliacs with antibodies to human factor VIII:C and also for previously nonhemophiliac patients with spontaneously acquired inhibitors to human factor VIII:C; patients with inhibitors who are bleeding or who are to undergo surgery

C

Should not be used to treat patients who have previously suffered acute allergic reaction to antihemophilic factor (porcine)

Rarely administration has been associated with anaphylaxis; adrenaline, hydrocortisone, and facilities for cardiopulmonary resuscitation should be available in case such a reaction occurs; infusion may be followed by a rise in plasma levels of antibody to both human and porcine factor VIII:C; inhibitor levels should be monitored both during and after treatment

Reactions tend to lessen in frequency and severity as further infusions are given; hydrocortisone and/or antihistamines may help to prevent or alleviate side effects and may be prescribed as precautionary measures

Central nervous system: Fever, headache, chills

Dermatologic: Rashes

Gastrointestinal: Nausea, vomiting

Store at temperature of -15°C to <20°C; use before expiration date; reconstituted Hyate:C® must not be stored, stable for 24 hours at room temperature

Factor VIII:C is the coagulation portion of the factor VIII complex in plasma. Factor VIII:C acts as a cofactor for factor IX to activate factor X in the intrinsic pathway of blood coagulation.

Clinical response should be used to assess efficacy rather than relying upon a particular laboratory value for recovery of factor VIII:C.

Antibody level to human factor VIII:C <50 Bethesda units/mL: 100-150 porcine units/kg (body weight) is recommended

Antibody level to human factor VIII:C >50 Bethesda units/mL: Activity of the antibody to porcine factor VIII:C should be determined; an antiporcine antibody level >20 Bethesda units/mL indicates that the patient is unlikely to benefit from treatment; for lower titers, a dose of 100-150 porcine units/kg is recommended

If a patient has previously been treated with Hyate:C®, this may provide a guide to his likely response and, therefore, assist in estimation of the preliminary dose

Subsequent doses: Following administration of the initial dose, if the recovery of factor VIII:C in the patient's plasma is not sufficient, a further higher dose should be administered; if recovery after the second dose is still insufficient, a third and higher dose may prove effective

Administer by I.V. route only; infusion rate should be <10 mL/minute

Treatment is not normally indicated in patients with an antibody titer <5 Bethesda units/mL (BU/mL) against human factor VIII:C and is likely to be ineffective in patients with an antibody titer >50 Bethesda units/mL against human factor VIII:C

An antibody titer <15-20 Bethesda units/mL against porcine factor VIII:C indicates suitability for treatment with antihemophilic factor (Porcine) Hyate:C®

Factor VIII levels: 50% to 150%, draw 6-8 hours after dose administration

No information available to require special precautions

No effects or complications reported

Sodium ion concentration is not more than 200 mmol/L; the assayed amount of activity is stated on the label, but may vary depending on the type of assay and hemophilic substrate plasma used

Powder for injection, lyophilized: 400-700 porcine units to be reconstituted with 20 mL sterile water