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Pronunciation |
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(an
tee hee moe FIL ik FAK ter POR
seen) |
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U.S. Brand
Names |
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Hyate®:C |
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Generic
Available |
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No |
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Pharmacological Index |
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Antihemophilic Agent |
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Use |
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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 |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Should not be used to treat patients who have previously suffered acute
allergic reaction to antihemophilic factor (porcine) |
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Warnings/Precautions |
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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 |
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Adverse
Reactions |
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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 |
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Stability |
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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 |
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Mechanism of
Action |
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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. |
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Usual Dosage |
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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 |
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Administration |
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Administer by I.V. route only; infusion rate should be <10
mL/minute |
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Reference Range |
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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
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Nursing
Implications |
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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 |
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Dosage Forms |
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Powder for injection, lyophilized: 400-700 porcine units to be reconstituted
with 20 mL sterile water |
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