Novoeight ®, Antihemophilic Factor (Recombinant)
Rx Only
BRIEF SUMMARY: Please consult package insert for full
prescribing information
INDICATIONS AND USAGE: Novoeight ®, Antihemophilic
Factor (Recombinant), is indicated for use in adults and children
with hemophilia A (congenital factor VIII deficiency or classic
hemophilia) for: Control and prevention of bleeding episodes;
Perioperative management; Routine prophylaxis to prevent or
reduce the frequency of bleeding episodes. Novoeight ® is not
indicated for the treatment of von Willebrand disease.
CONTRAINDICATIONS: Do not use in patients who have had
life-threatening hypersensitivity reactions, including anaphylaxis,
to Novoeight ® or its components (including traces of hamster
proteins).
after 15 exposure days that was not confirmed when checked after
20 exposure days. In vivo recovery was normal for this child and
no clinical adverse findings were observed. No patients developed
de novo anti-murine antibodies. Nineteen subjects were positive
for anti-Chinese hamster ovary (CHO) cell protein antibodies. Two
of these subjects changed from anti-CHO negative to anti-CHO
positive and 6 subjects changed from anti-CHO positive to
anti-CHO negative. The remaining 11 subjects were either positive
throughout the trials (n=6), negative at baseline and end-of trial
but with transient positive samples (n=2), or positive at baseline
and end-of trial but with negative samples in between (n=3). No
clinical adverse findings were observed in any of these subjects.
The detection of antibody formation is highly dependent on the
sensitivity and specificity of the assay. Additionally, the observed
incidence of antibody (including neutralizing antibody) positivity in
an assay may be influenced by several factors, including assay
methodology, sample handling, timing of sample collection,
concomitant medications, and underlying disease.
WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions:
Hypersensitivity reactions, including anaphylaxis, are possible
with Novoeight ®. Novoeight® contains trace amounts of hamster
proteins. Patients treated with this product may develop
hypersensitivity to these non-human mammalian proteins. Early
signs of hypersensitivity reactions that can progress to anaphylaxis
include angioedema, chest tightness, dyspnea, wheezing,
urticaria, and pruritus. Immediately discontinue administration
and initiate appropriate treatment if allergic- or anaphylactictype reactions occur. Neutralizing Antibodies: Formation of
neutralizing antibodies (inhibitors) to factor VIII can occur following
administration of Novoeight ®. Monitor all patients for the development
of inhibitors by appropriate clinical observation and laboratory
testing. If the expected plasma levels of factor VIII activity are not
attained, or if bleeding is not controlled with an appropriate dose,
perform testing for factor VIII inhibitors. Monitoring Laboratory
Tests: Monitor plasma factor VIII activity levels by the one-stage
clotting assay or the chromogenic substrate assay to con