ADVATE Important Information
Indications
ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A
(congenital factor VIII deficiency) for:
Control and prevention of bleeding episodes.
Perioperative management.
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ADVATE is not indicated for the treatment of von Willebrand disease.
DETAILED IMPORTANT RISK INFORMATION
CONTRAINDICATIONS
Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster
protein or other constituents of the product.
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions
Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms
include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting.
Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Neutralizing Antibodies
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in
previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients
for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If
expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an
expected dose, perform an assay that measures factor VIII inhibitor concentration.
ADVERSE REACTIONS
Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions observed in clinical trials (>5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.
Click to read Full Prescribing Information .
MYPKFIT FOR ADVATE INTENDED USE
The myPKFiT software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. The myPKFiT software can be used to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16 years of age and older and body weight of 45 kg or greater, using that patient’s age and body weight information and local laboratory FVIII one-stage clotting activity measurements of sparse samples collected from that patient.
A minimum of two sparse sampling points are required at the recommended 3-4 hours (± 30 minutes) and at 24-32 hours (±1 hour) post-infusion.
HCPs will also be able to evaluate various prophylaxis dose regimens tailored to an individual patient's needs and treatment plan.
The software output may be used to guide decisions on appropriate ADVATE dose and infusion intervals to maintain FVIII activity levels at or above a user specified minimum FVIII activity level between 1% to 3% above natural baseline for an individual patient in accordance with the FDA-approved dosing recommendations provided in the ADVATE Prescribing Information (PI).
myPKFiT should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADVATE, as per the ADVATE Prescribing Information (PI).
myPKFiT for ADVATE is not indicated for the treatment of von Willebrand disease. MyPKFiT for ADVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products.
myPKFiT for ADVATE is Rx only. For safe and proper use of the myPKFiT software, please refer to the
complete instructions for use in the User Manual.
IMPORTANT RISK INFORMATION
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