ADVATE has health-related quality-of-life results¹

ADVATE has shown clinically meaningful improvements in physical functioning, well-being, general health, and/or energy level, based on physical component score.^†1-3

Bodily pain

Reduced levels of pain and improvements in the limitations of work due to pain.^1,2

Role physical

Improvements in the ability to perform work or other daily activities.^1,2

Physical functioning

Changes not observed in limitations to a range of minor and major physical activities.^1,2

General health

Changes not observed in the views and expectations of overall health.^1,2

^†Clinically meaningful changes were not seen in the mental health-related component score and subcategories of Mental Health, Role Emotional, Social Functioning, and Vitality.

Prophylaxis with ADVATE improved physical health-related quality of life compared with on-demand treatment¹

After 12 months of prophylactic treatment, physical health-related quality of life improved in patients, mainly due to clinically meaningful improvements in^1-3:

Bodily pain

The amount of pain experienced by a patient and how much pain interferes with normal work.

Role physical

The impact physical health can have on performing work or other daily activities.

Clinically meaningful changes were not seen in¹:

Physical health

The physical health-related subcategories of General Health and Physical Functioning.

Mental Health

The mental health-related component score and subcategories of Mental Health, Role Emotional, Social Functioning, and Vitality.

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.

ADVATE has health-related quality-of-life results1

Bodily pain

Role physical

Physical functioning

General health

ADVATE has health-related quality-of-life results¹