Intended Use: myPKFiT is not indicated for the treatment of von Willebrand disease and should not be used for patients who have developed neutralizing antibody to FVIII products. myPKFiT is Rx only. For safe and proper use of the myPKFiT software, please refer to the complete instructions for use in the User Manual.

Please see the full intended use statement for myPKFiT below.

See data directly from your patients

The myPKFiT healthcare professional software connects with the patient app for real-time review of treatment data. View your patient's infusion schedule, breakthrough bleeds, and general treatment adherence.¹

Estimate PK curves to personalize dosing and infusion schedules

See patient data in real-time using myPKFiT® for ADVATE® [Antihemophilic Factor (Recombinant)] software.

Target trough level

Customize the factor VIII target trough level (1-3% above baseline) and myPKFiT adjusts the dose calculation accordingly.¹

PK-guided dosing

Customize dosing intervals and myPKFiT generates a chart showing the dosing regimen required to maintain target trough.¹

Factor awareness

Hover over the graph to see the estimated factor VIII level at any point along the curve.¹

Patient dosing resource

Print a PDF to share with your patient and export information into the myPKFiT app.

Help keep your patients engaged with their treatment plan

Encourage your patients to use the mobile app to track estimated factor levels, manage infusion schedules, and stay connected to you along the way.²

The myPKFiT® for ADVATE® [Antihemophilic Factor (Recombinant)] mobile app can help your patients stay engaged with their treatment plan.

Factor meter

Give patients access to current and future factor VIII level estimates so they can adapt their activities accordingly.²

Infusion tracker

Patients can log details such as date and time of their infusions and share that information with you.²

Infusion alerts

Patients receive a notification when it's time to infuse based on their personalized treatment schedule.²

Red zone alert

Patients receive alerts when their estimated factor VIII levels are low and they are at the highest risk for a bleed.²

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.