Designed to extend FVIII circulation time

The extended terminal half-life of ADYNOVATE was 1.4X–1.5X longer than that of ADVATE in adolescents and adults 12 years and older (based on one-stage clotting and chromogenetic assay, respectively).⁴

Median FVIII Activity as Determined by One-Stage Clotting Assay⁴

Adapted from Konkle et al. 2015

Pharmacokinetic (PK) analysis

In the adolescent and adult (12 years and older) pivotal study, a PK comparison of ADYNOVATE vs ADVATE was conducted in 26 patients prior to initiation of prophylactic treatment with ADYNOVATE.⁴

PK analysis in children <12 years old

In the pediatric phase 3, prospective, uncontrolled, multicenter, open-label study, a PK comparison of ADYNOVATE vs ADVATE was conducted in 31 children less than 12 years old prior to initiation of prophylactic treatment with ADYNOVATE.⁵ This analysis demonstrated higher clearance, a shorter half-life, and lower incremental recovery of factor VIII compared to patients 12 years and older. Because clearance (based on per kg body weight) has been demonstrated to be higher in children (<12 years), dose adjustment or more frequent dosing based on per kg body weight may be needed in this population.¹

PEGylation Technology^† was deliberately chosen because^4,5

It allows for half-life extension while maintaining the integrity of the ADVATE protein³

It has a long history of use as an extension technology⁶

PEGylation is the covalent attachment of a polyethylene glycol polymer, called PEG, to a drug or protein.^1,6

^†Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions: Hypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
See Detailed Important Risk Information below.

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information

Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

On-demand treatment and control of bleeding episodes
Perioperative management
Routine prophylaxis to reduce the frequency of bleeding episodes

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).

WARNINGS & PRECAUTIONS

Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.

ADVERSE REACTIONS

The most common adverse reactions (≥1% of subjects) reported in the clinical studies were headache, diarrhea, rash, nausea, dizziness and urticaria.

Click here for ADYNOVATE Prescribing Information.
Click here for ADYNOVATE Prescribing Information en Español.

ADVATE [Antihemophilic Factor (Recombinant)] 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 here for ADVATE Prescribing Information.
Click here for ADVATE Prescribing Information en Español.

myPKFiT^® for ADYNOVATE 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 ADYNOVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 12 years of age and older and body weight of 29 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 hours (± 30 minutes) and at 48 hours (±2 hours) and/or 72 hours (±2 hours).
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 ADYNOVATE 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 ADYNOVATE Prescribing Information (PI).
myPKFiT should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADYNOVATE, as per the ADYNOVATE Prescribing Information (PI).
myPKFiT for ADYNOVATE is not indicated for the treatment of von Willebrand disease. MyPKFiT for ADYNOVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products.

myPKFiT for ADYNOVATE is Rx only. For safe and proper use of the myPKFiT software, please refer to the complete instructions for use in the User Manual.

ADYNOVATE: Striving to meet the treatment needs of hemophilia A patients

ADYNOVATE is a full-length recombinant FVIII protein with an extended terminal half-life.¹

Treatment that can be personalized to work with your patients' needs¹

Simple, twice-weekly dosing schedule given on the same 2 days every week.¹

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

How does ADYNOVATE work?

Designed to extend FVIII circulation time

Median FVIII Activity as Determined by One-Stage Clotting Assay⁴

Pharmacokinetic (PK) analysis

PK analysis in children <12 years old

PEGylation Technology^† was deliberately chosen because^4,5

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

ADYNOVATE: Striving to meet the treatment needs of hemophilia A patients

ADYNOVATE is a full-length recombinant FVIII protein with an extended terminal half-life.1

Treatment that can be personalized to work with your patients' needs1

Simple, twice-weekly dosing schedule given on the same 2 days every week.1

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

How does ADYNOVATE work?

Designed to extend FVIII circulation time

Median FVIII Activity as Determined by One-Stage Clotting Assay4

Pharmacokinetic (PK) analysis

PK analysis in children <12 years old

PEGylation Technology† was deliberately chosen because4,5

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Are you a U.S. healthcare professional?

ADYNOVATE is a full-length recombinant FVIII protein with an extended terminal half-life.¹

Treatment that can be personalized to work with your patients' needs¹

Simple, twice-weekly dosing schedule given on the same 2 days every week.¹

Median FVIII Activity as Determined by One-Stage Clotting Assay⁴

PEGylation Technology^† was deliberately chosen because^4,5

Are you a U.S. healthcare
professional?