Simple dosing schedule on the same 2 days every week

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

ADYNOVATE has a twice-weekly prophylactic dosing schedule given on the same 2 days every week.¹ Work with your patients to find a schedule that's right for them.

These are examples of what ADYNOVATE prophylaxis could look like.

In clinical studies, the majority of patients experienced the right dose from the start^1,2

ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] twice weekly calendar.

98% of adults and adolescents (12 years and older) did not have a dose adjustment (118 of 120)^†1
91% of children (less than 12 years) did not have a dose adjustment (60 of 66)^‡2

^†Two patients increased their dose to 60 IU/kg due to bleeding in target joints

^‡Reported reasons for dose adjustment included FVIII trough levels <1%, increased risk of bleeding, and bleeding episodes

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported with ADYNOVATE. Hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, pruritus, and nausea and vomiting. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
See Detailed Important Risk Information below.

Dosing for on-demand treatment and control of bleeding episodes

This information is provided as a guide for dosing ADYNOVATE for the on-demand treatment and control of bleeding episodes. Maintain plasma factor VIII activity level at or above the described plasma levels (in IU per dL or % of normal) outlined in the table below.¹

Type of bleeding	Minor MinorEarly hemarthrosis, mild muscle bleeding, or mild oral bleeding episode	Moderate ModerateMuscle bleeding, moderate bleeding into the oral cavity, definite hermathroses, and known trauma	Major MajorSignificant gastrointestinal bleeding, intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding in the retropharyngeal or retrioperitoneal spaces or iliopsoas sheath, fractures, head trauma
Target Factor VIII level (IU/dL or % of normal)	20-40	30-60	60-100
Dose^§(IU/kg)	10-20	15-30	30-50
Frequency of dosing(hours)	12-24	12-24	8-24
Duration of therapy	Until the bleeding is resolved

Type of bleeding	Target Factor VIII level (IU/dL or % of normal)	Dose^§ (IU/kg)	Frequency of dosing (hours)	Duration of therapy
MinorEarly hemarthrosis, mild muscle bleeding, or mild oral bleeding episode	20-40	10-20	12-24	Until the bleeding is resolved
ModerateMuscle bleeding, moderate bleeding into the oral cavity, definite hemarthroses, and known trauma	30-60	15-30	12-24	Until the bleeding is resolved
Major Significant gastrointestinal bleeding, intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding in the retropharyngeal or retroperitoneal spaces or iliopsoas sheath, fractures, head trauma	60-100	30-50	8-24	Until the bleeding is resolved

Calculating the appropriate dose¹

^§Dose (IU/kg) = Desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL).

Please see full Prescribing Information for additional details on dosing.

Dosing for perioperative management

This information is provided as a guide for dosing ADYNOVATE during surgery. Consideration should be given to maintain a factor VIII activity at or above the target range outlined in the table below.¹

Type of surgery	Minor MinorIncluding tooth extraction	Major MajorIntracranial, intra-abdominal, or intrathoracic surgery, joint replacement surgery
Factor FVIII level required (IU/dL or % of normal)	20-40	60-100
Dose(IU/kg)	10-20	30-50
Frequency of dosing(hours)	Within one hour before surgery Repeat after 24 hours if necessary	Within one hour before the operation to achieve 100% activity. Repeat every 8 to 24 hours (6 to 24 hours for patients <12 years of age) to maintain FVIII activity within the target range
Duration of therapy	Single dose or repeat as needed until bleeding is resolved	Until adequate wound healing

Type of surgery	Factor VIII level required (IU/dL or % of normal)	Dose (IU/kg)	Frequency of dosing (hours)	Duration of therapy
MinorIncluding tooth extraction	60-100	30-50	Within one hour before surgery Repeat after 24 hours if necessary	Single dose or repeat as needed until bleeding is resolved
Major Intracranial, intra-abdominal, or intrathoracic surgery, joint replacement surgery	80-120(pre- & post- operative)	40-60	Within one hour before the operation to achieve 100% activity. Repeat every 8 to 24 hours (6 to 24 hours for patients <12 years of age) to maintain FVIII activity within the target range	Until adequate wound healing

Calculating the appropriate dose¹

Please see full Prescribing Information for additional details on dosing.

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.

	children and adults (≥12 years)	children and adults (<12 years)
DOSE	40-50 IU/KG	55 IU/KG with a maximum of 70 IU/kg
Frequency of doses	twice weekly	twice weekly

Simple dosing schedule on the same 2 days every week

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

In clinical studies, the majority of patients experienced the right dose from the start^1,2

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

ADYNOVATE prophylaxis indicated dose¹

Dosing for on-demand treatment and control of bleeding episodes

Calculating the appropriate dose¹

Dosing for perioperative management

Calculating the appropriate dose¹

Seven available dosage strengths¹

Simple dosing schedule on the same 2 days every week

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

In clinical studies, the majority of patients experienced the right dose from the start1,2

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

ADYNOVATE prophylaxis indicated dose1

Dosing for on-demand treatment and control of bleeding episodes

Calculating the appropriate dose1

Dosing for perioperative management

Calculating the appropriate dose1

Seven available dosage strengths1

Are you a U.S. healthcare professional?

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

In clinical studies, the majority of patients experienced the right dose from the start^1,2

ADYNOVATE prophylaxis indicated dose¹

Calculating the appropriate dose¹

Calculating the appropriate dose¹

Seven available dosage strengths¹

Are you a U.S. healthcare
professional?