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Dosing

Simple, twice-weekly dosing schedule: same 2 days every week1

These are examples of what ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] prophylaxis could look like.
Work with your patients to find a schedule that’s right for them.

Consistent dosing:
In the clinical trials, the majority of patients experienced the right dose, right from the start

*Two subjects increased their dose to 60 IU/kg due to bleeding in target joints.1

†Reported reasons for dose adjustment included FVIII trough levels <1%, increased risk of bleeding, and bleeding episodes.2

ADYNOVATE prophylaxis indicated dose1

Dose Frequency of Doses
Children and Adults(≥12 years) 40-50 IU/kg Twice-weekly
Children(<12 years) 55 IU/kg, with a maximum of 70 IU/kg Twice-weekly

Adjust the dose based on the patient's clinical response.

Dosing for on-demand treatment and control of bleeding episodes1

This information is provided as a guide for dosing ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] 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).

Type of Bleeding Target FVIII Level(IU/dL or % of normal) Dose*(IU/kg) Frequency of Dosing(hours) Duration of Therapy

Minor

Early hemarthrosis, mild muscle bleeding, or mild oral bleeding episode
20-40 10-20 12-24 Until the bleeding is resolved

Moderate

Muscle 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, bleeding in the retropharyngeal or retroperitoneal spaces or iliopsoas sheath, fractures, head trauma
60-100 30-50 8-24 Until the bleeding is resolved

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

Dosing for perioperative management1

This information is provided as a guide for dosing ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] during surgery. Consideration should be given to maintain a factor VIII activity at or above the target range.

Type of Surgery FVIII Level Required(% of normal or IU/dL) Dose(IU/kg) Frequency of Doses(hours) Duration of Treatment

Minor

Including 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- and 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
Detailed Important Risk Information
Prescribing Information (PI)
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, 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

Limitation of Use

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

DETAILED IMPORTANT RISK INFORMATION


Click here for ADYNOVATE full Prescribing Information.



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

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.

Click here for ADVATE full Prescribing Information.