Simple, twice-weekly dosing schedule: same 2 days every week1
These are examples of what ADYNOVATE® prophylaxis could look like.
Work with your patients to find a schedule that’s right for them.
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
Adjust the dose based on the patient's clinical response.
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.1
Dosing for on-demand treatment and control of bleeding episodes1
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).
|Type of Bleeding||Target FVIII 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|
MajorSignificant 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® 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|
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|
MajorIntracranial, 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|