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Detailed Important Risk Information Full Prescribing Information U.S. Patient Site

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.

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These are examples of what ADYNOVATE prophylaxis could look like.

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

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.

70% .

of patients reduced
their dosing (69 out of 98)3

In a clinical study patients 12 years and older were able to reduce the frequency of prophylaxis dosing from their pre-study prophylaxis dosing regimen by 30% or more, which is approximately 1 fewer infusion per week.3

ADYNOVATE prophylaxis indicated dose1

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

Adjust the dose and dosing intervals 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 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		 MinorEarly hemarthrosis, mild muscle bleeding,
or mild oral bleeding episode		 ModerateMuscle bleeding, moderate bleeding into
the oral cavity, definite hermathroses, and
known trauma		 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		 MinorIncluding tooth extraction 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.

Seven available dosage strengths1

With 7 available dosage strengths, treatment with ADYNOVATE can be personalized to meet each individual patient's needs.1

ADYNOVATE is a lyophilized powder in single-dose vials. The actual factor VIII potency is labeled on each ADYNOVATE vial to ease the identification of doses. This may be more or less than the nominal vial potency/content.1

Two ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] single-use vials: 2mL and 5mL labeled with the IU/NDC code.

§ADYNOVATE in a BAXJECT III® system is packaged with 2 mL and 5 mL of Sterile Water for Injection (sWFI), one Terumo Microbore Infusion set (2 mL only), one full Prescribing Information insert, and one patient insert.
IU per vial/NDC code.

BAXJECT III® reconstitution

Easy one-step activation for reconstituting with ADYNOVATE

Watch the How-To Video
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