ADVATE® Factor VIII Dosing

11 ADVATE potencies allow for flexible dosing options^1,2

ADVATE has more single-dose infusion options than any other factor VIII product.^†1,2

2 mL and 5 mL vials and their associated dosing options.

^†As of January 2022.

ADVATE 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.¹

IU per vial/NDC code.

On-Demand

ADVATE dosing for
on-demand management¹

The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in the table below.

Type of bleeding episodes	Minor^‡	Moderate^§	Major^‖
FVIII level required (% of normal or IU/dL)	20-40	30-60	60-100
Dose (IU/kg)	10-20	15-30	30-50
Frequency of doses (hrs) for patients 6 and older	12-24	12-24	8-24
Frequency of doses (hrs) for patients under 6	8-24	8-24	6-12
Duration of therapy (days)	Until the bleeding is resolved (approximately 1 to 3 days)	Until the bleeding is resolved (approximately 3 days or more)	Until the bleeding is resolved

Type of bleeding episodes	FVIII level required (% of normal or IU/dL)	Dose (IU/kg)	Frequency of doses (hours) for patients 6 and older	Frequency of doses (hours) for patients under 6	Duration of therapy (days)
Minor^‡	20-40	10-20	12-24	8-24	Until the bleeding is resolved (approximately 1 to 3 days)
Moderate^§	30-60	15-30	12-24	8-24	Until the bleeding is resolved (approximately 3 days or more)
Major^‖	60-100	30-50	8-24	6-12	Until bleeding is resolved

How to calculate the dose

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.

^‡Minor bleeds include: Early hemarthrosis, mild muscle bleeding, or mild oral bleeding episode

^§Moderate bleeds include: Muscle bleeding, bleeding into the oral cavity, definite hemarthrosis, and known trauma

^‖Major bleeds include: Significant gastrointestinal bleeding, intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces or iliopsoas sheath, fractures, and head trauma

Surgical

ADVATE dosing for
perioperative management¹

The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma level (in % of normal or in IU/dL) outlined in the table below.

Type of surgery	Minor Including tooth extraction	Major Intracranial, intra-abdominal, or intrathoracic surgery, joint replacement
FVIII level required (% of normal or IU/dL)	60-100	80-120 (pre- and post-operative)
Dose (IU/kg)	30-50	40-60
Frequency of doses (hours)	Single dose within 1 hour of the operation 12-24 (as needed to control bleeding)	1 dose perioperative to achieve 100% activity Every 8-24 to keep FVIII activity in desired range. (Every 6-24 hours for patients under the age of 6)
Duration of therapy (days)	Single dose or repeat until bleeding is resolved For dental procedures, adjunctive therapy may be considered	Until healing is complete

Type of surgery	FVIII level required (% of normal or IU/dL)	Dose (IU/kg)	Frequency of doses (hours)	Duration of therapy (days)
Minor Including tooth extraction	60-100	30-50	Single dose within 1 hour of the operation 12-24 (as needed to control bleeding)	Single dose or repeat until bleeding is resolved For dental procedures, adjunctive therapy may be considered
Major Intracranial, intra-abdominal, or intrathoracic surgery, joint replacement	80-120 (pre- and post-operative)	40-60	1 dose perioperative to achieve 100% activity Every 8-24 to keep FVIII activity in desired range. (Every 6-24 hours for patients under the age of 6)	Until healing is complete

Type of surgery

FVIII level required
(% of normal or IU/dL)

Dose (IU/kg)

Frequency of doses (hours)

Duration of therapy (days)

Minor
Including tooth extraction

60-100

30-50

Single dose within 1 hour of the
operation

12-24 (as needed to control
bleeding)

Single dose or repeat until
bleeding is resolved

For dental procedures,
adjunctive therapy
may be considered

Major
Intracranial, intra-abdominal,
or intrathoracic surgery,
joint replacement

80-120
(pre- and post-operative)

40-60

1 dose perioperative to
achieve 100% activity

Every 8-24 to keep FVIII
activity in desired range.
(Every 6-24 hours for patients
under the age of 6)

Until healing is complete

How to calculate the dose

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.

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 to read Full Prescribing Information.

11 ADVATE potencies allow for flexible dosing options1,2

ADVATE dosing for routine prophylaxis1

ADVATE dosing for on-demand management1

ADVATE dosing for perioperative management1

11 ADVATE potencies allow for flexible dosing options^1,2

ADVATE dosing for routine prophylaxis¹

ADVATE dosing for
on-demand management¹

ADVATE dosing for
perioperative management¹