Having trouble with the
BAXJECT III Reconstitution system?

Learn how to recover ADYNOVATE if the initial reconstitution procedure fails in the video below.

BAXJECT III reconstitution troubleshooting video (length: 6:34)

How to store and handle ADYNOVATE¹

Store ADYNOVATE in powder form at 2° to 8°C (36° to 46°F)
Do not freeze
ADYNOVATE may be stored at room temperature not to exceed 30°C (86°F) for a period of up to 3 months not to exceed the expiration date
After storage at room temperature, do not return the product to the refrigerator
Do not use beyond expiration date printed on the carton or vial
Store vials in their original box and protect from extreme light exposure
After reconstitution, do not refrigerate the solution. Use the reconstituted solution immediately or within 3 hours after reconstitution. Discard any remaining solution

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

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.

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.

BAXJECT III offers one-step activation for reconstituting¹

Easy one-step activation for reconstituting with ADYNOVATE¹

Infusion information for ADYNOVATE

ADYNOVATE prophylaxis indicated dose¹

Having trouble with the
BAXJECT III Reconstitution system?

How to store and handle ADYNOVATE¹

BAXJECT III offers one-step activation for reconstituting1

Easy one-step activation for reconstituting with ADYNOVATE1

Infusion information for ADYNOVATE

ADYNOVATE prophylaxis indicated dose1

Having trouble with the BAXJECT III Reconstitution system?

How to store and handle ADYNOVATE1

Are you a U.S. healthcare professional?

BAXJECT III offers one-step activation for reconstituting¹

Easy one-step activation for reconstituting with ADYNOVATE¹

ADYNOVATE prophylaxis indicated dose¹

Having trouble with the
BAXJECT III Reconstitution system?

How to store and handle ADYNOVATE¹

Are you a U.S. healthcare
professional?