Antihemophilic factor pegylated

ADYNOVATE ® is indicated in adult and pediatric patients 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. Limitations of Use ADYNOVATE is not indicated for the treatment of von Willebrand disease. ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: On-demand treatment and control of bleeding episodes.

ADYNOVATE, a PEGylated form of recombinant antihemophilic factor (ADVATE),, temporarily replaces the missing coagulation factor VIII needed for effective hemostasis in congenital hemophilia A patients. ADYNOVATE exhibits an extended terminal half-life through pegylation of the parent molecule, ADVATE, which reduces binding to the physiological factor VIII clearance receptor (LRP1).

For intravenous use after reconstitution only. One unit per kilogram body weight will raise the factor VIII level by 2% international units per deciliter (IU per dL). Each vial of ADYNOVATE is labeled with the actual amount of recombinant factor VIII present in IU. On-demand treatment and control of bleeding episodes and perioperative management: Estimated Increment of factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] × 2 (IU/dL per IU/kg). Dose (IU) = Body Weight (kg) × Desired factor VIII Rise (IU/dL or % of Normal) × 0.5 (IU/kg per IU/dL). Routine prophylaxis: Administer 40-50 IU/kg body weight twice weekly in adults and adolescents (12 years and older). Administer 55 IU/kg twice weekly in children (<12 years) with a maximum of 70 IU/kg. Adjust the dose and dosing intervals based on the patient's clinical response.

ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE ® ), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80). Do not use in patients who have had prior anaphylactic reaction to ADYNOVATE, the parent molecule (ADVATE ® ), mouse or hamster protein, or excipients of ADYNOVATE.

Hypersensitivity reactions, including anaphylaxis, have been reported. Should symptoms occur, discontinue treatment with ADYNOVATE and administer appropriate treatment. Development of factor VIII neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration.

The most common adverse reactions reported in ≥1% of patients were cough, headache, diarrhea, vomiting, rash, nausea, urticaria, and dizziness.

Store ADYNOVATE in powder form at 2°C to 8°C (36°F 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. If stored at room temperature, write the date on the carton when ADYNOVATE is removed from refrigeration. After storage at room temperature, do not return the product to the refrigerator. Store ADYNOVATE in the original box and protect from extreme exposure to light.