ELOCTATE Powder for solution, lyophilized Ref.[49696] Active ingredients: Coagulation factor VIII

4.1 Dosing Considerations

For intravenous use only after reconstitution

• Treatment with Eloctate (Antihemophilic Factor (Recombinant BDD), Fc Fusion Protein) should be initiated under the supervision of a healthcare professional experienced in the treatment of hemophilia A.
• Each vial of Eloctate has the FVIII potency in International Units (IU) stated on the label. The potency assignment of Eloctate is determined using a chromogenic substrate assay.
• Dose and duration of treatment depend on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the clinical condition of the patient. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.

4.2 Recommended Dose and Dosage Adjustment

Although dosing can be estimated by the guidelines below, it is recommended that standard routine laboratory tests such as factor VIII activity assays be performed (see WARNINGS AND PRECAUTIONS and Pharmacokinetics).

Method of Calculating Initial Estimated Dose

1 IU of Eloctate per kg body weight is expected to increase the circulating level of factor VIII by 2% (IU/dL).

Although patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to Eloctate, the expected in vivo peak increase in factor VIII level expressed as IU/dL (or % of normal) or the required dose can be estimated using the following formulas:

Dose (IU) = body weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)

OR

IU/dL (or % of normal) = [Total Dose (IU) / body weight (kg)] x 2 (IU/dL per IU/kg)

Dose adjustment may be necessary in pediatric patients <12 years of age (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics and CLINICAL PHARMACOLOGY, Pharmacokinetics, Pediatrics and Adolescents). For patients ≥12 years of age, dose adjustment is not usually required.

Dosing for Routine Prophylaxis

For individualized prophylaxis, the recommended regimen is 50 IU/kg every 3 to 5 days.

The dose may be adjusted based on patient response in the range of 25 to 65 IU/kg (see Pharmacokinetics). More frequent or higher doses up to 80 IU/kg may be required in pediatric patients <12 years of age.

For weekly prophylaxis, the recommended dose is 65 IU/kg.

Dosing for Control and Prevention of Bleeding Episodes

The following table can be used to guide dosing in bleeding episodes:

Table 1. Bleeding Episode Dosing Guide:

Adapted from: WFH 2012

Subsequent doses and duration of treatment depends on the individual clinical response, the severity of the factor VIII deficiency, and the location and extent of bleeding (see Pharmacokinetics).

Dosing for Perioperative Management (Surgical Prophylaxis)

Careful control and monitoring of dose and duration of treatment is especially important in cases of major surgery. Verify target activity has been achieved prior to surgery. The following table can be used to guide dosing for perioperative management.

Table 2. Perioperative Management Dosing Guide:

4.4 Administration

Eloctate is administered by intravenous (IV) injection after reconstitution with sterile Water for Injection.

Eloctate should be administered using the infusion set provided with the drug product, and the prefilled diluent syringe provided. In addition, the solution should be withdrawn from the vial using the vial adapter.

Detailed instructions for preparation and administration are included in PART III: PATIENT MEDICATION INFORMATION.

Reconstitute lyophilized Eloctate powder for injection with the supplied diluent (sterile Water for Injection) from the pre-filled syringe provided. Gently rotate the vial until all of the powder is dissolved.

After reconstitution, the solution is drawn back into the syringe. The solution should be clear to slightly opalescent and colourless.

Dispose of all unused solution, empty vials, and used needles and syringes in an appropriate container and dispose of according to local requirements.

No symptoms of overdose have been reported.

For management of a suspected drug overdose, contact your regional poison control centre.

Store unopened vials at 2°C to 8°C. The product may be stored at room temperature (15°C to 30°C) for a single 6-month period. The date that the product is removed from refrigeration should be noted on the carton. Do not use Eloctate (Antihemophilic Factor (Recombinant BDD), Fc Fusion Protein) after the expiry date printed on the label or 6 months after removing the carton from refrigeration, whichever is earlier.

Protect from light.

Do not freeze the pre-filled syringe.

Product after reconstitution: The reconstituted product can be stored at room temperature (15-30°C) for 6 hours. Protect from direct sunlight. After reconstitution, if the product is not used within 6 hours, it must be discarded.