de for dosing withESPEROCT during surgery (perioperative management) is provided in Table 2 below.
T
able 2:Dosing for Perioperative Management with ESPEROCT
Type of surgery
Adolescents/Adults
≥12 years
Pre-operative Dose
(IU/kg)
Children
<12 years
Pre-operative Dose
(IU/kg)
Additional Doses
Minor
Including tooth extraction 50 65
Additional dose(s) can be
administered after 24 hours if
necessary
Major
Intracranial,
intra-abdominal,
intrathoracic, or joint
replacement surgery
50 65
Additional doses can be
administered approximately every
24 hours for the first week and
then approximately every 48 hours
until wound healing has occurred
Routine Prophylaxis
Adults and adolescents (≥ 12 years): The recommended starting dose is 50 IU of ESPEROCT per kg body weight every 4days. This regimen may be individually adjusted to less or more frequent dosing based on bleeding episodes.
Children (< 12 years): A dose of 65 IU of ESPEROCT per kg body weight twice weekly. This regimen may be individuallyadjusted to less or more frequent dosing based on bleeding episodes.
• ESPEROCT also may be dosed to achieve a specific target Factor VIII activity level, depending on the severity ofhemophilia, for on-demand treatment/control of bleeding episodes or perioperative management. To achieve a specifictarget Factor VIII activity level, use the following formula:
Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % normal) × 0.5
• Base the dose and frequency of ESPEROCT on the individual clinical response. Patients may vary in theirpharmacokinetic and clinical responses.
• If monitoring of Factor VIII activity is performed, use a chromogenic or one-stage clotting assay appropriate for use withESPEROCT [see Warnings and Precautions (5.3)].
2.2 Preparation and Reconstitution
• Always wash hands and ensure that the area is clean before performing the reconstitution procedures.
• Use aseptic technique during the reconstitution procedures.
• If the dose requires more than one vial of ESPEROCT per infusion, reconstitute each vial according to the following
instructions.
Overview of ESPEROCT Package
Reconstitution
1. Bring the ESPEROCT vial and the pre-filled diluent syringe to room temperature.
A
2. Remove the plastic cap from the ESPEROCT vial.
B
3. Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to dry prior to use.
4. Remove the protective paper from the vial adapter. Do not remove the vial adapter from the protective cap.
C
5. Place the ESPEROCT vial on a flat and solid surface. While holding the protective cap, place the vial adapter over the
ESPEROCT vial and press down firmly on the protective cap until the vial adapter spike penetrates the rubber stopper.
D
6. Carefully remove the protective cap from the vial adapter.
7. Grasp the plunger rod as shown in the diagram. Attach the plunger rod to the syringe by holding the plunger rod by the
wide top end. Turn the plunger rod clockwise into the rubber plunger inside the pre-filled diluent syringe until resistance
is felt.
F
8. Break off the syringe cap from the pre-filled diluent syringe by snapping the perforation of the cap.
G
9. Connect the pre-filled diluent syringe to the vial adapter by turning it clockwise until it is secured.
H
10. Push the plunger rod to slowly inject all the diluent into the vial.
I
11. Without |
