Jivi Dosage

Generic name: DAMOCTOCOG ALFA PEGOL 500[iU] in 2.5mL;
Dosage form: injection
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Jul 31, 2023.

For intravenous use after reconstitution only.

Dose

•: Each vial label of Jivi states the Factor VIII potency in international units (IU). One IU is defined by the current WHO (World Health Organization) international standard for Factor VIII concentrate.
•: Dosage and duration of treatment depend on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.
•: Potency assignment for Jivi is determined using a chromogenic substrate assay.
•: Monitor the Factor VIII activity of Jivi in plasma using either a validated chromogenic substrate assay or a validated one-stage clotting assay [see Warnings and Precautions (5.4)].
•: Calculation of the required dose of Factor VIII is based on the empirical finding that 1 IU of Factor VIII per kilogram body weight increases the plasma Factor VIII level by 2 IU/dL.
•: Estimate the required dose for on-demand treatment and control of bleeding and perioperative management using the following formula:

Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL)
x reciprocal of expected recovery (or observed recovery, if available) (e.g., 0.5 for a recovery of 2 IU/dL per IU/kg)

: Estimate the expected in vivo peak increase using the following formula:
: Estimated increment of Factor VIII (IU/dL or % of normal) = [Total dose (IU)/body weight (kg)]
x 2 (IU/dL per IU/kg)

1.: Adjust dose and frequency to the patient’s clinical response. Patients may vary in their pharmacokinetic [e.g., half-life, incremental recovery and AUC (area under the curve)] and clinical responses to Jivi.
2.: The total recommended maximum dose per infusion is approximately 6000 IU (rounded to vial size) [see Clinical Studies (14)].

On-demand Treatment and Control of Bleeding Episodes

A guide for dosing Jivi for the on-demand treatment and control of bleeding episodes is provided in Table 1. 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 Table 1.

Table 1: Dosing for Control of Bleeding Episodes
Degree of Bleeding Hemorrhage/Hemorrhagic Event	Factor VIII Level Required (IU/dL or % of normal)	Dose (IU/kg)	Frequency of Doses (hours)	Duration of Treatment
Minor (e.g., early hemarthrosis, minor muscle bleeding, oral bleeds)	20–40	10–20	Repeat every 24–48 hours	Until bleeding is resolved
Moderate (e.g., more extensive hemarthrosis, muscle bleeding, or hematoma)	30–60	15–30	Repeat every 24–48 hours	Until bleeding is resolved
Major (e.g., intracranial, intra-abdominal or intrathoracic hemorrhages, gastrointestinal bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath, life- or limb- threatening hemorrhage)	60–100	30–50	Repeat every 8–24 hours	Until bleeding is resolved

Perioperative Management of Bleeding

A guide for dosing Jivi during surgery (perioperative management) is provided in Table 2. 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 Table 2. During major surgery, monitoring with appropriate laboratory tests, including serial Factor VIII activity assays, is highly recommended [see Warnings and Precautions (5.4)].

Table 2: Dosing for Perioperative Management
Type of Surgery	Factor VIII Level Required (IU/dL or % of normal)	Dose (IU/kg)	Frequency of Doses (hours)	Duration of Treatment (days)
Minor (e.g., tooth extraction)	30–60 (pre- and post-operative)	15-30	Repeat every 24 hours	At least 1 day until healing is achieved
Major (e.g., intracranial, intra-abdominal, intrathoracic, or joint replacement surgery)	80–100 (pre- and post-operative)	40-50	Repeat every 12–24 hours	Until adequate wound healing is complete, then continue therapy for at least another 7 days to maintain Factor VIII activity of 30–60% (IU/dL)

Routine Prophylaxis

•

The recommended initial regimen is 30–40 IU/kg twice weekly.

•

Based on the bleeding episodes:

•: The regimen may be adjusted to 45–60 IU/kg every 5 days.
•: A regimen may be further individually adjusted to less or more frequent dosing.

Preparation and Reconstitution

Reconstitute and administer Jivi with the components provided with each package. If any component of the package is opened or damaged, do not use this component.

Reconstitution

Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures.

1. Warm both unopened Jivi vial and prefilled diluent syringe in your hands to a comfortable temperature (do not exceed 37°C or 99°F).
1. Remove the protective cap from the vial (A). Aseptically cleanse the rubber stopper with a sterile alcohol swab, being careful not to handle the rubber stopper.
1. Place the product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down (B). The adapter will snap over the vial cap. Do not remove the adapter housing at this step.
1. Holding the syringe by the barrel, snap the syringe cap off the tip (C). Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.
1. Now remove and discard the adapter plastic housing (D).
1. Attach the prefilled syringe to the vial adapter thread by turning clockwise (E).
1. Remove the clear plastic plunger rod from the carton. Grasp the plunger rod by the top plate. Avoid touching the sides and threads of the plunger rod. Attach the plunger rod by turning it clockwise into the threaded rubber stopper of the prefilled syringe (F).
1. Inject the diluent slowly by pushing down on the plunger rod (G).
1. Swirl vial gently until all powder on all sides of the vial is dissolved (H). Do not shake vial. Be sure that all powder is completely dissolved. Do not use if solution contains visible particles or is cloudy.
1. Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe (I). Pooling: If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. Use a larger plastic syringe (not provided) to combine the contents of the vials into the syringe.
1. Filter the reconstituted product to remove potential particulate matter in the solution. Filtering is achieved by using the vial adapter. Withdraw all the solution through the vial adapter into the syringe by pulling the plunger rod back slowly and smoothly (J). Tilt the vial to the side and back to make sure all the solution has been drawn toward the large opening in the rubber stopper and into the syringe. Remove as much air as possible before removing the syringe from the vial by slowly and carefully pushing the air back into the vial.
1. Detach the syringe with plunger rod from the vial adapter by turning counter-clockwise. Attach the syringe to the infusion set provided and inject the reconstituted product intravenously (K). Note: follow instructions for infusion set provided.

Administration

For intravenous use only.

•: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
•: Do not use if you notice any particulate matter or discoloration and immediately contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937).
•: Administer reconstituted Jivi as soon as possible. If not, store at room temperature for no longer than 3 hours.
•: Infuse Jivi intravenously over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient (maximum infusion rate 2.5 mL/min).