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 Dec 2, 2024.
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.
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- 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.
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- Monitor the Factor VIII activity of Jivi in plasma using either a validated chromogenic substrate assay or a validated one-stage clotting assay.
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- 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).
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.
Degree of Bleeding Hemorrhage/Hemorrhagic Event |
Factor VIII Level Required |
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 |
Until bleeding is resolved |
Moderate (e.g., more extensive hemarthrosis, muscle bleeding, or hematoma) |
30–60 |
15–30 |
Repeat every |
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 |
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.
Type of Surgery |
Factor VIII Level Required |
Dose (IU/kg) |
Frequency of Doses (hours) |
Duration of Treatment (days) |
Minor (e.g., tooth extraction) |
30–60 |
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 |
40-50 |
Repeat every |
Until adequate wound healing is complete, then continue therapy for at least another 7 days to maintain Factor VIII activity of |
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.
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.
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- 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).
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- 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).
Frequently asked questions
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