y) and clinical responses to KOVALTRY.
On-demand Treatment and Control of Bleeding Episodes
A guide for dosing KOVALTRY 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
Factor VIII Level Required
(IU/dL or % of normal)
Frequency of Doses (hours)
Duration of Therapy (days)
Minor (Early hemarthrosis, minor muscle, oral bleeds)
20–40
Repeat every
12–24 hours
At least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
Moderate (More extensive hemarthrosis, muscle bleeding, or hematoma)
30–60
Repeat every
12–24 hours
3 to 4 days or more until pain and acute disability are resolved
Major (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
Repeat every
8–24 hours
Until bleeding is resolved
Perioperative Management of Bleeding
A guide for dosing KOVALTRY 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 (5.5)].
Table 2: Dosing for Perioperative Management
Type of Surgery
Factor VIII Level Required
(IU/dL or % of normal)
Frequency of Doses (hours)
Duration of Therapy (days)
Minor (Such as tooth extraction)
30–60
(pre- and post-operative)
Repeat every 24 hours
At least 1 day until healing is achieved
Major (Such as intracranial, intra-abdominal, intrathoracic, or joint replacement surgery)
80–100
(pre- and post-operative)
Repeat every
8–24 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
•Individualize the patient’s dose based on clinical response.
•Adults and adolescents: 20 to 40 IU of KOVALTRY per kg of body weight two or three times per week.
•Children ≤12 years old: 25 to 50 IU of KOVALTRY per kg body weight twice weekly, three times weekly, or every other day according to individual requirements [see Use in Specific Populations (8.4)].
2.2 Preparation and Reconstitution
•Reconstitute and administer KOVALTRY with the components provided with each package. If any component of the package is opened or damaged, do not use this component.
•For any questions about the handling, reconstitution and administration of KOVALTRY, contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937).
The procedures below are provided as general guidelines for the reconstitution of KOVALTRY using the sterile vial adapter with a 15 micrometer filter and a prefilled diluent syringe, which together serve as an alternative needleless reconstitution s
