The required dose can be determined using the following formula1:
Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5
Estimate the expected in vivo peak increase in FVIII level, expressed as IU/dL (or % normal), using the following formula:
Estimated Increment of Factor VIII (% normal or IU/dL) = [Total Dose (IU)/Body Weight (kg)] x 2
Dose and duration of treatment depend on:
Dosage Guidelines for controlling and Preventing Bleeds in Patients with Hemophilia A1†
- Large bruises
- Significant cuts or scrapes
- Uncomplicated joint hemorrhage
- Nose, mouth and gum bleeds
- Dental extractions
- Joint hemorrhage
- Muscle hemorrhage
- Major trauma
- Intracranial and intraperitoneal bleeding
Until healing has been achieved for up to 10 days. Intracranial hemorrhage may require prophylaxis therapy for up to 6 months.
For the next 7–10 days, or until healing has been achieved.
†Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Base the dose and frequency on the individual clinical response. Consideration should be given to maintaining a FVIII activity at or above the target range.
KOĀTE is supplied as a lyophilized powder for reconstitution in single-use vials of 250, 500, and 1,000 IUs of FVIII activity, packaged with 5mL or 10mL of sterile water for injection and a Mix2Vial® transfer device.
The exact number of IUs per vial is stated on each KOĀTE carton and vial label.
MIX2VIAL® Practice Kit
- Helps familiarize patients, caregivers, and nurses with reconstitution and the infusion process.
- Includes illustrated step-by-step instructions and demonstration supplies to practice with.
Reach out to your Kedrion Biopharma representative to order practice kits for your patients.
- Components used in the packaging of KOĀTE are not made with natural rubber latex.
- KOĀTE can be stored either at room temperature or refrigerated.
- Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze KOĀTE.
- Store at room temperature (up to 25°C [77°F]) for up to 6 months.
- Store KOĀTE in its original packaging to protect it from light.
- Since there are no preservatives in the vial, KOĀTE should be used immediately or within 3 hours of reconstitution.
- Do not use KOĀTE after the expiration date.
Reference: 1. KOĀTE [prescribing information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2018.