KOĀTE DOSING*

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†

TYPE OF BLEEDING
FACTOR VIII:C
LEVEL REQUIRED
(% OF NORMAL)
DOSES
(IU/kg)
FREQUENCY
OF DOSES
(HOURS)
DURATION
OF THERAPY (DAYS)
Minor
  • Large bruises
  • Significant cuts or scrapes
  • Uncomplicated joint hemorrhage
30
15
12
(twice daily)
Until hemorrhage stops and healing has been achieved (1-2 days).
Moderate
  • Nose, mouth and gum bleeds
  • Dental extractions
  • Hematuria
50
25
12
(twice daily)
Until healing has been achieved (2-7 days, on average)
Major
  • Joint hemorrhage
  • Muscle hemorrhage
  • Major trauma
  • Hematuria
  • Intracranial and intraperitoneal bleeding
80-100
Initial 40-50
Maintenance: 25
12
(twice daily)
For at least 3-5 days
Until healing has been achieved for up to 10 days. Intracranial hemorrhage may require prophylaxis therapy for up to 6 months.
Surgery
Prior to surgery:
80-100
After Surgery:
60-100
40-50
30-50
Once
12
(twice daily)
Prior to Surgery
For the next 7–10 days, or until healing has been achieved.
*Calculation of the required dose of FVIII is based on the empirical finding that one IU of FVIII per kg body weight raises the plasma FVIII activity by approximately 2% of normal activity or 2 IU/dL.
†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.
Please see Full Prescribing Information for complete Dosage and Administration information.

NEEDLE-FREE RECONSTITUTION

 

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.

 
 
 
PACKAGE COLOR
STRENGTH
DILUENT VOLUME
NDC NUMBER
J CODE
 
250 IU
5 mL
76125-256-20 or 76125-257-25
 
 
500 IU
5 mL
76125-668-30 or 76125-663-50
J7190
 
1,000 IU
10 mL
76125-676-50 or 76125-678-10
 

STORAGE AND HANDLING

  •   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.

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