Needle-Free Reconstitution1

Packaged with a MIX 2 VIAL®

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.

MIX 2 VIAL®

  • 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.

ORDER KOĀTE

Dosing Guidelines*

The required dose can be determined using the following formula1:

Dose (IU) = Body Weight (kg) x Desired FVIII 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 formula1:

Estimated Increment of FVIII (% normal or IU/dL) = [Total Dose (IU)/Body Weight (kg)] x 2

Dose and duration of treatment depend on:

Severity of the FVIII deficiency | Location and extent of bleeding | Patient's clinical condition

Dosage Guidelines for Controlling and Preventing Bleeds in Patients with Hemophilia A1†

Type of Bleeding

Large bruises

Significant cuts or scrapes

Uncomplicated joint hemorrhage

Factor VIII:C Level Required (% of Normal)

30

Doses (kg IU/kg)

15

Frequency of Doses (Hours)

12 (twice daily)

Duration of Therapy (Days)

Until hemorrhage stops and healing has been achieved (1-2 days)

Type of Bleeding

Nose, mouth and gum bleeds

Dental extractions

Hematuria

Factor VIII:C Level Required (% of Normal)

50

Doses (kg IU/kg)

25

Frequency of Doses (Hours)

12 (twice daily)

Duration of Therapy (Days)

Until healing has been achieved (2-7 days, on average)

Type of Bleeding

Joint hemorrhage

Muscle hemorrhage

Major trauma

Hematuria

Intracranial and intraperitoneal bleeding

Factor VIII:C Level Required (% of Normal)

80-100

Doses (kg IU/kg)

Initial: 40-50

Maintenance: 25

Frequency of Doses (Hours)

12 (twice daily)

Duration of Therapy (Days)

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

Factor VIII:C Level Required (% of Normal)

Prior to surgery: 80-100

After surgery: 60-100

Doses (kg IU/kg)

40-50

30-50

Frequency of Doses (Hours)

Once

12 (twice daily)

Duration of Therapy (Days)

Prior to surgery

For the next 7-10 days, or until healing has been achieved

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.