Generic name: Antihemophilic Factor Human 250[iU] in 5mL;
Dosage form: injection
Medically reviewed by Drugs.com. Last updated on Jan 22, 2020.
For intravenous use after reconstitution only.
- Dose and duration of treatment depend on the severity of the Factor VIII deficiency, location and extent of bleeding, and the patient’s clinical condition.
- Each vial of KOĀTE is labeled with the actual Factor VIII potency in international units (IU). Calculation of the required dose of Factor VIII is based on the empirical finding that one IU of Factor VIII per kg body weight raises the plasma Factor VIII activity by approximately 2% of normal activity or 2 IU/dL.
- The required dose can be determined using the following formula:
Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (% normal or IU/dL) x 0.5
- Estimate the expected in vivo peak increase in Factor VIII 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
- 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.
Control and Prevention of Bleeding Episodes
A guide for dosing KOĀTE for the control and prevention of bleeding episodes (1,2) is provided in Table 1. Consideration should be given to maintaining a Factor VIII activity at or above the target range.
|Type of Bleeding||Factor VIII:C
(% of normal)
|Frequency of Doses
|Duration of Therapy
Significant cuts or scrapes
Uncomplicated joint hemorrhage
|Until hemorrhage stops and healing has been achieved (1–2 days).|
Nose, mouth and gum bleeds
|Until healing has been achieved (2–7 days, on average).|
Intracranial and intraperitoneal bleeding
|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:
|Prior to surgery
For the next 7–10 days, or until healing has been achieved.
Preparation and Reconstitution
- Use aseptic technique (clean and sanitized) and a flat work surface during the reconstitution procedure.
- Bring the vials of KOĀTE and the diluent (Sterile Water for Injection) to room temperature before use.
- Remove the shrink band from the KOĀTE vial. Do not use KOĀTE if the shrink band is absent or shows signs of tampering, and notify Grifols Therapeutics LLC immediately.
- Remove the plastic cap from the KOĀTE vial (Fig. A) and clean the top of the stopper with an alcohol swab. Allow the stopper to dry.
- Repeat this step with the vial of sterile water.
- Carefully remove the plastic sheath from the short end of the transfer needle and insert the exposed needle into the diluent vial to the hub (Fig. B)
- Place the KOĀTE vial upright on a flat surface. Remove the sheath from the other end of the transfer needle.
- While holding the KOĀTE vial securely on a flat surface insert the needle into the vial at a 45° angle to minimize foaming (Fig. C). The vacuum will draw the diluent into the concentrate vial. If vacuum is lost, use a sterile syringe and needle to remove the sterile water from the diluent vial and inject it into the KOĀTE, directing the stream of fluid against the wall of the vial.
- Remove the diluent vial and transfer needle (Fig. D).
- Agitate vigorously for 10-15 seconds, (Fig. E1) then swirl continuously until completely dissolved (Fig. E2). Avoid excessive foaming. The reconstituted solution should be clear to opalescent. Do not use if particulate matter and discoloration is observed.
- Clean the top of the vial of reconstituted KOĀTE with alcohol swab and let surface dry.
- Attach the filter needle (from the package) to a sterile syringe. Withdraw the KOĀTE solution into the syringe through the filter needle (Fig. F).
- Remove the filter needle from the syringe and discard the filter needle into a puncture proof container. Use KOĀTE within 3 hours after reconstitution. Do not refrigerate after reconstitution.
For intravenous administration only
- If the dose requires more than one vial of KOĀTE:
- Reconstitute each vial using a new transfer needle.
- Draw up all the solution into a single syringe.
- Visually inspect the final solution for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed.
- Attach the syringe to the connector end of an infusion set.
- Administer intravenously. The rate of administration should be determined by the patient’s comfort level, and no faster than 10 mL per minute.