Generic Name: ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 1000[iU] in 2.5mL;
Dosage Form: injection
Drug Class: Miscellaneous coagulation modifiers
For intravenous use after reconstitution only.
Dose
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- Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.1 Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.
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- Each vial of Kogenate FS has the recombinant factor VIII (rFVIII) potency in international units (IU, unit) stated on the label. One IU (unit), as defined by the World Health Organization standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma.
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- The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas:
Dosage (units) = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
or
IU/dL (or % normal) = Total Dose (IU)/body weight (kg) x 2 [IU/dL]/[IU/kg]
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- Titrate dose to the patient’s clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to Kogenate FS.2,3,4 Although the dose can be estimated by the calculations above, it is highly recommended that appropriate laboratory tests, including serial factor VIII activity assays, are performed [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].
On-Demand Treatment andControl of Bleeding Episodes
A guide for dosing Kogenate FS for 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.
|
Type of Bleeding Episodes |
Factor VIII Level Required |
Dose (IU/kg) |
Frequency of Doses (hours) |
Duration of Therapy (days) |
|
Minor Early hemarthrosis, minor muscle or oral bleeds. |
20 – 40 |
10 – 20 |
Repeat dose if there is evidence of further bleeding. |
Until bleeding is resolved |
|
Moderate Bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma. |
30 – 60 |
15 – 30 |
12 – 24 |
Until bleeding is resolved |
|
Major Gastrointestinal bleeding. Intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath. Fractures. Head trauma. |
80 – 100 |
Initial: 40 – 50 Repeat: 20 – 25 |
8 – 12 |
Until bleeding is resolved |
Perioperative Management of Bleeding
A guide for dosing Kogenate FS during surgery (perioperative management of bleeding) 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.
|
Type of Surgery |
Factor VIII Level Required |
Dose (IU/kg) |
Frequency of Doses (hours) |
Duration of Therapy (days) |
|
Minor Including tooth extraction |
30 – 60 |
15 – 30 |
12 – 24 |
Until bleeding is resolved. |
|
Major Examples include tonsillectomy, inguinal herniotomy, synovectomy, total knee replacement, craniotomy, osteosynthesis, trauma. |
100 |
50 Pre-operatively to achieve 100% activity. |
6 – 12 to keep FVIII activity in desired range |
Until healing is complete. |
Preparation and Reconstitution
Kogenate FS is administered by intravenous injection after reconstitution. Patients should follow the specific reconstitution and administration procedures provided by their physicians.
Reconstitute and administer Kogenate FS with the components provided with each package. If any component of the package is opened or damaged, do not use this component.
Product reconstitution, administration, and handling of the administration set and needles must be done with caution because percutaneous puncture with a needle contaminated with blood can transmit infectious viruses, including HIV (AIDS) and hepatitis. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted Kogenate FS product, in an appropriate container. Obtain immediate medical attention if injury occurs.
The procedures below are provided as general guidelines for the reconstitution of Kogenate FS provided with a sterile vial adapter with 15-micrometer filter and a prefilled diluent syringe, which together serve as an alternative needleless reconstitution system.
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- Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures.
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- Reconstitute Kogenate FS with the components provided with each package. If any component of the package is opened or damaged, do not use this component.
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- Filter the reconstituted product prior to administration to remove potential particulate matter in the solution. Filtering can be achieved by using the vial adapter.
Vacuum Transfer and Reconstitution
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- Prepare the product under aseptic conditions.
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- Warm both unopened vial and syringe in your hands to a comfortable temperature (do not exceed 37°C or 99°F).
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- Remove protective cap from the vial (A). Aseptically cleanse the rubber stopper with alcohol, being careful not to handle the rubber stopper.
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- Place product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down (B). The adapter will snap over the vial cap. Do not remove the adapter housing at this step.
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- Holding the syringe by the barrel, snap the syringe cap off the tip (C). Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.
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- Now remove and discard the adapter housing (D).
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- Attach the prefilled syringe to the threaded vial adapter by turning clockwise (E).
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- Grasp the plunger rod by the top plate and remove from carton. Avoid touching the sides and threads of the plunger rod. Immediately attach the plunger rod by turning it firmly clockwise into the threaded syringe rubber stopper (F).
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- Inject the diluent by slowly pushing down on the plunger rod (G).
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- Swirl vial gently until all material is dissolved (H). Do not shake vial. Be sure that the powder is completely dissolved. Do not use solutions containing visible particles or that are cloudy.
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- Withdraw solution into the syringe by holding the vial on end above the vial adapter and syringe (I) then draw the plunger rod out slowly and smoothly. Ensure that the entire content of the vial is drawn into the syringe.
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- With the plunger rod in place, remove the syringe from the vial adapter (the latter should remain attached to the vial). Attach the syringe to the administration set provided and inject intravenously (J).
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- If the same patient is to receive more than one bottle, reconstitute each bottle with the diluent syringe provided then combine solutions in a larger syringe (not provided) and administer as usual.
Administration
For intravenous use after reconstitution only.
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- Inspect Kogenate FS visually for particulate matter and discoloration prior to administration, wherever solution and container permit. Do not use Kogenate FS if you notice any particulates or turbidity in the solution.
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- Store the reconstituted Kogenate FS at room temperature prior to administration, but administer it within 3 hours.
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- Administer Kogenate FS using the administration set provided over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient. Determine the pulse rate before and during administration of Kogenate FS. If there is a significant increase in pulse rate, reduce the rate of administration or temporarily halt the infusion allowing the symptoms to disappear promptly.
