Kogenate FS Dosage

Generic name: antihemophilic factor (recombinant)
Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

For Intravenous Use After Reconstitution

  • Treatment with Kogenate FS should be initiated under the supervision of a physician experienced in the treatment of hemophilia A.
  • Each vial of Kogenate FS has the recombinant factor VIII (rFVIII) potency in international units stated on the label.
  • 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. [See Table 1 and Table 2.]

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]

Examples (assuming patient’s baseline factor VIII level is <1% of normal):

  1. A dose of 1750 IU Kogenate FS administered to a 70 kg patient should be expected to result in a peak post-infusion factor VIII increase of 1750 IU x {[2 IU/dL]/[IU/kg]}/[70 kg] = 50 IU/dL (50% of normal).
  2. A peak level of 50% is required in a 15 kg child. In this situation, the appropriate dose would be:
    50 IU/dL/{[2 IU/dL]/[IU/kg]} x 15 kg = 375 IU.

Doses administered should be titrated 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, whenever possible, appropriate laboratory tests including serial factor VIII activity assays be performed. [See Warnings and Precautions (5.4) and Clinical Pharmacology (12.3).]

Control and Prevention of Bleeding Episodes

The careful control of treatment dose is especially important in cases of life-threatening bleeding episodes or major surgery.

The following table can be used to guide dosing in bleeding episodes.

Table 1 Control and Prevention of Bleeding Episodes for Children and Adults
Type of Bleeding Episode Factor VIII Level Required
(IU/dL or % of normal)
Dosage and Frequency Necessary to Maintain the Therapeutic Plasma Level

Minor

Early hemarthrosis, minor muscle or oral bleeds.
20–40

10–20 IU per kg

Repeat dose if there is evidence of further bleeding.

Moderate

Bleeding  into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma.
30–60

15–30 IU per kg

Repeat dose every 12–24 hours 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 dose 40–50 IU per kg

Repeat dose 20–25 IU per kg every 8–12 hours until bleeding is resolved.

 

Peri-operative Management

The careful control of treatment dose is especially important in cases of major surgery or life-threatening bleeding episodes.

The following table can be used to guide dosing in surgery:

Table 2 Peri-operative Management for Adults and Children
Type of Surgery Factor VIII Level Required
(IU/dL or % of normal)
Dosage and Frequency Necessary to Maintain the Therapeutic Plasma Level

Minor

Including tooth extraction
30–60

15–30 IU per kg

Repeat dose every 12–24 hours until bleeding is resolved.

Major

Examples include tonsillectomy, inguinal herniotomy, synovectomy, total knee replacement, craniotomy, osteosynthesis, trauma.
100

Pre-operative dose 50 IU per kg

Verify 100% activity prior to surgery. Repeat as necessary after 6 to 12 hours initially, and for 10 to 14 days until healing is complete.

Routine Prophylaxis in Children with No Pre-existing Joint Damage. 

The recommended dose for routine prophylaxis is 25 IU/kg of body weight every other day.5

Instructions for Use

Kogenate FS is administered by intravenous (IV) injection after reconstitution. Patients should follow the specific reconstitution and administration procedures provided by their physicians.

For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling. [See FDA-Approved Patient Labeling (17).]

Reconstitution, product administration, and handling of the administration set and needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted Kogenate FS product, in an appropriate container.

Preparation and Reconstitution

The procedures below are provided as general guidelines for the reconstitution and administration of Kogenate FS with BIO-SET®, a needleless self-contained reconstitution system. Always work on a clean surface and wash hands before performing the following procedures.

Vacuum Transfer and Reconstitution

  1. Warm the unopened diluent (as needed) and the concentrate to a temperature not to exceed 37°C or 99°F.
  2. Remove the cap from the concentrate. Take out the prefilled diluent syringe and remove the tip cap. (Fig. A).
  3. Connect the prefilled diluent syringe to the concentrate vial by gently screwing on to the BIO-SET connection (Fig. B).
  4. Place the vial on a rigid, non-skid surface and hold it firmly with one hand. With the other hand, strongly press down the fingerplate near the syringe tip using your thumb and index finger (Fig. C) until the fingerplate meets the top edge of the BIO-SET. This confirms that the system is activated (Fig. D).
  5. Grasp the plunger rod by the top plate and remove from carton. Avoid touching the sides and threads of the plunger rod. Immediately screw plunger rod into the syringe rubber stopper (Fig. E).
  6. Inject the diluent into the concentrate by pushing down the plunger rod slowly (Fig. F).
  7. Swirl gently until completely dissolved without creating excessive foaming (Fig. G).
  8. Kogenate FS should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  9. Invert vial/syringe and transfer the solution into syringe that was used to deliver the diluent (Fig. H). Ensure that the entire contents of the reconstituted Kogenate FS vial are drawn into the syringe.
  10. Unscrew the filled syringe to disconnect it from the empty concentrate vial (Fig. I).
  11. Attach the filled syringe to the administration set provided and immediately inject intravenously (Fig. J). NOTE: See accompanying instructions for Infusion Set with Filter.
  12. If the same patient is to receive more than one vial, the diluent syringe provided should be used to reconstitute the powder in the product vials as described above. The reconstituted solutions should then be combined in a larger plastic syringe (not provided) and administered as usual (Fig. J).
Reconstitution graphics

Administration

For Intravenous Use Only After Reconstitution

  • Kogenate FS should be inspected visually for particulate matter and discoloration prior to administration, wherever solution and container permit. Turbid or discolored solution should be discarded.
  • Reconstituted Kogenate FS may be stored at room temperature prior to administration, but is to be administered within 3 hours. It is recommended to use the IV administration set provided.
  • A dose of Kogenate FS may be administered over a period of 1 to 15 minutes. The rate of administration however, should be adapted to the response of each individual patient. The pulse rate should be determined before and during administration of Kogenate FS. If there is a significant increase in pulse rate, reducing the rate of administration or temporarily halting the injection allows the symptoms to disappear promptly.
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