and supportive therapy should be administered.
DOSAGE AND ADMINISTRATION
Mononine® is intended for intravenous administration only. It should be reconstituted with the volume of Sterile Water for Injection, USP supplied with the lot, and administered within three hours of reconstitution. Do not refrigerate after reconstitution. After administration, any unused solution and the administration equipment should be discarded.
As a general rule, 1 IU of Factor IX activity per kg can be expected to increase the circulating level of Factor IX by 1% [IU/dL] of normal. The following formula provides a guide to dosage calculations:
Number of Factor IX = Body Weight × desired Factor IX × 1.0 IU/kg
IU required (IU) (in kg) increase (% or IU/dL normal) [per IU/dL]
The amount of Mononine® to be infused, as well as the frequency of infusions, will vary with each patient and with the clinical situation.11,12
As a general rule, the level of Factor IX required for treatment of different conditions is as follows:
Minor Spontaneous Hemorrhage, Prophylaxis Major Trauma or Surgery
Desired levels of Factor IX for Hemostasis 15-25%
[or IU/dL] 25-50%
[or IU/dL]
Initial loading dose to achieve desired level up to 20-30 IU/kg up to 75 IU/kg
Frequency of dosing once; repeated in 24 hours if necessary every 18-30 hours, depending on T1/2 and measured Factor IX levels
Duration of treatment once; repeated if necessary up to ten days, depending upon nature of insult
Recovery of the loading dose varies from patient to patient. Doses administered should be titrated to the patient's response. Mononine® administered in doses of ≥75 IU/kg were well tolerated (see CLINICAL PHARMACOLOGY).
In the presence of an inhibitor to Factor IX, higher doses of Mononine® might be necessary to overcome the inhibitor (see PRECAUTIONS). No data on the treatment of patients with inhibitors to Factor IX with Mononine® are available.
For information on rate of administration, see Rate of Administration, below.
Reconstitution
Warm both the diluent and Mononine® in unopened vials to room temperature [not above 37°C (98°F)].
Remove the caps from both vials to expose the central portions of the rubber stoppers.
Treat the surface of the rubber stoppers with antiseptic solution and allow them to dry.
Using aseptic technique, insert one end of the double-end needle into the rubber stopper of the diluent vial. Invert the diluent vial and insert the other end of the double-end needle into the rubber stopper of the Mononine® vial. Direct the diluent, which will be drawn in by vacuum, over the entire surface of the Mononine® cake. (In order to assure transfer of all the diluent, adjust the position of the tip of the needle in the diluent vial to the inside edge of the diluent stopper.) Rotate the vial to ensure complete wetting of the cake during the transfer process.
Remove the diluent vial to release the vacuum, then remove the double-end needle from the Mononine® vial.
Gently swirl the vial until the powder is dissolved and the solution is ready for administration. The concentrate routinely and easily reconstitutes within one minute. To assure sterility, Mononine® should be administered within three hours after reconstitution.
Product should be filtered prior to use as described under Administration. Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration, |
