" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
Mononine® (coagulation factor ix (human)) , is indicated for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease.
Mononine® (coagulation factor ix (human)) , contains non-detectable levels of Factors II, VII and X ( < 0. 0025 IU per Factor IX unit using standard coagulation assays) and is, therefore, not indicated for replacement therapy of these clotting factors. Mononine® (coagulation factor ix (human)) is also not indicated in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors.
DOSAGE AND ADMINISTRATION
Mononine® (coagulation factor ix (human)) 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 required (IU) = Body Weight (in kg) x desired Factor IX increase (% or IU/dL normal) x 1.0 IU/kg IU [per IU/dL]
The amount of Mononine® (coagulation factor ix (human)) 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 T½ 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® (coagulation factor ix (human)) 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® (coagulation factor ix (human)) might be necessary to overcome the inhibitor (see PRECAUTIONS). No data on the treatment of patients with inhibitors to Factor IX with Mononine® (coagulation factor ix (human)) are available.
For information on rate of administration, see Rate of Administration, below.
- Warm both the diluent and Coagulation Factor IX (Human), Mononine® (coagulation factor ix (human)) , 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 dilu-ent vial. Invert the diluent vial and insert the other end of the double-end needle into the rubber stopper of the Mononine® (coagulation factor ix (human)) vial. Direct the diluent, which will be drawn in by vacuum, over the entire surface of the Mononine® (coagulation factor ix (human)) 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® (coagulation factor ix (human)) 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® (coagulation factor ix (human)) 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, whenever solution and container permit.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Plastic disposable syringes are recommended with Mononine® (coagulation factor ix (human)) solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type. Please note, this concentrate is supplied with a SELF-VENTING filter spike.
- Using aseptic technique, attach the vented filter spike to a sterile diposable
CAUTION: The use of other, non-vented filter needles or spikes without the proper procedure may result in an air lock and prevent the complete transfer of the concentrate.
CAUTION: DO NOT INJECT AIR INTO THE MONONINE® (coagulation factor ix (human)) VIAL. The self-venting feature of the vented filter spike precludes the need to inject air in order to facilitate withdrawal of the reconstituted solution. The injection of air could cause partial product loss through the vent filter.
- Insert the vented filter spike into the stopper of the Mononine® (coagulation factor ix (human)) vial, invert the vial, and position the filter spike so that the orifice is at the inside edge of the stopper.
- Withdraw the reconstituted solution into the syringe.
- Discard the filter spike. Perform venipuncture using the enclosed winged
needle with microbore tubing. Attach the syringe to the luer end of the tubing.
CAUTION: Use of other winged needles without microbore tubing, although compatible with the concentrate, will result in a larger retention of solution within the winged infusion set.
Rate of Administration
The rate of administration should be determined by the response and comfort of the patient; intravenous dosage administration rates of up to 225 IU/minute have been regularly tolerated without incident. When reconstituted as directed, i. e. , to approximately 100 IU/mL, Mononine® (coagulation factor ix (human)) should be administered at a rate of approximately 2. 0 mL per minute.
When stored at refrigerator temperature, 2-8°C (36-46°F), Mononine® (coagulation factor ix (human)) is stable for the period indicated by the expiration date on its label. Within this period, Mononine® (coagulation factor ix (human)) may be stored at room temperature not to exceed 25°C (77°F), for up to one month.
Avoid freezing, which may damage container for the diluent.
Mononine® (coagulation factor ix (human)) is supplied in a single dose vial with Sterile Water for Injection, USP, double-ended needle for reconstitution, vented filter spike for withdrawal, winged infusion set and alcohol swabs. Factor IX activity in IU is stated on the label of each vial.
The following strengths are available:
NDC 0053-7668-02 in 10 mL vials containing approximately
500 IU (Dosage-MID)
NDC 0053-7668-04 in 20 mL vials containing approximately 1,000 IU (Dosage-HIGH)
11. Kasper CK, Dietrich SL. Comprehensive Management of Hemophilia. ClinHaematol 14(2):489-512, 1985.
12. JohnsonAJ, AronsonDL, WilliamsWJ. Preparationandclinicaluseofplasma and plasma fractions. Chap 167 in Hematology3rdEdition, WilliamsWJ, BeutlerE, Erslev AJ, Lichtman MA (Eds.), McGraw Hill Book Co. New York: pp 1563-1583, 1983.
Manufactured by: CSL Behring LLC, Kankakee, IL 60901 USA. Revised January, 2007.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/6/2009
Additional Mononine Information
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