Mononine
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Questions & Answers
Side Effects & Adverse Reactions
Mononine® is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Mononine® is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections and by inactivating and/or removing certain viruses during manufacture (see DESCRIPTION section for virus reduction measures). The manufacturing procedure for Mononine® includes processing steps designed to reduce further the risk of virus transmission. Stringent procedures, utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of virus transmission. The primary virus reduction step of the Mononine® manufacturing process is the use of a nanofilter designed to separate viruses from Factor IX. In addition, the purification procedure (several chromatography steps) used in the manufacture of Mononine® also provides virus reduction capacity. Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-866-915-6958 (in the U.S. and Canada). The physician should discuss the risks and benefits of this product with the patient.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly nonA, nonB hepatitis. (See Information For Patients.)
Since the use of Factor IX Complex concentrates has historically been associated with the development of thromboembolic complications, the use of Factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).
Hypersensitivity and allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Frequently, these events have occurred in close temporal association with the development of factor IX inhibitors. Patients should be informed of the early symptoms and signs of hypersensitivity reactions, including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. Patients should be advised to discontinue use of product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if any of these symptoms occur.
Preliminary information suggests a relationship may exist between the presence of major deletion mutations in the factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.
Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in Hemophilia B patients with factor IX inhibitors and a history of severe allergic reactions to factor IX. The safety and efficacy of using Mononine® in attempted immune tolerance induction has not been established.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Mononine® is indicated for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease.
Mononine® is not indicated in the treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII.
Mononine® 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® 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.
History
There is currently no drug history available for this drug.
Other Information
Coagulation Factor IX (Human), Mononine® is a sterile, stable, lyophilized concentrate of Factor IX prepared from pooled human plasma and is intended for use in therapy of Factor IX deficiency, known as Hemophilia B or Christmas disease. Mononine® is purified of extraneous plasma-derived proteins, including Factors II, VII and X, by use of immunoaffinity chromatography. A murine monoclonal antibody to Factor IX is used as an affinity ligand to isolate Factor IX from the source material. Factor IX is then dissociated from the monoclonal antibody, recovered, purified further, formulated and provided as a sterile, lyophilized powder. The immunoaffinity protocol utilized results in a highly pure Factor IX preparation. It shows predominantly a single component by SDS polyacrylamide electrophoretic evaluation and has a specific activity of not less than 190 Factor IX units per mg total protein.
All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be nonreactive (negative).
This concentrate has been processed by monoclonal antibody immunoaffinity chromatography during its manufacture, which has been shown to be capable of reducing the risk of viral transmission. Additionally, a chemical treatment protocol and nanofiltration used in its manufacture have also been shown to be capable of significant virus reductions. However, no procedure has been shown to be totally effective in removing the risk of viral infectivity from coagulation factor concentrates (see CLINICAL PHARMACOLOGY and WARNINGS).
Mononine® is a highly purified preparation of Factor IX. When stored as directed, it will maintain its labeled potency for the period indicated on the container label.
Each vial contains the labeled amount of Factor IX activity expressed in International Units (IU). One IU represents the activity of Factor IX present in 1 mL of normal, pooled plasma. When reconstituted as recommended, the resulting solution is a clear, colorless, isotonic preparation of neutral pH, containing approximately 100 times the Factor IX potency found in an equal volume of plasma. Each mL of the reconstituted concentrate contains approximately 100 IU of Factor IX and non-detectable levels of Factors II, VII and X (<0.0025 IU per Factor IX unit using standard coagulation assays). Each vial also contains histidine (approx. 10mM), sodium chloride (approx. 0.066M), mannitol (approx. 3%) and polysorbate 80 (approx. 0.0075%). Hydrochloric acid and/or sodium hydroxide may have been used to adjust pH. Mononine® also contains trace amounts (≤50 ng mouse protein/100 Factor IX activity units) of the murine monoclonal antibody used in its purification (see CLINICAL PHARMACOLOGY).
Mononine® is to be administered only intravenously.
Sources
Mononine Manufacturers
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Csl Behring Llc
![Mononine (Coagulation Factor Ix Human) Kit [Csl Behring Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Mononine | Csl Behring Llc
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 insultRecovery 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, whenever solution and container permit. Administration Intravenous InjectionParenteral 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® 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 disposable syringe.
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® 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® 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 AdministrationThe 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® should be administered at a rate of approximately 2.0 mL per minute.
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