Monoclate-p
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Questions & Answers
Side Effects & Adverse Reactions
Monoclate-P® is made from human blood. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Monoclate-P® 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 inactivating and/or removing certain viruses during manufacture (see DESCRIPTION section for viral reduction measures). The manufacturing procedure for Monoclate-P® includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. The primary viral reduction step of the Monoclate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Monoclate-P® also provides viral 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 can not 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. or Canada).
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections (see Information For Patients).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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
Monoclate-P® is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Surgical prophylaxis in severe AHF deficiency can be accomplished with an appropriately-dosed pre-surgical IV bolus of Monoclate-P® followed by intermittent maintenance doses (see DOSAGE AND ADMINISTRATION).
Monoclate-P® is not effective in controlling the bleeding of patients with von Willebrand's disease.
History
There is currently no drug history available for this drug.
Other Information
Antihemophilic Factor (Human), Monoclate-P®, Factor VIII:C Pasteurized, Monoclonal Antibody Purified, is a sterile, stable, lyophilized concentrate of Factor VIII:C with reduced amounts of VWF:Ag and purified of extraneous plasma-derived protein by use of affinity chromatography. A murine monoclonal antibody to VWF:Ag is used as an affinity ligand to first isolate the Factor VIII Complex. Factor VIII:C is then dissociated from VWF:Ag, recovered, formulated and provided as a sterile lyophilized powder.1,2,3 The concentrate as formulated contains Albumin (Human) as a stabilizer, resulting in a concentrate with a specific activity between 4 and 10 units/mg of total protein. In the absence of this added Albumin (Human) stabilizer, specific activity has been determined to exceed 3000 units/mg of protein.4 Monoclate-P® has been prepared from pooled human plasma and is intended for use in therapy of classical hemophilia (Hemophilia A).
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 pasteurized by heating at 60°C for 10 hours in aqueous solution form during its manufacture in order to further reduce the risk of viral transmission.5 However, no procedure has been shown to be totally effective in removing viral infectivity from coagulant factor concentrates (see CLINICAL PHARMACOLOGY and WARNINGS).
Monoclate-P® is a highly purified preparation of Factor VIII:C. When stored as directed, it will maintain its labeled potency for the period indicated on the container and package labels.6,7
Upon reconstitution of the 250, 500 and 1000 IU concentrates, a clear, colorless solution is obtained, containing 50 to 150 times as much Factor VIII:C as does an equal volume of plasma.
Upon reconstitution of the 1500 IU concentrate, a clear, colorless solution is obtained, containing 120 to 180 times as much Factor VIII:C as does an equal volume of plasma.
Each vial contains the labeled amount of antihemophilic factor (AHF) activity as expressed in terms of International Units (IU) of antihemophilic activity. One unit of antihemophilic activity is equivalent to that quantity of AHF present in one mL of normal human plasma. When reconstituted as recommended, the resulting solution contains approximately 300 to 450 millimoles of sodium ions per liter and has 2 to 3 times the tonicity of saline. It contains approximately 2-5 millimoles of calcium ions per liter, contributed as calcium chloride, approximately 1 to 2% Albumin (Human), 0.8% mannitol, and 1.2 mM histidine. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. Monoclate-P® also contains trace amounts (≤50 ng per 100 IU of AHF) of the murine monoclonal antibody used in its purification (see CLINICAL PHARMACOLOGY).
Monoclate-P® is to be administered only intravenously.
Sources
Monoclate-p Manufacturers
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Csl Behring Llc
![Monoclate-p (Antihemophilic Factor Human) Kit [Csl Behring Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Monoclate-p | Csl Behring Llc
Monoclate-P® is for intravenous administration only. As a general rule 1 unit of AHF activity per kg will increase the circulating AHF level by 2%.10 The following formula10 provides a guide of dosage calculations for both adult and pediatric patients:
Number of AHF = Body weight × desired Factor VIII × 0.5 IU Required (in kg) increase (% normal)Although dosage must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors), the following general dosages are suggested.11
MILD HEMORRHAGES - Minor hemorrhagic episodes will generally subside with a single infusion if a level of 30% or more is attained. MODERATE HEMORRHAGE AND MINOR SURGERY - For more serious hemorrhages and minor surgical procedures, the patient's Factor VIII level should be raised to 30-50% of normal, which usually requires an initial dose of 15-25 IU per kg. If further therapy is required a maintenance dose is 10-15 IU per kg every 8-12 hours. SEVERE HEMORRHAGE - In hemorrhages near vital organs (neck, throat, subperitoneal) it may be desirable to raise the Factor VIII level to 80-100% of normal which can be achieved with an initial dose of 40-50 IU per kg and a maintenance dose of 20-25 IU per kg every 8-12 hours. MAJOR SURGERY - For surgical procedures a dose of AHF sufficient to achieve a level 80-100% of normal should be given an hour prior to surgery. A second dose, half the size of the priming dose, should be given five hours after the first dose. Factor VIII levels should be maintained at a daily minimum of at least 30% for a period of 10-14 days postoperatively. Close laboratory control to maintain AHF plasma levels deemed appropriate to maintain hemostasis is recommended. Reconstitution Warm both the diluent and Monoclate-P® 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 Monoclate-P® vial. Direct the diluent, which will be drawn in by vacuum, over the entire surface of the Monoclate-P® 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 Monoclate-P® 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, Monoclate-P® should be administered within three hours after reconstitution. Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administration CAUTION: This kit contains two devices, a stainless steel 5 micron filter needle, individually labeled as a 5 micron filter needle and contained in a separate blister pack, and an all plastic 5 micron vented filter spike which is supplied with the four-item administration components blister pack, either of which may be used to withdraw the reconstituted product for administration. The withdrawal directions specific for each of these alternate devices must be followed exactly for whichever device is chosen for use as described below. Product loss or inability to withdraw product will result if the improper instructions are followed. A. Administration using the stainless steel filter needle for withdrawal(This item is individually packaged in a separate, labeled blister pack.)
Intravenous Injection
Plastic disposable syringes are recommended with Monoclate-P® solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type.
1. Using aseptic technique, attach the filter needle to a sterile disposable syringe. 2. Draw air into the syringe equal to or greater than the contents of the vial. 3. Insert the filter needle into the stopper of the Monoclate-P ® vial, invert the vial, position the filter needle above the level of the liquid and inject all of the air into the vial. 4. Pull the filter needle back down below the level of the liquid until the tip is at the inside edge of the stopper. 5. Withdraw the reconstituted solution into the syringe being careful to always keep the tip of the needle below the level of the liquid. CAUTION: Failure to inject air into the vial, or allowing air to pass through the filter needle while filling the syringe with reconstituted solution, may cause the needle to clog. 6. Discard the filter needle. 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. 7. Administer solution intravenously at a rate (approximately 2 mL/minute) comfortable to the patient. B. Administration using the all plastic vented filter spike for withdrawal(This spike is supplied in the four-item Administration Components pack.)
Intravenous Injection
Plastic disposable syringes are recommended with Monoclate-P® solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type.
1. Using aseptic technique, attach the vented filter spike to a sterile disposable syringe. CAUTION: DO NOT INJECT AIR INTO THE MONOCLATE-P ® 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. 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. 2. Insert the vented filter spike into the stopper of the Monoclate-P ® vial, invert the vial, and position the filter spike so that the orifice is at the inside edge of the stopper. 3. Withdraw the reconstituted solution into the syringe. 4. 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. 5. Administer solution intravenously at a rate (approximately 2 mL/minute) comfortable to the patient.
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