Methoxy polyethylene glycolepoetin beta information. Methoxy polyethylene glycolepoetin beta arizona complete health. Methoxy polyethylene glycolepoetin beta springerlink. In patients with anaemia associated with chronic kidney disease ckd, both on and not on dialysis, who had not previously received an erythropoiesisstimulating agent esa, methoxy polyethylene glycolepoetin beta administered intravenously. Mircera methoxy polyethylene glycolepoetin beta injection, solution vifor international inc. Nov 14, 2007 mircera methoxy polyethylene glycolepoetin beta injectiion company.
Methoxy polyethylene glycolepoetin beta for the treatment of other conditionsdiseases is considered, including, but not limited to, the treatment of anemia due to cancer chemotherapy or as a substitute. Darbepoetin alfa, epoetin alfa, and methoxy polyethylene glycolepoetin beta page 4 of unitedhealthcare oxford clinical policy effective 10012017 19962017, oxford health plans. Its long halflife allows it to be administered once per month in maintenance therapy. Medscape anemia associated with chonic kidney disease dosing for mircera methoxy polyethylene glycol epoetin beta, frequencybased adverse effects, comprehensive interactions, contraindications. Like other erythropoiesisstimulating drugs, methoxy polyethylene glycolepoetin beta increases the risk of death in patients with cancer and should not be used to treat their anaemia. Methoxy polyethylene glycolepoetin beta australian prescriber. See full prescribing information for complete boxed warning. This medicine is not used to treat anemia caused by cancer medicines. Mircera methoxy polyethylene glycolepoetin beta injection april 15, 2019 this notice provides information for 340b covered entities regarding the distribution of mircera methoxy polyethylene glycolepoetin beta, which is marketed by vifor pharma.
Us mircera warning this drug may raise the chance of heart attack, stroke, heart. Esas increase the risk of death, myocardial infarction. A randomized trial marian klinger, md, phd,1 manual arias, phd,2 vassilis vargemezis, md,3. Mircera contains the active ingredient methoxy polyethylene glycol epoetin beta and belongs to a group of medicines known as hormones. We compared cardiovascular outcomes and allcause mortality associated with monthly methoxy polyethylene glycol epoetin beta with those of the shorteracting agents epoetin alfa beta and darbepoetin alfa in patients with anemia of ckd. Find patient medical information for epoetin beta, methoxy polyethylene glycol injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Effect of methoxy polyethylene glycolepoetin beta on oxidative stress in predialysis patients with chronic kidney disease. Methoxy polyethylene glycolepoetin beta mircera davis. Methoxy polyethylene glycolepoetin beta pegepo is an erythropoiesisstimulating agent esa that can activate erythropoietin receptors on erythroid progenitor cells to induce the formation of. Epoetin beta, methoxy polyethylene glycol injection. Methoxy polyethylene glycolepoetin beta drug bnf content. Anemia response to methoxy polyethylene glycolepoetin beta.
Pdf effect of methoxy polyethylene glycolepoetin beta. Do not put methoxy polyethylene glycol epoetin beta back in the refrigerator after it has been stored at room temperature. The active substance, methoxy polyethylene glycolepoetinbeta, is a covalent conjugate of a protein produced by recombinant dna technology in chinese hamster ovarian cells and a linear methoxy polyethylene. Read it again each time methoxy polyethylene glycolepoetin beta is refilled. It does not constitute a contract or guarantee regarding payment or results. Mircera methoxy polyethylene glycolepoetin beta is an erythropoiesisstimulating agent esa indicated for the treatment of anemia associated with chronic kidney disease ckd in adult patients. One prefilled syringe contains 40 micrograms of methoxy polyethylene glycolepoetin beta at a concentration of 3 microgramsml. Methoxy polyethylene glycolepoetin beta pegepo contains a single 30 kda peg chain and is used to treat patients suffering from anemia.
Pdf use of methoxy polyethylene glycolepoetin beta in. Exogenous replacement of erythropoietin by recombinant human erythropoietin as esas has become a widely accepted therapy of renal anemia. Mircera, methoxy polyethylene glycolepoetin beta, is an esa which differs from erythropoietin through formation of a chemical bond between either the nterminal amino group or the. Methoxy polyethylene glycolepoetin beta mpgepo is the only esa that is generated by chemical modification of glycosylated erythropoietin through the integration of one specific, long, linear chain of polyethylene. Epoetin beta and methoxy polyethylene glycol is a combination medicine used to treat anemia lack of red blood cells and to reduce the need for blood cell transfusions. Retrieved april 24, 2019 from micromedex healthcare series. Mircera methoxy polyethylene glycolepoetin beta prior. Methoxy polyethylene glycolepoetin beta mpgepo is the only esa that is. Methoxy polyethylene glycolepoetin beta mpgepo is the only esa that is generated by chemical modification of glycosylated erythropoietin through the integration of one specific, long, linear chain of polyethylene glycol. Aug 05, 2019 a dose of methoxy polyethylene glycol epoetin beta approximately 3fold greater than the recommended human dose was administered to lactating rats. Mircera has an approximate molecular weight of 60 kda. Methoxy polyethylene glycolepoetin beta is a biological medicine.
Sep 17, 2012 methoxy polyethylene glycolepoetin beta mircera is a continuous erythropoietin receptor activator, with a long halflife approximately hours. May 29, 2019 epoetin beta and methoxy polyethylene glycol is a combination medicine used to treat anemia lack of red blood cells and to reduce the need for blood cell transfusions. Methoxy polyethylene glycol epoetin beta pegepo is an erythropoiesisstimulating agent esa that can activate erythropoietin receptors on erythroid progenitor cells to induce the formation of. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Methoxy polyethylene glycolepoetin beta injection route. One prefilled syringe contains 200 micrograms of methoxy polyethylene glycol epoetin beta at a concentration of 667 micgrogramsml. A thirdgeneration erythropoietic beta molecule created by integrating a large polymer chain into the molecule, thus increasing the molecular weight to twice that of epoetin at approximately 60 kda. Mircera contains the active ingredient methoxy polyethylene glycolepoetin beta and belongs to a group of medicines known as hormones.
This esa induces continuous erythropoietin receptor activation and has a long halflife approximately hours. This clinical policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Mircera is a longacting erythropoietin receptor activator cera. Epoetin beta and methoxy polyethylene glycol uses, side. Mircera, innmethoxy polyethylene glycolepoetin beta. Epoetin beta and methoxy polyethylene glycol is a manmade form of a protein normally produced by the kidneys that helps your body produce red blood cells. Pdf chronic kidney disease ckd is a risk factor for endstage renal failure. Methoxy polyethylene glycol epoetin beta mpgepo is the only esa that is generated by chemical modification of glycosylated erythropoietin through the integration of one specific, long, linear chain of polyethylene glycol. Cera is a category of drugs, including but not limited to methoxy polyethylene glycolepoetin beta. Methoxy polyethylene glycolepoetin beta an overview.
Its long halflife allows it to be administered once per month in maintenance. Toward confirmation of the safety and efficacy of methoxy. Methoxy polyethylene glycolepoetin beta in the treatment of a. Methoxy polyethylene glycolepoetin beta mircera protocol methoxy polyethylene glycolepoetin beta mircera icd 10 code d63. The kidneys produce the natural hormone erythropoietin, which stimulates the production of red blood cells in the bone marrow and spleen. Epoetin beta and methoxy polyethylene glycol is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old. Biological medicines must be prescribed and dispensed by brand name, see biological medicines and biosimilar medicines, under.
One prefilled syringe contains 40 micrograms of methoxy polyethylene glycol epoetin beta at a concentration of 3 microgramsml. A dose of methoxy polyethylene glycolepoetin beta approximately 3fold greater than the recommended human dose was administered to lactating rats. If stored at room temperature and not used within 30 days, throw this drug away. If stored at room temperature and not used within 30 days, throw methoxy polyethylene glycol epoetin beta away. Methoxy polyethylene glycolepoetin beta injection is used to treat anemia in adults with chronic kidney disease ckd who may or may not be on dialysis or in children with ckd who are on dialysis. Methoxy polyethylene glycolepoetin beta view synonyms. Epoetin beta and methoxy polyethylene glycol is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old who are on hemodialysis. We compared cardiovascular outcomes and allcause mortality associated with monthly methoxy polyethylene glycolepoetin beta with those of the shorteracting agents epoetin alfa beta.
Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents e. Methoxy polyethylene glycolepoetin beta pegepo is indicated for the treatment of anaemia due to chronic kidney disease. Esas increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence. Methoxy polyethylene glycolepoetin beta for nonesrd non. Methoxy polyethylene glycolepoetin beta australian. Highlights of prescribing information these highlights do not include all the information. Epoetin beta and methoxy polyethylene glycol is a combination medicine used to treat anemia in people with chronic kidney disease. Hoffman laroche application no 125164 approval date. Doses of methoxy polyethylene glycolepoetin beta were to be decreased by 25% for haemoglobin. Cardiovascular safety and allcause mortality of methoxy.
Mircera is a longacting erythropoietin receptor activator cera indicated for the treatment of patients with anaemia associated with chronic kidney disease. Pdf methoxy polyethylene glycolepoetin beta for anemia with. Methoxy polyethylene glycolepoetin beta mircera is a continuous erythropoietin receptor activator, with a long halflife approximately hours. This medicine comes with an extra patient fact sheet called a medication guide. Both igm and igg antibodies against polyethylene glycol. Oct 17, 2019 if needed, you may store at room temperature for up to 30 days. Methoxy polyethylene glycolepoetin beta can be given subcutaneously or intravenously. In patients with anaemia associated with chronic kidney disease ckd, both on and not on dialysis, who had not previously received an erythropoiesisstimulating agent esa, methoxy polyethylene glycolepoetin beta. Pdf effect of methoxy polyethylene glycolepoetin beta on. Mircera methoxy polyethylene g lycol epoetin beta correction of anemia 1. Background and objectives erythropoiesisstimulating agents correct anemia of ckd but may increase cardiovascular risk. Methoxy ethylene glycolepoetin beta is a longer acting esa that acts as a continuous erythropoietin receptor activator and is given once every. Methoxy polyethylene glycol epoetin beta is the active ingredient of a drug marketed by hoffmannla roche under the brand name mircera.
Methoxy polyethylene glycolepoetin mircera will be increased and decreased in 1step or 2step increments, based on scale above. Coverage decisions and the administration of benefits are. Methoxy polyethylene glycolepoetin beta request pdf. Mircera methoxy polyethylene glycolepoetin beta prior authorization request form caterpillar prescription drug benefit phone. To provide optimal managementof esrd related anemia in dialysis. Patients who had received 800016000 iu or 16000 iu of epoetin alfa per week were given 200 or 360. Methoxy polyethylene glycolepoetin beta for anemia with. Biological medicines must be prescribed and dispensed by brand name, see biological medicines and biosimilar medicines, under guidance on prescribing. Erythropoiesis stimulating agents injectable medication precertification request keywords aranesp darbepoetin alfa epogen epoetin alfa mircera methoxy polyethylene glycolepoetin beta procrit. Anemia response to methoxy polyethylene glycolepoetin. Mircera will be administered iv to hd patients, and sc to pd patients. Methoxy polyethylene glycolepoetin beta this information from lexicomp explains what you need to know about this medication, including what its used for, how to take it, its side effects, and when to call your healthcare provider. To provide optimal management of esrd related anemia in dialysis patients hemoglobin target goal. If you have any questions about methoxy polyethylene glycolepoetin beta.
Mircera methoxy polyethylene glycolepoetin beta injection, for. The kidneys produce the natural hormone erythropoietin, which. Mircera, methoxy polyethylene glycol epoetin beta, is an esa which differs from erythropoietin through formation of a chemical bond between an amino group present in erythropoietin beta and methoxy polyethylene glycol peg butanoic acid. Pdf treatment of anemia associated with chronic kidney disease. We find that the preexisting human antipeg igm and igg. Methoxy polyethylene glycolepoetin beta is the active ingredient of a drug marketed by hoffmannla roche under the brand name mircera. This medicine is not for treating anemia caused by cancer chemotherapy. When your body does not make enough of this protein because of kidney failure, you can develop a condition called anemia lack of red blood cells. If needed, you may store at room temperature for up to 30 days. Erythropoiesis stimulating agents injectable medication. Dailymed mircera methoxy polyethylene glycolepoetin. Darbepoetin alfa, epoetin alfa, and methoxy polyethylene glycolepoetin beta page 3 of unitedhealthcare oxford clinical policy effective 10012017 19962017, oxford health plans, llc esas are unproven and not medically necessary to treat anemia of ckd in patients not on dialysis for a hematocrit greater than 30%. After single and multiple sc administrations of 14cpeg erythropoetin in rats, radioactivity was detected in all analyzed tissues except oesophagus. Methoxy polyethylene glycol epoetin beta pegepo is indicated for the treatment of anaemia due to chronic kidney disease.
Its long halflife allows it to be administered once per month in. Methoxy polyethylene glycolepoetin beta and continuous erythropoietin receptor activator. Methoxy polyethylene glycol epoetin beta was detected in maternal milk 4 hours postdose and reached maximum concentration 48 hours postdose. Effect of methoxy polyethylene glycol epoetin beta on oxidative stress in predialysis patients with chronic kidney disease. Methoxy polyethylene glycolepoetin beta for esrd dialysis. Mircera, methoxy polyethylene glycolepoetin beta, is an esa which differs from erythropoietin through formation of a chemical bond between an amino group present in erythropoietin beta and methoxy polyethylene. Dailymed mircera methoxy polyethylene glycolepoetin beta. In rat, both unchanged methoxy polyethylene glycolepoetin beta. Methoxy polyethylene glycol epoetin beta for the treatment of other conditionsdiseases is considered, including, but not limited to, the treatment of anemia due to cancer chemotherapy or as a substitute for red blood cell transfusions in individuals who require immediate correction of anemia, investigational. Limitations of use mircera is not indicated and is not. Data on methoxy polyethylene glycolepoetin beta metabolism in animals is not available. Methoxy polyethylene glycolepoetin beta is an erythropoietin continuous receptor activator with increased halflife when compared to erythropoietin. Subcutaneous injections can be given in the abdomen, arm or thigh.
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