Methoxy polyethylene glycol-epoetin beta


Generic Medicine Info
Indications and Dosage
Intravenous, Subcutaneous
Anaemia of chronic renal failure
Adult: Patients not previously treated w/ erythropoiesis-stimulating agent (ESA): Initially, 0.6 mcg/kg once every 2 wk via IV or SC inj. Increase dose by approx 25% if Hb level is <10 g/dL. Reduce dose by approx 25% if Hb level approaches 12 g/dL. If Hb level continues to increase despite dose reduction, interrupt treatment until Hb level begins to decrease and restart treatment at a dose approx 25% lower than the previous dose. If Hb level stabilises, a once mthly dose that is twice the dose administered every 2 wk may be given. Titrate as necessary. Dosage adjustments should not be made more often than once mthly. Alternatively, for non-dialysis patients, an initial dose of 1.2 mcg/kg once mthly via SC inj may be given. Patients currently treated w/ ESA (darbepoetin alfa or epoetin): Administer once mthly or once every 2 wk based on previous wkly ESA dose, started on the next scheduled dose of ESA. Dosage adjustments is the same w/ patients not currently treated w/ ESA.
Contraindications
History of serious allergic reactions, uncontrolled HTN, pure red cell aplasia.
Special Precautions
Patients w/ history of CV disease or stroke. Perisurgical patients. Not indicated for treatment of anaemia due to cancer chemotherapy or hepatitis C, or as substitute for RBC transfusions in patients requiring immediate correction of anaemia. Pregnancy and lactation.
Adverse Reactions
Significant: Pure red cell aplasia, exacerbation of HTN, hypertensive encephalopathy, seizures, serious allergic reactions (e.g. angioedema, bronchospasm, anaphylaxis).
Nervous: Headache, flu-like symptoms.
CV: Hypotension, peripheral oedema.
GI: Diarrhoea, nausea, vomiting, constipation, GI bleeding.
Resp: Nasopharyngitis, upper resp tract infection, dyspnoea.
Genitourinary: UTI.
Endocrine: Hypervolaemia.
Haematologic: Haemorrhage, changes in platelet count.
Musculoskeletal: Muscle spasm, bone pain, myalgia.
Dermatologic: Rash.
Others: Local pain, fever.
Potentially Fatal: Serious CV events (e.g. thrombosis) or cerebrovascular events (e.g. stroke).
MonitoringParameters
Evaluate Fe status prior to and during treatment. Monitor BP before and during treatment, and Hb levels at least wkly until stable then at least mthly.
Overdosage
Symptoms: Elevated Hb levels, severe HTN. Management: Dosage reduction or discontinuation, w/ phlebotomy, as clinically indicated.
Lab Interference
May interfere w/ antibody assay.
Action
Description: Methoxy polyethylene glycol-epoetin beta, a continuous erythropoietin receptor activator, stimulates erythropoiesis through interaction w/ the erythropoietin receptor on progenitor cells in the bone, thereby increasing RBC production. It has properties similar to epoetins but has longer duration of action.
Onset: Hb increase: 7-15 days.
Pharmacokinetics:
Absorption: Absolute bioavailability: Approx 60% (SC). Time to peak plasma concentration: 72 hr (SC).
Excretion: Terminal elimination half-life: Approx 134 hr (IV); approx 140 hr (SC).
Storage
Store between 2-8°C. Do not freeze. Protect from light.
Any unused portions should be disposed of in accordance w/ local requirements.
ATC Classification
B03XA03 - methoxy polyethylene glycol-epoetin beta ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
References
Anon. Methoxy Polyethylene Glycol-Epoetin Beta. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/04/2017.

Buckingham R (ed). Methoxy Polyethylene Glycol-Epoetin Beta. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2017 .

Joint Formulary Committee. Methoxy Polyethylene Glycol-Epoetin Beta. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2017.

Mircera Injection, Solution (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/04/2017.

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