Methoxy polyethylene glycol-epoetin beta: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

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).

Pregnancy Category (US FDA)

Parenteral: C

Monitoring Parameters

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.

MIMS Class

Haematopoietic Agents

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.

Disclaimer: This information is independently developed by MIMS based on Methoxy polyethylene glycol-epoetin beta from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com