Methoxy Polyethylene Glycol / Epoetin Beta

Pronunciation: meth-OX-ee POL-ee-ETH-i-leen GLYE-kol/e-POE-e-tin BAY-ta
Class: Hematopoietic

Trade Names

Mircera
- Injection, solution 50 mcg per 0.3 mL
- Injection, solution 50 mcg/mL
- Injection, solution 75 mcg per 0.3 mL
- Injection, solution 100 mcg per 0.3 mL
- Injection, solution 100 mcg/mL
- Injection, solution 150 mcg per 0.3 mL
- Injection, solution 200 mcg per 0.3 mL
- Injection, solution 200 mcg/mL
- Injection, solution 250 mcg per 0.3 mL
- Injection, solution 300 mcg/mL
- Injection, solution 400 mcg per 0.6 mL
- Injection, solution 400 mcg/mL
- Injection, solution 600 mcg per 0.6 mL
- Injection, solution 600 mcg/mL
- Injection, solution 800 mcg per 0.6 mL
- Injection, solution 1,000 mcg/mL

Pharmacology

A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the blood stream in response to hypoxia. In responding to hypoxia, erythropoietin interacts with erythroid progenitor cells to increase red cell production.

Pharmacokinetics

Absorption

Absolute bioavailability was 62% after subcutaneous administration.

Elimination

Terminal half-life was 134 ± 65 h and 139 ± 67 h (IV and subcutaneous, respectively), and total systemic Cl was 0.49 ± 0.18 mL/h/kg (subcutaneous).

Onset

7 to 15 days following initial dose.

Indications and Usage

Treatment of anemia associated with chronic renal failure (CRF) in adults.

Contraindications

Uncontrollable hypertension; hypersensitivity or allergy to any component of product.

Dosage and Administration

Patients Not Currently Treated With an Erythropoiesis-Stimulating Agent (ESA)
Adults

IV/Subcutaneous Start with 0.6 mcg/kg once every 2 wks. Once the hemoglobin has been maintained in the range between 10 and 12 g/dL, administer once monthly at a dose that is twice the every-2-week dose and titrate as necessary.

Patients Currently Treated With an ESA
Adults

IV/Subcutaneous Administer once every 2 wk or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Base the dose on the total weekly ESA dose at the time of conversion. Previous weekly epoetin alfa dose less than 8,000 units/wk; previous weekly darbepoetin alfa dose less than 40 mcg/wk: Administer 60 mcg every 2 wk or 120 mcg/mo. Previous weekly epoetin alfa dose 8,000 to 16,000 units/wk; previous weekly darbepoetin alfa dose 40 to 80 mcg/wk: Administer 100 mcg every 2 wk or 200 mcg/mo. Previous weekly epoetin alfa dose greater than 16,000 units/wk; previous weekly darbepoetin alfa dose more than 80 mcg/wk: Administer 180 mcg every 2 wk or 360 mcg/mo.

General Advice

  • Reduce dose as hemoglobin approaches 12 g/dL or increases by more than 1 g/dL in any 2-wk period.
  • Maintain hemoglobin levels within the range of 10 to 12 g/dL.
  • The IV route is recommended for patients receiving hemodialysis.
  • When administering subcutaneously, inject in the abdomen, arm, or thigh.
  • Administer the lowest dose that will maintain a hemoglobin level sufficient to avoid the need for recurrent RBC transfusions.
  • Do not make dose adjustments more often than once a month.
  • Adjust dose in increments or decrements of approximately 25%.
  • If the increase in hemoglobin is greater than 1 g/dL in 2 wk or if the hemoglobin is increasing and approaching 12 g/dL, reduce the dose approximately 25%. If the hemoglobin continues to increase, discontinue this medication until the hemoglobin begins to decrease, then restart treatment at a dose approximately 25% below the previously administered dose.
  • For patients not converted from another ESA, if the hemoglobin increase is less than 1 g/dL over the initial 4 wk of treatment and iron stores are adequate, increase the dose by approximately 25%.
  • If a dose is missed, administer the missed dose as soon as possible and restart this medication at the prescribed dosing frequency.
  • Always store in original cartons.
  • Do not mix with any parenteral solution.

Storage/Stability

Store at 36° to 46°F. Do not freeze or shake. Protect from light. When necessary, vials may be stored at temperatures up to 77°F and for no more than 7 days. When necessary, prefilled syringes may be stored at temperatures up to 77°F and for no more than 30 days.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension (13%); procedural hypotension (8%); arteriovenous fistula thrombosis, hypotension (5%).

CNS

Headache (9%).

EENT

Nasopharyngitis (11%).

GI

Diarrhea (11%); vomiting (6%); constipation (5%).

Genitourinary

UTI (5%).

Local

Arteriovenous fistula site complication (5%).

Metabolic-Nutritional

Fluid overload (7%).

Musculoskeletal

Muscle spasms (8%); back pain (6%); pain in extremity (5%).

Respiratory

Upper respiratory tract infection (9%); cough (6%).

Precautions

Warnings

Renal failure

Risk of death or serious CV events (ie, MI, stroke, CHF, hemodialysis vascular access thrombosis) may be increased when ESAs are administered to target higher versus lower Hgb levels (eg, 13.5 vs. 11.3 g/dL).

Cancer

Not indicated for anemia due to cancer chemotherapy.


Monitor

Regularly monitor hematological parameters; maintaining Hgb levels within the range of 10 to 12 g/dL. Monitor Hgb every 2 wk until Hgb level stabilizes between 10 and 12 g/dL and the dose of therapy is established, then monitor at least monthly. Monitor and control BP during treatment. During the first several months of therapy, closely monitor premonitory neurologic symptoms. Evaluate iron status before and during treatment. Evaluate iron status before and during treatment. Provide supplemental iron in patients whose serum ferritin is below 100 mcg/mL or whose serum transferrin saturation is below 20%.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Allergic reactions

Serious allergic reactions have been reported.

CRF not requiring dialysis

Lower maintenance doses may be required than for patients receiving dialysis.

Dialysis management

Treatment may result in increased RBC or decreased plasma volume, which could reduce dialysis efficiency and necessitate adjustments in dialysis prescription.

Hematologic effects

Average platelet counts may decrease.

Hypertension

Should be controlled adequately before initiation of therapy.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity.

Lack or loss of response

Lack of or failure to maintain a Hgb response with doses within the recommended dosing range should prompt a search for causative factors.

Pure red cell aplasia

Pure red cell aplasia and severe anemia, with or without other cytopenias, have been associated with development of neutralizing antibodies to erythropoietin in patients receiving ESAs.

Seizures

May occur.

Overdosage

Symptoms

Any CV events described in Warnings and Precautions or Adverse Reactions, excessive and rapid increase in hemoglobin concentration.

Patient Information

  • Instruct patients to inform health care provider or obtain medical attention immediately if they experience blood clots in the hemodialysis vascular access; chest pain; cool or pale arm or leg; dizziness; leg pain; loss of balance or coordination; loss of consciousness; seizures; sudden confusion or trouble speaking or understanding speech; sudden numbness or weakness of the face, arm, or leg (especially on one side of the body); sudden severe headache with no known cause; sudden trouble seeing in one or both eyes; sudden trouble walking; trouble breathing or shortness of breath.
  • Instruct patients to inform health care provider if they have heart disease, high BP, a blood disorder, history of stroke, blood clots or seizures, or if they have or develop cancer.
  • Instruct patient to inform health care provider if a lump, swelling, or bruising develops at the injection site and does not go away.

Copyright © 2009 Wolters Kluwer Health.

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