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OMONTYS
Anemias
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Drug Name:

OMONTYS Rx

OMONTYS (peginesatide) 10mg/mL multiple-use vial by Affymax and Takeda

Generic Name and Formulations:
Peginesatide 2mg, 3mg, 4mg, 5mg, 6mg per 0.5mL single-use vial (preservative-free); 1mg, 2mg, 3mg, 4mg, 5mg, 6mg per 0.5mL single-use prefilled syringe (preservative-free); 10mg/mL, 20mg/2mL multiple-use vial (w. preservatives); solution for IV or SC inj.

Company:
Affymax and Takeda

e-Prescribe this drug via Surescripts

Therapeutic Use:

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Indications for OMONTYS:

Anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Adult Dose for OMONTYS:

Use lowest effective dose. Initiate when Hb <10g/dL. Not currently on ESA: Initially 0.04mg/kg as a single IV or SC inj once monthly. Converting from epoetin alfa: give first Omontys dose 1 week after last epoetin alfa dose. Converting from darbepoetin alfa: give first Omontys dose at next scheduled dose in place of darbepoetin alfa. See literature for estimated Omontys starting doses for patients based on previous weekly ESA dose. Do not increase dose > once every 4 weeks. If Hb rises rapidly (eg, >1g/dL in 2 weeks prior to dose or >2g/dL in 4 weeks), reduce dose by 25% or more to reduce rapid responses. If Hb approaches or exceeds 11g/dL, reduce or interrupt dose; when Hb decreases, resume at a dose approx. 25% below previous dose. If response is inadequate and Hb does not increase by >1g/dL after 4 weeks, increase dose by 25%. If response inadequate over 12-week escalation period, use lowest dose that will maintain Hb sufficient to reduce need for RBC transfusions. Discontinue if response does not improve.

Children's Dose for OMONTYS:

Not established.

Pharmacological Class:

Erythropoiesis-stimulating agent (ESA).

Contraindications:

Uncontrolled hypertension.

Warnings/Precautions:

Risk of death, serious cardiovascular reactions, stroke when ESA given to target Hb >11g/dL. Not for patients with CKD not on dialysis or for anemia due to cancer chemotherapy. Not a substitute for RBC transfusions in patients who require immediate correction of anemia. Evaluate iron status before and during therapy; maintain iron repletion. Correct or exclude other causes of anemia. Monitor Hb at least every 2 weeks, then monthly. Control hypertension prior to initiating; reduce or withhold dose if BP difficult to control. Risk of tumor progression/recurrence in cancer patients receiving ESAs. Consider antibody formation in treatment failures. Adjust anticoagulant dose to prevent clotting of extracorporeal circuit during hemodialysis. Pregnancy (Cat. C). Nursing mothers.

Adverse Reactions:

Dyspnea, diarrhea, nausea, cough, arteriovenous fistula site complication; serious allergic reactions (discontinue permanently if occurs).

How Supplied:

Single-use vial, single-use prefilled syringe, multi-use vial—1