OMONTYS Rx

Indication(s):

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

Pharmacology:

Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in red cell precursors in vitro.

Clinical Trials:

The efficacy and safety of Omontys in patients with CKD on dialysis were demonstrated in two randomized, active-controlled, open-label clinical studies that evaluated Omontys in the maintenance of hemoglobin (Hb) concentrations in patients who were being treated with another ESA (epoetin alfa or epoetin beta) at the time of study entry. The primary efficacy endpoint for each study was the change in Hb from baseline to the evaluation period (Weeks 29 to 36) using a non-inferiority comparison with epoetin. The median dose of Omontys was 0.07mg/kg administered once monthly and the median dose of epoetin was 113units/kg administered weekly (in 1 to 3 doses).

Patients were randomized (2 to 1) to receive Omontys once monthly, or to continue on their current ESA 1–3 times per week. The Omontys starting dose was based on the patient’s total weekly ESA dose during the last week of the screening period. Treatment with Omontys once monthly and with epoetin 1–3 times per week maintained Hb concentrations within the study pre-specified Hb range (10–12g/dL). In both studies, the proportion of patients receiving transfusions was similar in each treatment group.

Legal Classification:

Rx

Adults:

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:

Not established.

Contraindication(s):

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 Reaction(s)

Dyspnea, diarrhea, nausea, cough, arteriovenous fistula site complication.

How Supplied:

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

LAST UPDATED:

12/17/2012