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The biosimilar clinical development program for RETACRIT included 2 randomized, multicenter, double-blind, active-controlled trials in adult subjects with CKD on hemodialysis.
Difference between RETACRIT and Epogen in mean weekly hemoglobin (Hb) levels during the last 4 weeks of the double-blind treatment period
Difference between RETACRIT and Epogen in mean weekly dosage per kg body weight during the last 4 weeks of the double-blind treatment period
*RETACRIT does not have a designation of interchangeability with Epogen/Procrit.
†Calculated from Hb levels and dose data collected during the last 4 weeks of treatment in the double-blind Maintenance Period with each study drug.
‡For SC (16-week Treatment Period) and IV (24-week Treatment Period) clinical studies.
§No statistically significant difference was observed between treatment groups.
||Results were comparable; no test for statistical significance was performed.
adult patients with CKD on hemodialysis2
Subject eligibility determined during the Screening Period, within 4 weeks prior to randomization. Stable subjects taking intravenous (IV) Epogen were randomized to receive either RETACRIT or Epogen by SC injection 1 to 3 times per week, for 12-18 weeks. All subjects must have been optimally titrated and stable with SC administration for entry into Maintenance Period.
adult patients with CKD on hemodialysis2
Subject eligibility determined during the Screening Period, within 4 weeks prior to randomization. Stable subjects [taking intravenous (IV) Epogen were randomized to receive either RETACRIT or Epogen by SC injection1 to 3 times per week, for 12-18 weeks. All subjects must have been optimally titrated and stable with SC administration for entry into Maintenance Period.
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¶Statistical analysis supporting biosimilarity: 95% confidence interval for LS mean for the difference between RETACRIT and Epogen treatment groups during last 4 weeks of maintenance was -0.17 to 0.24 g/dL/week (SC study) and -0.25 to 0.01 g/dL/week (IV study) and was contained within prespecified acceptance limits of +/-0.5 g/dL/week.
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#Statistical analysis supporting biosimilarity: 95% confidence interval for LS mean for the difference between RETACRIT and Epogen treatment groups during last 4 weeks of maintenance was -14.51 to 9.82 U/kg/week (SC study) and -10.40 to 11.13 U/kg/week (IV study) and was contained within prespecified acceptance limits of +/-45 U/kg/week.
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**Prespecified secondary efficacy endpoint. Other secondary efficacy analyses conducted on the ITT population (7 endpoints) provided supportive results for the conclusion of no statistically significant difference between treatment groups.
WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
CHRONIC KIDNEY DISEASE
CANCER
PERISURGERY
CONTRAINDICATIONS
RETACRIT® is contraindicated in patients with:
RETACRIT® from multiple-dose vials contains benzyl alcohol and is contraindicated in:
INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM
INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER
HYPERTENSION
SEIZURES
LACK OR LOSS OF HEMOGLOBIN RESPONSE TO RETACRIT®
PURE RED CELL APLASIA
SERIOUS ALLERGIC REACTIONS
SEVERE CUTANEOUS REACTIONS
RISK OF SERIOUS ADVERSE REACTIONS DUE TO BENZYL ALCOHOL PRESERVATIVE
RISK IN PATIENTS WITH PHENYLKETONURIA
DIALYSIS MANAGEMENT
ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE
ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER
SURGERY/PERISURGERY
ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION
ANEMIA DUE TO CHRONIC KIDNEY DISEASE
RETACRIT® is indicated for the treatment of anemia due to CKD, including patients on dialysis and not on dialysis, to decrease the need for RBC transfusion.
ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION
RETACRIT® is indicated for the treatment of anemia due to zidovudine administered at ≤4,200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤500 mUnits/mL.
ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER
RETACRIT® is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
REDUCTION OF ALLOGENEIC RED BLOOD CELL TRANSFUSIONS IN PATIENTS UNDERGOING ELECTIVE, NONCARDIAC, NONVASCULAR SURGERY
RETACRIT® is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin >10 to ≤13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT® is not indicated for patients who are willing to donate autologous blood preoperatively.
Limitations of Use
RETACRIT® has not been shown to improve quality of life, fatigue, or patient well-being.
RETACRIT® is not indicated for use:
Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide, for RETACRIT.
ANEMIA DUE TO CHRONIC KIDNEY DISEASE
RETACRIT® is indicated for the treatment of anemia due to CKD, including patients on dialysis and not on dialysis, to decrease the need for RBC transfusion.
ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION
RETACRIT® is indicated for the treatment of anemia due to zidovudine administered at ≤4,200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤500 mUnits/mL.
ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER
RETACRIT® is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
REDUCTION OF ALLOGENEIC RED BLOOD CELL TRANSFUSIONS IN PATIENTS UNDERGOING ELECTIVE, NONCARDIAC, NONVASCULAR SURGERY
RETACRIT® is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin >10 to ≤13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT® is not indicated for patients who are willing to donate autologous blood preoperatively.
Limitations of Use
RETACRIT® has not been shown to improve quality of life, fatigue, or patient well-being.
RETACRIT® is not indicated for use:
Please see full Prescribing Information, including BOXED WARNING.
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