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RETACRIT™ (epoetin alfa-epbx)

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RETACRIT™ Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

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1 INDICATIONS AND USAGE

1.1 Anemia Due to Chronic Kidney Disease

RETACRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

Evaluation of Iron Stores and...

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3 DOSAGE FORMS AND STRENGTHS

Injection:

  • 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and...
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5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

  • In controlled clinical trials of patients with CKD...
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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

  • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

RETACRIT from multiple-...

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10 OVERDOSAGE

RETACRIT overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of RETACRIT dosage and/or with phlebotomy, as clinically indicated...

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11 DESCRIPTION

Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Epoetin alfa products stimulate erythropoiesis by the same mechanism as endogenous erythropoietin.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of epoetin alfa products has not been evaluated.

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14 CLINICAL STUDIES

14.1 Patients with Chronic Kidney Disease

Adult Patients on Dialysis...

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16 HOW SUPPLIED/STORAGE AND HANDLING

RETACRIT (epoetin alfa-epbx) injection is a sterile, clear, and colorless solution in single-dose and multiple-dose vials available as:

...
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This Medication Guide has been...
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Instructions for Use

RETACRIT® (Ret-uh-krit)
(epoetin alfa-epbx)

Use these Instructions for Use if you or your caregiver has been trained...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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