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RETACRIT™ Index Section (epoetin alfa-epbx)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

1 INDICATIONS AND USAGE

1.1 Anemia Due to Chronic Kidney Disease

1.2 Anemia Due to Zidovudine in Patients with HIV-infection

1.3 Anemia Due to Chemotherapy in Patients with Cancer

1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

1.5 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

2.2 Patients with Chronic Kidney Disease

2.3 Zidovudine-treated Patients with HIV-infection

2.4 Patients on Cancer Chemotherapy

2.5 Surgery Patients

2.6 Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

5.2 Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer

5.3 Hypertension

5.4 Seizures

5.5 Lack or Loss of Hemoglobin Response to RETACRIT

5.6 Pure Red Cell Aplasia

5.7 Serious Allergic Reactions

5.8 Severe Cutaneous Reactions

5.9 Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative

5.10 Risk in Patients with Phenylketonuria

5.11 Dialysis Management

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

6.3 Immunogenicity

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Patients with Chronic Kidney Disease

14.2 Zidovudine-treated Patients with HIV-Infection

14.3 Patients with Cancer on Chemotherapy

14.4 Surgery Patients

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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