RETACRIT™ Contraindications (epoetin alfa-epbx) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

RETACRIT is contraindicated in patients with:

Uncontrolled hypertension [see Warnings and Precautions (5.3)].
Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs [see Warnings and Precautions (5.6)].
Serious allergic reactions to RETACRIT or other epoetin alfa products [see Warnings and Precautions (5.7)].

RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in:

Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.2 and 8.4)].

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
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Resources

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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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4 CONTRAINDICATIONS

RETACRIT is contraindicated in patients with:

Uncontrolled hypertension [see Warnings and Precautions (5.3)].
Pure red cell...

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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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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.