EPOETIN ALFA-EPBX

Other

Brand names: RETACRIT

Intravenous, Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Epoetin alfa products stimulate erythropoiesis by the same mechanism as endogenous erythropoietin.

Indications

and upon initiation

there is a minimum of two additional months of planned chemotherapy ( 1.3 ). • Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective

noncardiac

nonvascular surgery ( 1.4 ). Limitations of Use RETACRIT has not been shown to improve quality of life

fatigue

or patient well-being ( 1.5 ). RETACRIT is not indicated for use: • In patients with cancer receiving hormonal agents

Contraindications

• infants
• pregnant women
• and lactating women [see Warnings and Precautions (5.9)
• Use in Specific Populations (8.1
• 8.2

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit ( 5
• Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer ( 5
• Seizures: Epoetin alfa products increase the risk for seizures in patients with CKD ( 5
• Serious Allergic Reactions: Discontinue RETACRIT and manage reactions ( 5

Known Side Effects

7 documented side effects by frequency

Shortness of Breath

1-10%

Nausea

1-10%

Vomiting

1-10%

Itching

1-10%

Diarrhea

0.1-1%

Low Blood Pressure

0.1-1%

Weakness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous, Subcutaneous