Epoetin Alfa-Epbx (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- RETACRIT
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)].
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 [see Warnings and Precautions (5.1)] •Increased mortality and/or increased risk of tumor progression or recurrence in Patients with Cancer [see Warnings and Precautions (5.2)] •Hypertension [see Warnings and Precautions (5.3)] •Seizures [see Warnings and Precautions (5.4)] •PRCA [see Warnings and Precautions (5.6)] •Serious allergic reactions [see Warnings and Precautions (5.7)] •Severe Cutaneous Reactions [see Warnings and Precautions (5.8)]
Mechanism of Action
Epoetin alfa products stimulate erythropoiesis by the same mechanism as endogenous erythropoietin.
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 [see Clinical Pharmacology (12.2)]. Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions (5.3)].