HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use RETACRIT safely and effectively. See full prescribing information for RETACRIT.
RETACRIT® (epoetin alfa-epbx) injection, for intravenous or subcutaneous use
Initial U.S. Approval: 2018
RETACRIT (epoetin alfa-epbx) is biosimilar to EPOGEN/PROCRIT (epoetin alfa)
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
See full prescribing information for complete boxed warning.
Chronic Kidney Disease:
- In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL (5.1).
- No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks (2.2).
- Use the lowest RETACRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions (5.1).
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (5.2).
- Use the lowest dose to avoid RBC transfusions (2.4).
- Use ESAs only for anemia from myelosuppressive chemotherapy (1.3).
- ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5).
- Discontinue following the completion of a chemotherapy course (2.4).
- Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended (5.1).
RECENT MAJOR CHANGES
|Dosage and Administration, Important Dosing Information (2.1, 2.6)
|Warnings and Precautions, Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative (5.9)
INDICATIONS AND USAGE
RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for:
- Treatment of anemia due to
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).
- Zidovudine in patients with HIV-infection (1.2).
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3).
- Reduction of allogeneic 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, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (1.5).
- In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5).
- In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion (1.5).
- In patients scheduled for surgery who are willing to donate autologous blood (1.5).
- In patients undergoing cardiac or vascular surgery (1.5).
- As a substitute for RBC transfusions in patients who require immediate correction of anemia (1.5).
DOSAGE AND ADMINISTRATION
- Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment (2.1).
- In pregnant women, lactating women, neonates, infants: Use only single-dose vials (2.1).
- Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis (2.2).
- Patients on Zidovudine due to HIV-infection: 100 Units/kg 3 times weekly (2.3).
- Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years) (2.4).
- Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly (2.5).
DOSAGE FORMS AND STRENGTHS
- 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL in single-dose vials (3).
- 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL in multiple-dose vials containing benzyl alcohol (3).
- Uncontrolled hypertension (4).
- Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs (4).
- Serious allergic reactions to RETACRIT or other epoetin alfa products (4).
- Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women (4).
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 (5.1 and 14.1). Use caution in patients with coexistent cardiovascular disease and stroke (5.1).
- Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer (5.2).
- Hypertension: Control hypertension prior to initiating and during treatment with RETACRIT (5.3).
- Seizures: Epoetin alfa products increase the risk for seizures in patients with CKD (5.4). Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms (5.4).
- PRCA: If severe anemia and low reticulocyte count develop during RETACRIT treatment, withhold RETACRIT and evaluate for PRCA (5.6).
- Serious Allergic Reactions: Discontinue RETACRIT and manage reactions (5.7).
- Severe Cutaneous Reactions: Discontinue RETACRIT (5.8).
- Phenylketonurics: Contains phenylalanine (5.10).
- Patients with CKD: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection (6.1).
- Patients on Zidovudine due to HIV-infection: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation (6.1).
- Patients with Cancer on Chemotherapy: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis (6.1).
- Surgery Patients: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc., a Pfizer Company, at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.