RETACRIT 3000 [iU]/mL
epoetin alfa-epbx · INJECTION, SOLUTION · Vifor (International) Inc.
RETACRIT is a injection, solution containing epoetin alfa-epbx at 3000 [iU]/mL, taken intravenous. Manufactured by Vifor (International) Inc..
Key Facts
- Brand Name
- RETACRIT
- Generic Name
- epoetin alfa-epbx
- NDC Code (Product)
59353-003- Manufacturer
- Vifor (International) Inc.
- Strength
- 3000 [iU]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA125545
- Marketing Start
- 06/18/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). o 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 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, 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 autologo…
Dosage & Administration
2 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 ). 2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supp…
Contraindications
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) ] . • 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 ).
Adverse Reactions
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 [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) ] • 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 …
Frequently Asked Questions
What is RETACRIT used for?
RETACRIT contains epoetin alfa-epbx. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is RETACRIT a controlled substance?
RETACRIT is not classified as a controlled substance by the DEA.
What is the generic name for RETACRIT?
The generic name for RETACRIT is epoetin alfa-epbx. There are no other listed brand versions of epoetin alfa-epbx.
What is the NDC code for RETACRIT 3000 [iU]/mL?
The NDC (National Drug Code) for RETACRIT 3000 [iU]/mL is 59353-003, listed by Vifor (International) Inc..
Other RETACRIT Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)