Epoetin Alfa-epbx
Generic Name: epoetin alfa-epbx
Brand Names:
Retacrit
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 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin.
Overview
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 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin.
Uses
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 ).
Dosage
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 ).
Side Effects
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 spas...
Warnings
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE 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. 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 ( 5.1 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 ). 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) ] .
Pregnancy
8.1 Pregnancy Risk Summary RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications (4) ] . When therapy with RETACRIT is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix RETACRIT with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol (see Clinical Considerations ) [see Dosage and Administration (2.1) ] .
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. When exposed to freezing temperatures, the green area of the freeze strip indicator in the carton of the multiple-dose vials will show signs of cloudy or white discoloration. Do not shake. Do not use RETACRIT that has been shaken or frozen or if the green area of the freeze strip indicator is cloudy or white.
Frequently Asked Questions
What is Epoetin Alfa-epbx used for?▼
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 ).
What are the side effects of Epoetin Alfa-epbx?▼
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 spas...
Can I take Epoetin Alfa-epbx during pregnancy?▼
8.1 Pregnancy Risk Summary RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications (4) ] . When therapy with RETACRIT is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix RETACRIT with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol (see Clinical Considerations ) [see Dosage and Administration (2.1) ] .
What are the important warnings for Epoetin Alfa-epbx?▼
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE 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. 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 ( 5.1 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 ). 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) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.