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EPREX STERILE is a brand name for Epoetin Alfa, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EPREX® (epoetin alfa) is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions. Eprex therapy is not intended for patients who require immediate correction of severe anemia. Eprex may obviate the need for…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration XX/2022 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 08/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES .....................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS..............................................................................................................
1 Pediatrics ........................................................................................................... 2 Geriatrics............................................................................................................
5 2 CONTRAINDICATIONS ............................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................... 6 4 DOSAGE AND ADMINISTRATION ..............................................................................
1 Dosing Considerations........................................................................................ 2 Recommended Dose and Dosage Adjustment .................................................... 4 Administration...................................................................................................
12 5 OVERDOSAGE ......................................................................................................... 12
, Hypertension). Increased Mortality, Serious Adverse Cardiovascular Reactions, Thromboemb olic Events and Stroke During hemodialysis, patients treated with Eprex may require increased anticoagulation with heparin to prevent clotting of the artificial kidney.
25 events per patient -year on Eprex therapy. 04 events per patient-year of Eprex therapy. Patients with pre- existing vascular disease should be monitored closely. Patients with CRF experienced greater risks for death, serious adverse cardiovascular reactions and stroke when administered ESAs to target hemoglobin levels of 130 g/L and above in clinical studies.
No trial has identified a hemoglobin target level, dose or dosing strategy that does not increase these risks. Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for adverse cardiovascular reactions and mortality than other patients.
Eprex and other ESAs increased the risks for death and for serious adverse cardiovascular reactions and thromboembolic events in controlled clinical trials of patients with cancer. These reactions included myocardial infarction, stroke, congestive heart failure and an increased risk of serious arterial and venous thromboembolic events including hemodialysis vascular access thrombosis.
0 Page 17 of 75 to these risks (see 14 CLINICAL TRIALS, CRF; CANCER). CRF patients with hypo-responsiveness to ESAs may be at an increased risk for mortality and adverse cardiovascular reactions. These patients should be evaluated for treatable conditions (see 7 WARNINGS AND PRECAUTIONS: Lack or Loss of Response and 4 DOSAGE AND ADMINISTRATION: CRF PATIENTS).
g. deep venous thrombosis or pulmonary embolism) (see 14 CLINICAL TRIALS and 4 DOSAGE AND ADMINISTRATION, CRF PATIENTS; CANCER PATIENTS RECEIVING CHEMOTHERAPY). To minimize the risks for death and serious adverse cardiovascular reactions, Eprex and other ESAs should follow the recommended dose for each indication.
, Sensitivity/Resistance 08/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES .....................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS..............................................................................................................
1 Pediatrics ........................................................................................................... 2 Geriatrics............................................................................................................
5 2 CONTRAINDICATIONS ............................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................... 6 4 DOSAGE AND ADMINISTRATION ..............................................................................
1 Dosing Considerations........................................................................................ 2 Recommended Dose and Dosage Adjustment .................................................... 4 Administration...................................................................................................
12 5 OVERDOSAGE ......................................................................................................... 12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................... 13 7 WARNINGS AND PRECAUTIONS ............................................................................
1 Special Populations .......................................................................................... 1 Pregnant Women .......................................................................................... 2 Breast-feeding...............................................................................................
Eprex (epoetin alfa) is contraindicated in patients: who develop pure red cell aplasia (PRCA) following treatment with any erythropoiesis regulating hormone (see 7 WARNINGS AND PRECAUTIONS, Immune); with uncontrolled hypertension; with known hypersensitivity to mammalian cell-derived products or any component of the product; (see 4 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING); who for any reason cannot receive adequate antithrombotic treatment.
The use of Eprex in patients scheduled for elective surgery and not participating in an autologous blood donation program is contraindicated in patients with severe coronary, peripheral arterial, carotid, or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Contraindications defined by the guidelines and methods of practice for ABD programs should be respected in patients receiving Eprex. 0 Page 6 of 75
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For CRF patients, individualize dosing to achieve and maintain hemoglobin levels within the recommended range of 100 -115 g/L. The hemoglobin concentrations should not exceed 120 g/L; the rate of hemoglobin increase should not exceed 10 g/L in any 2-week period.
For patients with cancer, use the lowest dose sufficient to avoid blood transfusions (see 4 DOSAGE AND ADMINISTRATION). Cardiovascular – Surgery Patients Rarely, blood pressure may rise in the perioperative period in patie nts being treated with Eprex.
Therefore, blood pressure should be monitored. Thrombotic/Vascular Events Independent of Eprex treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Therefore, routine volume replacement should be performed in such patients in autologous blood donation programs. , sickle cell anemia, myelodysplastic syndromes, or hypercoagulable disorders). Hepatic/Biliary/Pancreatic Hepatic Dysfunction The safety of Eprex has not been established in patients with hepatic dysfunction.
Use in Patients with Known Porphyria:
The initial presentation or exacerbation of porphyria has been observed rarely in Eprex -treated patients. Eprex should be used with caution in patients with known porphyria. 0 Page 18 of 75 rate of rise of hemoglobin. This effect may be related to an increased rate of n ucleic acid synthesis in the bone marrow.
Consequently, Eprex should be administered with caution to patients with a history of gout. Immune Pure Red Cell Aplasia Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Eprex.
This has been reported in patients receiving Eprex. Any patient who develops a sudden loss of response to Eprex, accompanied by severe anemia and low reticulocyte count should be evaluated for the etiology of loss of effect, including the presence of neutralizing antibodies to erythropoietin.
If anti-erythropoietin antibody-associated anemia is suspected, withhold Eprex and other erythropoietic proteins. Contact Janssen Inc. at 1-800-567-3331 to perform assays for binding and neutralizing antibodies. Eprex should be permanently discontinued in patients with antibody-mediated anemia.
Patients should not be switched to other erythropoietic proteins as antibodies may cross-react (see 8 ADVERSE REACTIONS). Monitoring and Laboratory Tests Hematology All patients receiving Eprex should have hematocrit/hemoglobin levels measured once a week until hematocrit/hemoglobin has been stabilized and measured periodically thereafter (see Monitoring and Laboratory Tests – CRF Patients, Hematology for additional laboratory monitoring in CRF patients).
There may be a moderate dose-dependent rise in the platelet count, within the normal range, during treatment with Eprex. […]
3 Pediatrics ...................................................................................................... 22 8 ADVERSE REACTIONS ............................................................................................ 1 Adverse Reaction Overview..............................................................................
2 Clinical Trial Adverse Reactions ........................................................................ 1 Clinical Trial Adverse Reactions - Pediatrics .................................................. 3 Less Common Clinical Trial Adverse Reactions.................................................
5 Post-Market Adverse Reactions ........................................................................ 30 9 DRUG INTERACTIONS ............................................................................................. 4 Drug-Drug Interactions......................................................................................
5 Drug-Food Interactions ..................................................................................... 6 Drug-Herb Interactions...................................................................................... 7 Drug-Laboratory Test Interactions .....................................................................
31 10 CLINICAL PHARMACOLOGY ................................................................................... 1 Mechanism of Action ..................................................................................... 2 Pharmacodynamics .......................................................................................
3 Pharmacokinetics.......................................................................................... 37 11 STORAGE, STABILITY AND DISPOSAL .................................................................. 42 12 SPECIAL HANDLING INSTRUCTIONS .....................................................................
42 PART II: SCIENTIFIC INFORMATION .................................................................................. 43 13 PHARMACEUTICAL INFORMATION ........................................................................ 43 14 CLINICAL TRIALS ....................................................................................................
1 Clinical Trials by Indication ............................................................................ 43 CRF ...........................................................................................................................
43 Zidovudine-treated/HIV............................................................................................... 47 Cancer.......................................................................................................................
47 Surgery...................................................................................................................... 54 16 NON-CLINICAL TOXICOLOGY .................................................................................
56 PATIENT MEDICATION INFORMATION .............................................................................. 0 Page 4 of 75 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS EPREX® (epoetin alfa) is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions.
Eprex therapy is not intended for patients who require immediate correction of severe anemia. Eprex may obviate the need for maintenance transfusions but is not a substitute for emergency […]