Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. If you have cancer and you will not be receiving chemotherapy that may cause anemia. Most patients with chronic kidney disease will require supplemental iron (e.g., iron dextran; iron salts; iron sucrose, sucroferric oxyhydroxide; polysaccharide-iron complex; sodium ferric gluconate complex) during epoetin alfa receipt. If you or your caregiver has been trained to give Epogen shots (injections) at home: During treatment with Epogen, continue to follow your healthcare provider’s instructions for diet and medicines. Mechanism of Action. In the subgroup of patients (89/125 Epogen and 88/130 placebo) with pre-study endogenous serum erythropoietin levels ≤ 500 mUnits/mL, Epogen reduced the mean cumulative number of units of blood transfused per patient by approximately 40% as compared to the placebo group. Multiple Dose Vials 1080 Concurrent administration of androgens can increase the patient's response to epoetin alfa, reducing the amount required to treat anemia. Administer supplemental iron therapy when serum ferritin is < 100 mcg/L or when serum transferrin saturation is < 20%. However, the exact mechanism of action is unknown. Randomized, Controlled Studies With Decreased Survival and/or Decreased Locoregional Control. AMGEN® 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, Table 1: Randomized Controlled Trials Showing Adverse Cardiovascular Outcomes in Patients With CKD, Hemoglobin Target; Higher vs. Lower (g/dL), . After subcutaneous administration, Cmax was achieved within 5 to 24 hours. Increased mortality and/or increased risk of tumor progression or recurrence in Patients With Cancer, Injection site reactions, including irritation and pain. Advise breast-feeding women to not breast-feed for at least 2 weeks after the last dose of epoetin alfa, if a multidose vial was used. ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE, In controlled trials, patients experienced greater risks for death, serious, cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target, No trial has identified a hemoglobin target level, E, dose, or dosing strategy that does not increase these risks, Use the lowest Epogen dose sufficient to reduce the, ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in, patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers, To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC, ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure, Discontinue following the completion of a chemotherapy course, Due to increased risk of Deep Venous Thrombosis (DVT), DVT. In adult and pediatric patients with CKD, the elimination half-life (t1/2) of plasma erythropoietin after intravenous administration of Epogen ranged from 4 to 13 hours. • When the puncture-proof disposable container is full, tape around the cap or lid to make sure the cap or lid does not come off. Based on Kaplan-Meier estimates, at the time of study termination, the 12-month survival was lower in the epoetin alfa group than in the placebo group (70% vs. 76%; HR 1.37, 95% CI: 1.07, 1.75; p = 0.012). Further evaluation of this combination needs to be made. Do not mix Epogen with bacteriostatic saline containing benzyl alcohol, if administering Epogen to a lactating woman [see Dosage and Administration (2.1)]. Pharmacology, adverse reactions, warnings and side effects. In double-blind, placebo-controlled studies of 3 months duration involving approximately 300 zidovudine-treated patients with HIV-infection, adverse reactions with an incidence of ≥ 1% in patients treated with Epogen were: The data below were obtained in Study C1, a 16-week, double-blind, placebo-controlled study that enrolled 344 patients with anemia secondary to chemotherapy. Serious and fatal reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including Epogen multiple-dose vials. Rx Only, NDC 55513-267-10 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Most patients with chronic kidney disease will require supplemental iron (e.g., iron dextran; iron salts; iron sucrose, sucroferric oxyhydroxide; polysaccharide-iron complex; sodium ferric gluconate complex) during epoetin alfa receipt. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. During fetal development, EPO is produced in the liver, and prior to birth at term, production is transferred to the kidney. It is given by injection just under the skin or into a vein. Erythropoietin (EPO) interacts directly with the EPO receptor on the red blood cell (RBC) surface, triggering activation of several signal transduction pathways, resulting in the proliferation and … Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Epoetin alfa is contraindicated for use by patients with uncontrolled hypertension; control hypertension before and during epoetin alfa therapy in all patients. After the 150 Units/kg 3 times weekly dosing, the values of Tmax and CL were similar (13.3 ± 12.4 vs. 14.2 ± 6.7 hours, and 20.2 ± 15.9 vs. 23.6 ± 9.5 mL/hr/kg) between week 1 when patients were receiving chemotherapy (n = 14) and week 3 when patients were not receiving chemotherapy (n = 4). Wash your hands well with soap and water before preparing the medicine. In a 26-week, double-blind, placebo-controlled study, 118 patients on dialysis with an average hemoglobin of approximately 7 g/dL were randomized to either Epogen or placebo. if you are told by your healthcare provider that you may inject Epogen at home, read this Medication Guide each time you receive a new supply of medicine. Permanently discontinue Epogen in patients who develop PRCA following treatment with Epogen or other erythropoietin protein drugs. Epoetin alfa belongs to a class of drugs called colony-stimulating factors because of their ability to stimulate cells in the bone marrow to multiply and form colonies of identical cells. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. Dose-dependent increases in hemoglobin and hematocrit were observed with reductions in transfusion requirements. Iron - Injectable Only: (Minor) Inadequate iron stores will interfere with the therapeutic response to epoetin alfa (e.g., red blood cell production). Thousand Oaks, CA 91320-1799 U.S.A. Normal Hematocrit Study (NHS): A prospective, randomized, open-label study of 1265 patients with chronic kidney disease on dialysis with documented evidence of congestive heart failure or ischemic heart disease was designed to test the hypothesis that a higher target hematocrit (Hct) would result in improved outcomes compared with a lower target Hct. Most patients with chronic kidney disease will require supplemental iron (e.g., iron dextran; iron salts; iron sucrose, sucroferric oxyhydroxide; polysaccharide-iron complex; sodium ferric gluconate complex) during epoetin alfa receipt. Individualize dosing and use the lowest dose of Epogen sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Ferric carboxymaltose: (Minor) Inadequate iron stores will interfere with the therapeutic response to epoetin alfa (e.g., red blood cell production). We do not record any personal information entered above. Most patients with chronic kidney disease will require supplemental iron (e.g., iron dextran; iron salts; iron sucrose, sucroferric oxyhydroxide; polysaccharide-iron complex; sodium ferric gluconate complex) during epoetin alfa receipt. Patients receiving zidovudine with endogenous serum erythropoietin levels more than 500 mUnits/mL are unlikely to respond to epoetin alfa treatment. In each trial, the potential benefit of ESA therapy was offset by worse cardiovascular safety outcomes resulting in an unfavorable benefit-risk profile [see Warnings and Precautions (5.1)]. Epoetin alfa produces a dose-dependent increase in the hematocrit; an increase of 2% per week may be seen during the initial phase of therapy. Further evaluation of this combination needs to be made. Use only the type of disposable syringe and needle that your healthcare provider has prescribed. U.S. License No. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. if you are told by your healthcare provider that there is new information about Epogen. Sixty-nine percent of patients were white, 55% were male, and the median age of patients was 12 years (range: 5 to 18 years). In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. Hemoglobin increases greater than 1 g/dL in any 2-week period or. For patients with cancer, 900 units/kg/week IV (Max: 60,000 units) until completion of chemotherapy. Rx Only, NDC 55513-144-10 EPOGEN prescription and dosage sizes information for physicians and healthcare professionals. The multiple-dose vials of Epogen contain benzyl alcohol. It is used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. EPOGEN ® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions. In patients on hemodialysis, the intravenous (IV) route is recommended. Due to effective plasma donor screening for prior exposure to certain viruses, testing for the presence of viruses, and manufacturing processes designed to reduce the risk of transmitting viral infection, the risk of transmission of infectious agents associated with epoetin alfa products formulated with albumin is remote. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Slowly pull back on the plunger to fill the syringe with Epogen liquid to the number (mL or cc) that matches the dose your healthcare provider prescribed. ESA Effects on rates of death and other serious cardiac adverse reactions. Ninety-one percent of patients were white, 44% were male, and the median age of patients was 66 years (range: 20 to 88 years). Erythropoietin (EPO) is a glycoprotein that regulates the production of red blood cells by stimulating the division and differentiation of committed erythroid progenitor cells in the bone marrow. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in lactating women [see Contraindications (4), Warnings and Precautions (5.9)]. Patients responded to Epogen administered subcutaneously in a manner similar to patients receiving intravenous administration. At the end of the initial 12 weeks, a statistically significant rise in mean hemoglobin (3.1 g/dL vs. 0.3 g/dL) was observed only in the Epogen arm. Efficacy results are shown in Table 9. Throw away the syringe in the puncture-proof disposable container. Their mechanism of action is entirely different from the one used by Amgen and Johnson & Johnson products. Iron Dextran: (Minor) Inadequate iron stores will interfere with the therapeutic response to epoetin alfa (e.g., red blood cell production). Store at 2˚ to 8˚C (36˚ to 46˚F). Slowly push the plunger up to force the air bubbles out of the syringe. Consider initiating Epogen treatment only when the hemoglobin level is less than 10 g/dL. 11. Evaluate other causes of anemia, and discontinue if responsiveness does not improve. Store Epogen vials in the carton it comes in to protect from light. Do not give yourself the injection unless you have received training from your healthcare provider. • Keep the puncture-proof disposable container out of the reach of children. 1 mL In patients undergoing cardiac or vascular surgery. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The Epogen liquid in the vial is clear and colorless. 1080 Three double-blind, placebo-controlled studies, including 244 patients with CKD on dialysis, were used to identify the adverse reactions to Epogen. Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. The initial dose of Epogen was 50 Units/kg intravenously or subcutaneously 3 times weekly. Mechanism of metformin. Keep the needle inside the vial. Do not administer with other drug solutions except as described below:Preservative-free epoetin alfa may be admixed in a syringe with bacteriostatic 0.9% Sodium Chloride Injection, USP, with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at the time of administration. In controlled clinical trials, erythropoiesis-stimulating agents (ESAs) increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of thromboembolism (deep venous thrombosis [DVT]) in patients undergoing orthopedic procedures.
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