Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Epoetin alfa is contraindicated in patients with pure red cell aplasia (PRCA) that begins after treatment with epoetin or other erythropoietin protein drugs. Epogen therapy also resulted in significant increases in hemoglobin in comparison to placebo. Talk with your healthcare provider about the kind of cancer you have. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. If the syringe package is undamaged, open the package and remove the syringe. Concurrent administration of androgens can increase the patient's response to epoetin alfa, reducing the amount required to treat anemia. Two (2%) of placebo-treated patients and 3 (3%) of epoetin alfa-treated patients dropped out of the study prior to week 5. Across all studies, 72 patients were treated with concomitant non cisplatin-containing chemotherapy regimens and 59 patients were treated with concomitant cisplatin-containing chemotherapy regimens. AMGEN® Evaluate transferrin saturation and serum ferritin before and during epoetin alfa treatment. Amgen Inc. There is no information regarding the presence of Epogen in human milk, the effects on the breastfed infant, or the effects on milk production. Neutralizing antibodies to epoetin alfa that cross-react with endogenous erythropoietin and other ESAs can result in PRCA or severe anemia (with or without other cytopenias) [see Warnings and Precautions (5.6)]. Exam #4 - epoetin alfa (epogen, procrit) therapeutic class. Epogen, Procrit, Retacrit. The most common investigator-attributed cause of death within the first 4 months was disease progression; 28 of 41 deaths in the epoetin alfa arm and 13 of 16 deaths in the placebo arm were attributed to disease progression. 600 Units/kg intravenously weekly until completion of a chemotherapy course. When administered intravenously to male and female rats prior to and during mating, and to females through the beginning of implantation (up to gestational day 7; dosing stopped prior to the beginning of organogenesis), doses of 100 and 500 Units/kg/day of Epogen caused slight increases in pre-implantation loss, post-implantation loss and decreases in the incidence of live fetuses. During fetal development, EPO is produced in the liver, and prior to birth at term, production is transferred to the kidney. Study 8 was a multicenter, randomized, double-blind study (epoetin alfa vs. placebo) in which patients with advanced non-small cell lung cancer receiving only palliative radiotherapy or no active therapy were treated with epoetin alfa to achieve and maintain hemoglobin levels between 12 and 14 g/dL. Efficacy results are shown in Table 9. If the Hgb rises more than 1 g/dL in any 2-week period, reduce the dose by 25% or more as needed to reduce rapid responses. The safety data from the pediatric studies and postmarketing reports are similar to those obtained from the studies of Epogen in adult patients with CKD [see Warnings and Precautions (5) and Adverse Reactions (6.1)]. The mechanism of action of endogenous erythropoietin and the therapeutic use of epoetin alfa to stimulate red blood cell production and improve the quality of life in cancer patients are reviewed here. Increased mortality and/or increased risk of tumor progression or recurrence in Patients With Cancer, Injection site reactions, including irritation and pain. There are reports of pregnant women with anemia alone or anemia associated with severe renal disease and other hematologic disorders who received Epogen. 50 units/kg/dose IV or subcutaneously 3 times weekly initially; for patients on dialysis, administer IV. Do not recap the needle. The trial was terminated early with adverse safety findings. For adult patients with CKD not on dialysis: • Initiate Epogen treatment only when the hemoglobin level is less than 10 g/dL. Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation): 2,000 Units/mL (NDC 55513-126-10), 3,000 Units/mL (NDC 55513-267-10), 4,000 Units/mL (NDC 55513-148-10), or 10,000 Units/mL (NDC 55513-144-10) supplied in dispensing packs containing ten 1 mL single-dose vials. Polyhydramnios and intrauterine growth restriction were reported in women with chronic renal disease, which is associated with an increased risk for these adverse pregnancy outcomes. Sterile Solution – No Preservative After initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin concentration is stable and sufficient to minimize the need for RBC transfusion. MECHANISM OF ACTION. (10,000 Units/mL) There may be special state and local laws for disposing of used needles and syringes. 150 units/kg/dose subcutaneously 3 times weekly or 40,000 units subcutaneously once weekly only when the hemoglobin (Hgb) is less than 10 g/dL and only until the chemotherapy course is completed. A medicine called zidovudine (AZT) used to treat HIV infection. Erythropoiesis stimulants may cause or worsen hypertension, and excess doses or duration can lead to polycythemia or serious thrombotic events (e.g., myocardial infarction, stroke). ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS) (see Table 2). Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. 50 to 100 units/kg/dose IV or subcutaneously 3 times weekly initially; for patients on dialysis, administer IV. Epogen vials come in several dose strengths. 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. As with the endogenous erythropoietin (EPO), epoetin alfa does not appear extravascularly in humans. Do not mix epoetin alfa with bacteriostatic saline containing benzyl alcohol. Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions (5.3)]. Epoetin alfa is contraindicated in patients with serious allergic reactions, such as anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria, to the product. Epoetin alfa was the first rhEPO produced and approved for pharmaceutical use, followed by several related products and by newer ESAs with the same mechanism but more prolonged action. ©2012,2017 Amgen Inc. Store Epogen vials in the carton it comes in to protect from light. U.S. License No. If the Hgb rises more than 1 g/dL in any 2-week period, reduce the dose by 25% or more as needed to reduce rapid responses. Ethinyl Estradiol; Norethindrone; Ferrous fumarate: (Minor) Inadequate iron stores will interfere with the therapeutic response to epoetin alfa (e.g., red blood cell production). If Hgb approaches or exceeds 11 g/dL, reduce or interrupt the dose. U.S. License No. Randomization was stratified by cancer type (solid tumors, Hodgkin’s disease, acute lymphocytic leukemia, vs. non-Hodgkin’s lymphoma); patients were randomized to receive epoetin alfa at 600 Units/kg maximum 40,000 Units (n = 111) or placebo (n = 111) as a weekly intravenous injection. Throw away the syringe in the puncture-proof disposable container. ○ The upper outer area of the buttocks. Zidovudine-treated Patients with HIV-infection. Decreases in dose can occur more frequently. Rx Only, ferrous sulfate, pyridoxine, Revlimid, Aranesp, Procrit, Vitamin B6, lenalidomide, epoetin alfa, Retacrit, darbepoetin alfa. A limited number of HIV-infected adolescents have been treated off-label with doses up to 400 units/kg/dose subcutaneously/IV 3 times per week. For lack or loss of hemoglobin response to Epogen, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding). CHOIR: A randomized, prospective trial, 1432 patients with anemia due to CKD who were not undergoing dialysis and who had not previously received epoetin alfa therapy were randomized to epoetin alfa treatment targeting a maintenance hemoglobin concentration of either 13.5 g/dL or 11.3 g/dL. Further evaluation of this combination needs to be made. Epogen is indicated in pediatric patients, ages 1 month to 16 years of age, for the treatment of anemia associated with CKD requiring dialysis. Epogen multiple-dose vials contain 11 mg of benzyl alcohol per mL. Endogenous erythropoietin is present in human milk. Iron Salts: (Minor) Inadequate iron stores will interfere with the therapeutic response to epoetin alfa (e.g., red blood cell production). The safety and efficacy of Epogen were studied in a placebo-controlled, randomized study of 113 pediatric patients with anemia (hemoglobin ≤ 9 g/dL) undergoing peritoneal dialysis or hemodialysis. In patients with cancer, use ESAs only for anemia from myelosuppressive chemotherapy, and use the lowest dose needed to avoid red blood cell transfusions. Epogen works like the human protein called erythropoietin to help your body make more RBCs. In patients undergoing cardiac or vascular surgery. The intravenous route is recommended for patients on hemodialysis. The dose strength of the Epogen vial (number of Units per mL on the vial label) is the same as your healthcare provider prescribed. Epogen (epoetin alfa) injection for intravenous or subcutaneous administration is formulated as a sterile, clear, colorless liquid in vials in multiple formulations. You are able and willing to donate blood prior to surgery. • Epogen can be injected in your vein through a special access port placed by your healthcare provider. Do not use any vials exhibiting particulate matter or discoloration. Manufactured by Amgen Inc. See Figure 8. Do not use a vial of Epogen that has been frozen. Epogen-treated patients experienced improvements in exercise tolerance and patient-reported physical functioning at month 2 that were maintained throughout the study. Epogen® Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. Call your healthcare provider or get medical help right away if you have any of these symptoms: Chronic kidney disease (you may or may not be on dialysis). 8. As a substitute for RBC transfusions in patients who require immediate correction of anemia. Use caution when administering epoetin alfa from a single-dose vial to a breast-feeding woman. • Wipe off the venous port of the hemodialysis tubing with an alcohol wipe. Single Dose Vials (containing 1 mL) Do Not Freeze or Shake. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions [see Patient Counseling Information (17)]. Epogen was administered daily at a dose of 100 to 300 IU/kg subcutaneously for 15 days or at 600 IU/kg once weekly for 4 weeks. The stimulation of erythropoiesis increases the demand for iron, making iron supplementation necessary for many patients. • If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Epogen. Store at 36oF to 46oF (2oC to 8oC). After initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin concentration is stable and sufficient to minimize the need for RBC transfusion. For the combined Epogen treatment groups, a total of 90 (25%) and 268 (75%) women between the ages of 29 and 89 years were enrolled. 10 x 2000 Units/mL Single Dose Vials In these studies, the mean age of patients was 57 years (range: 24 to 79 years). recombinant What are the possible side effects of Epogen? What is urokinase-injection, and how does it work (mechanism of action)? EPOETIN ALFA For lack or loss of hemoglobin response to epoetin alfa, evaluate for causative factors, including iron-deficiency anemia. Do not shake. Only use disposable syringes and needles. ○ 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of Epogen as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). Turn the vial and syringe upside down. Sterile Solution – No Preservative Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799 U.S.A. Thousand Oaks, CA 91320-1799 U.S.A. We do not record any personal information entered above. After initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin concentration is stable and sufficient to minimize the need for RBC transfusion. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). The rate of hemoglobin increase varies among patients and is dependent upon the dose of Epogen administered. Retacrit contains phenylalanine, a component of aspartame. erythropoietin. Limitations of Use: Aranesp ® and EPOGEN ® have not been shown to improve quality of life, fatigue, or patient well-being. Prasterone, Dehydroepiandrosterone, DHEA (Dietary Supplements): (Moderate) Androgens are known to stimulate erythropoiesis. Epoetin alfa should be clear and colorless.Protect vials from light.Do not shake or freeze.Discard unused epoetin alfa in preservative-free vials; do not re-enter preservative-free vials. Do not store the vial for more than 21 days. A major cardiovascular event (death, myocardial infarction, stroke, or hospitalization for congestive heart failure) occurred in 125 of the 715 patients (18%) in the higher hemoglobin group compared to 97 of the 717 patients (14%) in the lower hemoglobin group [hazard ratio (HR) 1.34, 95% CI: 1.03, 1.74; p = 0.03]. There is a potential for similar risks to infants exposed to benzyl alcohol through human milk. Epoetin alfa has the same biological activity as native EPO. Urokinase is an enzyme (protein) that disrupts the clotting cycle and breaks down blood clots lodged in the lungs in people with pulmonary embolism. To remove air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. • Pull the needle out of the skin and press a cotton ball or gauze over the injection site and hold it there for several seconds. Insufficient numbers of patients age 65 years or older were enrolled in clinical studies of Epogen for the treatment of patients treated with zidovudine for HIV-infection to determine whether they respond differently from younger patients. Production and secretion of EPO and the expression of its receptor (EPO-R) are regulated by tissue oxygenation. 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. Gather the other supplies you will need for your injection (vial, syringe, alcohol wipes, cotton ball, and a puncture-proof container for throwing away the syringe and needle). Do not re-enter preservative-free vials. After initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin concentration is stable and sufficient to minimize the need for RBC transfusion. Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications (4)]. Concurrent administration of androgens can increase the patient's response to epoetin alfa, reducing the amount required to treat anemia. Evaluate transferrin saturation and serum ferritin before and during epoetin alfa treatment. There was no accumulation of serum erythropoietin after the 2 dosing regimens during the study period. Safety and effectiveness in pediatric patients less than 1 month old have not been established [see Clinical Studies (14.1)]. Do not recycle. Epoetin alfa is a 165 amino acid glycoprotein manufactured by recombinant DNA technology, and has the same biological effects as endogenous erythropoietin Hypoxia is the primary physiological stimulus for erythropoietin production in the body Check the date on the Epogen vial to be sure that the drug has not expired. There was no evidence of a statistically significant reduction in proportion of patients receiving RBC transfusions. Osteitis fibrosa impairs response to epoetin by replacing active marrow erythroid elements with fibrosis. Deep venous thrombosis prophylaxis is strongly recommended when ESAs are used for the reduction of allogeneic RBC transfusions in surgical patients [see Dosage and Administration (2.5)]. Investigator-assessed time to tumor progression was not different between the 2 groups. Do not use a vial of Epogen after the expiration date on the label. The major clinical benefits of ESAs are effective treatment of anemia and avoidance of blood transfusion risks. The mean number of units transfused per patient was approximately 0.3 units in both treatment groups. The erythropoietic response observed in both treatment groups resulted in similar RBC transfusion rates [11/69 (16%) in the 600 Units/kg weekly group and 14/71 (20%) in the 300 Units/kg daily group]. Further evaluation of this combination needs to be made. At randomization, the baseline Hgb was 10.8 g/dL; after 8 weeks of treatment, Hgb increased by an average of 2.2 +/- 1.3 g/dL in the epoetin group compared to 0.1 +/- 1.0 g/dL in the placebo group (p less than 0.001). Erythropoietin also causes a shift of marrow reticulocytes into the circulation. 13. ○ The abdomen (except for the 2-inch area around the navel) Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Multiple-dose vials contain benzyl alcohol. “What are the possible side effects of Epogen?”. 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. Evaluate the iron status in all patients before and during treatment. Keep the tip of the needle in the Epogen liquid. 20,000 Units/mL Medically reviewed by Drugs.com. Evaluate transferrin saturation and serum ferritin before and during epoetin alfa treatment. Do not use a single-dose vial of Epogen more than one time. For patients who do not respond adequately over a 12-week escalation period, increasing the dose further is unlikely to improve response and may increase risks. For Intravenous or Subcutaneous Use Only In patients scheduled for surgery who are willing to donate autologous blood. Randomized, Controlled Studies With Decreased Survival and/or Decreased Locoregional Control, Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women, Serious and fatal reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including Epogen multiple-dose vials. The results of 6 studies of similar design and that randomized 131 patients to epoetin alfa or placebo were pooled to assess the safety and effectiveness of epoetin alfa. The dose requirements for Epogen in geriatric and younger patients within the 4 studies using the 3 times weekly schedule and 2 studies using the weekly schedule were similar. 600 units/kg/dose IV weekly only when the hemoglobin (Hgb) is less than 10 g/dL and only until the chemotherapy course is completed. Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Blood loss should be considered in patients who require increasing doses of epoetin to maintain a stable hemoglobin/hematocrit, in patients whose hemoglobin/hematocrit concentrations are falling, and in patients whose iron stores are not sustained with repetitive IV iron loading. Have high blood pressure that is not controlled (uncontrolled hypertension). The production and activity of EPO is linked in a negative feedback loop, which maintains optimal red cell mass for oxygen transport. A total of 358 patients were randomly assigned to receive Epogen and 103 (22%) patients were randomly assigned to receive placebo. 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. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. One Amgen Center Drive The study was terminated prematurely due to an increase in thromboembolic adverse reactions in epoetin alfa-treated patients compared to control (19% vs. 9%). In a study of 167 term neonates with moderate to severe HIE, the use of erythropoietin (300 or 500 units/kg/dose every other day for 2 weeks beginning less than 48 hours after birth) resulted in improved neurological outcomes in patients with moderate (but not severe) HIE compared to conventional treatment (no erythropoietin). For the once weekly Epogen-treatment group, a total of 76 men (45%) and 92 women (55%) between the ages of 20 and 88 years were treated. Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women [see Contraindications (4)]. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. There appears to be a plateau of optimal oxygen transport to tissues occurring around hematocrits of 35% to 55% with significant decreases in oxygen transport above and below these values. Pooled Analysis (Three Times Per Week Dosing). For these reasons, comparison of the incidence of antibodies to epoetin alfa with the incidence of antibodies to other products may be misleading. Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Their mechanism of action is entirely different from the one used by Amgen and Johnson & Johnson products. Epogen increases the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 … Epogen overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Epogen dosage and/or with phlebotomy, as clinically indicated [see Pharmacodynamics (12.2)].

La Mia Baby Cotton Yarn, Hyundai Veloster Clutch Replacement Cost, Cruwear Vs Rex 45, Coupling Nut M4, Copter Royale Kill Record, Missouri Fox Trotter For Sale In Canada, Ch3nh3br Molar Mass, What Holds Halite Together, Razer Kraken Xbox One Adapter, Makita Ls1040 Blade Size,