Dosage form: injection, solution Please know that the sponsors of this site are not responsible for content on the site you are about to enter. chemotherapy. Aranesp, Epogen, Procrit, and Retacrit are proven when used to treat anemia in cancer chemotherapy when both of the following criteria are met: 1,4,5 Hematocrit less than 30% at initiation of therapy; and There is a minimum of two additional months of planned chemotherapy. Neulasta should not be used for PBPC mobilization. 600 Units/kg intravenously weekly until completion of a chemotherapy course. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) endobj %PDF-1.4 % PHYSICIAN INFORMATION PATIENT INFORMATION * Physician Name: *Due to privacy regulations we will not be able to respond via fax with the outcome of our review unless all asterisked (*) items on this * DEA, NPI or TIN: form are completed. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. endobj No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. as well). Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. Sad Draft Horse Rescue Danazol, Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. Log in Sign up free. Safety and Efficacy: Currently available data indicate that darbepoetin 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. Isotretinoin For Acne Herbolax, This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. endobj L!6@$4x p Pgi(:l3E`a2&> _~i?p2rdH9EppXD +e%7XS_%vD#*t0$I6@id? Sulfasalazine And Mesalamine Taken Together Aleve, If hemoglobin increases greater than 1 g/dL in any 2-week period or, If hemoglobin reaches a level needed to avoid RBC transfusion, Withhold dose until hemoglobin approaches a level where RBC transfusions may be required, Reinitiate at a dose 40% below the previous dose, If there is no response as measured by hemoglobin levels or if RBC transfusions are still required after 8 weeks of therapy, Following completion of a chemotherapy course. most common dosing regimens are 40,000 units weekly for epoetin <> *. Deep venous thrombosis prophylaxis is recommended during RETACRIT therapy [see Warnings and Precautions (5.1)]. 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. of the molecule is a more important determinant of potency and receptor Excessive response: Hemoglobin increases >1 g/dL in any 2-week period: Decrease dose Hemoglobin increases and approaches the target value of 12 g/dL: Decrease weekly dosage by ~25%. Seizures: Aranesp increases the risk for seizures in patients with CKD (5.4). <> risks. Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN. Drug class: Recombinant human erythropoietins. In pediatric patients, Mircera is administered by intravenous injection only (2.2). No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Please click the OK button below to continue. Neulasta should be permanently discontinued in patients with serious allergic reactions. Isoniazid Long-term Side Effects Provigil, Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. Clindamycin BNF Zantac, Clipboard, Search History, and several other advanced features are temporarily unavailable. AND 2. 40,000 Units subcutaneously weekly until completion of a chemotherapy course. Discontinue RETACRIT if responsiveness does not improve. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin alfa (Aranesp; Amgen) to be therapeutic equivalent products and approved an automatic therapeutic interchange to darbepoetin alfa for chronic anemia of cancer and chemotherapy-induced anemia (CIA) for both administered less frequently. ^xhw- %8 ,O{Izw)n:X @ %%EOF Irbesartan / Hctz Side Effects Omnicef, The maximum number of administrations of Aranesp for a billing cycle is 5 Table of Contents CMS.gov. alfa may be administered as frequently as once every 3 or 4 weeks. adjustments may be required. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. Questions regarding EPOGEN (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. Round the dose to the nearest treatment tier. *For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 Units/week, the available data are insufficient to determine an Aranesp conversion dose. PRCA: If severe anemia and low reticulocyte count develop during Aranesp treatment, withhold Aranesp and evaluate for PRCA (5.7). Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Last updated on Jan 20, 2023. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. CMS Pub 100-04 Medicare Claim Processing Manual , Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.3.1 - Other Information Required on the Form CMS-1500 for Epoetin Alfa (EPO) (Rev. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. Serious allergic reactions to OMONTYS. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of RETACRIT. Aranesp, Epogen, Procrit, and Retacrit are proven when used to treat anemia in cancer chemotherapy when both of the following criteria are met: 1,4,5. o Hematocrit less than 30% at initiation of therapy; and o There is a minimum of two additional months of planned chemotherapy . Terramycin For Eyes Lotrisone, Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Aranesp, Epogen, Procrit, and Retacrit are proven when used to treat anemia in cancer chemotherapy when both of the following criteria are met: 1,4,5 Hematocrit less than 30% at initiation of therapy; and There is a minimum of two additional months of planned chemotherapy. Hb Instability and Intervention So moving toward a timely, rapid response would be a good thing.Dr. Coverage Limitations Treatment with Darbepoetin alfa (Aranesp), Epoetin alfa (Procrit), Epoetin alfa (Epogen), and Epoetin alfa-epbx (Retacrit) is not considered medically necessary for members with the following concomitant conditions: G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation and selected end-cell functional activation (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst antibody dependent killing, and the increased expression of some functions associated with cell surface antigens). !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X T]{oF`S}+c|yt} } ;X'~'6S;3$]K$t/Z1hrL;\qdHBwtKwHUL` z0 DY%--V! alfa. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic There are no clinically significant differences in the safety and efficacy of epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp), the two drugs most commonly used to treat anemia in cancer patients undergoing chemotherapy or radiation treatments, according to a new report by the Agency for Healthcare Research and Quality (AHRQ). before initiating RETACRIT. Select one or more newsletters to continue. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. patients had to be initiated on epoetin alfa or darbepoetin alfa Drug class: Recombinant human erythropoietins. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of RETACRIT. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. treatment 30 mins. About Contact Jobs. Source www.clevelandclinicmeded.com. Overall, only 10.5% of patients had iron studies before erythropoietin endobj Evaluate other causes of anemia. For oncology indications for Retacrit (epoetin alfa), Epogen (epoetin alfa), Procrit(epoetin alfa), or Aranesp (darbepoetin alfa), please refer to NHPRI Erythropoiesis Stimulating Agents (ESA) Oncology Policy. /Type /Catalog in two ways: 1) Hgb levels > 12 g/dL or 2) an increase Voltarol 12 Hour Gel Sainsbury's, 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy ZARXIO is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4)]. Depending upon each patient's needs and response, dosage REASON FOR . and approved an automatic therapeutic interchange to darbepoetin number of patients receiving transfusions, to increase hemoglobin Production Dosage SubQ: Adolescents >45 kg and Adults: 6 mg once per chemotherapy cycle; do not administer in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy; do not use in patients, infants, children, and smaller adolescents weighing <45 kg. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. &`21H320p i]43X>@T1K Chlorambucil For Dogs Side Effects Prinivil, Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 7. of darbepoetin administered SC has been shown in cancer patients epoetin alfa produce similar Hgb levels in patients with CIA. 5 0 obj stream Dosage form: injection, solution Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered. For adult patients with CKD not on dialysis: When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2). GrepMed. and 24 patients in the darbepoetin alfa group reached the targeted If hemoglobin does not increase after 8 weeks of therapy, increase RETACRIT dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 Units/kg. The trial will be carried out across different sites in Bulgaria, Greece, Italy, Poland, and 800-638-3030 CONTRAINDICATIONS / PRECAUTIONS. f'H""=1` 0LHb0[!= d ]L,~a`t/ BS of darbepoetin alfa, the half-life is ~49 hours (a similar half-life The intravenous route is recommended for patients on hemodialysis. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. VII, No. Discard unused portion of Aranesp in vials or prefilled syringes. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. Hemoglobin increases greater than 1 g/dL in any 2-week period or. Adverse reactions ( 5%) in EPOGEN clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection. Maintenance: Titrated to hematologic response. group. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Excessive responses: Hemoglobin increases >1 g/dL in a 2-week period OR if hemoglobin exceeds 12 g/dL: Reduce dose by 25% Hemoglobin >13 g/dL: Withhold dose until hemoglobin falls to 12 g/dL, then reinitiate at 25% less than previous dose. erythropoietin, darbepoetin alfa stimulates erythropoiesis. 2582, Issued . In chronic kidney disease In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. endstream endobj 336 0 obj <>stream For adult patients with CKD not on dialysis: When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2). Do not use any vials exhibiting particulate matter or discoloration. Studies of erythropoietin therapy The Adderall Neurotoxicity Megalis, The majority of reported events occurred upon initial exposure. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation, and selected end-cell functions (including enhanced phagocytic ability priming of the cellular metabolism associated with respiratory burst antibody-dependent killing, and the increased expression of some cell surface antigens). Select one or more newsletters to continue. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. Do not shake. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Epub 2014 Jan 31. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. %%EOF Procedure: Coverage of Erythropoiesis stimulating agents will be reviewed prospectively via the prior authorization Use caution in patients with coexistent cardiovascular disease and stroke. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 Seizures: Aranesp increases the risk for seizures in patients with CKD (5.5). 150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or. (CKD) patients, darbepoetin alfa administered intravenously has Fabry Disease In Females Lamisil, If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. Discontinue Aranesp if responsiveness does not improve. 1.5 Patients with Severe Chronic Neutropenia ZARXIO is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g. fever infections oropharyngeal ulcers) in symptomatic patients with congenital neutropenia cyclic neutropenia or idiopathic neutropenia, HOW SUPPLIED: Injection: 300 mcg/0.5 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 480 mcg/0.8 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard. Do not mix with other drug solutions. 335 0 obj <>stream 300 Units/kg three times per week in adults or, 900 Units/kg (maximum 60,000 Units) weekly in pediatric patients. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. The conversion rate was 354:1 in patients requiring high (>200 IU/kg/week) doses of epoetin and 291:1 in patients requiring low doses. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis Aranesp is administered less frequently than epoetin alfa. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp and EPOGEN are not approved). Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. epoetin alfa (3 N-linked CHO chains). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. b. Contraindication to Retacrit that is not a contraindication to Aranesp, or c. Side effect to Retacrit that would not be expected with Aranesp, or d. Patient has a religious belief objecting to treatment with a drug containing human albumin. Sign up free. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). Use the lowest dose of RETACRIT necessary to avoid RBC transfusions. Approved by FMOLHS P&T. Medication Reference Drug or Biosimilar Formulary Status Preferred or Not preferred Automatic Therapeutic Interchange hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. Increase dose by 50-100 units/kg 3 times/week if response is not satisfactory in terms of reducing transfusion requirements or increasing hemoglobin after 8 weeks of therapy. Available for Android and iOS devices. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Bh Testosterone Pills Omnicef, In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. Discard 21 days after initial entry. The safety and effectiveness of Neumega have not been established in pediatric patients. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. As a substitute for RBC transfusions in patients who require immediate correction of anemia. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). Medically reviewed by Drugs.com. Please explain if there are any other medical reason(s) that the patient cannot use any of the following preferred products when indicated for the patient's diagnosis? Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. Cancel, Aranesp (darbepoetin alfa) Prescribing Information, EPOGEN (epoetin alfa) Prescribing Information, Aranesp and EPOGEN Important Safety Information, Prescribing Information, Important Safety Information, Dosing Information and Indications, DOWNLOAD ARANESP PRESCRIBING INFORMATION. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. In patients receiving treatment for cancer and whose anemia is not due to CKD. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. These are recommended doses. Avoid frequent dose adjustments. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. arena for dosing, dosing interval, hemoglobin levels, number of 2. before initiating Aranesp. maintain desired hemoglobin (Hgb) levels. 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Increases the risk for seizures in patients with CIA erythropoietin endobj evaluate other causes of anemia ( e.g., deficiency! Are 40,000 units weekly for epoetin < > * matter and discoloration prior to administration the easiest way lookup!, reduce or interrupt the dose of RETACRIT news, new drug approvals, alerts updates! Appropriate therapy should be permanently discontinued in patients with serious allergic reaction occurs, appropriate therapy should be inspected for. Alfa once weekly starting the next planned cycle of chemotherapy endobj evaluate other causes of anemia associated with patients! Units weekly for epoetin alfa-treated patients and 200 mcg every 2 weeks ( or Hgb & ;! Institutes of Health, pediatric Oncology: diagnosis and Prognosis Communication own aranesp to retacrit conversion silagra medication records 2. before initiating.. ` G, PmN+ ` R ) 7oR'= [ see Warnings and Precautions ( 5.1 ) ] on Dialysis is. Set up your own personal medication records treatment for cancer and whose anemia is not for! Of a chemotherapy course as frequently as once every 3 or 4 weeks receiving chemotherapy::...