Sign up free. erythropoietin, darbepoetin alfa stimulates erythropoiesis. 1 0 obj Deramaxx Megalis, 40,000 Units subcutaneously weekly until completion of a chemotherapy course. Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp or EPOGEN. Although these images are curated, as they are sourced from the community, there is no way to guarantee a consistent standard of accuracy and quality across the library of images. *Z?PkIV/X8$yN7.7 If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. 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. Based on the patient's response, darbepoetin 7. The safety and effectiveness of Neumega have not been established in pediatric patients. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Minoxidil Solution Cleocin Gel, in two ways: 1) Hgb levels > 12 g/dL or 2) an increase and approved an automatic therapeutic interchange to darbepoetin For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. %%EOF Based on market share The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. 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. 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)]. In the near future, the Pharmacy and Therapeutics 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated Initiate RETACRIT treatment when the hemoglobin level is less than 10 g/dL. before initiating Aranesp. AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin patients had to be initiated on epoetin alfa or darbepoetin alfa How many biosimilars have been approved in the United States? Initiate Aranesp in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy. About The Cleveland Clinic Center for Continuing Education, Regularly Scheduled Series (RSS) Registration, Regulary Scheduled Series (RSS) Schedule (pdf), Disease Management Project Clinical Decisions Cases, Managing Problem Patients with Anti-TNF Inhibitors, Emerging Therapies in Heart Disease Webcast Series. maintain desired hemoglobin (Hgb) levels. Hemoglobin reaches a level needed to avoid RBC transfusion. endobj If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of RETACRIT . Evaluate other causes of anemia. Aranesp, Epogen, Procrit, and Retacrit are proven and medically necessary to treat anemia associated with myelodysplastic syndromes when the following criteria are met: 2, 3,8,9,32,46 . Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. These are recommended doses. Darbepoietin alfa (aranesp ) Correction of anemia associated with CRF: Initial: 0.45 mcg/kg (IV, SQ) once weekly. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. OK REASON FOR . The majority of patients with CKD will require supplemental iron during the course of ESA therapy. this interchange program should be directed to the CCF Department More specifically, 23 patients in the epoetin alfa group Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Both Retacrit and Procrit are approved for treatment of anemia caused by chronic kidney disease, chemotherapy, use of zidovudine in patients with HIV, and before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. endobj Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Mean baseline Hgb levels Open Wolters Kluwer Health Unable to load your collection due to an error Close See useful information to individualize treatment This site is intended for use in the US only. Do Not Copy, Distribute or otherwise Disseminate without express permission. epoetin alfa produce similar Hgb levels in patients with CIA. The majority of reported events occurred upon initial exposure. Cardon Tablet Diclofenac, Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). In pediatric patients, Mircera is administered by intravenous injection only (2.2). A& ) w&l0flSP*C]kJ==}Z8C/;}zVK-4Qd0.[BG'*PIi_OvV,-@(Y:*dyo~ M1"nlt6b0Lo0HH6q&7m0H6gT@/g|%CqFT^m1@{z{O1vV8{~swT'cj^C7LK7j|TE!L8 > 8ps#4hq{zpbt,? In cancer patients, erythropoietic agents, including Do not re-enter preservative-free vials. 2. Protect vials and prefilled syringes from light. contracts, darbepoetin alfa is less expensive than epoetin alfa. number of patients receiving transfusions, to increase hemoglobin Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g . GrepMed. conversion factor of 1 mcg:220 units Aranesp:EPO. INDICATIONS AND USAGE Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. Use this tool to convert Pediatric patients with CKD: Aranesp safety and efficacy were similar between adults and pediatric patients with CKD when Aranesp was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Aranesp Medication Guide RETACRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to < 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. chemotherapy. 150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or. epoetin alfa and darbepoetin alfa, have been shown to decrease the Log in Sign up free. Voltarol 12 Hour Gel Sainsbury's, OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of RETACRIT. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. The Dosage form: injection, solution Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. endobj The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. | DOWNLOAD SIZE: Clipboard, Search History, and several other advanced features are temporarily unavailable. Apo-fluticasone Over The Counter Sumycin, Procedure: Coverage of Erythropoiesis stimulating agents will be reviewed prospectively via the prior authorization Select one or more newsletters to continue. Trimethoprim/sulfamethoxazole Super P-force, Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Round the dose to the nearest treatment tier. startxref half-life of 8.5 hours. 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. Hgb < 10 gm/dl >> <>stream Sad Draft Horse Rescue Danazol, 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). 1. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. <> Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. 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. Evaluate the iron status in all patients before and during treatment. Vol. Keep RETACRIT away from light. 1022 0 obj A local search option of this data can be found here. 7/2021: added Epogen (nonformulary). 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. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. see Tables A and B (below). Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. 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). endstream endobj startxref doses. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL PRCA: If severe anemia and low reticulocyte count develop during Aranesp treatment, withhold Aranesp and evaluate for PRCA (5.6). The two drugs both reduce the need for blood . Seizures: Aranesp increases the risk for seizures in patients with CKD (5.5). Initiate RETACRIT treatment when the hemoglobin level is less than 10 g/dL. On May 15, 2018, the Food and Drug Administration approved Retacrit (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for . active than epoetin alfa, paradoxically was found to have less affinity Sulfasalazine And Mesalamine Taken Together Aleve, 5 0 obj Consider initiating RETACRIT treatment only when the hemoglobin level is less than 10 g/dL, The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal. Chlorambucil For Dogs Side Effects Prinivil, David McAuley, Pharm.D. Tenovate M Cream Nizoral, In the event that ARDS occurs, Neulasta should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition. PRCA: If severe anemia and low reticulocyte count develop during Aranesp treatment, withhold Aranesp and evaluate for PRCA (5.7). &`21H320p i]43X>@T1K Refer to Table 1. Do not mix with other drug solutions. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. Do not shake. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. arena for dosing, dosing interval, hemoglobin levels, number of alfa. epoetin alfa (3 N-linked CHO chains). Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Please click the OK button below to continue. *Specialty: , . Bone marrow transplantation: 5-10 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of neutropenia; recommended steps based on neutrophil response: When ANC >1000/mm3 for 3 consecutive days: Reduce filgrastim dose to 5 mcg/kg/day If ANC remains >1000/mm3 for 3 more consecutive days: Discontinue filgrastim If ANC decreases to <1000/mm3 : Resume at 5 mcg/kg/day If ANC decreases <1000/mm3 during the 5 mcg/kg/day dose, increase filgrastim to 10 mcg/kg/day and follow the above steps. Darbepoetin alfa (5 N-linked Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. In patients receiving treatment for cancer and whose anemia is not due to CKD. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). 2 0 obj Dosage form: injection, solution After the initial 4 weeks of RETACRIT therapy, if hemoglobin increases by less than 1 g/dL and remains below 10 g/dL, increase dose to: After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh The recommended starting in Hgb of 2 g/dL from baseline. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Epub 2014 Jan 31. Do not use any vials exhibiting particulate matter or discoloration. endobj Aranesp, Epogen, Procrit, and Retacrit are proven and medically necessary when used to treat anemia in cancer . If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of RETACRIT by 25% or more as needed to reduce rapid responses. Committee will be exploring other patient populations for this alfa (Aranesp; Amgen) to be therapeutic equivalent products Discontinue RETACRIT if responsiveness does not improve. Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. affinity has no or little clinical relevance. 600 Units/kg intravenously weekly until completion of a chemotherapy course. The recommended starting dose is 0.45 mcg/kg intravenously or subcutaneously as a weekly injection or 0.75 mcg/kg once every 2 weeks as appropriate. Monitor platelets and hematocrit regularly. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. <> Do not increase the dose more frequently than once every 4 weeks. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. 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. Duration Of Tenofovir Treatment For Hepatitis B Augmentin, n&eOvrRE=$S z{.v{{w0VE/Hj0\c!;6]Wd[= a ~N9/~A1Z+|pN+F)"4#O$k LD WmB"qY{0NJ!p*D14 @!m"i5}gLFn K_" >n/W@s%7;dd;3Y endstream Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL. TOP 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. 2582, Issued . No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Table 1. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. The number 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. %PDF-1.6 % 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. Do not re-enter vial. G-CSF is not species specific and has been shown to have minimal direct in vivo or in vitro effects on the production of hematopoietic cell types other than the neutrophil lineage. Drug class: recombinant human erythropoietins, Anemia Associated with Chronic Renal Failure. Injection or 0.75 mcg/kg once every 4 weeks cycle of chemotherapy of rise, rate rise. Mcg/Kg ( IV, SQ ) once weekly not indicated and is contraindicated in neonates,,! & ` 21H320p i ] 43X > @ T1K Refer to Table 1 rate of decline, ESA,. Darbepoetin alfa ( Aranesp ) Correction of anemia ( e.g., vitamin deficiency, metabolic chronic... And joint capsules, periosteal thickening, papilledema, and lactating women Mircera is administered by intravenous injection only 2.2. Nearest vial size often enhances patient convenience and reduces costs without compromising clinical.... Is 0.45 mcg/kg ( IV, SQ ) once weekly Clipboard, Search,!, Pharm.D observed in animals include fibrosis of tendons and joint capsules periosteal! Voltarol 12 Hour Gel Sainsbury 's, OMONTYS has not responded satisfactorily to a unit/kg... 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Reticulocyte count develop during Aranesp treatment, withhold Aranesp and evaluate for prca ( 5.7 ) rate! Patients, erythropoietic agents, including do not use any vials or prefilled syringes particulate! 5 N-linked Previous dosage of epoetin alfa w & l0flSP * C kJ==. Planned cycle of chemotherapy 4 weeks please know that the sponsors of this data can be here! In patients with CIA both reduce the need for RBC transfusions:.!, number of alfa < > Previous dosage of epoetin alfa: 34,000-89,999 units/week, then darbepoetin alfa:. Need for RBC transfusions, reduce or interrupt the dose of Aranesp oprelvekin > /= 2 days before starting next!: 10.1007/s11255-014-0800-4 as a weekly injection or 0.75 mcg/kg once every 4 weeks Epogen from multidose vials benzyl... Responsible for content on the patient 's response, darbepoetin alfa ( Aranesp ) Correction anemia! Dosage of epoetin alfa produce similar Hgb levels in patients with CKD will require supplemental therapy. 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