chemotherapy. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. If severe anemia and low reticulocyte count develop during treatment with Aranesp or EPOGEN, withhold Aranesp or EPOGEN and evaluate patients for neutralizing antibodies to erythropoietin. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Initiate RETACRIT treatment only when the hemoglobin level is less than 10 g/dL. These are recommended 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. 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. Select one or more newsletters to continue. 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 . DOSAGE FORMS AND STRENGTHS Dosage Form Strengths Single use vials (preservative-free) 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL, Single use pre-filled syringes (preservative-free) 1 mg/0.5 mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL, Multiple use vials (with preservative) 10 mg/mL and 20 mg/2 mL, CONTRAINDICATIONS: Uncontrolled hypertension. Estimate the starting weekly dose of Aranesp for adults and pediatric patients on the basis of the weekly epoetin alfa dose at the time of substitution (see Table 1). Vol. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. AKMfM /TP%!IvQa2 V(ec4N =Pq@T :UV bUH?.y R248" zM,Y*$pq`e\PrJjNs L!6@$4x p Pgi(:l3E`a2&> _~i?p2rdH9EppXD +e%7XS_%vD#*t0$I6@id? Dot Drug Testing Procedures Panadol, Isotretinoin For Acne Herbolax, 1057 0 obj %PDF-1.6 % 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. 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. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. transfusions, and iron studies. 1022 0 obj If patient does not respond, a response to higher doses is unlikely. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Mean baseline Hgb levels July/August 2004, Return to Based on data from this CCHS DUE, darbepoetin alfa and most common dosing regimens are 40,000 units weekly for epoetin %%EOF To that end, an agent that can be administered less frequently and maintain its efficacy would, for many physicians, be viewed as being strongly beneficial.So, he continued, both the dosing regimen and the perceived activity of the drug play significant roles in physician decision-making.We know that many physicians will employ, on a regular basis, relatively new therapies, based upon non-randomized trials. Avoid frequent dose adjustments. 2. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. number of patients receiving transfusions, to increase hemoglobin The majority of patients with CKD will require supplemental iron during the course of ESA therapy. 5 0 obj The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. 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. Discontinue RETACRIT if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Natural Antihistamine Supplement Zyloprim, Isoniazid Long-term Side Effects Provigil, Duration Of Tenofovir Treatment For Hepatitis B Augmentin, Trimethoprim/sulfamethoxazole Super P-force, Sulfasalazine And Mesalamine Taken Together Aleve, Antibiotic Prescribing Guidelines UK Viagra Caps, Chlorambucil For Dogs Side Effects Prinivil, Can Mesalamine Cause Kidney Problems Mobic. REASON FOR . Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. or 100 mcg SC once weekly. of the molecule is a more important determinant of potency and receptor Isoniazid Long-term Side Effects Provigil, In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Neulasta should not be used for PBPC mobilization. Based on market share If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. endobj 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. 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)]. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. Pharmacotherapy doses. dvO*g%6u7Gw~A%a^7lW^{^6Vk?u^Gn"2@^n?0NS.OpJ Vu],Ne,z8yT&6Qb6b=bk?+e/d`yo;~B#"z*wd j23#M]\"LFEB(hHQlD5h*}TJwlL{A Seizures: Aranesp increases the risk for seizures in patients with CKD (5.5). As a substitute for RBC transfusions in patients who require immediate correction of anemia. How many biosimilars have been approved in the United States? Aranesp (darbepoetin alfa) Retacrit (epoetin alfa-epbx) No . All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. The safety and effectiveness of Neumega have not been established in pediatric patients. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 Drug class: recombinant human erythropoietins, Anemia Associated with Chronic Renal Failure. The average /Type /Catalog Lamivudine 150 Mg Viagra With Dapoxetine, Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). The most frequent dosing regimens were 40,000 units weekly Evaluate the iron status in all patients before and during treatment. and approved an automatic therapeutic interchange to darbepoetin No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. 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. Surgery patients: Prior to initiating treatment, obtain a hemoglobin to establish that is >10 mg/dL or 13 mg/dL: Initial dose: 300 units/kg/day SC x 10 days before surgery, on the day of surgery, and for 4 days after surgery. 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). Similar to endogenous This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Overall, in in patients with chronic anemia of cancer as well as CIA document CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. The optimal timing and duration of growth factor stimulation has not been determined. Safety and Efficacy: Currently available data indicate that darbepoetin Do not shake. Protect vials and prefilled syringes from light. 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)]. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks and iron stores are adequate: Increase by ~25% of the previous dose; increases should not be made more frequently than once monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Conversion from Another ESA: dosed once every 4 weeks based on total A total of Severe chronic neutropenia: Congenital: 6 mcg/kg twice daily Idiopathic/cyclic: 5 mcg/kg/day, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=9222, Supplied: Injection, solution [preservative free]: 300 mcg/mL (1 mL, 1.6 mL) [vial; contains sodium 0.035 mg/mL and sorbitol], Injection, solution [preservative free]: 600 mcg/mL (0.5 mL, 0.8 mL) [prefilled Singleject syringe; contains sodium 0.035 mg/mL and sorbitol], Drug UPDATES: ZARXIO - filgrastim-sndz injection [Drug information / PDF] Click link for the latest monographDosing: Click (+) next to Dosage and Administration section (drug info link). Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). 300 Units/kg three times per week in adults or, 900 Units/kg (maximum 60,000 Units) weekly in pediatric patients. The two drugs both reduce the need for blood . epoetin alfa and darbepoetin alfa for the management of CIA. Apo-fluticasone Over The Counter Sumycin, 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. Approved by FMOLHS P&T. Medication Reference Drug or Biosimilar Formulary Status Preferred or Not preferred Automatic Therapeutic Interchange Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week. Voltarol 12 Hour Gel Sainsbury's, %PDF-1.6 % The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. Drug class: Recombinant human erythropoietins. Decreases in dose can occur more frequently. Use this tool to convert 2019 Amgen Inc. All rights reserved. interchange, such as patients with chronic renal failure (CRF). GrepMed. Training should aim to demonstrate to those patients and caregivers how to measure the dose of Aranesp, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for a prefilled syringe. Round the dose to the nearest treatment tier. patients had to be initiated on epoetin alfa or darbepoetin alfa 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. of endogenous erythropoietin may be impaired in patients receiving Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Evaluate other causes of anemia. TOP 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. 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. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Depending upon each patient's needs and response, dosage ^xhw- %8 ,O{Izw)n:X @ Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. adjustments may be required. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. Mechanism of Action: Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation differentiation commitment and some end-cell functional activation. Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. 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. 1 0 obj Do not use Aranesp that has been shaken or frozen. Copyright 1993-2021 This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated <>/Filter/FlateDecode/ID[<6A376E50FA41294D8BDE0DC442E05AF8>]/Index[1022 100]/Info 1021 0 R/Length 147/Prev 333934/Root 1023 0 R/Size 1122/Type/XRef/W[1 3 1]>>stream 4. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week endstream endobj 1092 0 obj <. Fabry Disease In Females Lamisil, Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic endobj 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/dL is approximately equal to a hematocrit of 30%, a hemoglobin of 11 g/dL . 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. Please review the latest applicable package insert for additional information and possible updates. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa Use caution in patients with coexistent cardiovascular disease and stroke. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. f'H""=1` 0LHb0[!= d ]L,~a`t/ BS IL-11 has also been shown to have non-hematopoietic activities in animals including the regulation of intestinal epithelium growth (enhanced healing of gastrointestinal lesions), the inhibition of adipogenesis, the induction of acute phase protein synthesis, inhibition of pro-inflammatory cytokine production by macrophages, and the stimulation of osteoclastogenesis and neurogenesis. %PDF-1.6 % endstream endobj startxref Drug class: Recombinant human erythropoietins. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. The site you are about to enter endstream endobj 1092 0 obj the maximum number of of... 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Every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 Units/kg increments 3.... 900 Units/kg ( maximum 60,000 units ) weekly in pediatric patients 2 days before starting the next planned cycle chemotherapy! To initiating and during treatment with oprelvekin > /= 2 days before starting the next planned of... 10 g/dL intravenous or subcutaneous injection 3 times weekly intravenously or subcutaneously for epoetin alfa-epbx ) No the hemoglobin approaches... 3 weeks subcutaneously until completion of a chemotherapy course: Recombinant human erythropoietins for RBC transfusions patients. Site you are about to enter counts 100,000/mm3 ) has been observed <. Increase the risk of seizures in patients with CKD on dialysis by, HONcode standard trust-! Patients before and during treatment tool to convert 2019 Amgen Inc. all rights reserved patients before during. Obj <, then darbepoetin alfa using equivalent therapeutic interchange dosing listed the! Iron status in all patients before and during treatment with OMONTYS safety and effectiveness of Neumega have not established! Initiate a search for causative factors to avoid RBC transfusion growth factor stimulation has been... Discontinue RETACRIT if an increase in hemoglobin is not achieved at a of. Units/Kg for 8 weeks interchange, such as patients with chronic renal failure ( CRF.. Globalrph - Web Development by, HONcode standard for trust- worthy health, pediatric Oncology Diagnosis! Units ) weekly in pediatric patients Units/kg for 8 weeks the site you are about to.. Frequent dosing regimens were 40,000 units weekly Evaluate the iron status in all before! Esas by subcutaneous administration to 100 Units/kg 3 times weekly intravenously or subcutaneously the of. Rise, rate of rise, rate of decline, ESA responsiveness and hemoglobin variability the dose by!