treatment 30 mins. Hgb level. Single-dose vials of RETACRIT should be used only one time. Available for Android and iOS devices. Fluticasone Ointment Price Indocin, Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. Table 1. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. epoetin alfa (3 N-linked CHO chains). Adjust dose as follows to achieve and maintain a target hemoglobin: Inadequate response: Hemoglobin increases <1 g/dL after 6 weeks of therapy: Increase dose to 4.5 mcg/kg. Medically reviewed by Drugs.com. The number supports your decision 5. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. 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. Use caution in patients with coexistent cardiovascular disease and stroke. CONTRAINDICATIONS Neumega is contraindicated in patients with a history of hypersensitivity to Neumega or any component of the product, Dosage SubQ: Note: First dose should not be administered until 24-36 hours after the end of chemotherapy. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. Initiate RETACRIT treatment when the hemoglobin level is less than 10 g/dL. 0 Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions [see Boxed Warning and Clinical Studies (14)]. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. 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. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. before initiating Aranesp. Estimated Aranesp Starting Doses (mcg/week) for Patients with CKD on Dialysis Based on Previous Epoetin alfa Dose (Units/week), Previous Weekly Epoetin alfa Dose (Units/week). 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. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. Questions regarding Aranesp (darbepoetin alfa) Retacrit (epoetin alfa-epbx) No . , . Initiate RETACRIT 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. 600 Units/kg intravenously weekly until completion of a chemotherapy course. Neulasta should be permanently discontinued in patients with serious allergic reactions. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. group. of darbepoetin administered SC has been shown in cancer patients similar over the course of therapy for both groups. 7. TOP 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. IV endobj and approved an automatic therapeutic interchange to darbepoetin If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of RETACRIT. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms (5.5). The intravenous route is recommended for patients on hemodialysis. Aranesp, Epogen, Procrit, and Retacrit are proven and medically necessary when used to treat anemia in cancer . Store RETACRIT in the refrigerator between 36F to 46F (2C to 8C). Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. Drug class: Recombinant human erythropoietins. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. therapy. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Store unused portions of RETACRIT in multiple-dose vials at 2C to 8C (36F to 46F). alfa. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. Drug class: recombinant human erythropoietins, Anemia Associated with Chronic Renal Failure. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required. Safety and Efficacy: Currently available data indicate that darbepoetin \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Epogen is used in the dialysis area at CCF. KY6ahb/(~.L'ZTwbQ85IQdr@$^[O'&_XrL2wSpqhvpeq0jAUW a,! Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. ferrous sulfate, pyridoxine, Revlimid, Aranesp, lenalidomide, Vitamin B6, Procrit, epoetin alfa, Epogen. Do not re-enter preservative-free vials. More specifically, 23 patients in the epoetin alfa group epoetin alfa and darbepoetin alfa for the management of CIA. Clindamycin BNF Zantac, of endogenous erythropoietin may be impaired in patients receiving The two drugs both reduce the need for blood . Evaluation of Iron Stores and Nutritional Factors. If patient does not respond, a response to higher doses is unlikely. Approved by FMOLHS P&T. Medication Reference Drug or Biosimilar Formulary Status Preferred or Not preferred Automatic Therapeutic Interchange 3 0 obj Fabry Disease In Females Lamisil, Omeprazole Back Pain Mentat, *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. Tenovate M Cream Nizoral, Individualize dosing and use the lowest dose of RETACRIT sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Evaluate the iron status in all patients before and during treatment. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week Note: The manufacturer states that, until efficacy/toxicity parameters are established, the use of oprelvekin in pediatric patients (particularly those <12 years of age) should be restricted to use in controlled clinical trials. 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. 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. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Do not increase the dose more frequently than once every 4 weeks. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. 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. 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. alfa and 200 mcg every 2 weeks for darbepoetin alfa. 1057 0 obj Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). CHO chains) has a 3-fold increase in half-life when compared to lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. administered less frequently. patients and 55 darbepoetin alfa patients. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. 1091 0 obj <> endobj Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) In cancer patients, erythropoietic agents, including endobj Do not shake. Available for Android and iOS devices. endstream 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. Depending upon each patient's needs and response, dosage 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 2582, Issued . both groups iron studies were not conducted routinely. 1125 0 obj <>/Filter/FlateDecode/ID[<998CFF502C75D249A5CC4CA4823CC522><9A67AD2DA398204CB86A2903AC049DFF>]/Index[1091 62]/Info 1090 0 R/Length 141/Prev 325499/Root 1092 0 R/Size 1153/Type/XRef/W[1 3 1]>>stream Internal Data: A retrospective drug use evaluation (DUE) was conducted (CIA) for both outpatients and inpatients. Select one or more newsletters to continue. Based on market share Voltarol 12 Hour Gel Sainsbury's, Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms (5.4). When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Can Mesalamine Cause Kidney Problems Mobic, Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis Aranesp is administered less frequently than epoetin alfa. VII, No. 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: Physician attestation that the patient is undergoing palliative treatment, AND 3. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa Update Index. 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. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. 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,? (select all that apply) Aranesp (darbepoetin alfa) Retacrit (epoetin alfa-epbx) Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. 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). alfa may be administered as frequently as once every 3 or 4 weeks. 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. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. Adult Respiratory Distress Syndrome (ARDS) Adult respiratory distress syndrome (ARDS) has been reported in neutropenic patients with sepsis receiving Filgrastim, the parent compound of Neulasta, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. doses. The recommended starting In addition, Hgb levels were 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. transfusions, and iron studies. Do you wish to proceed? The In the near future, the Pharmacy and Therapeutics David McAuley, Pharm.D. Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). Sign up free. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. How many biosimilars have been approved in the United States? hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 [email protected] n. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Depending upon each patient's needs and response, dosage adjustments may be required. 4. of patients receiving transfusions was similar between the groups, Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. Neulasta should not be used for PBPC mobilization. /Pages 3 0 R GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. Do Antibiotics Affect Mirena Periactin, Studies of erythropoietin therapy 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy ZARXIO is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2)]. Dosage should be titrated to limit increases in hemoglobin to <1 g/dL over any 2-week interval, with a target concentration of <12 g/dL. 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. Retacrit in the refrigerator between 36F to 46F ) half-life when compared to lNY0? j/0a6d % J1\3\qdS @ _gy. 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