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). The probability of switching between different epoetins was associated with the duration of treatment: about 15 % of users switched within 12 months and almost 25 % within 2 years of observation. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to RETACRIT therapy, 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 epoetin alfa. 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. Accessibility This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned Epub 2004 Feb 19. 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)]. WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefits. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. 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. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. Scroll left to view table. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. Clipboard, Search History, and several other advanced features are temporarily unavailable. Patients receiving RETACRIT may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis, Adverse reactions in 5% of epoetin alfa-treated patients on dialysis were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation. 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. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). Follow the Oncology Center of Excellence on Twitter @FDAOncology. In addition, as with Epogen/Procrit, Retacrit contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. Dosage form: injection, solution >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r SN:]AW&g{auwi(D)Si'(EK 9P$a8d_R/au&tIk=[A'"Uh 5E~"{dC4dMs/*e?&Io}a\d05zVJ)~OL:MK'tiM>)r4zoBp`Vju`'78f4*q-PFa_,R2(r\?ASM^B6DT&s+IfUSqS6H5l~b)lMx:'j_sT[.q"ju g/8f5>tWw]}vAQNK0: st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c Aranesp is the only long-acting erythropoiesis-stimulating agent (ESA) approved for both once weekly (QW) and once every three weeks (Q3W) dosing 1, 2 Aranesp dosing options of QW or Q3W may allow for synchronization with common myelosuppressive chemotherapy regimens. number of patients receiving transfusions, to increase hemoglobin For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. PMC It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products, said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDAs Center for Drug Evaluation and Research. Do not increase the dose more frequently than once every 4 weeks. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. If patient does not respond, a response to higher doses is unlikely. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. . If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. The most frequent dosing regimens were 40,000 units weekly 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 needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. and approved an automatic therapeutic interchange to darbepoetin Following initiation and titration of epoetin alfa, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving RETACRIT, Appropriately control hypertension prior to initiation of and during treatment with RETACRIT. maintain desired hemoglobin (Hgb) levels. In addition, do not mix RETACRIT with bacteriostatic saline (which also contains benzyl alcohol) when administering RETACRIT to these patient populations, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including RETACRIT multiple-dose vials. 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 . Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. RETACRIT safely and effectively. Do not use Aranesp that has been shaken or frozen. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. Retacrit has been approved as a biosimilar, not as an interchangeable product. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. %PDF-1.6 % Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. Discontinue Aranesp if responsiveness does not improve. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB 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. 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)]. Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria . OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Ann Pharmacother. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. Do not dilute. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . CHO chains) has a 3-fold increase in half-life when compared to 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 . The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. and 24 patients in the darbepoetin alfa group reached the targeted Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1). 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. % This site complies with the HONcode standard for trust- worthy health information: verify here. Would you like email updates of new search results? What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? affinity has no or little clinical relevance. 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 the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. The dose should be titrated to meet and zi){#_YD2}y5g{b_qh3d{~"/7{k~} }^?>~4LF=,q\Qnw/UUuQTN /Bu*"=rl w.WO/I:$woS'/rmG M/d=w+6E/pB)OOq5A:P+o{ K2`._iD6vGfch>PN/VTH3|GH-a/D}-J"{6Mj9K`a2'> Iltm< Studies of erythropoietin therapy HHS Vulnerability Disclosure, Help 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. 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. When therapy with RETACRITis needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy, In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure, In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion, In patients scheduled for surgery who are willing to donate autologous blood, In patients undergoing cardiac or vascular surgery, As a substitute for RBC transfusions in patients who require immediate correction of anemia, Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs, Serious allergic reactions to RETACRIT or other epoetin alfa products, Neonates, infants, pregnant women, and lactating women. Pharmacotherapy FOIA Based on data from this CCHS DUE, darbepoetin alfa and alfa and 200 mcg every 2 weeks for darbepoetin alfa. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). Depending upon each patient's needs and response, dosage Neulasta should not be used for PBPC mobilization. After the initial 4 weeks of RETACRIT therapy, if hemoglobin increases by less than 1 g/dL, 300 Units/kg 3 times per week in adults or, 900 Units/kg (maximum 60,000 Units) weekly in pediatric patients. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. epoetin alfa and darbepoetin alfa for the management of CIA. Copyright 1993-2021 \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! 1. Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy, RETACRIT is contraindicated in patients with uncontrolled hypertension. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Epub 2016 Mar 4. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . Protect vials and prefilled syringes from light. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. It is used in two groups of patients: adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly); adults who are receiving chemotherapy for nonmyeloid cancer (cancer not originating in . Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Chronic Kidney Disease: 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. see Tables A and B (below). Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 The IV route is recommended for patients on hemodialysis, For adult patients with CKD not on dialysis, The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC, The recommended starting dose for pediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly IV or SC, Recommended dosing for patients with HIV treated with zidovudine, The recommended starting dose in adults is 100 Units/kg as an IV or SC injection 3 times per week, 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 red blood cell (RBC) transfusions or 300 Units/kg, Recommended starting dose for adults and children undergoing cancer chemotherapy*, 150 Units/kg SC 3 times per week until completion of a chemotherapy course, or, 40,000 Units SC weekly until completion of a chemotherapy course, 600 Units/kg IV weekly until completion of a chemotherapy course. alfa for chronic anemia of cancer and chemotherapy-induced anemia The FDAs approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. Alternative dose: 600 units/kg in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of Aranesp or whether the patient would benefit from a different Aranesp presentation. 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. Pussell BA, Walker R; Australian Renal Anaemia Group. Supplied Injection, powder for reconstitution: 5 mg, INDICATIONS AND USAGE Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Patients with anemia and chronic kidney disease undergoing maintenance hemodialysis and receiving routine intravenous (IV) Epogen were randomized 1: 1 to switch to IV RetacritTM or continue standard-of-care (Epogen) for 24 weeks, using analogous versions of the FMCNA ESA-dosing algorithm. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Oncology (Cancer) / Hematologic Malignancies Approval Notifications, Verified Clinical Benefit | Cancer Accelerated Approvals, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description, FDA approves Retacrit as a biosimilar to Epogen/Procrit, Drug Information Soundcast in Clinical Oncology. Similar to endogenous Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. alfa may be administered as frequently as once every 3 or 4 weeks. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks, In controlled clinical trials of patients with cancer, epoetin alfa increased the risks for death and serious adverse cardiovascular reactions. patients had to be initiated on epoetin alfa or darbepoetin alfa and transmitted securely. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. alfa. Do not shake. 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. in patients with chronic anemia of cancer as well as CIA document If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. 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. 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. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. alfa (Aranesp; Amgen) to be therapeutic equivalent products a half-life of 25.3 hours compared to epoetin alfa, which has a The dose of MIRCERA , given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of . The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. half-life of 8.5 hours. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation ZARXIO is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae e.g.febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)]. This site is intended for U.S. healthcare professionals. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Conversion of IV to SC EPO: a. <> An official website of the United States government, : Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Aranesp, and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Epub 2009 Aug 4. Dr. Gerald Diaz @GeraldMD. A local search option of this data can be found here. Methods: In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Beneficial dose conversion after switching from higher doses of shorter-acting erythropoiesis-stimulating agents to C.E.R.A in CKD patients in clinical practice: MINERVA Study. HrsW-D/tCPs. Careers. endobj similar over the course of therapy for both groups. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. 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 This site needs JavaScript to work properly. 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. Like Epogen/Procrit, the labeling for Retacrit contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. 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. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Drug class: Recombinant human erythropoietins. Dose adjustment: If response is not satisfactory after a sufficient period of evaluation (8 weeks of 3 times/week and 4 weeks of once weekly therapy), the dose may be increased every 4 weeks (or longer) up to 300 units/kg 3 times/week, or when dosed weekly, increased all at once to 60,000 units weekly. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAs MedWatch Reporting System or by calling 1-800-FDA-1088. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 2. 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. Based on the patient's response, darbepoetin 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. this interchange program should be directed to the CCF Department Aranesp Dosing and Conversion Brochure. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. Referrals to independent nonprofitpatient assistance programs. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The average Epub 2014 Jan 31. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin