Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Epub 2014 Jan 31. 3 0 obj
AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. alfa may be administered as frequently as once every 3 or 4 weeks. RETACRIT Dosage and Administration (epoetin alfa-epbx) 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 . Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. PMC 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. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions, Epoetin alfa products, including RETACRIT, increase the risk of seizures in patients with CKD. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. Aranesp (darbepoetin alfa) | Dosing Considerations Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. Mircera Dosage Guide - Drugs.com RETACRIT is a registered trademark of Pfizer Inc. Epogen is a registered trademark of Amgen Inc. Procrit is a registered trademark of Janssen Products, LP. 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. RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Evaluate the iron status in all patients before and during treatment. 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. alfa and 200 mcg every 2 weeks for darbepoetin alfa. Martnez Castelao A, Reyes A, Valds F, Otero A, Lpez de Novales E, Pallard L, Tabernero JM, Hernndez Jaras J, Llads F. Brunkhorst R, Bommer J, Braun J, Haag-Weber M, Gill C, Wagner J, Wagener T; German Aranesp Study Group. 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 . 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. 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. Before sharing sensitive information, make sure you're on a federal government site. In cancer patients, erythropoietic agents, including
Do not increase the dose more frequently than once every 4 weeks. of endogenous erythropoietin may be impaired in patients receiving
The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. 4y\@:hT4\j
EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. MeSH PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna eCollection 2017. chemotherapy. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. and approved an automatic therapeutic interchange to darbepoetin
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)]. The number
The recommended starting
overall. This site is intended for U.S. healthcare professionals. Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. 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. The optimal timing and duration of growth factor stimulation has not been determined. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW Overall, in both groups iron studies were not conducted routinely. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Epogen (epoetin alfa)injection, for intravenous or subcutaneous use Initial U.S.Approval: 1989 WARNING:ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. Conversion of IV to SC EPO: a. 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. 150 units/kg SC 3 times/week or 40,000 units once weekly. The most frequent dosing regimens were 40,000 units weekly
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. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. Epoetin alfa. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. The https:// ensures that you are connecting to the 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. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned The average
alfa. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. affinity has no or little clinical relevance. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. in Hgb of 2 g/dL from baseline. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known, Phenylalanine can be harmful to patients with phenylketonuria (PKU). Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. The most common side effects of epoetin alfa-treated patients in clinical studies of the reference product were high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills. for the erythropoietin receptors, suggesting the slower clearance
Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. scMJkP`@SzQ`
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m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. 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. Do Not Copy, Distribute or otherwise Disseminate without express permission. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance 335 0 obj
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Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 microg/week (P = 0.02). Committee will be exploring other patient populations for this
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If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin
Patient treatments were converted from subcutaneous epoetin alfa to weekly, intravenous darbepoetin alfa at month 0, at a conversion dose of 200 units epoetin alfa to 1 microg darbepoetin. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Epub 2014 Aug 14. A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. Use caution in patients with coexistent cardiovascular disease and stroke. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Federal government websites often end in .gov or .mil. or 100 mcg SC once weekly. <>stream
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. 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. Based on the patient's response, darbepoetin
Switching Between Epoetins: A Practice in Support of Biosimilar Use Call 1-888-4ASSIST to find out more. What is the practical conversion dose when changing from epoetin alfa 1022 0 obj Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. The .gov means its official.Federal government websites often end in .gov or .mil. 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. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. alfa is as well tolerated and efficacious as epoetin alfa even when
patients had to be initiated on epoetin alfa or darbepoetin alfa
A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. However, this may result in the over treatment of uraemic anaemia. endstream Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). 0 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. Decreases in dose can occur more frequently. The site is secure. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. %PDF-1.5
There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. maintain desired hemoglobin (Hgb) levels. All Rights Reserved. Medically reviewed by Drugs.com. The .gov means its official.Federal government websites often end in .gov or .mil. These adverse reactions included myocardial infarction and stroke, 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, ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). transfusions, and iron studies. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin
Depending upon each patient's needs and response, dosage adjustments may be required. Immediately and permanently discontinue RETACRIT and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs, 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 epoetin alfa) in the postmarketing setting. 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. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6
r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* _____ (if . Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). Recommended regimens for patients undergoing elective, noncardiac, nonvascular surgery, 300 Units/kg per day SC for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery, 600 Units/kg SC in 4 doses, administered 21, 14, and 7 days before surgery and on the day of surgery. 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.