Generic name: DARBEPOETIN ALFA 10ug in 0.4mL <> Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. Monitor platelets and hematocrit regularly. 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. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. for the erythropoietin receptors, suggesting the slower clearance The recommended starting To report an adverse event, please call 1-800-438-1985. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. alfa- and darbepoetin alfa-treated patients, respectively. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. REASON FOR . 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. Available for Android and iOS devices. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. % dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. Epub 2009 Aug 4. 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 products discussed in this site may have different product labeling in different countries. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. 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. 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. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. While a discounted alternative to Epogen and Procrit is welcome, there is a catch. Drug class: Recombinant human erythropoietins. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. 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. 2022Pfizer Inc. All rights reserved. 4 0 obj Before sharing sensitive information, make sure you're on a federal government site. Nephrol Dial Transplant. of patients receiving transfusions was similar between the groups, 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. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Copyright 1993-2021 Dr. Gerald Diaz @GeraldMD. Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disease should prescribe Neulasta for such patients, and only after careful consideration of the potential risks and benefits. Do not mix with other drug solutions. Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. Decreases in dose can occur more frequently. Epub 2014 Aug 14. 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. 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 . 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. Depending upon each patient's needs and response, dosage HrsW-D/tCPs. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. Before Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. VII, No. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. 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. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. b. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. Keep the tip of the needle in the RETACRIT liquid. The PMC gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. JKn&,&LzN hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. 2. Internal Data: A retrospective drug use evaluation (DUE) was conducted \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! in patients with chronic anemia of cancer as well as CIA document 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. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly.In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. before initiating Aranesp. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. Pharmacotherapy e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. in Hgb of 2 g/dL from baseline. 33 Dose. 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. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Studies of erythropoietin therapy The average If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. endstream endobj 336 0 obj <>stream The site is secure. Discard unused portion of Aranesp in vials or prefilled syringes. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. . Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). transfusions, and iron studies. We comply with the HONcode standard for trustworthy health information. 3 0 obj Use the lowest dose of Aranesp necessary to avoid RBC transfusions. Do not increase the dose more frequently than once every 4 weeks. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin 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). Evaluation of Iron Stores and Nutritional Factors. Background Anaemia is defined as a reduction of haemoglobin concentration, red . Darbepoetin alfa, although several fold more biologically IV Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. 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. administered less frequently. Slowly push the plunger up to force the air bubbles out of the syringe. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. <>>> Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. Dosage form: injection, solution May 15, 2018. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . 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. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency, For lack or loss of hemoglobin response to RETACRIT, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, bleeding). The intravenous route is recommended for patients on hemodialysis. doses. The .gov means its official.Federal government websites often end in .gov or .mil. Initial U.S. Approval: 2018 . Unable to load your collection due to an error, Unable to load your delegates due to an error. conversion factor of 1 mcg:220 units Aranesp:EPO. 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. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Conclusion: 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. interchange, such as patients with chronic renal failure (CRF). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. and transmitted securely. 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. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Serious allergic reactions to OMONTYS. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. both groups iron studies were not conducted routinely. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) This site is intended only for U.S. healthcare professionals. alfa may be administered as frequently as once every 3 or 4 weeks. Epub 2014 Jan 31. Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. epoetin alfa and darbepoetin alfa for the management of CIA. Do not dilute. Bookshelf Avoid frequent dose adjustments. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. The safety and effectiveness of Neumega have not been established in pediatric patients. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee 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. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. GrepMed and the images sourced through this website are NOT a substitute for clinical judgement.