5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Clipboard, Search History, and several other advanced features are temporarily unavailable. hemoglobin of > 12 g/dL was reached in 47 patients (41%) Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. In chronic kidney disease PMC Follow the Oncology Center of Excellence on Twitter @FDAOncology. Select one or more newsletters to continue. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks and iron stores are adequate: Increase by ~25% of the previous dose; increases should not be made more frequently than once monthly. endobj Excessive responses: Hemoglobin increases >1 g/dL in a 2-week period OR if hemoglobin exceeds 12 g/dL: Reduce dose by 25% Hemoglobin >13 g/dL: Withhold dose until hemoglobin falls to 12 g/dL, then reinitiate at 25% less than previous dose. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. response rates ranging from ~60% to 85%. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* Wien Med Wochenschr. Evaluate the iron status in all patients before and during treatment. Before prescribing RETACRIT single-dose vials to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including RETACRIT, Patients may require adjustments in their dialysis prescriptions after initiation of RETACRIT. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . for at least 3 weeks between July 2002 and July 2003. patients and 55 darbepoetin alfa patients. therapy. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l Note: The manufacturer states that, until efficacy/toxicity parameters are established, the use of oprelvekin in pediatric patients (particularly those <12 years of age) should be restricted to use in controlled clinical trials. >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r SN:]AW&g{auwi(D)Si'(EK 9P$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/$Apx>GW mo^6*{INX%!ZuH@=_c If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Aranesp, and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known, Phenylalanine can be harmful to patients with phenylketonuria (PKU). Similar to endogenous Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. of endogenous erythropoietin may be impaired in patients receiving Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. alfa (Aranesp; Amgen) to be therapeutic equivalent products 150 units/kg SC 3 times/week or 40,000 units once weekly. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. All Rights Reserved. Before sharing sensitive information, make sure you're on a federal government site. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Before The most frequent dosing regimens were 40,000 units weekly The safety and effectiveness of Neumega have not been established in pediatric patients. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week before initiating Aranesp. Based on data from this CCHS DUE, darbepoetin alfa and Overall, in both groups iron studies were not conducted routinely. ChronicKidney Disease: 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. !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X T]{oF`S}+c|yt} } ;X'~'6S;3$]K$t/Z1hrL;\qdHBwtKwHUL` z0 DY%--V! Retacrit has been approved as a biosimilar, not as an interchangeable product. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? In pediatric patients, Mircera is administered by intravenous injection only (2.2). Both drugs are costly: January 2003 prices posted by Medicare put reimbursement rates at $12.69 per 1000 units of Procrit (translating to about $534.32 for the Average Wholesale Price [AWP] for a once-a-week dose of 40,000 units) and $23.69 per 5 micrograms of Aranesp (about $994.98 for the AWP for a 3 mcg/kg dose every other week). GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). 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. 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. 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. . Hgb level. 1. 33 Dose. Nephrology (Carlton). 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. arena for dosing, dosing interval, hemoglobin levels, number of 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. alfa. Initiate Aranesp 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 subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. 1121 0 obj The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. . 1. Overall, only 10.5% of patients had iron studies before erythropoietin 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. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. The site is secure. 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%. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . Available for Android and iOS devices. 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. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. <> 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)]. Drug class: recombinant human erythropoietins, Aranesp (Darbepoetin Alfa Prefilled Syringes), Anemia Associated with Chronic Renal Failure, If hemoglobin exceeds a level needed to avoid RBC transfusion, If hemoglobin increases by less than 1 g/dL. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. A local search option of this data can be found here. Discontinue RETACRIT therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected, RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. 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. 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. In patients receiving treatment for cancer and whose anemia is not due to CKD. 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. These are recommended Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. official website and that any information you provide is encrypted The site is secure. 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). 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. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y Background: Evaluate other causes of anemia. Epoetin alfa. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. endobj Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. 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. The information provided is for educational purposes only. scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. Epub 2016 Mar 4. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. The .gov means its official.Federal government websites often end in .gov or .mil. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Please review the latest applicable package insert for additional information and possible updates. Do not re-enter vial. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. and transmitted securely. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Patients on Cancer Chemotherapy Initiate Aranesp 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. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. 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. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. This site is intended only for U.S. healthcare professionals. Results: 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. Maintain the route of administration (intravenous or subcutaneous injection). 4. 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.