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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa
Refer to Aranesp package insert for pediatric dosing conversion.
Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Evaluate the iron status in all patients before and during treatment. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Based on data from this CCHS DUE, darbepoetin alfa and
Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. Overall, in
11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated
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Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. Results:
Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW 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. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. 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. gs+"!y]|"bA=!ZuP
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EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? Dr. Gerald Diaz @GeraldMD. 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. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin.
PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb Depending upon each patient's needs and response, dosage
and 24 patients in the darbepoetin alfa group reached the targeted
Maintain the route of administration (intravenous or subcutaneous injection). alfa (Aranesp; Amgen) to be therapeutic equivalent products
patients had to be initiated on epoetin alfa or darbepoetin alfa
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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. 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.
Amgen 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 .
PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. 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< Epub 2004 Feb 19.
PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa endstream Cancer patients on chemotherapy (Treatment of patients with erythropoietin levels >200 mU/mL is not recommended). Safety and Efficacy: Currently available data indicate that darbepoetin
If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. MeSH Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy).
transfusions, and iron studies. endstream
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Conclusion: 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. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. see Tables A and B (below). See full prescribing information for RETACRIT. Background Anaemia is defined as a reduction of haemoglobin concentration, red . 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). 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. Do not shake. The implementation date for the interchange program is October 11, 2004. 1 0 obj
PDF Highlights of Prescribing Information ------------------dosage and most common dosing regimens are 40,000 units weekly for epoetin
This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. The site is secure. If patient does not respond, a response to higher doses is unlikely. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . Epub 2009 Aug 4. for at least 3 weeks between July 2002 and July 2003. FDA Approved Indication(s) Epogen, Procrit, and Retacrit are indicatedfor: Treatment of anemia due to: o Chronic kidney disease (CKD) in patients on dialysis and not on dialysis alfa- and darbepoetin alfa-treated patients, respectively. 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. The intravenous route is recommended for patients on hemodialysis. 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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. 3 0 obj
PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. erythropoietin, darbepoetin alfa stimulates erythropoiesis. official website and that any information you provide is encrypted For recommended dose equivalency,
b. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. 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. 1. of patients receiving transfusions was similar between the groups,
Serious allergic reactions to OMONTYS. 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. An official website of the United States government. scMJkP`@SzQ`
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Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. Refer to Table 1. similar over the course of therapy for both groups. The
The .gov means its official.Federal government websites often end in .gov or .mil. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc
yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week
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e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. therapy. Discontinue Aranesp if responsiveness does not improve.
PDF Highlights of Prescribing Information ----------------------- Dosage Wien Med Wochenschr. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Neulasta should be permanently discontinued in patients with serious allergic reactions. %PDF-1.6
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7/2021: added Epogen (nonformulary). The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. 1. Conversion from Another ESA: dosed once every 4 weeks based on total Monitor platelets and hematocrit regularly. <> The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx 4. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? HrsW-D/tCPs. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). Excessive response: Hemoglobin increases >1 g/dL in any 2-week period: Decrease dose Hemoglobin increases and approaches the target value of 12 g/dL: Decrease weekly dosage by ~25%. 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. sharing sensitive information, make sure youre on a federal No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Do not mix with other drug solutions. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. (CKD) patients, darbepoetin alfa administered intravenously has
Federal government websites often end in .gov or .mil. Aranesp is administered less frequently than epoetin alfa. Discard unused portion of Aranesp in vials or prefilled syringes. Table 1. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6
r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* or 100 mcg SC once weekly. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. 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. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin
Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. 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). 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. at the Cleveland Clinic Health System (CCHS) reviewing the use of
2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. Surgery patients: Prior to initiating treatment, obtain a hemoglobin to establish that is >10 mg/dL or 13 mg/dL: Initial dose: 300 units/kg/day SC x 10 days before surgery, on the day of surgery, and for 4 days after surgery. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l Similar to endogenous
Unable to load your collection due to an error, Unable to load your delegates due to an error. Do not dilute. 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. levels, and to improve quality of life. 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. Referrals to independent nonprofitpatient assistance programs. endobj Learn how to combine multiple dosing options for precise titration and individualize anemia management. Follow the Oncology Center of Excellence on Twitter @FDAOncology.
VII, No. before initiating Aranesp. 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).
If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered. An official website of the United States government, : This site complies with the HONcode standard for trust- worthy health information: verify here. 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. 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. Epub 2014 Aug 14. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. As a substitute for RBC transfusions in patients who require immediate correction of anemia.
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May 15, 2018. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . _____ (if . OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r
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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 National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. 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. Last updated on Jan 20, 2023. Contributed by. Accessibility Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit Clipboard, Search History, and several other advanced features are temporarily unavailable. Decreases in dose can occur more frequently. Nephrol Dial Transplant. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 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.