Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. W bO? alfa (Aranesp; Amgen) to be therapeutic equivalent products
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. Accessibility startxref The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The information provided is for educational purposes only. The .gov means its official.Federal government websites often end in .gov or .mil. A target
Maintain the route of administration (intravenous or subcutaneous injection). Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. For adult patients with CKD not on dialysis: When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2). 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. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Darbepoetin alfa, although several fold more biologically
ChronicKidney Disease: When therapy with RETACRIT is needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In controlled clinical trials of patients with chronic kidney disease (CKD) comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL), epoetin alfa increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups, 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 benefit. Based on the patient's response, darbepoetin
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. 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 The
It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Cancer patients on chemotherapy (Treatment of patients with erythropoietin levels >200 mU/mL is not recommended). These are recommended doses. 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. [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. This site is intended only for U.S. healthcare professionals. epoetin alfa produce similar Hgb levels in patients with CIA. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. >/@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 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. The intravenous route is recommended for patients on hemodialysis. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa
The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . Conclusion: 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 . Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Copyright 1993-2021 RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. *For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 Units/week, the available data are insufficient to determine an Aranesp conversion dose. 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. Round the dose to the nearest treatment tier. zi){#_YD2}y5g{b_qh3d{~"/7{k~} }^?>~4LF=,q\Qnw/UUuQTN /Bu*"=rl w.WO/I:$woS'/rmG
M/d=w+6E/pB)OOq5A:P+o{ K2`._iD6vGfch>PN/VTH3|GH-a/D}-J"{6Mj9K`a2'> Iltm< Do not mix with other drug solutions. . Production
Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. In order to be included in the DUE,
Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products, said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDAs Center for Drug Evaluation and Research. In addition, do not mix RETACRIT with bacteriostatic saline (which also contains benzyl alcohol) when administering RETACRIT to these patient populations, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including RETACRIT multiple-dose vials. Response rates are defined
_____ (if . If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh Available for Android and iOS devices. 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. More specifically, 23 patients in the epoetin alfa group
Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Discard unused portion of Aranesp in vials or prefilled syringes. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. adverse event to Retacrit (epoetin alfa), and the adverse event was not an expected adverse event attributed to the active ingredient as described in the prescribing information; OR For patients that are currently on treatment with Aranesp (darbepoetin alfa) they can remain on July/August 2004, Return to
Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Similar to endogenous
interchange, such as patients with chronic renal failure (CRF). . -m]|;VB
&mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$
8\n^l|w,|1K
sewEVzhc
MT"_jlhV&AV7^Hiud:.B.4=>^ 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 alfa may be administered as frequently as once every 3 or 4 weeks. <>
_
p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) therapy. The FDAs approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated
RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. both groups iron studies were not conducted routinely. Learn how to combine multiple dosing options for precise titration and individualize anemia management. In patients receiving treatment for cancer and whose anemia is not due to CKD. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. Do not dilute. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. *Z?PkIV/X8$yN7.7 Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. Evaluation of Iron Stores and Nutritional Factors. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Clipboard, Search History, and several other advanced features are temporarily unavailable. and 24 patients in the darbepoetin alfa group reached the targeted
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). Studies of erythropoietin therapy
Keep the tip of the needle in the RETACRIT liquid. <> for epoetin alfa-treated patients and 200 mcg every 2 weeks (or
hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. %PDF-1.5
arena for dosing, dosing interval, hemoglobin levels, number of
Federal government websites often end in .gov or .mil. . 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. Evaluate the iron status in all patients before and during treatment. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . In CKD, for subcutaneous (SC) administration
Initial U.S. Approval: 2018 . 3 0 obj
Generic name: DARBEPOETIN ALFA 10ug in 0.4mL 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. 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). In cancer patients, erythropoietic agents, including
CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Decreases in dose can occur more frequently. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. 2. In addition, at this time, this interchange program does not affect
epoetin alfa and darbepoetin alfa, have been shown to decrease the
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. Neulasta should be permanently discontinued in patients with serious allergic reactions. 4. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 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. sharing sensitive information, make sure youre on a federal transfusions, and iron studies. 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. 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. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6
r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Ann Pharmacother. before initiating Aranesp. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Last updated on Jan 20, 2023. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Scroll left to view table. However, this may result in the over treatment of uraemic anaemia. in patients with chronic anemia of cancer as well as CIA document
For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g . conversion factor of 1 mcg:220 units Aranesp:EPO. contracts, darbepoetin alfa is less expensive than epoetin alfa. SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. HHS Vulnerability Disclosure, Help An official website of the United States government, : Epogen is used in the dialysis area at CCF. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. 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. 4. 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. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. %
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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Darbepoetin alfa (5 N-linked
number of patients receiving transfusions, to increase hemoglobin
G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation and selected end-cell functional activation (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst antibody dependent killing, and the increased expression of some functions associated with cell surface antigens). epoetin alfa and darbepoetin alfa for the management of CIA. active than epoetin alfa, paradoxically was found to have less affinity
No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. administered less frequently. 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. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. Dr. Gerald Diaz @GeraldMD. Disclaimer. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin
e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Background Anaemia is defined as a reduction of haemoglobin concentration, red . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. scMJkP`@SzQ`
o3O3Dl6o
8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36
m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ This site is intended for U.S. healthcare professionals. and transmitted securely. The average
The number
WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. 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). erythropoietin, darbepoetin alfa stimulates erythropoiesis. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Refer to Table 1. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . see Tables A and B (below). 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. maintain desired hemoglobin (Hgb) levels. overall. 8600 Rockville Pike Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. 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. <>stream
Conversion from Another ESA: dosed once every 4 weeks based on total Avoid frequent dose adjustments. In addition, Hgb levels were
No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. (CKD) patients, darbepoetin alfa administered intravenously has
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. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Contributed by. RETACRIT safely and effectively. Pfizer for Professionals 1-800-505-4426 The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. 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 U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic . When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. 1057 0 obj Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. Do Not Copy, Distribute or otherwise Disseminate without express permission. government site. Please enable it to take advantage of the complete set of features! National Library of Medicine If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . 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 . 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 . In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. Epub 2009 Aug 4. adverse event to Retacrit (epoetin alfa), and the adverse event was not an expected adverse event attributed to the active ingredient as described in the prescribing information; OR For patients that are currently on treatment with Aranesp (darbepoetin alfa) they can remain on When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Unauthorized use of these marks is strictly prohibited. Monitor platelets and hematocrit regularly. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. of patients receiving transfusions was similar between the groups,
OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). 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%. endobj
This site complies with the HONcode standard for trust- worthy health information: verify here. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Follow the Oncology Center of Excellence on Twitter @FDAOncology. duration of therapy was 13.2 weeks and 13.6 weeks in the 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).