A target 0 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). Internal Data: A retrospective drug use evaluation (DUE) was conducted Aranesp is administered less frequently than epoetin alfa. Epub 2014 Aug 14. Switch from epoetin to darbepoetin alfa in hemodialysis: dose Epogen is used in the dialysis area at CCF. Do not re-enter vial. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). !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! Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. %PDF-1.6 % Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. government site. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh therapy. In order to be included in the DUE, Epub 2014 Jan 31. 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. 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. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy both groups iron studies were not conducted routinely. 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. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. as well). Decreases in dose can occur more frequently. 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. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin levels, and to improve quality of life. The dose should be titrated to meet and Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. CHO chains) has a 3-fold increase in half-life when compared to Do not mix with other drug solutions. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). Before sharing sensitive information, make sure you're on a federal government site. PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. Similar to endogenous overall. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Approved by FMOLHS P&T. . 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. PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx W bO? Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. 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 . 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. PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. In addition, at this time, this interchange program does not affect \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Pussell BA, Walker R; Australian Renal Anaemia Group. Use caution in patients with coexistent cardiovascular disease and stroke. Clipboard, Search History, and several other advanced features are temporarily unavailable. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. This site needs JavaScript to work properly. If patient does not respond, a response to higher doses is unlikely. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. Darbepoetin alfa, although several fold more biologically alfa. 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. PDF Home Dialysis Programs Standing Orders - Erythropoietin and 24 patients in the darbepoetin alfa group reached the targeted Unauthorized use of these marks is strictly prohibited. The majority of reported events occurred upon initial exposure. 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. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. 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. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. 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< 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. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. a half-life of 25.3 hours compared to epoetin alfa, which has a 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. Monitor platelets and hematocrit regularly. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx of Pharmacy Drug Information Center (216-444-6456, option #1). Darbepoetin alfa (Aranesp) Place of Service Hospital Administration AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. Evaluation of Iron Stores and Nutritional Factors. Last updated on Jan 20, 2023. 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. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. 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. b. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? %PDF-1.5 1057 0 obj %PDF-1.6 % Questions regarding Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Conversion from Another ESA: dosed once every 4 weeks based on total Do not shake. <>/Filter/FlateDecode/ID[<6A376E50FA41294D8BDE0DC442E05AF8>]/Index[1022 100]/Info 1021 0 R/Length 147/Prev 333934/Root 1023 0 R/Size 1122/Type/XRef/W[1 3 1]>>stream A single hemoglobin excursion may not require a dosing change. 335 0 obj <>stream and transmitted securely. Retacrit has been approved as a biosimilar, not as an interchangeable product. The information provided is for educational purposes only. The optimal timing and duration of growth factor stimulation has not been determined. The implementation date for the interchange program is October 11, 2004. Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. PDF Highlights of Prescribing Information ----------------------- Dosage Select one or more newsletters to continue. arena for dosing, dosing interval, hemoglobin levels, number of of the molecule is a more important determinant of potency and receptor 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. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy.