Do not dilute. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) Check again for air bubbles. Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. Although these images are curated, as they are sourced from the community, there is no way to guarantee a consistent standard of accuracy and quality across the library of images. alfa and 200 mcg every 2 weeks for darbepoetin alfa. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Key: Hgb = hemoglobin level, measured in . Scroll left to view table. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin Questions regarding Mean baseline Hgb levels Approved by FMOLHS P&T. . Accessibility FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx In the near future, the Pharmacy and Therapeutics epoetin alfa and darbepoetin alfa, have been shown to decrease the Use the lowest dose of Aranesp necessary to avoid RBC transfusions. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. Referrals to independent nonprofitpatient assistance programs. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin Medically reviewed by Drugs.com. If there are still air bubbles, repeat the steps above to remove them. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. What is the practical conversion dose when changing from epoetin alfa Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Neulasta should be permanently discontinued in patients with serious allergic reactions. 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. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). The dose should be titrated to meet and Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). Slowly push the plunger up to force the air bubbles out of the syringe. The recommended starting Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. 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. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. chemotherapy. Severe chronic neutropenia: Congenital: 6 mcg/kg twice daily Idiopathic/cyclic: 5 mcg/kg/day, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=9222, Supplied: Injection, solution [preservative free]: 300 mcg/mL (1 mL, 1.6 mL) [vial; contains sodium 0.035 mg/mL and sorbitol], Injection, solution [preservative free]: 600 mcg/mL (0.5 mL, 0.8 mL) [prefilled Singleject syringe; contains sodium 0.035 mg/mL and sorbitol], Drug UPDATES: ZARXIO - filgrastim-sndz injection [Drug information / PDF] Click link for the latest monographDosing: Click (+) next to Dosage and Administration section (drug info link). Epub 2016 Mar 4. Discontinue Aranesp if responsiveness does not improve. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . Adult Respiratory Distress Syndrome (ARDS) Adult respiratory distress syndrome (ARDS) has been reported in neutropenic patients with sepsis receiving Filgrastim, the parent compound of Neulasta, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 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. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 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. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. In chronic kidney disease If patient does not respond, a response to higher doses is unlikely. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. stream This site is intended only for U.S. healthcare professionals. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. PDF Highlights of Prescribing Information ------------------dosage and 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). hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. Overall, in Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. 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. Use caution in patients with coexistent cardiovascular disease and stroke. endstream 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. %%EOF 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. The most frequent dosing regimens were 40,000 units weekly endobj An official website of the United States government, : Conversion of IV to SC EPO: a. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Product Information and Dosing | Mircera RETACRIT safely and effectively. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. 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 . If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses. alfa- and darbepoetin alfa-treated patients, respectively. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. Pharmacotherapy Avoid frequent dose adjustments. hemoglobin of > 12 g/dL was reached in 47 patients (41%) The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). Based on data from this CCHS DUE, darbepoetin alfa and HrsW-D/tCPs. in patients with chronic anemia of cancer as well as CIA document <>/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 Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned Depending upon each patient's needs and response, dosage adjustments may be required. 4. 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 . Methods: No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Refer to Aranesp package insert for pediatric dosing conversion. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. see Tables A and B (below). 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.