In addition, do not mix RETACRIT with bacteriostatic saline (which also contains benzyl alcohol) when administering RETACRIT to these patient populations [see Dosage and Administration (2)]. How should I dispose of the vials, syringes, and needles? At the end of the initial 12 weeks, a statistically significant rise in mean hemoglobin (3.1 g/dL vs. 0.3 g/dL) was observed only in the epoetin alfa arm. Pfizer recognizes the public concern in relation to COVID-19, which continues to evolve. Preterm, low birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. Polyhydramnios and intrauterine growth restriction were reported in women with chronic renal disease, which is associated with an increased risk for these adverse pregnancy outcomes. Patients responded to epoetin alfa administered subcutaneously in a manner similar to patients receiving intravenous administration. Do not use RETACRIT if the liquid in the vial looks discolored or cloudy, or if the liquid has lumps, flakes, or particles. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.9)]. Following an interim analysis of 70 patients (planned accrual 300 patients), a significant difference in survival in favor of the patients in the placebo arm of the study was observed (median survival 63 vs. 129 days; HR 1.84; p = 0.04). During the first several months following initiation of RETACRIT. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies to other epoetin alfa products may be misleading. RETACRIT offers the potential to help address treatment costs, while maintaining the established clinical efficacy and safety of epoetin alfa—brought to you by Pfizer, a committed leader in biosimilar innovation and development.2, To report an adverse event, please call 1-800-438-1985. In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol, Table 3. Study 7 was a randomized, open-label, controlled study conducted in 522 patients with primary squamous cell carcinoma of the head and neck receiving radiation therapy alone (no chemotherapy) who were randomized to receive darbepoetin alfa to maintain hemoglobin levels of 14 to 15.5 g/dL or no darbepoetin alfa.

Copyright © 2002-2020 Pfizer Inc. All rights reserved. may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis. Do not shake. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. In patients on hemodialysis, the intravenous (IV) route is recommended. ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. After removing a dose from the multiple-dose vial, store the vial in the refrigerator (but not the freezer). Of the 757 patients who received epoetin alfa in the 3 studies of CKD patients on dialysis, 361 (47%) were age 65 years and over, while 100 (13%) were 75 years and over.

The preservative benzyl alcohol has been associated with serious adverse reactions and death when administered intravenously to neonates and infants [see Warnings and Precautions (5.9), Use in Specific Populations (8.4)]. Differences were observed after the 40,000 Units weekly dosing with longer Tmax (38 ± 18 hours) and lower CL (9.2 ± 4.7 mL/hr/kg) during week 1 when patients were receiving chemotherapy (n = 18) compared with those (22 ± 4.5 hours, 13.9 ± 7.6 mL/hr/kg, respectively) during week 3 when patients were not receiving chemotherapy (n = 7). Safety and effectiveness in pediatric patients less than 1 month old have not been established [see Clinical Studies (14.1)]. RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being. Individualize maintenance dose. The multiple-dose vials of RETACRIT contain benzyl alcohol. Patients may require adjustments in their dialysis prescriptions after initiation of RETACRIT. ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS) (see Table 2). *Biosimilar means that the biological product is approved based on the data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Randomization was stratified by type of malignancy (lung vs. breast vs. other), concurrent radiation therapy planned (yes or no), and baseline hemoglobin (< 9 g/dL vs. ≥ 9 g/dL); patients were randomized to epoetin alfa 40,000 Units (n = 174) or placebo (n = 170) as a weekly subcutaneous injection commencing on the first day of the chemotherapy cycle. In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. When therapy with RETACRIT is needed in neonates and infants, use the single-dose vial, which is a benzyl alcohol-free formulation. The 3-year survival rate was lower (86% vs. 90%; HR 1.42, 95% CI: 0.93, 2.18) and the 3-year relapse-free survival rate was lower (72% vs. 78%; HR 1.33, 95% CI: 0.99, 1.79) in the darbepoetin alfa-treated arm compared to the control arm. If you decide to take RETACRIT, your healthcare provider should prescribe the smallest dose of RETACRIT that is necessary to reduce your chance of needing RBC transfusions. The intravenous route is recommended for patients on hemodialysis.

A final analysis was performed after a median follow-up of approximately 3 years. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. This content is intended for U.S. Healthcare Professionals. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. The carcinogenic potential of epoetin alfa products has not been evaluated. Patients were randomized to receive epoetin alfa at 150 Units/kg (n = 63) or placebo (n = 68), subcutaneously three times per week for 12 weeks in each study. When administered intravenously to male and female rats prior to and during mating, and to females through the beginning of implantation (up to gestational day 7; dosing stopped prior to the beginning of organogenesis), doses of 100 and 500 Units/kg/day of epoetin alfa caused slight increases in pre-implantation loss, post-implantation loss and decreases in the incidence of live fetuses.

People with anemia have a lower-than-normal number of RBCs.

From pretreatment to presurgery, the mean increase in hemoglobin in the 600 Units/kg weekly group (1.44 g/dL) was greater than that observed in the 300 Units/kg daily group.