Aranespä is indicated for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis. Hypertensive encephalopathy and seizures have been observed in patients with CRF treated with Aranespä or Epoetin alfa. 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 . The studies were designed to assess the safety and effectiveness of Aranespä but not to support conclusions regarding comparisons between the 2 products. The safety and efficacy of Aranespä therapy have not been established in patients with underlying hematologic diseases (eg, hemolytic anemia, sickle cell anemia, thalassemia, porphyria). 2. In both studies, the starting dose of Aranespä was 0.45 mcg/kg administered once weekly. Production of endogenous erythropoietin is impaired in patients with chronic renal failure (CRF), and erythropoietin deficiency is the primary cause of their anemia. Aranesp … Indications and Usage Accessed December 2019. 0000003436 00000 n Aranesp darf nur auf Verschreibung des Arztes oder der Ärztin angewendet werden. Aranespä should be administered once every 2 weeks if a patient was receiving Epoetin alfa once per week. Package leaflet: Information for the user. Deficiencies of folic acid or vitamin B12 should be excluded or corrected. Aranesp is administered less frequently than epoetin alfa. Do not administer Aranespä in conjunction with other drug solutions. Neither molecule bound to human tissues other than those expressing the erythropoietin receptor. Aranesp ä is an erythropoiesis stimulating protein closely related to erythropoietin that is produced in Chinese hamster … within 4 weeks with < 2-fold increase in peak concentration when compared to the initial dose. In Aranespä clinical trials, approximately 40% of patients required initiation or intensification of antihypertensive therapy during the early phase of treatment when the hemoglobin was increasing. Aranespä dosage should be adjusted to maintain a target hemoglobin not to exceed 12 g/dL. 0000007266 00000 n This patient package insert contains information and directions for patients who will be receiving injections of Aranespä and their caregivers. Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. �� �т��K$�)��:atl�̂L�"�:���"��A�{w]�-�?�����>���. Albumin solution contains 2.5 mg albumin (human), 2.23 mg sodium phosphate monobasic monohydrate, 0.53 mg sodium phosphate dibasic anhydrous, and 8.18 mg sodium chloride in After initiation of Aranespä therapy, the hemoglobin should be determined weekly until it has stabilized and the maintenance dose has been established (see DOSAGE AND ADMINISTRATION). Aranespä is available in 2 solutions, an albumin solution and a polysorbate solution. Bewahren Sie die Aranesp-Fertigspritze immer in der Originalverpackung auf, um den Inhalt vor Licht zu schützen. If the hemoglobin is increasing and approaching 12 g/dL, the dose should be reduced by approximately 25%. a Infection includes sepsis, bacteremia, pneumonia, peritonitis, and abscess. Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. Aranesp [package insert] Thousand Oaks, CA; Amgen Inc; January 2019. The additional carbohydrate chains increase the approximate molecular weight of the ©2018, Magellan Rx Management 150 mcg/0.3 mL 55513-0027-04 VII. 0000006204 00000 n Restricted Access – Do not disseminate or copy without approval. This patient package insert contains information and directions for patients who will be receiving injections of Aranespä and their caregivers. Following SC administration, the absorption is slow and rate-limiting, and the terminal half-life is 49 hours (range: 27 to 89 hours), which reflects the absorption half-life. Through a robust pipeline of promising drug candidates, pharmaceutical innovator Kyowa Kirin aims to ensure people around the world have access to safe, effective treatment. Intravenous injection of Aranespä to female rats every other day from day 6 of gestation through day 23 of lactation at doses of 2.5 mcg/kg/dose and higher resulted in offspring (F1 generation) with decreased body weights, which correlated with a low incidence of deaths, as well as delayed eye opening and delayed preputial separation. For many patients, the appropriate maintenance dose will be lower than this starting dose. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) darbepoetin alfa. For patients randomized to Aranespä, the initial weekly dose was determined on the basis of the previous total weekly dose of recombinant erythropoietin. No overall differences in safety or efficacy were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. malignant processes, osteofibrosis cystica, occult blood loss, hemolysis, severe aluminum toxicity, and bone marrow fibrosis may compromise an erythropoietic response. If it is determined that a patient can safely and effectively administer Aranespä at home, appropriate instruction on the proper use of Aranespä should be provided for patients and their caregivers, including careful review of the Information for Patients and Caregivers insert. Supplemental iron therapy is recommended for all patients whose serum ferritin is below 100 mcg/L or whose serum transferrin saturation is below 20%. Protect from light. DESCRIPTION. xref Mutagenicity: Aranespä was negative in the in vitro bacterial and CHO cell assays to detect mutagenicity and in the in vivo mouse micronucleus assay to detect clastogenicity. Impairment of Fertility: When administered intravenously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected at any doses evaluated (up to 10 mcg/kg/dose, administered 3 times weekly). Clinical Pharmacology Adverse Reactions These highlights do not include all the information needed to use PROLASTIN ®-C . Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. 0000010446 00000 n Contact FDA | Restricted Access – Do not disseminate or copy without approval. Aranesp im Kühlschrank (bei 2 °C bis 8 °C) lagern, jedoch nicht einfrieren. The pharmacokinetic parameters indicate dose-linearity over the therapeutic dose range. During Aranespä therapy, patients should be advised of the importance of compliance with antihypertensive therapy and dietary restrictions. Clinical Studies Erythrocyte aplasia, in association with antibodies to erythropoietin, has been reported on rare occasions in patients treated with other recombinant erythropoietins. 2. In order to prevent the hemoglobin from exceeding the recommended target (12 g/dL) or rising too rapidly (greater than 1.0 g/dL in 2 weeks), the guidelines for dose and frequency of dose adjustments should be followed (see DOSAGE AND ADMINISTRATION: Dose Adjustment). 0000007605 00000 n Aranespä is supplied in 2 formulations with different excipients, one containing polysorbate 80 and another containing albumin (human), a derivative of human blood (see DESCRIPTION). If an anaphylactic reaction occurs, Aranespä should be immediately discontinued and appropriate therapy should be administered. Study 3 was a double-blind The dose should be adjusted for each patient to achieve and maintain a target hemoglobin levelnot to exceed 12 g/dL. Patients and caregivers should also be cautioned against the reuse of needles, syringes, or drug product, and be thoroughly instructed in their proper disposal. HIGHLIGHTS OF PRESCRIBING INFORMATION . 2001;84(Suppl 1):3-10. Anzeige. The hemoglobin should then be monitored at regular intervals. The NCCN Compendium ® is a derivative work of the NCCN Guidelines . 1.10 g/dL (95% CI: 0.82 g/dL, 1.37 g/dL). Scope: Medicaid, Commerical, Medicare … xڬT}Le�vW�ڔJaKǦ�,�����f�k�V�0)0���08�� Adverse Events Occurring in ³ 5% of Patients. aranesp package insert pdf Posted on July 31, 2020 by admin Throughout this section of the package insert, the Aranesp™ study numbers In 2 open-label studies, Aranesp™ or Epoetin alfa … In CRF patients the hemoglobin should be managed carefully, not to exceed a target of 12 g/dL. Description Clinical Pharmacology Clinical Studies Indications and. Egrie JC and Browne JK. Description Clinical Pharmacology Clinical Studies Indications and. Aranespä is available in the following packages: 1 mL Single-dose Vial, Polysorbate Solution. 3531 44 0000014408 00000 n The distribution of Aranespä in adult CRF patients is predominantly confined to the vascular space (approximately 60 mL/kg). Rates of thrombotic events (eg, vascular access thrombosis, venous thrombosis, and pulmonary emboli) with Aranespä Aranesp [package insert] Thousand Oaks, CA; Amgen Inc; January 2019. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROCRIT safely and effectively. In the event of polycythemia, Aranespä should be temporarily withheld (see DOSAGE AND ADMINISTRATION: Dose Adjustment). 0000027358 00000 n 0000014554 00000 n Vascular access thrombosis in hemodialysis patients occurred in clinical trials at an annualized rate of 0.22 events per patient year of Aranespä therapy. Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. This product, the process of its manufacture, or its use, may be covered by one or more US Patents, including US Patent No. 0000013224 00000 n An increase in postimplantation fetal loss was observed in studies assessing fertility (see Carcinogenesis, Mutagenesis, and Impairment of Fertility: Impairment of Fertility). Description Clinical Pharmacology Clinical Studies Indications and. Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. The reason for the increased mortality observed in this study is unknown; however, the incidence of nonfatal myocardial infarction, vascular access thrombosis, and other thrombotic events was also higher in the group randomized to a target hemoglobin of 14 g/dL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Symptoms have recurred with rechallenge, suggesting a causal relationship exists in some instances. 1 . 0000003056 00000 n trailer Patients should be informed of the signs and symptoms of allergic drug reactions and be advised of appropriate actions. 2. Precautions Using a panel of human tissues, the in vitro tissue binding profile of Aranespä was identical to Epoetin alfa. Epogen is not indicatedfor use: In patients with cancer receiving hormonal agents, biologic … %%EOF Predialysis patients, in particular, may require lower maintenance doses. Aranesp [package insert] Thousand Oaks, CA; Amgen Inc; January 2018. 0000016620 00000 n 0000011837 00000 n 0000037118 00000 n Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. 1 MEDICATION GUIDE PROCRIT® (PRO’−KRIT) (epoetin alfa) Read this Medication Guide: • before you start PROCRIT. Preparation and Administration of Aranespä. No deleterious effects on uterine implantation were seen in either species. National Comprehensive Cancer Network, 2020. Because many drugs are excreted in human milk, caution should be exercised when Aranespä is administered to a nursing woman. 0000006700 00000 n 0000005914 00000 n Description Clinical Pharmacology Clinical Studies Indications and. The words Albumin Free appear on the polysorbate container labels and the package main panels as well as other panels as space permits. See full prescribing information for PROCRIT. Also, some patients have been treated successfully with a SC dose of Aranespä administered once every 2 weeks. Throughout this section of the package insert, the Aranesp™ study numbers In 2 open-label studies, Aranesp™ or Epoetin alfa were administered for the. No adverse effects were seen in the F2 offspring. 0000011687 00000 n Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Aranespä cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. DESCRIPTION ARANESP (darbepoetin alfa) is an erythropoiesis-stimulating agent produced in Chinese hamster … Because of individual variability, doses should be titrated to not exceed a target hemoglobin concentration of 12 g/dL (see Dose Adjustment). Single-dose vials are available containing either 25, 40, 60, 100, or 200 mcg of Aranespä . <]>> No significant placental transfer of Aranespä was observed in rats. 2 . 0000004044 00000 n | What's New @ CDER, Description References 1. The route of administration (IV or SC) should be maintained. Page 1 of 16 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEPPRA® injection safely and effectively. Study 1 evaluated CRF patients receiving dialysis; Study 2 evaluated patients not requiring dialysis (predialysis patients). Estimated Aranespä Starting Doses (mcg/week) Based onPrevious Epoetin alfa Dose (Units/week), Previous Weekly Epoetin alfa Dose (Units/week). In responding to hypoxia, erythropoietin interacts with progenitor stem cells to increase red cell production. 0000037402 00000 n 2. Was müssen Sie vor dem Gebrauch beachten? Patients should be informed of the possible side effects of Aranespä and be instructed to report them to the prescribing physician. 0000037340 00000 n Aranesp [package insert] Thousand Oaks, CA; Amgen Inc; January 2019. Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. Conversion From Other Recombinant Erythropoietins. the importance of compliance with their Aranespä treatment, dietary and dialysis prescriptions, and the importance of judicious monitoring of blood pressure and hemoglobin concentration should be stressed. Home Page | Aranespä is formulated as a sterile, colorless, preservative-free protein solution for intravenous (IV) or subcutaneous (SC) administration. If the hemoglobin continues to increase, doses should be temporarily withheld until the hemoglobin begins to decrease, at which point therapy should be reinitiated at a dose approximately 25% below the previous dose. ©2018, Magellan Rx Management 150 mcg/0.3 mL 55513-0027-04 VII. Aranespä should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Carcinogenesis, Mutagenesis, and Impairment of Fertility. 4 1.5 Limitations of Use Epogenhas not been shown to improve quality of life, fatigue, or patient well-being. Doses must be individualized to ensure that hemoglobin is maintained at an appropriate level for each patient. Aranesp ®, Procrit®, Epogen®, and Retacrit ® stimulate erythropoiesis by the same mechanism as endogenous erythropoietin and are known collectively as erythropoietin-stimulating agents (ESAs). Aranespä is administered either IV or SC as a single weekly injection. [Amgen Logo] Manufactured by: Amgen Manufacturing, … See the accompanying Information for Patients and Caregivers leaflet for complete instructions on the preparation and administration of Aranespä . Further increases may be made at 4-week intervals until the specified hemoglobin is obtained. glycoprotein from 30,000 to 37,000 daltons. Supported by the totality of evidence for biosimilarity and the expertise of Sandoz, a Novartis Division 2,3. When Aranespä therapy is initiated or adjusted, the hemoglobin should be followed weekly until stabilized and monitored at least monthly thereafter. As with all therapeutic proteins, there is a potential for immunogenicity. 0000002685 00000 n 0000006924 00000 n Description Clinical Pharmacology Clinical Studies Indications and. The dose strength of the Aranesp vial (number of micrograms [mcg] in the colored square on the package and on the vial label) is the same as your healthcare provider prescribed. There have been rare reports of potentially serious allergic reactions including skin rash and urticaria associated with Aranespä . 0000005469 00000 n Site Info | Contact CDER Because there were no substantive differences in the rates of adverse reactions between these subpopulations, or between these subpopulations and the entire population of patients treated with Aranespä, data from all 1598 patients were pooled. Due to the longer serum half-life, Aranespä should be administered less frequently than Epoetin alfa.
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