romiplostim indications

Lancet Haematol. 2009;144(3):409-415. Disclaimer, National Library of Medicine The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. National Comprehensive Cancer Network, Inc. Romiplostim is a man-made form of a protein that increases production of . 1 INDICATIONS AND USAGE 1.1 Patients with Immune Thrombocytopenia (ITP) . Concomitant use of romiplostim and chemotherapy for advanced rectal cancer associated with idiopathic thrombocytopenic purpura. Systematic literature review and meta-analysis on use of Thrombopoietic agents for chemotherapy-induced thrombocytopenia. UpToDate [online serial]. Romiplostim decreases your risk of bleeding by increasing the number of platelets. Romiplostim is used in certain patients with ITP who have not gotten better with other treatment. 2018;5(3):e117-e126. Rapid blood cell recovery with immunosuppressive therapy combined with romiplostim in a patient with very severe hepatitis-associated aplastic anemia whounderwent liver transplantation. UpToDate [online serial]. Expert Opin Biol Ther. NCCN Clinical Practice Guidelines in Oncology, Version 3.2022. Haematologica. Nplate [package insert]. Bone Marrow Transplant. Dizziness, headache, indigestion, joint pain, muscle tenderness or weakness, shoulder pain, stomach pain or upset, and trouble in sleeping. Treatment of Primary Immune Thrombocytopenia (ITP) Treatment. The site is secure. The authors concluded that although these findings were promising, data from randomized clinical trials are needed to fully understand the role of romiplostim after SCT. Blood. Your treatment with romiplostim. India is the world's capital for quality medicines, be it pharmaceutical formulations, herbal medicines or nutraceuticals. Kantarjian HM, Fenaux P, Sekeres MA, et al. Person'swith higher scores (e.g., intermediate-2 and high risk; IPSS 1.5) are at higher risk of transformation to acute myelogenous leukemia. Zeiser R. Treatment of chronic graft-versus-host disease. Aetna considers romiplostim experimental and investigational for the following indications (not an all-inclusive list) because its effectiveness for these indications has not been established: Stem cell mobilization Thrombocytopenia during pregnancy Thrombocytopenia following allogeneic stem cell transplantation Evans syndrome Bethesda, MD 20894, Web Policies However, much of the information may also apply to unapproved uses that are being studied. For additional language assistance: Therapeutic, prophylactic, or diagnostic injection, Immune thrombocytopenic purpura [idiopathic], Other secondary thrombocytopenia [chemotherapy-induced thrombocytopenia], Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter, subsequent encounter, or sequela, Radiation sickness, unspecified [Hematopoietic syndrome of acute radiation syndrome], Other aplastic anemias and other bone marrow failure syndromes, Purpura and other hemorrhagic conditions [thrombocytopenia associated with Evans syndrome], Graft-versus-host disease [associated with thrombocytopenia], Other diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism complicating pregnancy [thrombocytopenia], Complications of stem cell transplant [thrombocytopenia following allogeneic stem cell transplantation]. Int J Hematol. Profession (construction worker) or lifestyle (e.g., plays contact sports) that predispose member to trauma. IPSS (International Prognostic Scoring System), IPSS-R (Revised International Prognostic Scoring System). <span>Purpose: Rapid depletion of white blood cells, platelets, and reticulocytes are hallmarks of hematopoietic injury of acute radiation syndrome (H-ARS) and, if left untreated, can lead to severe health consequences including death. Successful treatment of cyclic thrombocytopenia with thrombopoietin-mimetic agents: a report of two patients. 2019 Apr;25(3):567-576. doi: 10.1177/1078155217748470. Romiplostim for severe thrombocytopenia in the treatment of chronic hepatitis C virus infection: A new option for clinicians? Eltrombopag versus romiplostim in treatment of children with persistent or chronic immune thrombocytopenia: A systematic review incorporating an indirect-comparison meta-analysis. No. . UpToDate [online serial]. INDICATIONS Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Capecchi M, Serpenti F, Giannotta J, Pettine L, Reda G, Martinelli I, Artoni A, Barcellini W, Fattizzo B. 2016;19(5):614-622. 2011;157:267-288. Careers. Thrombocytopenic purpura - romiplostim. Romiplostim is an Fc-peptide fusion protein that binds to and activates the thrombopoietin (TPO) receptor, thereby increasing platelet production. Initial romiplostim dosing and time to platelet response in patients with treatment refractory immune thrombocytopenia. Limitations of use: 2009;46(1 Suppl 2):S26-S32. Off-Label Use of Thrombopoietin Receptor Agonists: Case Series and Review of the Literature. The prognosis and treatment for MDS vary depending on a person'sInternational Prognostic Scoring System (IPSS) score. Lancet. Nihon Shokakibyo Gakkai Zasshi. While all treatments resulted in increased platelet counts, romiplostim had the most pronounced effect at 6 months (p =0.04). Always seek the advice of a qualified physician for medical diagnosis and treatment. The .gov means its official.Federal government websites often end in .gov or .mil. Indicated for immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy Initial 1 mcg/kg SC qWeek Use lowest dose of Nplate to achieve. Blood Adv2019;3(23):38293866. Now fever, headache and body pains are the indications of paracetamol. Lower-risk MDS tends to grow and progress slowly, thus,a lower-risk scoregenerally indicates a better outlook. Stasi R, Evangelista ML, Amadori S. Novel thrombopoietic agents: A review of their use in idiopathic thrombocytopenic purpura. Provan D, Stasi R, Newland AC, et al. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. (2014) stated that primary immune thrombocytopenia is not a rare event during pregnancy, and it must be carefully managed to avoid hemorrhagic complications for the mother. Neunert C, Lim W, Crowther M, et al. Nplate is supplied as either 125 mcg per vial, 250 . Splenectomy is also clearly indicated in patients with life-threatening hemorrhage, although this is an extremely rare event. 8600 Rockville Pike Immune thrombocytopenia (ITP) in children: Management of chronic disease. Notify physician immediately if these signs occur. Lastly, splenectomy can also be considered in patients that have a poor health-related quality of life despite receiving other treatment, or at the request of the family. Romiplostim improved platelet counts in all 20 patients. 2019;94(7):741-750. Plymouth Meeting, PA: NCCN; January 2022. Waltham, MA: UpToDate;reviewed November 2021. 2012;23(4):264-273. and transmitted securely. A total of 7 transfusion-dependent pediatric patients (median age of 11 years), with platelet counts below 10 109/L, received 4 weekly doses of subcutaneous romiplostim to treat SFPR developed after HSCT. Other diagnoses/indications. (2014) that included 250 patients with thrombocytopenia with low-risk/intermediate 1-risk MDS who were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks. Zeiser R. Treatment of acute graft-versus-host disease: UpToDate [online serial]. angioedema, urticaria). Indications and Usage (1) 07/2011 Dosage and Administration, Nplate Distribution removal 12/2011 . Kantarjian H, Fenaux P, Sekeres MA, et al. Hematology. Int J Hematol. It may cause dizziness, do not drive a car or operate machinery while taking this medication. [citation needed] Romiplostim is indicated as a potential treatment for chronic idiopathic (immune) thrombocytopenic purpura (ITP). 2012;47(9):1154-1163. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician. 2009;113(11):2386-2393. Romiplostim. Appraisal Consultation Document. This page contains brief information about romiplostim and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials. Bussel JB, Soff G, Balduzzi A, Cooper N, Lawrence T, Semple JW. Lancman and colleagues (2018) stated that thrombocytopenia is a relatively common complication following allogeneic HSCT and is associated with increased bleeding, transfusion requirements, chronic GVHD, and all-cause mortality. 2001;68:210-214. Zhang J, Liang Y, Ai Y, et al. eCollection 2021. Decroocq et al. The International Prognostic Scoring System. It differs from the other two systems in that it includes the MDS subtype as a prognostic factor. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. NCCN notes that an open-label extension study evaluated the long-term efficacy and safety of romiplostim in 60 patients with lower-risk MDS and found that most achieved durable responses. Romiplostim is approved by the FDA for the treatment of thrombocytopaenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or . The site is secure. Since 2015, the United States Food and Drug Administration (U.S. FDA) has approved four radiation medical countermeasures for H-ARS following the Animal Rule; namely, Neupogen, Neulasta, Leukine and Nplate (romiplostim). J Clin Oncol. Aetna Inc. and its subsidiary companies are not responsible or liable for the content, accuracy, or privacy practices of linked sites, or for products or services described on these sites. It is not a substitute for medical advice. . Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: A double-blind randomised controlled trial. Use of romiplostim for primary immune thrombocytopenia in children. The efficacy of romiplostim in the treatment of severe thrombocytopenia associated to Evans syndrome refractory to rituximab. Find Clinical Trials for Romiplostim - Check for trials from NCI's list of cancer clinical trials now accepting patients. The reason for the decline is uncertain but may be related to increased availability of other effective second-line therapies. Examples of Risk Factors for Bleeding (not all inclusive): Prognosis ofindividuals with MDS can be calculated using a number of scoring systems. No universally accepted standards for the timing of splenectomy in chronic ITP exist, but the American Society of Hematology (ASH) guidelines recommend waiting until at least 12 months after the initial ITP diagnosis, if at all possible, and avoiding splenectomy for children < 5 years old. Jacobson and colleagues (2017) stated that therapy-related thrombocytopenia (TRT), due to chemotherapy and/or radiation therapy, is common with pediatric cancer treatments, and it can result in dose reductions and therapy delays. Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP. Available at: https://www.nccn.org/covid-19/pdf/HGF_COVID-19.pdf. Provan D, Arnold DM, Bussel JB, et al. An official website of the United States government, : Members with current platelet count less than 50x10, Members with current platelet count of 50x10, Members with current platelet count greater than 200x10, If the platelet count is less than50 10, If platelet count is greater than 200 10, If platelet count is greater than 400 10, If platelet count is greater than 200 10, If platelet count is greater than 400 10. 2012 Feb 12;72(3):415-35. doi: 10.2165/11208260-000000000-00000. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. J Clin Oncol. The authors concluded that their resultsindicate that use ofromiplostimis probably not associated with any increased risk ofAML or death, despite initial concerns. For adults with immune thrombocytopenia (ITP) Strive for stability, Reach for Remission When steroids stop working well enough, once-weekly Nplate (romiplostim) has been proven to provide platelet stability and the possibility to stop treatment* * Remission was a secondary objective in the Nplate clinical study. Withdrawal of this medication may lead to increased risk of low platelet counts; avoid injury or bruising. 2021;114(4):524-527. 2019;3(22): 37803817. Last Review10/27/2022. Canadian Agency for Drugs and Technologies in Health (CADTH). The authors concluded that prospective studies on this use of romiplostim are needed. 2017;64(8). Chemotherapy-induced thrombocytopenia (CIT) can cause delay or reduction in subsequent courses of chemotherapy. Ise M, Iizuka H, Kamoda Y, et al. NCCN does point out that romiplostim is not currently approved for use in persons with MDS. Cancer. what you should know about this drug before using it, other drugs that may interact with this drug, and. Medscape [online]. Furthermore, an UpToDate review on Immune thrombocytopenia (ITP) in children: Management of chronic disease (Bussel, 2022) states that Splenectomy is an appropriate option for the small percentage of patients with chronic ITP who have persistent clinically significant, generally severe thrombocytopenia accompanied by hemorrhagic symptoms, who require repeated or continuous pharmacologic interventions. American Society of Hematology 2019 guidelines for immune thrombocytopenia. There are a number of available 2nd-line treatments, including rituximab, thrombopoietin-receptor agonists, oral immunosuppressive agents, and splenectomy, but data comparing treatment outcomes are lacking. Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Regulatory Status FDA-approved indications: Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: (1) 1. Here, we report on a series of 20 patients who had protracted CIT and were treated with romiplostim, a thrombopoietin receptor agonist. Our Pharma Division deals only with the best, GMP certified generics and branded medication for the export market. Controversies in the treatment of paediatric immune thrombocytopenia. UpToDate [online serial]. The authors concluded that romiplostim could represent a beneficial first-line treatment, but further studies are needed. George JN, McIntosh JJ. -. Adult Indications and Dosage FDA-Labeled Indications and Dosage (Adult) Romiplostim is indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Value Health. The mean dose of romiplostim to achieve adequate platelet recovery was 2.9 mcg/kg (range 1.0-5.1). London, UK: NICE; March 30, 2010. Complications (5.2) 01/2021 -----INDICATIONS AND USAGE-----Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or . PLoS One. -, Hematology Am Soc Hematol Educ Program. Thrombopoietin receptor agonists for prevention and treatment of chemotherapy-induced thrombocytopenia in patients with solid tumours. WPSS (WHO classification-based Prognostic Scoring System). Bose P, Hussein KK, Terrell DR, et al. If patients resumed chemotherapy, weekly romiplostim was continued. Bakanay SM, Demirer T. Novel agents and approaches for stem cell mobilization in normal donors and patients. Tiu RV, Sekeres MA. Thrombopoietin THPO MGDF THPO Romiplostim for the treatment of chronic immune or idiopathic thrombocytopenic purpura: A single technology appraisal. Amgen, Inc. Nplate (romiplostim) for injection, for subcutaneous use. 2014;22(5):1217-1222. Romiplostim. Thus, since the benefits of splenectomy do not seem to outweigh its disadvantages in children, this intervention should only be used in selected cases: patients who cannot tolerate or do not respond to medical treatment, including corticosteroids, immunoglobulins, TPO-RAs and even immunosuppressive therapy. NCCN hematopoietic growth factors. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Lower risk is defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), WPSS (Very Low, Low, Intermediate). doi: 10.1002/14651858.CD012035.pub2. Mokhtar GM, Tantawy AA, El Sherif NH. What's New from OODP. This Clinical Policy Bulletin may be updated and therefore is subject to change. Plymouth Meeting, PA: NCCN; August 2022. The International Prognostic Scoring System, IPSS-R Myelodysplastic Syndrome Risk Assessment Calculator. Thrombocytopenia following allogeneic stem cell transplantation. Am J Hematol. A Review of Romiplostim Mechanism of Action and Clinical Applicability. Nplate (romiplostim) is not FDA-approved for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP (Amgen, 2018). 2014;18(6):E212-E215. Zhang J, Liang Y, Ai Y, et al. Store it in refrigerator (2 to 8C). 2014;37(1):97-101. There are 3 main prognostic scoring systems used in MDS: The IPSS is a commonly used tool in MDS which uses prognostic indicators to assign a risk score, and risk group,to help predict the course of disease. NOTE: Romiplostim is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome or any cause of thrombocytopenia other than ITP. The authors stated that the latest recommendations call for exhausting all options of medical treatment in children with chronic ITP before resorting to splenectomy, with especial emphasis on the use of TPO-Ras. 2008;8(7):1021-1030. Cancer. Furthermore, an UpToDate review on Hematopoietic support after hematopoietic cell transplantation (Negrin, 2022) states that With the approval of the thrombopoietic growth factors romiplostim and eltrombopag, additional studies are needed in the HCT setting to determine if these agents can effectively stimulate platelet production, reduce bleeding risks, and reduce transfusional requirements for platelets. Member has lower risk disease defined as Revised International Prognostic Scoring System (IPSS-R) (Very Low, Low, Intermediate), International Prognostic Scoring System (IPSS) (Low/Intermediate-1), or WHO classification-based Prognostic Scoring System (WPSS) (Very Low, Low, Intermediate); Member has severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents (such as azacitidine and decitabine), immunosuppressive therapy, or clinical trial; Chemotherapy administration has been delayed related to thrombocytopenia. 2021 Sep 28;11:680411. doi: 10.3389/fonc.2021.680411. It works by causing the cells in the bone marrow to produce more platelets. The authors concluded that these results are hypothesis-generating and help to improve the understanding of the effect of each treatment on specific patient outcomes. The risk of sepsis is particularly high in very young patients (i.e., < 5 years of age), in whom splenectomy should be avoided whenever possible. All comments are however constantly reviewed for spam and irrelevant material (such as product or personal advertisements, email addresses, telephone numbers and website address). After the introduction of rituximab, pharmacological treatment started to displace surgery as a 2nd-line treatment. 2016;7:99-106. in adults, romiplostim increased platelet counts and reduced the rate of bleeding events in multiple phase 1, 2, and 3 clinical trials for up to 52 weeks 61, 62, 72, 73 and long-term extension studies or pooled analyses for up to 5.4 years. Treatment of chemotherapy-induced thrombocytopenia in patients with non-hematologic malignancies. Hematopoietic support after hematopoietic cell transplantation. In total, 4 of the 5 patients demonstrated a response to romiplostim, which was defined as 7 consecutive days of platelet count of greater than 50109/L with transfusion independence, with 2 ongoing responses (greater than 365days each) at the conclusion of the study period. Minowa K, Arai K, Kasahara M, et al. We performed a retrospective review of the use of romiplostim for dose-limiting CIT at Memorial Sloan-Kettering Cancer Center from 2010-2012. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program, using the contact information at the bottom of this page. Negrin RS. U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Oncology Drug Products (OODP). Safety and efficacy of romiplostim in patients with lower-risk myelodysplastic syndrome and thrombocytopenia. 2008;20(6):690-696. Treating providers are solely responsible for medical advice and treatment of members. Here, we briefly present the treatment modalities for H-ARS. In adult patients at 5% higher patient incidence in Nplate versus placebo include: arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, an paresthesia; In pediatric patients at an incidence 25% include: contusion, upper respiratory tract infection, and oropharyngeal pain. Drugs. Romiplostim resulted in improvement in platelet counts, allowing resumption of chemotherapy without recurrence of dose-limiting CIT. By using our site, you acknowledge that you have read and understand our, (This service is provided from Medwonders Pvt Ltd), Dhanalakshmi Chinnuswamy,Diploma in Pharmacy, MBA (Healthcare), View feedback from our existing customers, Pharmaceutical, Drug ,Chemist Association - India. When possible, surgery should be performed using a laparoscopic approach. Splenectomy is generally reserved for patients > 5 years old who have persistent severe thrombocytopenia accompanied by clinically significant hemorrhagic symptoms and who require repeated or continuous pharmacologic interventions. Gastrointestinal disorders: Gastroenteritis, nausea, diarrhoea, constipation, abdominal pain, dyspepsia. Gonzalez-Nieto JA, Martin-Suarez I, Quattrino S, et al. What are the other precautions for Romiplostim? Indications and dose Chronic immune (idiopathic) thrombocytopenic purpura in patients refractory to other treatments (such as corticosteroids or immunoglobulins) (under expert supervision) Results: The role of AMG-531 in the treatment of thrombocytopenia in idiopathic thrombocytopenic purpura and myelodysplastic syndromes. 2011;117(5):992-1000. Most people with high-risk disease die from their disease within 1 year of diagnosis (Advani, 2006). Romiplostim should be used only when the degree of thrombocytopenia and clinical condition increase the risk for bleeding; . Splenectomy is effective in improving the platelet count and reducing the associated risk of bleeding in 60 to 80 % of children with chronic ITP. 2022 Jun 9;17(6):e0257673. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Indication: Idiopathic thrombocytopenic purpura. The drug was developed by Amgen through a restricted usage program called NEXUS. These investigators reported on the outcomes of 5 patients at their institution who received romiplostim for either primary engraftment failure or secondary failure of platelet recovery following SCT. Jacobson AE, Shah N, Setty BA. Signs include unusual fatigue, shortness of breath with exertion, pallor, and bruising. 2020;112(6):787-794. Sixteen patients achieved platelet recovery by 2 weeks. Nplate is indicated for the treatment of thrombocytopenia in: Adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Mowatt G, Boachie C, Crowther M, et al. Romiplostim, a peptide-antibody fusion product, is a thrombopoietin receptor agonist (TPO-RA) indicated for use in patients with ITP. Pediatr Hematol Oncol. Romiplostim injection may cause side effects. Romiplostim treatment allows for platelet transfusion-free liver transplantation in pediatric thrombocytopenic patient with primary sclerosing cholangitis. 2004 Jan 21;25(2):52-60 PLoS One. Would you like email updates of new search results? In general, and while most guidelines do not recommend splenectomy until ITP has lasted a minimum of 12 months, its use remains controversial. Coverage Indications, Limitations, and/or Medical Necessity. 2010;363(20):1889-1899. what you should tell your doctor before using this drug.

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