Disclaimer, National Library of Medicine Undergoing a medical or dental procedure where blood loss is anticipated, Comorbidity (e.g., peptic ulcer disease, hypertension). Romiplostim. It differs from the other two systems in that it includes the MDS subtype as a prognostic factor. Romiplostim (Nplate Amgen Canada Inc.). Three DVTs within 20 patients is within the anticipated thrombosis rates of patients with active cancer on chemotherapy. Romiplostim should be used only when the degree of thrombocytopenia and clinical condition increase the risk for bleeding; . Program (2) Warnings and Precautions: Progression of Myelodysplastic . Lower-risk MDS tends to grow and progress slowly, thus,a lower-risk scoregenerally indicates a better outlook. Although splenectomy is effective in most patients, it is also associated with substantial risks, especially overwhelming sepsis. Romiplostim improved platelet counts in all 20 patients. Autoimmune hemolytic anemia (AIHA) in children: Treatment and outcome. Waltham, MA: UpToDate; reviewed March 2022. Finally, sometimes the primary goal of treatment is to improve the quality of life (cases where medical treatment would a priori be preferred over surgical treatment). Rockville, MD: FDA; August 25, 2008. Tell your doctor if any of these symptoms are severe or do not go away: headache joint or muscle pain pain in the arms, legs, or shoulders numbness, burning, or tingling in the arms or legs stomach pain heartburn vomiting diarrhea difficulty falling asleep or staying asleep Levy B, Arnason JE, Bussel JB. what you should tell your doctor before using this drug. Responses to romiplostim were sustained in the absence of significant bone marrow disease, which was found to contribute to recurrent thrombocytopenia. Romiplostim was initiated at 1-2 mcg/kg weekly, with dose escalation by 1 mcg/kg per week until recovery of platelets ( 100 10(9)/L). (romiplostim) clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed. Newland A, Godeau B, Priego V, Viallard JF, Lpez Fernndez MF, Orejudos A, Eisen M. Br J Haematol. Overview of immunosuppressive agents used for prevention and treatment of graft-versus-host disease. Bussel JB. Myelodysplastic syndromes, for lower risk disease in patients with severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents,immunosuppressive therapy, or clinical trial, Chemotherapy-induced thrombocytopenia (CIT). Zeiser R. Treatment of acute graft-versus-host disease: UpToDate [online serial]. The International Prognostic Scoring System. Splenectomy is also clearly indicated in patients with life-threatening hemorrhage, although this is an extremely rare event. The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. [1] During development and clinical trials the drug was called AMG531. Chao NJ. 2017 Nov 27;11(11):CD012035. Cancer. Zhang J, Liang Y, Ai Y, et al. Thousand Oaks, CA: Amgen; revised February 2021. Please enable it to take advantage of the complete set of features! Indication: Idiopathic thrombocytopenic purpura. Federal government websites often end in .gov or .mil. 2020 Sep;13(3):171-174. The authors concluded that romiplostim could represent a beneficial first-line treatment, but further studies are needed. 2012;23(4):264-273. Systematic literature review and meta-analysis on use of Thrombopoietic agents for chemotherapy-induced thrombocytopenia. 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 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. Common side effects of Romiplostim include: bruising, headache, dizziness, joint pain, muscle weakness or tenderness, pain in the arms, legs, or shoulder, numbness or tingling in the hands or feet, trouble sleeping, stomach pain, indigestion, nausea, vomiting, diarrhea, cough, wheezing, chest tightness, trouble breathing, Decroocq J, Marcellin L, Le Ray C, Willems L. Rescue therapy with romiplostim for refractory primary immune thrombocytopenia during pregnancy. Last Review10/27/2022. Children aged 1 year and older who have had ITP for at least 6 months. 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. Common Drug Review. [citation needed] Romiplostim is indicated as a potential treatment for chronic idiopathic (immune) thrombocytopenic purpura (ITP). Most people with high-risk disease die from their disease within 1 year of diagnosis (Advani, 2006). PDR Drug Summaries are concise point-of-care prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice PDR's drug summaries are available free of charge and serve as a great resource for US based MDs, DOs, NPs and PAs in patient practice The study drug, romiplostim, was discontinued early because of the potential risk for disease progression to AML. Provan D, Arnold DM, Bussel JB, et al. . Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy. Hematol Oncol Stem Cell Ther. Chemotherapy-induced thrombocytopenia (CIT) can cause delay or reduction in subsequent courses of chemotherapy. PLoS One. Bose P, Hussein KK, Terrell DR, et al. Language services can be provided by calling the number on your member ID card. The mean dose of romiplostim to achieve adequate platelet recovery was 2.9 mcg/kg (range 1.0-5.1). HHS Vulnerability Disclosure, Help Careers. Examples of risk factors for bleeding (not all inclusive): The above policy is based on the following references: Last Review The efficacy of romiplostim in the treatment of severe thrombocytopenia associated to Evans syndrome refractory to rituximab. Children aged 1 year and older who have had ITP for at least 6 months. Yamada M, Shinzaki S, Nishida T, et al. Hematopoietic support after hematopoietic cell transplantation. 2008;68(7):901-912. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Furthermore, an UpToDate review on Thrombocytopenia in pregnancy (George and McIntosh, 2021) states that The safety of thrombopoietin-receptor agonists (e.g., romiplostim, eltrombopag) during pregnancy is unknown. Blood Adv2019;3(23):38293866. Ottawa, ON: CADTH; May 27, 2010. 2017;64(8). Romiplostim therapy in children with unresponsive chronic immune thrombocytopenia. Romiplostim: a review of its use in immune thrombocytopenia. FDA approves romiplostim (Nplate) for the treatment of thrombocytopenia. . Pediatr Blood Cancer. 2004 Jan 21;25(2):52-60 Cochrane Database Syst Rev. 2015;102(5):626-632. government site. ITP is a condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood. Indications and dose Chronic immune (idiopathic) thrombocytopenic purpura in patients refractory to other treatments (such as corticosteroids or immunoglobulins) (under expert supervision) Combined with future randomized trials, these findings will help clinicians select the optimal second-line treatment for an individual child with ITP. 2011;117(5):992-1000. Three deep vein thromboses (DVT) were observed; one of which was a recurrent DVT in a patient who had previously experienced a DVT and was off anticoagulation. Splenectomy is effective in improving the platelet count and reducing the associated risk of bleeding in 60 to 80 % of children with chronic ITP. Front Oncol. Use of romiplostim for primary immune thrombocytopenia in children. Sepsis prevented continued chemotherapy in one patient. NCCN does point out that romiplostim is not currently approved for use in persons with MDS. Bussel JB, Soff G, Balduzzi A, Cooper N, Lawrence T, Semple JW. This is not a complete list of side effects and others may occur. 1. [34386] Subcutaneous dosage Adults Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: A double-blind randomised controlled trial. National Comprehensive Cancer Network, Inc. The site is secure. 2021 Sep 28;11:680411. doi: 10.3389/fonc.2021.680411. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Notify physician immediately if these signs occur. Accessibility Inadequate response or intolerance to prior therapy with corticosteroids, immunoglobulins, or splenectomy; Untransfused platelet count at any point prior to the initiation of the requested medication is less than 30 x 10. Stasi R, Evangelista ML, Amadori S. Novel thrombopoietic agents: A review of their use in idiopathic thrombocytopenic purpura. Epub 2015 Nov 5. (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. Thrombotic/Thromboembolic Complications Signs include unusual fatigue, shortness of breath with exertion, pallor, and bruising. Here, we briefly present the treatment modalities for H-ARS. Immune system disorders: Hypersensitivity reactions (e.g. Thousand Oaks, CA: Amgen Inc.; October 2019. . The drug was developed by Amgen through a restricted usage program called NEXUS. 2021 May 26;15:2243-2268. doi: 10.2147/DDDT.S299591. 2014;111(3):521-528. Advani A. Hypomethylating agents in the treatment of myelodysplastic syndrome. Vishnu P, Aboulafia DM. Thrombocytopenia following allogeneic stem cell transplantation. -, Ann Oncol. The https:// ensures that you are connecting to the Myelodysplastic syndromes. These investigators described the cases of 2 pregnant patients with corticosteroid-refractory immune thrombocytopenia who were successfully treated by romiplostim without any fetal or maternal complications. Background: Romiplostim, a subcutaneous treatment for adult ITP, uses a platelet response-guided dose adjustment algorithm (USPI dosing, Table 1) to maintain patients' platelet count (PC).Romiplostim was recently approved for patients with ITP 12 months from diagnosis. 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. FDA label information for this drug is available at DailyMed. Blood Adv. Nplate [package insert]. Our Nplate (romiplostim) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This patient information sheet applies only to approved uses of the drug. The NCCN guidelines on"Myelodysplastic syndromes" (version 3.2022) state that "in a randomized study including patients low- or int-1-risk MDS (n=250), romiplostim was associated with increased platelet counts and decreased overall bleeding events (p=0.26 after 58 weeks of treatment compared to the placebo group). NOTE: Romiplostim is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome or any cause of thrombocytopenia other than ITP.
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