Case reports, Romiplostim for therapy-related thrombocytopenia in pediatric malignancies [Brief report]. Romiplostim - Wikipedia Romiplostim is approved to treat: Thrombocytopenia (low platelet levels). PDF HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do - Amgen 2019 Nov 1;37(31):2892-2898. doi: 10.1200/JCO.18.01931. In the settings of accelerated platelet destruction and reduced platelet production, which are typical of advanced liver disease, this contributes substantially to the degree of thrombocytopenia.151,185 Two TPO agents, avatrombopag and lusutrombopag, have been approved in the United States specifically to increase the platelet count in patients with thrombocytopenia and liver disease undergoing a procedure;186,187 eltrombopag was previously approved to treat thrombocytopenia in patients with hepatitis C with liver disease to allow for the initiation and maintenance of interferon-based therapy.129 Treatment with romiplostim was shown to improve platelet counts in a patient with hepatocellular carcinoma188 and in patients with hepatitis C virus,151 allowing most of these patients to undergo planned surgical procedures. Romiplostim is a prescription medication used for the treatment of chronic immune thrombocytopenia and hematopoietic syndrome associated with acute radiation syndrome. Various pathways can be activated by the different substances. Background. Paraneoplastic syndromes: A focus on pathophysiology and supportive (CIT) from lenalidomide or from radiation therapy alone will not be allowed Colony-stimulating factors for the treatment of the hematopoietic component of the acute radiation syndrome (H-ARS): a review. Romiplostim (Nplate), a thrombopoietin receptor agonist, is the first FDA-approved thrombopoiesis-stimulating protein for the treatment of low platelet (PLT) counts in adults with chronic immune thrombocytopenia. Romiplostim is available under the following different brand names: Nplate What Are Dosages of Romiplostim? highcharts stacked column horizontal. 15. 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In contrast, late or progressive ITP is often associated with irreversible autoimmunity, as characterized by lasting cytokine imbalance, loss of immune tolerance, and the generation of difficult-to-target long-lived plasma cells.95 Other events occurring in later stages of ITP that may justify the need for early intensive medical treatment include B-cell clonal expansion, antibody affinity maturation, epitope spreading, the functional diversification of autoantibody effector functions, and the generation of long-lived memory populations that differ from primary B cells.96. It is during this period that encouraging treatment-free response may be possible. Miranda Tradewell, PhD, and Maryann Travaglini, PharmD, ICON (North Wales, PA, USA), provided medical writing support with funding from Amgen Inc. ANKRD26, ankyrin repeat domain-containing protein 26; CIT, chemotherapy-induced thrombocytopenia; Fc, fragment crystallizable; HSCT, hematopoietic stem cell transplant; IFN-, interferon-; IL, interleukin; IQR, interquartile range; ITGB3, integrin beta-3; ITP, immune thrombocytopenia; MDS, myelodysplastic syndrome; MHCII, major histocompatibility complex class II; MPL, myeloproliferative leukemia virus; MYH9-RD, myosin heavy chain 9-related disease; Th1, type 1 T-helper; Th17, type 17 T-helper; TPO, thrombopoietin; TPO-R, thrombopoietin receptor; TPO-RA, thrombopoietin receptor agonist; Treg, regulatory T-cell. Find Clinical Trials for Romiplostim - Check for trials from NCI's list of cancer clinical trials now accepting patients. If patients resumed chemotherapy, weekly romiplostim was. Among the 10 patients for whom reticulin grading was reported, the highest grade of 4 was reported in one patient, grade of 3 in four, grade of 2 in two, and grade of 1 in three. 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). Research support, non-U.S. Govt, Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial. Nplate (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia 32% of Patients Achieved Treatment-Free Remission for at Least Six Months in a Single-Arm Trial 93% of Patients Achieved a Platelet Response Programmed anuclear cell death delimits platelet life span, Mechanisms of platelet clearance and translation to improve platelet storage, Imbalanced expression of Bcl-xL and Bax in platelets treated with plasma from immune thrombocytopenia, Detection of circulating B cells producing anti-GPIb autoantibodies in patients with immune thrombocytopenia, The Ashwell-Morell receptor regulates hepatic thrombopoietin production via JAK2-STAT3 signaling, Effect of recombinant interleukin-6 and thrombopoietin on isolated guinea pig bone marrow megakaryocyte protein phosphorylation and proplatelet formation, Interleukin-6 stimulates thrombopoiesis through thrombopoietin: role in inflammatory thrombocytosis. A large observational study of patients with primary immune thrombocytopenia receiving romiplostim in European clinical practice. The response rate is significantly lower in patients with a decreased number of megakaryocytes before treatment.162 No large prospective definitive studies have yet been reported. Romiplostim has been examined in mouse and macaque monkey models of acute radiation syndrome.142147 In a cell culture model, romiplostim in combination with IL-3 or IL-3 plus stem cell factor showed a strong regenerative effect on cell proliferation, megakaryopoiesis, thrombopoiesis, and megakaryocyte colony formation from X-irradiated CD34+ cells.146 In mice subjected to total body irradiation at 70% lethal dose after 30 days, a single 30-g/kg dose of romiplostim administered 24 hours after irradiation improved survival by 40% (57% versus 17% for control).142 Similarly, Yamaguchi et al found that a 50-g/kg romiplostim dose administered on 3 consecutive days starting within 2 hours of irradiation achieved complete rescue of mice exposed to lethal gamma irradiation.143 They proposed that the ability of romiplostim to reduce lethality and pancytopenia may be due to multiple mechanisms, including stimulation of splenic progenitor cells, induction of pulmonary megakaryocytopoiesis, prevention of bone marrow cell death, modulation of DNA repair, and production of cytokines. MeSH Oprelvekin (Interleukin-11) - 614 Adverse Effects Drug Interactions Sci Rep. 2022 Mar 3;12(1):3485. doi: 10.1038/s41598-022-07426-7. Romiplostim was not administered in the first cycle to mirror the clinical situation. Bethesda, MD 20894, Web Policies Radiological and nuclear emergency preparedness - FDA The utility of romiplostim to prevent or treat CIT has been examined in preclinical studies,109 case reports,110,111 retrospective analyses,112114 and clinical studies.115117 Preclinical data from McElroy et al indicate that there is an inverse relationship between platelet counts and endogenous TPO concentration in mice subjected to chemotherapy/radiation therapy; romiplostim enhanced platelet recovery particularly when administered in high doses (100 g/kg; an order of magnitude above the highest recommended dose in ITP of 10 g/kg).5,6,109 A phase 2 trial investigated romiplostim compared with observation in patients with solid tumors.117 Because of promising results from an interim analysis that included a crossover part and lack of evidence that untreated control patients would experience corrected thrombocytopenia with additional time, the study was converted to a single-arm, open-label study after institutional review board approval; in 60 patients with solid tumors and thrombocytopenia, romiplostim was able to significantly increase platelet count, reverse CIT, and reduce the recurrence of CIT in approximately 85% of patients. Romiplostim activates the extracellular domain of the TPO-R and eltrombopag and avatrombopag activate the transmembrane portion of the TPO-R. Key Phase 3 and Long-Term Studies on the Efficacy and Safety of Romiplostim in Patients with Chronic and Early Stage ITP. Predictive factors for thrombopoietin receptor agonist free responses in chronic ITP patients: a multicenter retrospective study with long-term follow-up. MacVittie TJ, Farese AM, Jackson WE 3rd. Here, we review the structure, mechanism, pharmacokinetics, and pharmacodynamics of romiplostim. Bussel JB, Buchanan GR, Nugent DJ, et al. Romiplostim and eltrombopag induce platelet response after 1 to 2 weeks of treatment, whereas avatrombopag has a response onset of 3 to 5 days. Romiplostim may be used to treat acute radiation syndrome. Autoantibodies may also destroy platelets through other mechanisms and inhibit platelet production by megakaryocytes. Unable to load your collection due to an error, Unable to load your delegates due to an error. Nplate (romiplostim): Basics, Side Effects & Reviews - GoodRx Clin Ther. Federal government websites often end in .gov or .mil. Stem Cell Res Ther. Hematopoietic Syndrome of Acute Radiation Syndrome. Romiplostim is in a class of medications called thrombopoietin receptor agonists. 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 weeks61,62,72,73 and long-term extension studies or pooled analyses for up to 5.4 years.63,7476 In pediatric populations, platelet responses were observed up to 24 weeks in clinical trials77,78 and for up to 7 years in long-term extension studies.79,80 In the extension study in pediatric patients with chronic ITP, romiplostim was associated with a treatment-free response (defined as a platelet count 50 109/L for 6 months with no ITP medications) in 15 patients (23%). Romiplostim in patients undergoing hematopoietic stem cell transplantation: results of a phase 1/2 multicenter trial, Use of thrombopoietin receptor agonists in prolonged thrombocytopenia after hematopoietic stem cell transplantation. Plasma concentrations of TPO increase in response to reduced platelet mass. Hematopoietic syndrome of acute radiation syndrome: Infants, Children, and Adolescents: SubQ: 10 mcg/kg once; administer dose as soon as possible after suspected or confirmed exposure to radiation levels >2 (gray) Gy; do not delay romiplostim if CBC is not readily available. Nplate (romiplostim) Now Approved For Earlier Use In Adults With It is not a substitute for medical advice. Nplate (Romiplostim) - New Indication. 8600 Rockville Pike Most patients who achieved platelet correction after receiving romiplostim were able to resume the same chemotherapy regimen that resulted in CIT.117 In a study of 15 patients with hematologic (four patients) and nonhematologic (11 patients) malignancies undergoing chemotherapy, 13 (87%) achieved a platelet response, with 11 patients (73%) achieving platelet counts >100 109/L allowing continuation of full-dose chemotherapy.115 There are several planned or ongoing studies in patients with CIT.118120 The optimal dosing regimen for romiplostim in the management of CIT will likely depend on the chemotherapy regimen being administered, the degree of platelet suppression expected, the time to reach the nadir, and the time to recovery of platelets. Romiplostim acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets. No further survival benefit was seen with higher (100 g/kg) or more frequent dosing (3 or 5 once daily doses at 30 g/kg) of romiplostim or combined treatment with pegfilgrastim. Please enable it to take advantage of the complete set of features! REMM Bibliography - Medical Management of Radiation Injury (Exposure Buy Nplate (romiplostim) Medicine | Nplate Price In India | AlleviareIndia Kojima S, Matsuyama T, Kodera Y, Tahara T, Kato T. Measurement of endogenous plasma thrombopoietin in patients with acquired aplastic anaemia by a sensitive enzyme-linked immunosorbent assay, Endogenous TPO (eTPO) levels in health and disease: possible clues for therapeutic intervention, Efficacy and safety of romiplostim in patients with acquired aplastic anemia ineligible or refractory to immunosuppressive therapy: interim analysis of phase 2/3 clinical trial, Efficacy and safety of romiplostim in refractory aplastic anaemia: a phase II/III, multicentre, open-label study, Study of AMG531(Romiplostim) in patients with aplastic anemia (NCT03957694), Study of AMG531 (Romiplostim) in patients with aplastic anemia (NCT04095936). Romiplostim is a unique kind of molecule known as a peptibody (a combination of a peptide and an antibody). Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune thrombocytopenia in adults. We have discussed the latest FDA-approved agent, romiplostim, as a treatment modality for H-ARS. Yamaguchi M, Hirouchi T, Yoshioka H, Watanabe J, Kashiwakura I. There was a significant reduction in chemotherapy dose delay or dose decrease, as well as a decrease in platelet transfusions, with TPO-RAs, with no apparent increased risk of thrombosis.122 The primary question remains whether these important practical findings will translate into improved survival. It has been reported that the high-dosage administration of domestically approved pharmaceutical drugs, especially granulocyte colony-stimulating factor (G-CSF) and romiplostim (RP), is a rapid and appropriate medical treatment for preventing severe acute radiation syndrome (ARS) of victims exposed to lethal total-body irradiation (TBI). People required to enter radiation-contaminated areas, such as first responders, military personnel, or clean-up crews, are at risk of developing severe adverse health effects associated with hematopoietic acute radiation syndrome (H-ARS) [].Depending on the dose of radiation, symptoms can occur in the period of hours to weeks, for the H-ARS subsyndrome, hypoplasia or aplasia . 1Department of Pediatrics, Division of Hematology, Weill Cornell Medicine, New York, NY, USA, 2Department of Medicine, Hematology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA, 3Clinica Pediatrica Universit degli Studi di Milano Bicocca, Ospedale San Gerardo, Monza, Italy, 4Hammersmith Hospital, Imperial College, London, UK, 6Division of Hematology and Transfusion Medicine, Lund University, Lund, Sweden, 7Department of Pharmacology, University of Toronto, Toronto, ON, Canada. Lozano ML, Mingot-Castellano ME, Perera M, et al. Thrombopoietin receptor agonists: ten years later, Romiplostim summary of product characteristics, Recombinant human thrombopoietin: basic biology and evaluation of clinical studies. The patient had consecutive platelet counts 340 109/L.79 Data from observational, real-world studies, which often describe effects on concomitant medications, such as corticosteroid dose reduction or discontinuation, have also shown that romiplostim often improved platelet counts and reduced bleeding events and hospitalizations in patients.81,82 The efficacy and safety results were similar to those observed in clinical trials.81. Romiplostim (Nplate) as an effective radiation countermeasure to Careers. Mechanisms of thrombocytopenia in chronic autoimmune thrombocytopenic purpura. Wei Y, Gong Y, Wei S, Chen Y, Cui J, Lin X, Yu Y, Yan H, Qin H, Yi L. Arch Pharm Res. 2022 May-Jun;36(3):1203-1221. doi: 10.21873/invivo.12820. In other studies, concurrent ITP medication use in adults was discontinued or decreased in responders with romiplostim use.63,74,75 No randomized trial comparing romiplostim with placebo identified a significantly higher rate of thromboembolic events in patients treated with romiplostim; however, in a pooled analysis of 14 studies that included adults and children treated with romiplostim for up to 5.4 years, the rate of thrombotic events was 5.5 per 100 patient-years for both the romiplostim and placebo groups.89 Therefore, the 5% rate of thrombotic/thromboembolic events in the long-term extension study of romiplostim being similar to the rate observed in an extension study of eltrombopag75,91 suggests that an incremental prothrombotic effect of treatment with thrombopoietic agents exists. Christakopoulas GE, DeFor TE, Hage SM, et al. Common mechanisms involved with platelet clearance include antibody and T-celldependent immune mechanisms, platelet apoptosis, and glycan modifications. Myelosuppression is a bone marrow problem that can lead to a decrease in blood cell counts. Effects of Gamma-Tocotrienol on Partial-Body Irradiation-Induced Intestinal Injury in a Nonhuman Primate Model. Myeloid Cytokines for Treatment of Acute Exposure to - REMM Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia, Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia, Predictors of remission in adults with immune thrombocytopenia (ITP) treated with romiplostim, Case study of remission in adults with immune thrombocytopenia following cessation of treatment with the thrombopoietin mimetic romiplostim, Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Generating an ePub file may take a long time, please be patient. Chemotherapy agents can affect the megakaryocyte and platelet production pathway in different ways, such as affecting pluripotent stem cells or megakaryocyte progenitors, inhibiting nuclear factor kappa B, increasing the rate of platelet destruction by reducing Bcl-xL activity, or enhancing platelet clearance by immune mechanisms.104. The use of romiplostim in treating chemotherapy-induced thrombocytopenia in patients with solid tumors. Fanale M, Stiff P, Noonan K, McCoy J, Rutstein M, Moskowitz C. Safety of romiplostim for treatment of severe chemotherapy induced thrombocytopenia (CIT) in patients with lymphoma receiving multi-cycle chemotherapy: results from an open-label dose- and schedule-finding study, Romiplostim treatment of chemotherapy-induced thrombocytopenia, Study of romiplostim for chemotherapy-induced thrombocytopenia in adult subjects with non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer (NCT03937154), {"type":"clinical-trial","attrs":{"text":"NCT03937154","term_id":"NCT03937154"}}, Study of romiplostim for chemotherapy induced thrombocytopenia (NCT02052882), {"type":"clinical-trial","attrs":{"text":"NCT02052882","term_id":"NCT02052882"}}, Study of romiplostim for chemo-induced thrombocytopenia in adults subjects with gastrointestinal or colorectal cancer (NCT03362177), {"type":"clinical-trial","attrs":{"text":"NCT03362177","term_id":"NCT03362177"}}. Yamaguchi M, Suzuki M, Funaba M, Chiba A, Kashiwakura I. 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. Through this mechanism, romiplostim reduces the need for other treatments and decreases bleeding events in patients with thrombocytopenia. Nichola Cooper has received honoraria for speaking engagements and participated in advisory boards with Amgen, Novartis, Principia, and Rigel; and has received support for clinical trials from Amgen, Novartis, Rigel, Principia, and UCB. Romiplostim: median (range) starting dose, 1 (13) g/kg, median (range) maintenance dose, 3 (14) g/kg; No treatment-related toxicity and no hemorrhagic events reported, Romiplostim achieved an increase in platelet counts and enabled the continued use of full-dose chemotherapy in the majority of patients, Randomized comparison versus untreated observation; converted to open-label romiplostim arm, 60 (comparative arm: romiplostim, n=15; observation, n=8), adults with solid tumors and postchemotherapy thrombocytopenia despite reduction in dose and delay of chemotherapy. de coloration appropri - Translation into English - examples French government site. Epub 2016 Sep 9. If you have question, please e-mail Allevaire Indian Team or call Allevaire India on +91-9818274099 (Mr. Kamal Kaushal)/ (Mr. Sanjeev) for further details. 8600 Rockville Pike Prove cliniche su Refractory Multiple Myeloma: romiplostim - Registro The site is secure. Preclinical activity of eltrombopag (SB-497115), an oral, nonpeptide thrombopoietin receptor agonist, Stem cell stimulation continues to pay off in aplastic anaemia. Regulatory Status FDA-approved indications: Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: (1) 1. The problem of thrombocytopenia after hematopoietic stem cell transplantation, Immune-mediated cytopenias after hematopoietic cell transplantation: pathophysiology, clinical manifestations, diagnosis, and treatment strategies. Romiplostim binds to and activates the TPO receptor on megakaryocyte precursors, thus promoting cell proliferation and viability, resulting in increased platelet production. Received 2020 Dec 29; Accepted 2021 May 6. Kapur R, Aslam R, Speck ER, Rebetz JM, Semple JW. Key Clinical Studies of Romiplostim in Various Clinical Disorders Other Than ITP. A careful and thorough evaluation should be given before use of TPO-RAs in patients with thrombocytopenia and myelodysplastic syndrome (MDS) experiencing bleeding and requiring platelet transfusion. The approval for romiplostim by the US Food and Drug Administration (but not EMA) was recently extended to cover this early use.5 Studies have also shown romiplostim to be effective in improving platelet counts in various preclinical and clinical settings, including CIT, aplastic anemia, animal models of acute radiation syndrome, and liver disease. Yang BB, Doshi S, Arkam K, Franklin J, Chow AT. 2022 Mar;58(3):133-145. doi: 10.1358/dot.2022.58.3.3367994.ABSTRACTDetonation of an improvised nuclear weapon, or a radiological dispersal device by terrorists, or an unintended radiological/nuclear accident in populated areas would result in a mass casualty scenario with radiation exposures of different severities. Nuclear and Radiological Emergencies: Biological Effects, Countermeasures and Biodosimetry. Kuter DJ, Mufti GJ, Bain BJ, Hasserjian RP, Davis W, Rutstein M. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim. Nikolay Chekalin HHS is purchasing $290M worth of Amgen's ( NASDAQ: AMGN) Nplate (romiplostim) for acute radiation sickness due to a radiological or nuclear emergency. romiplostim side effects Only one patient later experienced relapse at week 67 after about 30 weeks withholding romiplostim. Xue E, Lawrence T, Gernsheimer TB, Milano F. Retrospective evaluation of the use of romiplostim after hematopoietic stem cell transplantation. 2018 Nov;54(11):679-693. doi: 10.1358/dot.2018.54.11.2899370. Effects of tranexamic acid prophylaxis on bleeding outcomes in hematologic malignancy: the a-TREAT trial, Romiplostim promotes platelet recovery in a mouse model of multicycle chemotherapy-induced thrombocytopenia, Efficacy of romiplostim in the treatment of chemotherapy induced thrombocytopenia (CIT) in a patient with mantle cell lymphoma. Bone marrow cell assays also showed that improvement in platelet counts were associated with an increase in progenitor cells. Nishida T, Yamaguchi M, Tatara Y, Kashiwakura I. Int J Radiat Biol. In Vivo. The following side effects are common (occurring in greater than 30%) for patients taking romiplostim: Headache. One patient developed neutralizing antibodies to TPO, which occurred 100 weeks after treatment started and romiplostim was continued for about 4 months after detection of neutralizing antibodies.90. Here, we briefly present the treatment modalities for H-ARS. Steurer M, Quittet P, Papadaki HA, et al. Clipboard, Search History, and several other advanced features are temporarily unavailable. immune thrombocytopenia, pharmacokinetics, pharmacodynamics, structure, thrombopoietin receptor agonist. Yamaguchi M, Hirouchi T, Yokoyama K, Nishiyama A, Murakami S, Kashiwakura I. 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). In humans, moderate exposure to 2 to 4 Gy of ionizing radiation results in clinically manageable hematopoietic ARS (H-ARS), characterized by severe depletion of vital blood cells and bone marrow progenitors. 2022 May 31;11(6):1098. doi: 10.3390/antiox11061098. Thrombocytopenia and hemostatic disorders in chronic graft versus host disease. Furthermore, romiplostim was found to be effective for the management of CIT in patients with solid tumors receiving various chemotherapy regimens.121 Additional results of ongoing studies will help select the optimal dose of romiplostim in patients with CIT to minimize the chemotherapy delay or dose reduction, which may vary in efficacy according to the chemotherapy protocol and whether the bone marrow is involved by the malignancy. Geriatric Use Although neither romiplostim nor eltrombopag is approved for patients with MDS, treatment may improve platelet counts and reduce bleeding in a number of patients.190 In one of the first of these studies, treatment with romiplostim compared with placebo initially was thought to increase leukemic blast levels in blood. Romiplostim is a TPO-RA approved for use in patients with ITP in the United States, European Union, Australia, and several countries in Africa and Asia, as well as for use in patients with refractory aplastic anemia in Japan and Korea. Romiplostim decreases your risk of bleeding by increasing the number of platelets. and transmitted securely. The ePub format uses eBook readers, which have several "ease of reading" features It is the most common coagulation disorder among intensive care patients and is seen in 20% of medical patients and a third of surgical patients.. A normal human platelet count ranges from 150,000 to . MeSH Finally, romiplostim may be capable of activating Tregs through two epitopes of the Fc region termed Tregitopes. government site. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen. 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