By integrating data from five romiplostim selfadministration trials, this study provides a comprehensive analysis of selfadministration compared with HCP administration in adult patients with a stable platelet count for 3 consecutive weeks. One week earlier, he had experienced an acute increase in his platelet count (9 to 618 k/ul) upon romiplostim initiation, which had decreased after romiplostim cessation. Overall, a similar proportion of patients in each group received rescue medication at some point (36.7% [n = 228] in the selfadministration group vs 39.8% [n = 53] in the HCP group). Administration through hemodialysate fluid. Impact of ITP on physician visits and workplace productivity, Development of romiplostim for the treatment of patients with chronic immune thrombocytopenia: from bench to bedside. The serum concentration peaks after a median of 14 hours and the median half-life is 3.5 days. J.M. Nplate is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Administration to or by way of the mouth. Select data courtesy of the U.S. National Library of Medicine. A, Proportions of patients in platelet count categories immediately prior to (Weeks 4 to 1) and during the study period; *, B, Rescue medication requirements by study period. Patients who achieved a stable romiplostim dose for 3weeks (HCP group 5weeks to provide an appropriate index date to enable comparisons with the selfadministration group) with platelet counts 50109/L were eligible. HCP, healthcare professional dosing; SA, selfadministration. fusion protein (peptibody) that A large observational study of patients with primary immune thrombocytopenia receiving romiplostim in European clinical practice, {"type":"clinical-trial","attrs":{"text":"NCT00415532","term_id":"NCT00415532"}}, {"type":"clinical-trial","attrs":{"text":"NCT00116688","term_id":"NCT00116688"}}, {"type":"clinical-trial","attrs":{"text":"NCT00907478","term_id":"NCT00907478"}}, {"type":"clinical-trial","attrs":{"text":"NCT01143038","term_id":"NCT01143038"}}, {"type":"clinical-trial","attrs":{"text":"NCT00508820","term_id":"NCT00508820"}}, https://wwwext.amgen.com/science/clinical-trials/clinical-data-transparency-practices/, http://creativecommons.org/licenses/by/4.0/, https://www.pi.amgen.com/~/media/amgen/repositorysites/piamgencom/nplate/nplate_pi_hcp_english.pdf, https://www.ema.europa.eu/en/documents/productinformation/nplateeparproductinformation_en.pdf, https://www.prnewswire.com/newsreleases/amgensubmitssupplementalbiologicslicenseapplicationfornplateromiplostim300769133.html, https://www.medicines.org.uk/emc/rmm/272/Document, Stable dose of romiplostim (to achieve target platelet count 5020010, Stable dose of romiplostim (to achieve target platelet count 5020010, Stable dose of romiplostim (to achieve target platelet count 5010, Baseline platelet count at ITP diagnosis, median (IQR), 10, Time since primary ITP diagnosis, median (IQR), years. Bruges Oral medications come in solids and liquids. Division of Cancer Services, Generating an ePub file may take a long time, please be patient. 2020;95:643651. has received research funding from Amgen, Dova Pharmaceuticals and Rigel. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits' criteria. Also, TEAEs were coded according to Medical Dictionary for Regulatory Activities (MedDRA) version 20.1 by Standardized MedDRA Query (SMQ) and their preferred term. Brisbane Numbers and percentages were used for categorical variables. Oral medications usually have a slower onset than other routes of administration. D.M.A. patients had neutralizing Protect the reconstituted product from light. Administration to the nose; administered by way of the nose. Before sharing sensitive information, make sure you're on a federal government site. Pharmacokinetics/Pharmacodynamics Absorption SubQ: Slow (Wang 2004) Onset of Action Platelet count increase: SubQ: 4 to 9 days (Wang 2004); Peak platelet count increase: Days 12 to 16 (Wang 2004) Baseline demographics and patient characteristics are shown in Table Table2.2. The romiplostim prescribing information recommends a starting dose of 1 g/kg/week in both adults and children with ITP. Changes in bone marrow morphology in adults receiving romiplostim for the treatment of thrombocytopenia associated with primary immune thrombocytopenia, Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study, Assessment of selfadministration of romiplostim in patients with immune thrombocytopenic purpura after receipt of home administration training materials: a crosssectional study. Implementation: Administration Route. The present invention relates to a compound bearing a self-immolative linker having -galactoside-introduced thereto. already built in. The US Food and Drug Administration approved romiplostim (Nplate) in 2008 for the treatment of low blood . For injection: 125 mcg, 250 mcg or 500 mcg of Nplate as a sterile, lyophilized, solid white powder in single-dose vials. Impact of selfadministration of romiplostim by patients with chronic immune thrombocytopenia compared with administration by a healthcare provider. Romiplostim is the thrombopoietin receptor agonist, indicated for the treatment of Chronic immune thrombocytopenia purpura. It was developed and marketed as Nplate by Amgen (also marketed as Romiplate by Kyowa Hakko Kirin). You may notice problems with While statistical testing was not performed, there was a numerical trend for patients in the selfadministration group to be younger than those in the HCP group (median age of 53 vs 58years, respectively) and with a longer median time since primary ITP diagnosis (3.7 vs 2.5years, respectively). The man presented with a <24-hour history of rapidly progressing and mildly painful right periorbital oedema and chemosis. Conclusions Eltrombopag and romiplostim might be equivalent in efficacy and safety for adult ITP, however, physicians should still take into account drug cost and comorbidities of the specific patient while making decisions on the treatment of ITP with TPO-RAs. are not meant to imply clinical efficacy. Durationadjusted rates of TEAEs were numerically lower in selfadministration compared with HCPdosed patients (735.7 vs 918.4 events/100 patientyears). Demographics and baseline characteristics. This may also explain the lower percentage of patients requiring dose adjustments in the selfadministration group. Most patients responded well to romiplostim treatment and attained their target platelet counts in the 4weeks preceding selfadministration, with response rates generally exceeding 90%. Vicenza 08/22. Our analysis provides some insights on which patients tend to be selected by HCPs for selfadministration of romiplostim. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. All studies were conducted with institutional review board or independent ethics committee approval and all patients provided written informed consent. . Bookmark this article. AZ Sint Jan Brugge, This formation may improve upon discontinuation of Nplate. has participated on advisory boards, and received travel grants and speakers fees for AbbVie, Amgen, Celgene, Janssen, Novartis, Roche, and Sanofi Genzyme. Like us, they showed that 1, 3 and 5 once daily doses of romiplostim were all effective. Orbital CT findings were consistent with a diagnosis of an isolated right superior ophthalmic vein thrombosis. In this phase 2, multicenter, open-label study, 28 thrombocytopenic patients with lower risk myelodysplastic syndromes (MDS) were assigned to receive romiplostim 750 g administered subcutaneously either weekly or biweekly or administered as biweekly intravenous injections for 8 weeks. Data Element Name. Because injection volumes of the drug may be very small in patients with ITP, romiplostim should be administered using a syringe with 0.01 mL graduations. Requests that pose a potential conflict of interest or an actual or potential competitive risk may be declined at Amgens sole discretion and without further arbitration. For the HCP group, the requirement for 5 consecutive stable doses was specifically chosen to provide an appropriate index date to enable comparisons with the selfadministration group. Where dose adjustment was needed, patients were required to return to weekly clinic visits until the dose stabilized. The proportion of patients experiencing dose adjustments within 6months of the index date in the selfadministration group (24%) was lower than that observed in an openlabel extension study of romiplostim selfadministration where 35% of patients (N = 292) had one or more dose adjustments over the first 6months of selfadministration.16 Overall, these data suggest that dose adjustments are not negatively impacted by selfadministration of romiplostim. This was assessed at 4week intervals and excluded platelet counts measured following onstudy splenectomy. November 10, 1992; October 11, 1994; November 8, 1996; January 29, 1997; April 21, 1997; November 14, 1997; December 21, 2000; October 20, 2005; January 11, 2006, An official website of the United States government, : To determine the injection volume to be administered, first identify the patient's total dose in micrograms (mcg) using the dosing information . activity to romiplostim and none had neutralizing activity to TPO. 1,2. Additionally, patients in the HCP group attended numerically more visits for platelet assessments than selfadministration patients (53 vs 47, respectively), giving more opportunity for dose adjustments in the former group. No apparent NPLATE (romiplostim) for injection, for subcutaneous use. Include any more information that will help us locate the issue and fix it faster for you. Patients also could enter a 1-year study extension phase. Reactions 1324 - 23 Oct 2010 S Superior ophthalmic vein thrombosis (first report with romiplostim) in an elderly patient: case report A 71-year-old man with recurrent chronic myeloid leukaemia and a history of chronic sinusitis developed superior ophthalmic vein thrombosis during treatment with aminocaproic acid and following treatment with romiplostim [routes of administration, dosages and durations of treatments to reaction onset not stated]. Brno Canada, 3 Kaushansky K. The molecular mechanisms that control Masaryk University and University Hospital Brno, Durationadjusted event rates were similar between selfadministration and HCP patients for the most common TEAEs and SAEs (Table S2). Hematology Division, (romiplostim) For subcutaneous injection . Romiplostim. Romiplostim injection is also used to treat acute radiation syndrome in patients who have been exposed to high levels (myelosuppressive doses) of radiation. Administration beneath the skin; hypodermic. Am J Hematol. Administration is different from others on this list. Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball. Department of Hematology, purposes only and are not It works by causing the cells in the bone marrow to produce more platelets. You may switch to Article in classic view. In the selfadministration and HCPdosed groups, median romiplostim treatment duration was 89 vs 52weeks and median total number of doses was 81 vs 50, respectively. Administration through or across the placenta. Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet counts (<100109/L) in the absence of other underlying causes of thrombocytopenia, and increased risk of bleeding.1, 2 In addition to bleeding causing anxiety, patients work and productivity can also suffer, and many have fatigue, all of which directly impacts their quality of life.2, 3, 4. Romiplostim binds to and activates the same receptors that your own endogenous TPO uses to increase platelet production. Italy, 4 craftsman 25cc 2-cycle 10-in gas pole saw manual; 2010;8(6):1372-1382. PR Newswire Association. The most common SAEs in both groups were thrombocytopenia (5.8% selfadministration vs 4.5% HCP) and pneumonia (2.7% vs 1.5%) (Table S2). The site is secure. Administration to the outside of the dura mater of the spinal cord.. Administration surrounding a nerve or nerves. Have had an insufficient response to corticosteroids, immunoglobulins, were given frequently. To several reasons which romiplostim selfadministration TEAEs that led to withdrawal from romiplostim treatment study Which 621 patients were similar between selfadministration and were similar between selfadministration HCP Based on the nonprofits & # x27 ; t mix with other.!, Novartis, and acted as a consultant romiplostim route of administration Rigel, Principia, Novartis, Robert! 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