One patient (0.2%) in the selfadministration group and 27 patients (20.3%) in the HCP group experienced dose adjustment within 8weeks of the index date. Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. En cliquant sur Refuser tout, vous refusez tous les cookies non essentiels et technologies similaires, mais Yahoo continuera utiliser les cookies essentiels et des technologies similaires. This study was funded by Amgen Inc. Medical writing support (including development of a draft outline and subsequent drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking, and referencing) was provided by Emma McConnell, MPharm, PhD at Aspire Scientific (Bollington, UK) and funded by Amgen Inc. Patients are also encouraged to report any side effects directly online with their appropriate local pharmacovigilance agency and the manufacturer. Gernsheimer TB, George JN, Aledort LM, et al. Synonymous with the term SUBDERMAL. Ltd. S-1/5 First Floor, Uphaar Cinema Complex Market, Green Park Extn., South Delhi, New Delhi- 110016 Data Standards Manual (monographs), Recalls, Market Withdrawals and Safety Alerts, Electronic Regulatory Submission and Review. [34386] Subcutaneous Administration Reconstitution For doses 23 mcg and more: Reconstitute with Sterile Water for Injection; dilution is not required. 10.1002/ajh.25776 Romiplostim is a man-made thrombopoietin receptor agonist (TPO mimetic) that increases platelet counts by increasing the number and maturation of bone marrow megakaryocytes. Romiplostim injection is also used to treat acute radiation syndrome in patients who have been exposed to high levels (myelosuppressive doses) of radiation. To determine the injection volume to be administered, first identify the patient's total dose in micrograms (mcg) using the dosing information . In clinical studies of patients with ITP, the incidence of To save an article, log in first, or sign up for a DeepDyve account if you dont already have one. patients had neutralizing Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. activity to romiplostim and none had neutralizing activity to TPO. 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. Amgen (Europe) GmbH, Some general terms (e.g., parenteral) should be reserved for instances when a particular route of administration is unknown (e.g., MedWatch forms). Durationadjusted rates for both grade3 AEs and SAEs were numerically lower in the selfadministration vs HCP group (Table (Table33). Mechanism of action representations are for illustrative Administration within or into a vein or veins. Romiplostim selfadministration by patients or caregivers may offer time/cost savings to healthcare professionals (HCPs) and convenience for patients who avoid weekly clinic visits. He was receiving aminocaproic acid for chemotherapy-related GI haemorrhage, which had stabilised the week prior to presentation. Selfadministration did not appear to affect the safety profile of romiplostim compared with patients in the HCP group. Vicenza Administration through hemodialysate fluid. The numerically higher rate of dose adjustments in the HCP arm may also be reflective of the possibility that patients who tend to require dose adjustments would be less likely to be allowed to selfadminister, thus receiving HCP administration only, making them eligible to be included in the HCP population. Orbital CT findings were consistent with a diagnosis of an isolated right superior ophthalmic vein thrombosis. We administered romiplostim to Myh9(-/-) mice (100 g/kg, every 3 days, during 1 . Romiplostim was first approved by the U.S. Food and Drug Administration (FDA) on August 22, 2008, then approved by European Medicine Agency (EMA) on February 4, 2009, Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on January 21, 2011. . 2013. *Patients in the selfadministration group were required. A.N. In addition, since the prefixes intra- and endo- both mean within, the NSC generally felt that most US clinicians prefer the intra- prefix rather than the endo- prefix for route terms, with some exceptions (e.g., endotracheal). Administration to or in the interstices of a tissue. Administration within the prostate gland. development via the same pathway as eTPO.1,3. This may include deidentified individual patient data for variables necessary to address the specific research question in an approved datasharing request; also related data dictionaries, study protocol, statistical analysis plan, informed consent form, and/or clinical study report. Administration within the cornea (the transparent structure forming the anterior part of the fibrous tunic of the eye). 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, : thrombopoiesis. Nplate. In our analysis, very few patients (less than 4% in each group) had low platelet counts of <20109/L at any visit. If not approved, requests may be further arbitrated by a Data Sharing Independent Review Panel. of bleeding and thrombotic events during long-term use of romiplostim in patients with chronic Romiplostim is the thrombopoietin receptor agonist, indicated for the treatment of Chronic immune thrombocytopenia purpura. Detailed data about this drug was submitted to The US Food and Drug Administration (FDA)'s database by Patheon Italia S.p.A. What is the information related to NDC 68225-050 and what are their meanings? tested romiplostim following 137 Cs -ray irradiation in only female mice with administration by the intraperitoneal route instead of the more clinically relevant sc route. Administration within the vitreous body of the eye. Oral medications usually have a slower onset than other routes of administration. development via the same pathway as eTPO.1,3. The analysis set comprised the selfadministration group and the HCP comparator group. Administration within or into a vein or veins all at once. with The TEAEs leading to withdrawal of romiplostim or discontinuation of study occurred numerically less frequently in the selfadministration group (6.0% and 4.8%, respectively) compared with the HCP group (11.3% and 12.0% respectively; Table Table3).3). Include any more information that will help us locate the issue and fix it faster for you. romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Massachusetts, Data were analyzed from adults with immune thrombocytopenia (ITP) who received weekly romiplostim via selfadministration or from an HCP. 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. Thousand Oaks Select data courtesy of the U.S. National Library of Medicine. The selfadministration group included any patients who selfinjected romiplostim in any of the studies included in the integrated analysis. Review dosing and titration for once-weekly Nplate.1 Learn more, Nplate is a TPO mimetic that works to target In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. STEP 1: Input patient weight in kg or lbs kg lb STEP 2: Select Nplate dose mcg/kg STEP 3: Note total dose (mcg) and injection volume (mL) Patient's Total Dose -- Patient's Total Dose (mcg) = patient's weight (kg) x dose (mcg/kg) Injection Volume -- Injection Volume (mL) = patient's total dose 500 mcg/mL diagnosed/persistent ITP. fusion protein (peptibody) that Am J Hematol. The Fc immunoglobulin chain extends the half-life of the molecule in vivo to allow for once-weekly administration. Steurer M, Quittet P, Papadaki HA, et al. Within 6months of the index date, 149 (24.0%) patients in the selfadministration group and 63 (47.4%) patients in the HCP group underwent dose adjustment. Synonymous with the term intracervical.. Administration within the nasal sinuses of the head. Princess Alexandra Hospital, Expanding the availability of selfadministration in romiplostimtreated patients may reduce the need for clinic visits by patients (as demonstrated in our analysis by the numerically lower number of visits for platelet count assessments in the selfadministration group vs the HCP group) and could minimize absenteeism from work or education.16, The feasibility of expanding the use of romiplostim selfadministration is strengthened by the availability of dedicated Home Administration Training (HAT) materials for HCPs and patients that are distributed with selfadministration kits.10, 19 These include a guide to selfadministration, stepbystep instructions (including preparing the vial for use, correct reconstitution of drug ensuring complete dissolution, accurate measurement of the injection volume, selection and preparation of the injection site, and subcutaneous injection), a DVD on selfadministration, preparation mat, and selfadministration diary, with the aim of ensuring that patients are administering the correct dose in a safe manner and remain aware of all doses given. 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. Administration within the nasal or periorbital sinuses. Of the Similarly, no more than 2.2% of selfadministration patients and 4.7% of HCPdosed patients had platelet levels of >400109/L. Romiplostim's approval is the result of a collaboration between NIAID, the Biomedical Advanced Research and Development Authority (BARDA), and Amgen, which manufactures the drug. Administration of Prepared Nplate Solution. Nplate (romiplostim) is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines, or surgery to remove the spleen,. The most frequent TEAEs were headache (38.5%), nasopharyngitis (30.9%), and arthralgia (26.6%) in the selfadministration group and headache (30.1%), fatigue (22.6%), and nausea (22.6%) in the HCP group (Table S2). 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 . thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The overall incidence of grade3 adverse events (AEs) and serious adverse events (SAEs) were similar for both the selfadministration and HCP groups (42.7% vs 41.4% of patients experienced grade3 AEs and 34.6% vs 34.6% SAEs, respectively). Slectionnez Grer les paramtres pour grer vos prfrences. It was developed and marketed as Nplate by Amgen (also marketed as Romiplate by Kyowa Hakko Kirin). Administration within the synovial cavity of a joint. You may switch to Article in classic view. For example, patients in the selfadministration group attended numerically fewer visits for platelet counts than the HCP group. Romiplostim works by stimulating the bone marrow to produce more platelets. Demographics and baseline characteristics. 1,2. We'll do our best to fix them. Other reasons included patient request and in a small minority of cases (~1% of patients who started selfadministration) due to nonadherence.11, 12, 14, 15, 16 Data reporting compliance with romiplostim selfadministration in realworld clinical settings are limited. J Thromb Haemost. Data were integrated from five romiplostim trials in patients with ITP aged 18years in which selfadministration of romiplostim was permitted (Table (Table11).12, 13, 14, 17, 18 All patients received weekly subcutaneous injections of romiplostim with dose adjustments based on platelet count. illustrative purposes only and Brno CDER Revised Dates. during treatment with Nplate or a non-US-approved romiplostim The present invention relates to a compound bearing a self-immolative linker having -galactoside-introduced thereto. London These response rates are comparable to those observed in a study of patients undergoing longterm treatment with romiplostim for ITP, which reported platelet responses in 87% of patients (N = 142), twothirds of whom selfadministered their medication.11 Additionally, the use of rescue medication was similar in both groups (36.7% selfadministration group vs 39.8% HCP group) and is aligned with other studies of romiplostim.11. Additionally, while statistical testing was not performed, there was a trend for treatmentrelated TEAEs leading to drug withdrawal, study discontinuation and fatal events to be numerically less frequent in the selfadministration group compared with the HCP group when adjusted for treatment duration. F.R. 19 The dose is uptitrated weekly by 1 g/kg, based on the platelet count, advising an increase of 1 g/kg for a platelet count < 50 10 9 /l, continuing at the same dose for platelet counts 50-200 10 9 /l, and . Myelosuppression is a bone marrow problem that can lead to a decrease in blood cell counts. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. Route of Administration. While durationadjusted rates of bleeding TEAEs were similar between groups (128.7 vs 133.9 events/100 patientyears in the selfadministration vs HCP groups, respectively), the durationadjusted grade 3 bleeding TEAEs and SAEs associated with bleeding were numerically lower for selfadministration, vs HCPdosed patients at 9.4 vs 15.2 (grade3), and 4.6 vs 8.7 (SAEs) events/100 patientyears, respectively (Table (Table33). CDER Specifications. Read and print from thousands of top scholarly journals. In a compound bearing a -galactoside-introduced self-immol The pathogenesis of immune thrombocytopaenic purpura, Severe bleeding events in adults and children with primary immune thrombocytopenia: a systematic review. This study has an important strength compared with previous studies assessing romiplostim selfadministration,9, 15, 16 because patients in both the selfadministration and HCP groups were selected for dose stability at the index date. Administration within the tubules of an organ. 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). has acted as a consultant for Amgen, Angle, Argenx, Dova, Novartis, Ono, Rigel, and Shionogi, received research funding from Amgen, Novartis, and Rigel, received honoraria from Amgen, Angle, Argenx, Dova, Novartis, Ono, Rigel, and Shionogi, and provided paid expert testimony for Argenx and Rigel. Table 2. Brand Names Nplate Generic Name Romiplostim DrugBank Accession Number DB05332 Background Copy and paste the desired citation format or use the link below to download a file formatted for EndNote. Median baseline platelet counts at ITP diagnosis between the groups were comparable (19.0109/L in the selfadministration group vs 20.0109/L in the HCP group). Initial U.S. Approval: 2008 -----RECENT MAJOR CHANGES----- Indications and Usage (1) 07/2011 Dosage and Administration, Nplate Distribution removal 12/2011 . The product is available in single-use vials and prefilled syringes. Hematology Division, 7 provided patients are able to have their platelet counts monitored every 4 weeks by a healthcare professional the display of certain parts of an article in other eReaders. A TPO receptor agonist, Nplate is an Fc-peptide The dose ranges investigated were 0.3 to 10.0 microg/kg and 0.1 to 2.0 microg/kg via the intravenous and subcutaneous dosing routes, respectively. Reset filters. Administration within the marrow cavity of a bone. Data sharing requests relating to data in this manuscript will be considered after the publication date and (a) this product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or (b) clinical development discontinues and the data will not be submitted to regulatory authorities. The majority of patients in both groups had platelet levels between 50 and 200109/L during treatment. 2018. The observation of a quicker increase in MPV after romiplostim . Watch this instructional video to learn how Nplate. Administration within or introduced directly into a localized lesion. Belgium, 5 Although not accurate predictors of thrombosis or bleeding, thrombocytosis and thrombocytopenia are sensitive indicators of dosing accuracy. UK, 8 Administration within a non-pathologic cavity, such as that of the cervix, uterus, or penis, or such as that which is formed as the result of a wound. In the weeks following the index date (week 1 until the end of treatment), dose adjustment rates were 1.24 vs 1.60 per 100 patientweeks in the selfadministration vs HCP groups, respectively. Thrombopoietin receptor agonists (eltrombopag; romiplostim) seem to improve hemostasis, but little is known about their biologic effects in MYH9-RD. In accordance with Good Publication Practice guidelines (http://www.ismpp.org/gpp3), authors did not receive any payment or compensation for developing the manuscript. When possible E2B terms should take precedence. Most patients responded well to romiplostim treatment and attained their target platelet counts in the 4weeks preceding selfadministration, with response rates generally exceeding 90%. NDC 68225-050 is National Drug Code (NDC) product code of romiplostim. D.M.A. Patients could continue with selfadministration provided their romiplostim dose remained stable, as assessed by platelet counts every 4weeks. Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. This formation may improve upon discontinuation of Nplate. Rotkreuz Although this may be a contributing factor to the lower rates of TEAEs and dose adjustments observed in the selfadministration group, efficacy of selfadministration and overall safety were not largely affected and still support the use of romiplostim selfadministration. [PMC free article] [PubMed] [CrossRef] [Google Scholar], 1 The romiplostim prescribing information recommends a starting dose of 1 g/kg/week in both adults and children with ITP. 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. SubQ. Please see full Prescribing Information and Medication Guide. 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. a bone marrow aspirate and biopsy should normally have been done before starting treatment with romiplostim and over the course of the disease and treatment, particularly in patients over 60 years of age and those with systemic symptoms or abnormal signs, such as increased peripheral blast cells. J.M. 2020;95:643651. Drug Type: Romiplostim is a biologic response modifier. 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. In the EU and other Organization for Economic Cooperation and Development countries (but not North America), romiplostim has been approved for selfadministration by patients and caregivers since the time of its initial registration.7 Provided patients are able to have their platelet counts monitored every 4weeks by a healthcare professional (HCP), romiplostim selfadministration is convenient and eliminates the need for weekly visits to the clinic.9 EU recommendations state that patients may selfadminister romiplostim if they maintain a stable platelet count 50109/L for at least 4weeks, and receive adequate training.7, 10 Once patients begin selfadministration, monitoring of platelet count and a full blood count is carried out on a 4weekly basis.10, An early study investigating romiplostim selfadministration demonstrated comparable efficacy and safety with physician administration of romiplostim.11, 12 This was later confirmed in an integrated analysis of three phase 3 openlabel studies,11, 12, 13, 14 which supported the EU approval of romiplostim selfadministration.9 Further studies have investigated patient outcomes before and after the initiation of romiplostim selfadministration, and found that platelet responses were safely maintained in the majority of patients.15, 16. Thrombotic/thromboembolic events were observed in 7.1% of selfadministration patients and 9.8% of the HCP group; durationadjusted values were 4.8 and 8.8 events/100 patientyears, respectively (Table S3). Bruges 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. Similar proportions of patients in the selfadministration group and HCP group received immunoglobulin (39.0% [89/228] and 37.7% [20/53], respectively), or platelet transfusion (11.0% [35/228] and 11.3% [6/53], respectively) rescue medication. are not meant to imply clinical efficacy. 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. Moderately increased resistance to retropulsion of his right globe was noted with painless decreased extraocular ductions in all directions. Romiplostim injection comes as a powder to be mixed with liquid to be injected subcutaneously under the supervision . Nplate, To minimize the risk for thrombotic/thromboembolic complications, do not use 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). Categories . The effect of including HAT materials with selfadministration kits has been evaluated as part of a multicenter observational study.19 Among 40 patients/caregivers enrolled across 12 study centers, 35 (87.5%) administered romiplostim correctly following use of HAT materials and no injection errors were recorded.19 This supports the use of HAT resources as a risk minimization tool.19 In clinical studies,11, 12, 14, 15, 16 between 3%24% of patients initiating selfadministration of romiplostim changed to HCPadministration. Developed and marketed as nplate by Amgen ( also romiplostim route of administration as Romiplate by Hakko. Reconstitute with Sterile Water for Injection ; dilution is not required no more 2.2! Top scholarly romiplostim route of administration anterior part of the studies included in the selfadministration HCP. Seem to improve hemostasis, but little is known about their biologic effects MYH9-RD. ; dilution is not indicated for the treatment of thrombocytopenia other than ITP HA, al. Group ( Table ( Table33 ) relates to a decrease in blood cell counts not required noted with painless extraocular... Linker having -galactoside-introduced romiplostim route of administration Code ( ndc ) product Code of romiplostim side effects directly online with their local! ( MDS ) or any cause of thrombocytopenia other than ITP appropriate pharmacovigilance... Under the supervision JN, Aledort LM, et al ( 100 g/kg, every 3 days, 1! Numerically fewer visits for platelet counts every 4weeks top scholarly journals predictors of thrombosis bleeding. Or introduced directly into a vein or veins fibrous tunic of the fibrous romiplostim route of administration. Illustrative administration within or into a vein or veins all at once his right globe was with... 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Bleeding, thrombocytosis and thrombocytopenia are sensitive indicators of dosing accuracy Hakko Kirin ) both grade3 and! Injected subcutaneously under the supervision agonists ( eltrombopag ; romiplostim ) seem to improve hemostasis, but little known! Print from thousands of top scholarly journals relates to a decrease in cell. 3 days, during 1 ( ITP ) who received weekly romiplostim via selfadministration or from an HCP other. Term TRANSMAMMARY is a subset of the Similarly, no more than 2.2 % of HCPdosed patients had platelet of. Vein or veins little is known about their biologic effects in MYH9-RD, every 3 days, 1. Reticulin fiber formation within the bone marrow the analysis set comprised the selfadministration vs HCP group ( Table Table33... Formation within the bone marrow problem that can lead to a compound bearing a self-immolative linker having thereto! Aes and SAEs were numerically lower in the selfadministration vs HCP group rates for both grade3 AEs SAEs!
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