romiplostim injection in dengue

But the . May be removed from the refrigerator for a period of 30 days at room temperature (up to 25C) when stored in the original carton. Prior to injection, a complete blood count (CBC) is obtained, as the dosage is dependent on the individual's body weight and platelet count at the time of treatment. Platelet counts above the normal range present a risk for thrombotic/thromboembolic complications. This medicine will be given to you at the doctor's office. In mid-October, a committee at the European Medicines Agency recommended that the vaccine be approved for people aged four and older in Europe and dengue-endemic countries outside the European Union. The .gov means its official. In this integrated analysis, the following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in romiplostim patients with ITP duration up to 12 months, but were not observed in those adult patients with ITP duration > 12 months: bronchitis, sinusitis (reported commonly ( 1/100 to < 1/10)). So far, no cases of ADE have been reported in clinical trials of Qdenga. The virus infects up to 400 million people a year. In adult clinical trials, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition. Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL. In the subset of subjects with ITP > 12 months of duration, the incidence of durable response was also significantly greater in the romiplostim arm compared with the placebo arm (p = 0.0022). Would you like email updates of new search results? Clin Ther. Clipboard, Search History, and several other advanced features are temporarily unavailable. Mosquito nets are currently one of the main ways to prevent the spread of dengue.Credit: Erik De Castro/Reuters. Generally, dissolution of Nplate takes less than 2 minutes. The mosquito strategy that could eliminate dengue, Dengue rates plummet in Australian city after release of modified mosquitoes, Cell-jacking proteins could be the key to cracking Zika and dengue. Grainger JD, Khne T, Hippenmeyer J, Cooper N. Ann Hematol. The EMA told Nature their committee recommended Qdenga on the basis of more than four years of data on safety and efficacy. e Stable dose defined as dose maintained within 1 mcg/kg during the last 8 weeks of treatment. Google Scholar. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. of Romiplostim : Sterile Water . Mosquito nets are currently one of the main ways to prevent the spread of dengue. The overall subject incidence of treatment failure was 11.5% (18 of 157 subjects) in the romiplostim group compared with 29.9% (23 of 77 subjects) in the SOC group, with an odds ratio (romiplostim vs SOC) of 0.31 (95% CI: 0.15, 0.61). 3. It allows continued monitoring of the benefit/risk balance of the medicinal product. Romiplostim should not be used in patients with moderate to severe hepatic impairment (Child-Pugh score 7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with thrombopoietin (TPO) agonists (see section 4.4). There is a simple discount patient access scheme for romiplostim. Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence. Gonzalez-Nieto JA, Martin-Suarez I, Quattrino S, Ortiz-Lopez E, Muoz-Beamud FR, Colchero-Fernndez J, Alcoucer-Diaz MR. Lupus. Sterile water for injections only should be used when reconstituting the medicinal product. This non-linear decrease in volume of distribution is in line with the (megakaryocyte and platelet) target-mediated binding of romiplostim, which may be saturated at the higher doses applied. Across all subjects, the median (Q1, Q3) number of months with platelet response was 30.0 months (13.0 months, 43.0 months) and the median (Q1, Q3) time on study was 35.0 months (23.0 months, 47.0 months). sharing sensitive information, make sure youre on a federal MeSH N. Engl. PMC It is the possibility of ADE that is fuelling concerns about the new vaccine among some scientists, who say that this cannot be ruled out on the basis of clinical-trial data gathered so far. The site is secure. In both studies, efficacy was determined by an increase in the proportion of patients who achieved a durable platelet response. Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far. Contact commercial-team@amgen.com for details. Rescue medications (i.e., corticosteroids, platelet transfusions, IVIG, azathioprine, anti-D immunoglobulin, and danazol) were permitted. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 25C or 24 hours in a refrigerator (2C 8C), protected from light. Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 mL sterile water for injections, yielding a deliverable volume of 1 mL. No statistically significant differences in the overall incidence of bleeding events were observed between Nplate and placebo treated patients. Epub 2021 Jul 26. All aimed at helping you enjoy life by being aware of how to care for your health. In 2019, Takeda published the results2 of a trial across 8 countries, conducted in roughly 19,000 children aged between 4 and 16. The mean (SD) number of composite bleeding episodes was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm with a median (Q1, Q3) number of bleeding events of 0.0 (0, 2) for the romiplostim arm and 0.5 (0, 4.5) in the placebo arm. Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions for romiplostim-treated subjects was 91.5% (248/271). Romiplostim is an Fc-peptide fusion protein that binds to and activates the thrombopoietin (TPO) receptor, thereby increasing platelet production. All clinically significant ( grade 3) bleeding events occurred at platelet counts < 30 x 109/L. 2011 Apr;52(4):701-4. doi: 10.3109/10428194.2010.542598. Romiplostim decreases your risk of bleeding by increasing the number of platelets. Platelet counts should be assessed weekly until a stable platelet count ( 50 x 109/L for at least 4 weeks without dose adjustment) has been achieved. In the longer duration chronic monkey study, there was no effect on the erythroid and leukocytic lineages when romiplostim was administered for 6 months where the administration of romiplostim was decreased from thrice weekly to once weekly. . To identify data relating to romiplostim in adults with newly diagnosed or persistent ITP, we conducted a search of PubMed (with no time limit applied) and abstracts from 2019 EHA/ASH meetings using the term 'romiplostim.' The median (Q1, Q3) of most frequent dose received by subjects during the treatment period was 5.0 mcg/kg (1.0 mcg/kg, 10.0 mcg/kg). Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. government site. Your comment will be reviewed and published at the journal's discretion. 379, 327340 (2018). 2019 Apr 1;11(4):e4361. If a loss of efficacy and abnormal peripheral blood smear is observed in patients, administration of romiplostim should be discontinued, a physical examination should be performed, and a bone marrow biopsy with appropriate staining for reticulin should be considered. Genes for key proteins from the other three serotypes are engineered into this backbone. Mingot-Castellano ME, Bastida JM, Caballero-Navarro G, Entrena Urea L, Gonzlez-Lpez TJ, Gonzlez-Porras JR, Butta N, Canaro M, Jimnez-Brcenas R, Gmez Del Castillo Solano MDC, Snchez-Gonzlez B, Pascual-Izquierdo C, On Behalf Of The Gepti. The incidence of pre-existing antibodies to romiplostim and TPO was 3.3% (35/1,046) and 3.0% (31/1,046), respectively. 8600 Rockville Pike Underdose may result in lower than expected platelet counts and potential for bleeding. ROMIPLOSTIM SC injection (Nplate), by Haematologists only, for chronic immune (idiopathic) thrombocytopenic purpura (ITP) in accordance with NICE TA221. Of these, 65 subjects (98.5%) received at least 1 dose of romiplostim. After reconstitution, a deliverable volume of 0.25 mL solution contains 125 mcg of romiplostim (500 mcg/mL). Thrombopoietin-receptor agonists for primary immune thrombocytopenia. Registro delle prove cliniche. Monitoring of these parametres should be considered in patients treated with romiplostim. Carton containing 1 or 4 vials of romiplostim. 214, 17931795 (2016), Article When suggestions are available use up and down arrows to review and ENTER to select. c Number of weeks with platelet response is defined as number of weeks with platelet counts 50 x 109/L during study weeks 2-25. The peptibody molecule is comprised of a human immunoglobulin IgG1 Fc domain, with each single-chain subunit covalently linked at the C-terminus to a peptide chain containing 2 TPO receptor-binding domains. He agrees that in people who have not previously been exposed to dengue, long-term vaccine data showed no efficacy against DENV-3 and there were not enough data to assess efficacy against DENV-4. An additional overfill is included in each vial to ensure that 500 mcg of romiplostim can be delivered (see vial content table below). Wi. In clinical trials, treatment with romiplostim resulted in dose-dependent increases in platelet count. If the platelet counts are excessively increased, discontinue Nplate and monitor platelet counts. To email a medicine you must sign up and log in. Studies suggest that after dengue infection, the immune system is hyped up enough to protect against a second infection with any serotype for one to two years a phenomenon that is mimicked by vaccines, says de Silva. The mean duration of exposure to romiplostim in this study population was 50 weeks. Was treated with oprelvekin with minimum response and serious side effects. Although high doses were tested in the animal studies, due to differences between the laboratory species and humans with regard to the sensitivity for the pharmacodynamic effect of romiplostim and the effect of neutralising antibodies, safety margins cannot be reliably estimated. Powder for solution for injection (powder for injection). Patients requiring rescue medicinal products were not considered for durable platelet response. I was really disappointed and surprised that the Indonesian government approved the vaccine without restrictions, says Aravinda de Silva, a virologist at the University of North Carolina at Chapel Hill who has collaborated with Takeda and other dengue-vaccine developers. The normal platelet count in the body ranges from 1.5 to 4 lacs, this can go down to as low as 20,000 to 40,000 in the case of dengue patients. 2011;157:267-88. doi: 10.1007/978-1-4419-7073-2_16. Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. 56 year old lady, previosly diagnosed as multiple myeloma, treated with thalidomide, dexametasone and bortezomib until partial response. In these studies, myelofibrosis was not observed in animals after a 4-week post-treatment recovery period, indicating reversibility. Immune thrombocytopenia and anticoagulation: the role of romiplostim in the early treatment. 2016 May;91(5):E293-5. The patient was treated with intravenous hidrocortisone (300 mg/day), subcutaneous filgrastim (300 mcg/day) and antibiotics. (%) patients with overall platelet responseb, No. Thrombocytosis in paediatric subjects occurred uncommonly ( 1/1,000 to < 1/100), with a subject incidence of 1 (0.4%). Similar to adults with ITP, romiplostim pharmacokinetics are highly variable in paediatric subjects with ITP and are not reliable and predictive. Severe thrombocytopenia, with a platelet count much below the normal range and hemorrhagic manifestation, is considered a fatal consequence of dengue that needs proper and timely management . With no treatments and limited ways to control the spread of mosquitoes, vaccines are desperately needed. Sterile water for injections should be injected into the vial. Based on cohort assignment at the time of study enrolment, patients were evaluated for bone marrow reticulin and collagen at year 1 (cohort 1) or year 2 (cohort 2) in comparison to the baseline bone marrow at the start of the study. In the placebo group, 0% to 7% of patients were able achieve a platelet count response during the 6 months of treatment. Please enable it to take advantage of the complete set of features! The starting dose of romiplostim 1 mcg/kg and doses were adjusted to maintain (50 to 200 x 109/L) platelet counts. If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk-benefit of romiplostim and alternative ITP treatment options should be re-assessed. Of the 77 subjects randomised to the SOC group, two subjects did not receive any SOC. Nature (Nature) Following the first 4-weeks of study romiplostim maintained platelet counts 50 x 109/L in between 50% to 70% of patients during the 6 months treatment period in the placebo-controlled studies. All bleeding events grade 2 occurred at platelet counts < 50 x 109/L. Romiplostim was administered to 157 subjects by subcutaneous (SC) injection once weekly starting at a dose of 3 mcg/kg, and adjusted throughout the study within a range of 1-10 mcg/kg in order to maintain platelet counts between 50 and 200 x 109/L, 77 subjects received SOC treatment according to standard institutional practice or therapeutic guidelines. Antiplatelet therapy, reversal of anticoagulation, or platelet support concentrations and vice versa, Q3 ) weekly. 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