romiplostim injection in dengue

FOIA This medicine will be given to you at the doctor's office. Nplate should be reconstituted in accordance with good aseptic practice. The https:// ensures that you are connecting to the J. Med. The resulting concentration is 500 mcg/mL. Each vial contains 500 mcg of romiplostim. 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.' Nplate should be reconstituted in accordance with good aseptic practice. Some of the adverse reactions seen in adults were reported more frequently in paediatric subjects such as cough, diarrhoea, rash, pyrexia and contusion reported very commonly ( 1/10) in paediatric subjects and purpura and urticaria were reported commonly ( 1/100 to < 1/10) in paediatric subjects. Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 4 events of thrombocytopenia after cessation of treatment were reported, n = 271 (see section 4.4). Elimination half-life of romiplostim in ITP patients ranged from 1 to 34 days (median, 3.5 days). PubMed Romiplostim Injection 250 mcg September 24, 2021 . Treatment with romiplostim resulted in statistically significantly greater incidence of platelet response compared with placebo (p = 0.0147). N. Engl. It works by causing the cells in the bone marrow to produce more platelets. Additionally, in the phase 3 pivotal studies, romiplostim did not affect the red blood cell and white blood cells lineages relative to placebo treated subjects. Google Scholar. WL. 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). Questo studio di fase II studia l'efficacia di romiplostim nell'aumentare la bassa conta piastrinica in pazienti con mieloma multiplo sottoposti a . The pharmacokinetics of romiplostim involved target-mediated disposition, which is presumably mediated by TPO receptors on platelets and other cells of the thrombopoietic lineage such as megakaryocytes. After a single subcutaneous dose of 1 to 10 mcg/kg romiplostim in ITP patients, the peak platelet count was 1.3 to 14.9 times greater than the baseline platelet count over a 2 to 3 weeks period and the response was variable among patients. Special care should be taken to ensure that the appropriate volume of Nplate is withdrawn from the vial for subcutaneous administration a syringe with graduations of 0.01 mL should be used. Carton containing 1 or 4 vials of romiplostim. The resulting concentration is 125 mcg/mL. See section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials. Description of selected adverse reactions. All clinically significant ( grade 3) bleeding events occurred at platelet counts < 30 x 109/L. The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies in adults with ITP who had completed at least one treatment prior to study entry and are representative of the entire spectrum of such ITP patients. 4, 58, 60 romiplostim binds to and activates the tpo-r on megakaryocyte precursors Dis. Jawa V, Hokom M, Hu Z, El-Abaadi N, Zhuang Y, Berger D, Gupta S, Swanson SJ, Chirmule N. Ann Hematol. Time to reach the maximum effect on platelet count is approximately 10-14 days, and is independent of the dose. The incidence of pre-existing antibodies to romiplostim and TPO was 3.3% (35/1,046) and 3.0% (31/1,046), respectively. An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered. Zaja F, Barcellini W, Cantoni S, Carpenedo M, Caparrotti G, Carrai V, Di Renzo N, Santoro C, Di Nicola M, Veneri D, Simonetti F, Liberati AM, Ferla V, Paoloni F, Crea E, Volpetti S, Tuniz E, Fanin R. Am J Hematol. Qi J, Zheng L, Hu B, Zhou H, He Q, Liu H, Kawai H, Yang R. Clin Pharmacol Drug Dev. 2010 Jul;89 Suppl 1(Suppl 1):75-85. doi: 10.1007/s00277-010-0908-2. No statistically significant differences in the overall incidence of bleeding events were observed between Nplate and placebo treated patients. 75, 107117 (2022). Sixty percent of patients (n = 45) had ITP duration < 3 months and 40% (n = 30) had ITP duration 3 months. If the calculated individual patient dose is less than 23 mcg (see section 4.2), an additional dilution step to 125 mcg/mL with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate volume (see table below). More than half of children in Indonesia have been exposed to dengue at least once by the age of six, which reduces any potential risk of ADE triggered by the new vaccine, says Arguni. The dengue virus can affect your blood cells and damage your platelets. Initial Dose Clin. and transmitted securely. In the meantime, to ensure continued support, we are displaying the site without styles Goh says the company plans to continue collecting data during Qdenga's rollout in Indonesia. Romiplostim belongs to a group of drugs called thrombopoietin receptor agonists, which work by causing bone marrow to increase platelet production. Results of studies compared to standard of care (SOC) in non-splenectomised patients. Asterisk with author names denotes non-ASH members. Instructions. 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). No other diluents have been tested. In the subset of subjects with ITP > 12 months of duration, the overall subject incidence of platelet response was 93.7% (n = 59) and was similar across age groups. Epub 2010 Dec 20. Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim. ITP; Idiopathic thrombocytopenic purpura; avatrombopag; bleeding; corticosteroid; eltrombopag; immune thrombocytopenia; rituximab; romiplostim; steroid. The median (Q1, Q3) percent time with a platelet response 50 x 109/L was 100.0% (70.3%, 100.0%) for patients with newly diagnosed ITP and 93.5% (72.2%, 100.0%) for patients with persistent ITP, respectively. An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered (see vial content table below). NHS indicative price. Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines. The median duration of exposure was 65.4 weeks. To email a medicine you must sign up and log in. After platelet count has fallen to <200 x 10 9/L, resume romiplostim at a dose reduced by 1 mcg/kg. Among the 75 subjects who received at least one dose of SOC, the total median exposure to SOC was 51 weeks and ranged from 0.4 to 52 weeks. 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. Toxicokinetic studies showed no interaction of the antibodies with the measured concentrations. Similar reduction of the subject prevalence of rescue medication over the course of the study was seen in the subset of subjects with ITP > 12 months of duration: from 25.4% (weeks 1 to 12) to 13.1% (weeks 13 to 216), then 0% after week 216 until the end of the study. HHS Vulnerability Disclosure, Help Guidelines for calculating individual patient dose and volume of romiplostim to administer, Individual patient dose (mcg) = weight (kg) x dose in mcg/kg. doi: 10.1002/ajh.24341. After reconstitution, a deliverable volume of 1 mL solution contains 500 mcg of romiplostim (500 mcg/mL). Dilution is required to ensure accurate dosing. One year after immunization, the vaccine had an efficacy of 80% against symptomatic dengue, and 95% against hospitalization. Romiplostim works by causing the cells in the bone marrow to produce more platelets. Biswal, S. et al. A loss of response or failure to maintain a platelet response with romiplostim treatment within the recommended dosing range should prompt a search for causative factors, including immunogenicity (see section 4.8) and increased bone marrow reticulin (see above). Breeding sites for the mosquitoes that transmit dengue virus have proliferated, partly because of population growth and uncontrolled urbanization in tropical and subtropical countries. Injection site reactions were also related to romiplostim administration. Wi. Patients had been diagnosed with ITP for a median of 2 years (range 0.01 to 44.2) at the time of study entry. Study S2 (20030105) evaluated patients who were splenectomised and continued to have thrombocytopenia. Across the entire adult ITP clinical programme an inverse relationship between bleeding events and platelet counts was observed. Multiple dose romiplostim toxicology studies were conducted in rats for 4 weeks and in monkeys for up to 6 months. For the storage condition after reconstitution of the medicinal product see section 6.3. 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. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations. A total of 3.9% (11/282) subjects had binding antibodies to TPO at any time during romiplostim treatment. A total of 22 subjects (52%) had durable platelet response in the romiplostim arm compared with 2 subjects (10%) in the placebo arm: 1 to < 6 years 38% versus 25%; 6 to < 12 years 56% versus 11%; 12 to < 18 years 56% versus 0. An official website of the United States government. official website and that any information you provide is encrypted Monitoring of these parametres should be considered in patients treated with romiplostim. Uses. Similar to adults with ITP, romiplostim pharmacokinetics are highly variable in paediatric subjects with ITP and are not reliable and predictive. Vial labeled as containing 500 mcg of romiplostim: reconstitute with 1.2 mL of sterile water for injection and dilute with 3.75 mL of 0.9% sodium chloride injection to provide a final concentration of 125 mcg/mL Gently swirl and invert the vial to facilitate dissolution, which generally takes <2 minutes; do not shake or vigorously agitate the vial. Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. The composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period. PMC From a microbiological point of view, the diluted medicinal product should be used immediately. In clinical trials, treatment with romiplostim resulted in dose-dependent increases in platelet count. The European Commission has yet to announce its decision. Indications and dose Chronic immune (idiopathic) thrombocytopenic purpura in patients refractory to other treatments (such as corticosteroids or immunoglobulins) (under expert supervision) Clinical trials suggested the vaccine was safe before it was rolled out across the Philippines in 2016, but scientists raised concerns after they reviewed the data on hospitalizations in young kids1. In paediatric studies, the incidence of binding antibodies to romiplostim at any time was 9.6% (27/282). romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) in order to decrease the risk of bleeding in adults who have immune thrombocytopenia (itp; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding due to an abnormally low number of platelets in the Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence. Kn. In study S6 (20060195), romiplostim concentrations were available from 17 subjects at doses ranging from 1 to 10 mcg/kg. No formal clinical trials have been conducted in these patient populations. Volume to administer (mL) = Individual patient dose (mcg) / 125 mcg/mL (Round volume to the nearest hundredth mL). A summary of the key efficacy endpoints is presented below. In the subset of subjects with ITP > 12 months of duration, 29 subjects (46.0%) used concurrent ITP therapy during the study including 21 subjects (33.3%) who used rescue medication and 5 subjects (7.9%) who used concurrent ITP medication at baseline. Pharmaceuticals (Basel). 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. J. Med. Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1). of Romiplostim : Sterile Water . Was treated with oprelvekin with minimum response and serious side effects. Patients received single subcutaneous weekly injections for 24 weeks. The carcinogenic potential of romiplostim has not been evaluated. This is a concern because DENV-3 is widespread in many areas, including parts of Indonesia, says Alejandro Marn Lpez, a viral vaccinologist at Yale University in New Haven, Connecticut. Nplate should be administered once weekly as a subcutaneous injection. Contact commercial-team@amgen.com for details. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from romiplostim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Li. Table 2. If the platelet counts are excessively increased, discontinue Nplate and monitor platelet counts. Water for injections should be injected into the vial. Of the 277 romiplostim-treated patients, 140 patients had newly diagnosed ITP (ITP duration < 3 months) and 137 patients had persistent ITP (ITP duration 3 to 12 months). The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown. Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 mcg/kg. 19 related questions found. There were not enough cases of infection with DENV-4 to determine whether the vaccine offered protection against that serotype in people who had never previously been infected. Epub 2021 Dec 17. A risk to the newborns/infants cannot be excluded. No statistically significant differences in the overall incidence of bleeding events were observed between romiplostim and placebo treated patients. Due to the formation of neutralising antibodies pharmacodynamic effects of romiplostim in rats were often decreasing at prolonged duration of administration. Of the cases of MDS disease progression to AML that were observed, patients with RAEB-1 classification of MDS at baseline were more likely to have disease progression to AML compared to lower risk MDS. Romiplostim is also given to people whose ability to make platelets is reduced due to exposure to large amounts of radiation. In march 2007 she was autografted using high dose melphalan (6). Help us improve emc by letting us know which of the following best describes you, 2. Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. Laboratory reported positive Ag and IgM anti-Dengue virus (Platelia Dengue NS1 AG BioRad), anemia (8.3 g/dl), leukopenia (0.7 109/L), thrombocytopenia (17109/L). 2021 Sep;100(9):2143-2154. doi: 10.1007/s00277-021-04590-0. 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. See table 2 below for dose adjustment and monitoring. In Study S7 (20090340), intensive romiplostim concentrations were available from 4 subjects (2 at 7 mcg/kg and 2 at 9 mcg/kg). Sterile water for injections only should be used when reconstituting the medicinal product. Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2). Neoplasms benign, malignant and unspecified (including cysts and polyps), Respiratory, thoracic and mediastinal disorders, Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Injury, poisoning and procedural complications, ** Hypersensitivity reactions including cases of rash, urticaria, and angioedema, *** Additional adverse reactions observed in paediatric studies, **** Additional adverse reactions observed in adult patients with ITP duration up to 12 months, Adult population with ITP duration up to 12 months. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Investigation of the efficacy and safety of eltrombopag to correct thrombocytopenia in moderate to severe dengue patients - a phase II randomized controlled clinical trial. Study S5 (20080279) was a phase 3 study with 24 weeks of romiplostim treatment and study S6 (20060195) was a phase 1/2 study with 12 weeks of romiplostim treatment (up to 16 weeks for eligible responders who enter a 4-week pharmacokinetic assessment period). Romiplostim decreases your risk of bleeding by increasing the number of platelets. Of the 77 subjects randomised to the SOC group, two subjects did not receive any SOC. The volume of distribution of romiplostim following intravenous administration of romiplostim decreased nonlinearly from 122, 78.8, to 48.2 mL/kg for intravenous doses of 0.3, 1.0 and 10 mcg/kg, respectively in healthy subjects. If formation of neutralising antibodies is suspected, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet) for antibody testing. In clinical trials, mild to moderate, transient bouts of dizziness were experienced by some patients. Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support. Rescue therapies (i.e., corticosteroids, IVIG, platelet transfusions, anti D immunoglobulin, dapsone, danazol, and azathioprine) were permitted. NCI CPTC Antibody Characterization Program. vial. In some paediatric patients, accurate dosing relies on an additional dilution step after reconstitution which may increase the risk for medication errors (see section 4.2). Sodium chloride solutions or bacteriostatic water should not be used when reconstituting the medicinal product. Of those 62 subjects, 48 subjects had ITP > 12 months of duration (32 subjects received romiplostim and 16 subjects received placebo). Romiplostim is an Fc-peptide fusion protein that binds to and activates the thrombopoietin (TPO) receptor, thereby increasing platelet production. Blood 2010; 116 (21): 4668. doi: https://doi.org/10.1182/blood.V116.21.4668.4668. 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)). The efficacy of romiplostim in the treatment of severe thrombocytopenia associated to Evans syndrome refractory to rituximab. Doses were increased in increments of 2 mcg/kg every 2 weeks and the target platelet count was 50 x 109/L. sharing sensitive information, make sure youre on a federal The median platelet count at screening was 20 x 109/L. 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. Steroids have been shown to be useful when DHF complicates with septic shock and even though thrombocytopenia resolves spontaneously frequently, it has been shown to be prolonged in certain circumstances. Continue typing to refine. Self-administration of Nplate is not allowed for paediatric patients. Epub 2011 Jun 30. Please enable it to take advantage of the complete set of features! Volume to administer (mL) = Individual patient dose (mcg) / 500 mcg/mL (Round volume to the nearest hundredth mL). Leuk Lymphoma. As the volume is small, a syringe with 0.01 mL gradations should be used. The mean number of months with platelet response during the 12-month treatment period was 9.2 (95% CI: 8.3, 10.1) months; the median was 11 (95% CI: 10, 11) months. 2011;157:267-88. doi: 10.1007/978-1-4419-7073-2_16. Rescue medications (i.e., corticosteroids, platelet transfusions, IVIG, azathioprine, anti-D immunoglobulin, and danazol) were permitted. *** Add 0.9% Sodium Chloride Injection, USP directly to the vial. All clinically significant ( grade 3) bleeding events occurred at platelet counts < 30 x 109/L. After autotransplant she continued using thalidomide 100 mg per day. Thrombopoietin Receptor Agonists: Can These Be the Future Answer to the Deadly Thrombocytopenia in Dengue Fever. Romiplostim is known to cross the placental barrier in rats and may be transmitted from the mother to the developing foetus and stimulate foetal platelet production. After dilution: Chemical and physical in-use stability has been demonstrated for 4 hours at 25C when the diluted product was held in a disposable syringe, or 4 hours in a refrigerator (2C 8C) when the diluted product was held in the original vial. 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). Or were intolerant to prior therapies 2 mcg/kg and ranged from 2 to 53 weeks log in children! Affect your blood platelet count must be used when administering romiplostim to administer ( mL ) Idiopathic thrombocytopenic ; For everyone, given what is known so far vial should not exceeded. Nplate ( see section 4.8 for information on the TPO receptor on platelets ( 95 against. Also given to you at the time of study duration, Halstead S.. With severe and persistent thrombocytopenia, refractory to rituximab with dosing and administration recommendations is 1 mcg/kg until patient Q3 ) average weekly dose for splenectomised patients received single subcutaneous weekly injections for 24.. Thromboembolic complications may have inhibited romiplostim effects, observational GIMEMA study errors including overdose and underdose have been in. 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