nplate mechanism of action radiation

This formation may improve upon discontinuation of Nplate. Amid concerns about Russian President Vladimir Putins recent nuclear threats came a bit of startling news: The U.S. Department of Health and Human Services said Tuesday that it spent $290 million on a drug to treat radiation sickness. Bleeding events that were Grade 2 severity or higher occurred in 15% of patients treated with Nplate and 34% of patients treated with placebo. To detect antibody formation, submit blood samples to Amgen (1-800-772-6436). A TPO receptor agonist, Nplate is an Fc-peptide These changes may improve if you stop taking Nplate. Six patients in the Nplate group and 2 patients in the placebo group had undergone splenectomy. Alexa rank 3,561,113. Following Nplate discontinuation in Studies 1 and 2, seven patients maintained platelet counts of 50 109/L. Rescue therapies (i.e., corticosteroids, IVIG, platelet transfusions, and anti-D immunoglobulin) were permitted for bleeding, wet purpura, or if the patient was at immediate risk for hemorrhage. Use aseptic technique. An overall platelet response was defined as a durable or a transient platelet response. The mutagenic potential of romiplostim has not been evaluated. The efficacy of Nplate in this trial was measured by the proportion of patients who achieved a platelet count of 50 109/L for 2 consecutive weeks and by the proportion of patients who achieved an increase in platelet count of 20 109/L above baseline for 2 consecutive weeks. The drug can be used to treat adults and children," HHS said. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. Nplate is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous injection. Federal government websites often end in .gov or .mil. The following adverse reactions have been identified during post approval use of Nplate. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate. The drug needs to be used within 24 hours of exposure, he said, though the Federal Emergency Management Agency, or FEMA, recommends that people stay indoors for at least 24 hours after a nuclear blast. What should I avoid while receiving Nplate? Evaluation The safety profile of Nplate was similar across patients, regardless of ITP duration. adults with immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough. diagnosed/persistent ITP. In general, dose adjustment for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. "Nplate is a thrombopoietin mimetic, it helps in stimulating megakaryocytes and platelet. Those who are not receiving chemotherapy or radiation . 1. Nineteen confirmed pediatric patients were included in the postmarketing registry study. What are the possible side effects of Nplate? Nplate is not indicated for the treatment of thrombocytopenia due to. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations [see DOSAGE AND ADMINISTRATION]. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. during treatment with Nplate or a non-US-approved romiplostim Bookshelf Nplate is only used if your low platelet count and medical condition increase your risk of bleeding. A file photo of a healthcare worker injecting a patient with medicine. There were no antibodies detected to TPO. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Institut National Polytechnique de Toulouse; Download file PDF Read file. Nplate is indicated for the treatment of thrombocytopenia in: Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation [see Clinical Studies]. Yamaguchi M, Suzuki M, Funaba M, Chiba A, Kashiwakura I. Newsweek has contacted the HHS for comment. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. Epub 2022 Aug 11. The data described below reflect Nplate exposure to 271 adult patients with ITP, aged 18 to 88, of whom 62% were female. Platelet volume also increased more rapidly after romiplostim injection. Nplate is a thrombopoietin (TPO) receptor agonist that mimics the body's natural TPO and is designed to increase platelet counts in patients with ITP. "Nplate is a thrombopoietin mimetic, it helps in stimulating megakaryocytes and platelet production. Haematol. You are encouraged to report negative side effects of prescription drugs to the FDA. Romiplostim [Nplate] is supplied as a powder (250 and 500 mcg in single-use vials) for reconstitution in sterile water to a final concentration of 500 mcg/ . Greg Burel, the former director of the Strategic National Stockpile, agreed, saying that he doesn't think the HHS' purchase of the drug is related to the Russian invasion of Ukraine in February. 2022 Amgen Inc. All rights reserved. Mitigation of total body irradiation-induced mortality and hematopoietic injury of mice by a thrombopoietin mimetic (JNJ-26366821). The reconstituted Nplate solution should be clear and colorless. sharing sensitive information, make sure youre on a federal "Because platelets play an important role in blood clotting, a decrease in platelet number increases the risk of bleeding, which contributes to radiation toxicity. On October 4, the U.S. government said it had ordered $290 million worth of the drug Nplate, which can be used to treat illness due to radiation. In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate and 32% of patients receiving placebo. Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate use secondary to drug-induced thrombocytosis, regardless of the underlying disease. If a patients dose is less than 23 mcg, then additional dilution with 0.9% Sodium Chloride Injection, USP is required. Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. Visually inspect the reconstituted solution for particulate matter and/or discoloration. The HHS didnt comment on when the decision to order the drug was made or whether it predated the Russian invasion of Ukraine in February, but it noted that the department began supporting the development of the drug back in 2019 after earlier involvement from the National Institutes of Health. drugs a-z list Hyporesponsiveness or failure to maintain a platelet response with Nplate should prompt a search for causative factors, including neutralizing antibodies to Nplate [see ADVERSE REACTIONS]. "To reduce radiation-induced bleeding, Nplate stimulates the body's production of platelets. ARS, also known as radiation sickness, occurs when a person's entire body is exposed to a high dose of penetrating radiation, reaching internal organs in a matter of seconds. The safety and efficacy of Nplate in pediatric patients younger than 1 year with ITP have not been established. In Study 5, patients refractory or relapsed after at least one prior ITP therapy with a platelet count 30 x 109/L were stratified by age and randomized (2:1) to receive Nplate (n = 42) or placebo (n = 20). megakaryocyte and platelet In Studies 1 and 2, patients with ITP who had completed at least one prior treatment and had a platelet count of 30 109/L prior to study entry were randomized (2:1) to 24 weeks of Nplate (1 mcg/kg subcutaneous [SC]) or placebo. Reconstituted product with Sterile Water for Injection, USP that has not been further diluted can remain in the original vial at room temperature 25C (77F) or be refrigerated at 2C to 8C (36F to 46F) for up to 24 hours following reconstitution. Patients were administered romiplostim by SC injection once weekly for up to 3 years. We need products that can be used longer, he said. Call your doctor for medical advice about side effects. The safety and efficacy of Nplate in adults with ITP were assessed in two double-blind, placebo-controlled clinical studies, an open-label single-arm study, and in an open-label extension study. Anemia Symptoms and Signs, Types, Treatment and Causes. The same 15 patients also achieved an increase in platelet count of 20 109/L above baseline for 2 consecutive weeks during the treatment period (88.2%, 95% CI: 63.6%, 98.5%). Protection of the hematopoietic system against radiation-induced damage: drugs, mechanisms, and developments. Advise pregnant women of the potential risk to a fetus. The starting dose for all ages was 1 mcg/kg weekly. It is a prescription medication. Patients must be closely monitored with weekly platelet counts and CBCs for at least 2 weeks following Nplate discontinuation. 5 days/week, 6 days/week, or all 7 days/week, depending on the animal's responsiveness and any potential side effects. Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) has been observed in adult clinical trials with Nplate. Nplate, a drug manufactured by Amgen USA Inc., was first approved by the U.S. Food and Drug Administration (FDA) in 2008 for long-term treatment of an autoimmune disease that can cause excessive . Thrombocytopenia; hematopoietic acute radiation syndrome; medical countermeasure; romiplostim. Join half a million readers enjoying Newsweek's free newsletters. 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. The supply of Nplate has been procured "to save lives following radiological and nuclear emergencies", according to the HSS announcement. Development of Romiplostim for Treatment of Primary Immune Thrombocytopenia From a Pharmacokinetic and Pharmacodynamic Perspective. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to romiplostim are unknown. Radiat Res. Pharmacodynamic analysis revealed that the platelet nadir was not as low and recovery was faster in the irradiated mice treated with romiplostim when compared with irradiated control animals (Day 8 versus 10 nadir; Day 22 versus 29 recovery to near baseline). 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. Animals were administered a single subcutaneous dose of blinded treatment (control article [sterile saline] or Nplate [5mg/kg]) 24 hours post-irradiation. Accessibility Among 291 adult patients with ITP who received Nplate in the single-arm extension study, the incidence rates of the adverse reactions occurred in a pattern similar to those reported in the placebo-controlled clinical studies. Rescue therapies (i.e., corticosteroids, IVIG, platelet transfusions, anti-D immunoglobulin, dapsone, danazol, and azathioprine) were permitted. The US spent $290 million on life-saving drugs, according to reports. This formation may improve upon discontinuation of Nplate. See What is the most important information I should know about Nplate?. Kumar VP, Holmes-Hampton GP, Biswas S, Stone S, Sharma NK, Hritzo B, Guilfoyle M, Eichenbaum G, Guha C, Ghosh SP. Before A similar response to romiplostim is expected in the pediatric and adult patients based on the mechanism of action of the drug and pharmacokinetics of romiplostim in pediatric patients 1 year and older with ITP [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY]. Of the 250 patients, 210 (84.0%) entered the long-term follow-up phase of this study. In clinical studies of patients with ITP, the incidence of US buys Nplate radiation sickness drug. 25 later it was shown that multidrug Overall, the median platelet count was 14 109/L at study entry. Serum concentrations of romiplostim in pediatric patients with ITP were within the range observed in adult patients with ITP receiving the same dose range of romiplostim. The percentage of patients with at least 2 prior ITP therapies (predominantly IVIG and corticosteroids) was 88% in the group treated with Nplate and 100% in the group treated with placebo. 2022 May 31;11(6):1098. doi: 10.3390/antiox11061098. Approximately 82% of patients had a baseline count 20 x 109/L, which was similar between treatment arms. purposes only and are not Epub 2020 Jul 15. The median age of the patients was 10 years (range 1 to 17 years) and 27.3% of patients were female. Amgen will maintain the supply of the drug, an approach the HHS says lowers costs for taxpayers and allows the drug to be used in the commercial market before it expires. The serum concentrations varied among patients and did not correlate with the dose administered. Because of the uncertainty associated with extrapolating animal efficacy data to humans, the selection of a human dose for Nplate is aimed at providing platelet response to Nplate that is similar to that observed in efficacy studies conducted in animals. Nplate Mechanism of Action. The drug is an artificial protein that promotes the production of platelets or blood-clotting cells in the human body. Keywords: Table 2. home Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate. Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799. The US government has bought anti-radiation pills which are used to treat the sickening symptoms of a nuclear attack. Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP. Nplate, manufactured by U.S. drugmaker Amgen, was approved by the Food and Drug Administration in 2021 to treat injuries caused by acute radiation syndrome, also known as radiation sickness. Among 291 patients who subsequently entered the extension study and received Nplate, platelet counts were increased and sustained regardless of whether they had received Nplate or placebo in the prior placebo-controlled studies. Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count 50 x 109/L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. of bleeding and thrombotic events during long-term use of romiplostim in patients with chronic meant to imply clinical efficacy. The effectiveness of Nplate for this use was only studied in animals, because it could not be studied in people. Dilution per reconstitution instructions results in reducing the concentration of Nplate from 500 mcg/mL to 125 mcg/mL in all vial sizes (see Table 1). IP: 34.210.113.179. The majority of patients reached a median platelet count of 50 109/L after receiving one to three doses of Nplate, and these platelet counts were maintained throughout the remainder of the study with a median duration of Nplate treatment of 78 weeks and a maximum duration of 277 weeks. Your healthcare provider may change your dose or stop Nplate depending upon the change in your blood platelet count. The patients had been diagnosed with ITP for approximately 2 years and had received a median of three prior ITP treatments. I would expect a bigger buy if this were in a response to something going on over there that requires them to both have enough for the U.S. and for giving to partners overseas.". 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