Nplate has no amino acid sequence homology to eTPO. TOLEROGENIC COMPOSITIONS AND METHODS: : US15508221: : 2015-09-03: (): US20170348415A1: (): 2017-12-07: : Moderna Therapeut In clinical studies, most adult patients who responded to Nplate achieved and maintained platelet counts 50 x 109/L with a median dose of 2 mcg/kg. home In animal reproduction and developmental toxicity studies, romiplostim crossed the placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality (see Data). In clinical studies, treatment with Nplate resulted in dose-dependent increases in platelet counts. The recommended dose of Nplate is 10 mcg/kg administered once as a subcutaneous injection. domains.1, Nplate has no amino acid sequence homology to eTPO.1 No apparent correlation was observed between antibody activity and clinical effectiveness or safety. 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. However, it is not clear that the purchase of Nplate is linked to concerns regarding this. Sixty percent of patients had ITP duration < 3 months and 40% had ITP duration 3 months. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. On October 4, the United States Department for Health and Human Services (HHS) announced it was purchasing a supply of the drug Nplate "as part of long-standing, ongoing efforts to be better prepared to save lives following radiological and nuclear emergencies.". The serum concentrations varied among patients and did not correlate with the dose administered. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine. Disclaimer, National Library of Medicine Would you like email updates of new search results? Nplate was studied in two randomized, placebo-controlled, double-blind studies that were identical in design, with the exception that Study 1 evaluated nonsplenectomized patients with ITP and Study 2 evaluated splenectomized patients with ITP. You must have blood platelet counts done before you start, during, and after Nplate therapy is stopped (. Accessibility When you stop receiving Nplate, you will need blood tests for at least 2 weeks to check if your platelet count drops too low. thrombopoiesis. The study enrolled 75 patients of whom the median age was 39 years (range 19 to 85) and 59% were female. What Are the Best PsA Treatments for You? 8600 Rockville Pike Avoid excess or vigorous agitation: DO NOT SHAKE. In a 4-week repeat-dose toxicity study in which rats were dosed subcutaneously three times per week, romiplostim caused extramedullary hematopoiesis, bone hyperostosis, and marrow fibrosis at clinically equivalent and higher doses. The department said in a statement that the purchase of the drug, called Nplate, is part of its long-standing, ongoing efforts by the Administration for Strategic Preparedness and Response to better prepare the U.S. for the potential health impacts of a wide range of threats to national security.. Nplate is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous injection. Yamaguchi M, Suzuki M, Funaba M, Chiba A, Kashiwakura I. Of the 75 patients enrolled in Study 3, 70 (93%) had a platelet response 50 x 109/L during the 12-month treatment period. Radiat Res. 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. 125 mcg, 250 mcg or 500 mcg of deliverable Nplate as a sterile, lyophilized, solid white powder in single-dose vials. The safety and efficacy of Nplate in pediatric patients younger than 1 year with ITP have not been established. The data described below reflect Nplate exposure to 271 adult patients with ITP, aged 18 to 88, of whom 62% were female. Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). "Because platelets play an important role in blood clotting, a decrease in platelet number increases the risk of bleeding, which contributes to radiation toxicity. The prescribed Nplate dose may consist of a very small volume (e.g., 0.15 mL). The drug can be used to treat adults and children," HHS said. You can ask your pharmacist or healthcare provider for information about Nplate that is written for health professionals. All patients were negative for neutralizing activity to TPO. This means it is not available to buy over the counter. with For these reasons, comparison of incidence of antibodies to romiplostim with the incidence of antibodies to other products may be misleading. drugs a-z list Nplate for ITP is given by your healthcare provider as an injection under. The U.S. government is spending $290 million to purchase a supply of a drug that can be used to treat the effects of radiation sickness. binding antibody development During the study, the median weekly Nplate dose was 3 mcg/kg (25th-75th percentile: 2-4 mcg/kg). Administer Nplate regardless of whether a complete blood count (CBC) can be obtained. For these reasons, comparison of the incidence of antibodies to Nplate in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. Careers. 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. In a prenatal and postnatal development study in rats, at doses 11 times the MHD, there was an increase in perinatal pup mortality. In the long-term extension study in adult patients with ITP receiving weekly treatment of Nplate subcutaneously, the pharmacokinetics of romiplostim over the dose range of 3 to 15 mcg/kg indicated that peak serum concentrations of romiplostim were observed about 7 to 50 hours post dose (median: 14 hours) with half-life values ranging from 1 to 34 days (median: 3.5 days). Administer Nplate only using a syringe with 0.01 mL graduations for accurate dosage. CD2F1 male mice were injected s.c. with CBLB613 (0.025 mg/kg) or vehicle (n 8) and . Over a 24-week treatment period, dose was titrated up to a maximum of 10 mcg/kg weekly of either Nplate or placebo in an effort to maintain a target platelet count of 50 109/L to 200 109/L. Six patients in the Nplate group and 2 patients in the placebo group had undergone splenectomy. "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," it said. Clin Pharmacokinet. The most common side effects of Nplate in adults include: headache joint pain dizziness trouble sleeping muscle tenderness or weakness pain in arms and legs stomach (abdomen) pain shoulder pain indigestion tingling or numbness in hands and feet bronchitis inflammation of the sinuses (sinusitis) vomiting diarrhea upper respiratory tract infection Nplate is a prescription drug produced by California-based biotechnology company Amgen. In a pediatric placebo-controlled clinical study, the median of the most frequent dose of Nplate received by patients during weeks 17 through 24 was 5.5 mcg/kg. 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 received single weekly SC injections of Nplate over a 12-month treatment period, with individual dose adjustments to maintain platelet counts (50 x 109/L to 200 x 109/L). The incidence of death (overall survival) was 55.7% (93/167) in the Nplate arm versus 54.2% (45/83) in the placebo arm (HR [95% CI] = 1.03 [0.72, 1.47]). 8 years ago More. The incidence of pre-existing antibodies to endogenous TPO was 3% (31/1046) and the incidence of binding antibody development to endogenous TPO during treatment was 3.2% (33/1046). Alexa rank 3,561,113. After that, you will need to get blood tests every month. Patients were screened for immunogenicity to romiplostim using a BIAcore-based biosensor immunoassay. Vehicle, romiplostim, and/or pegfilgrastim were administered subcutaneously beginning 24 h after TBI for 1-5 days. In a single-arm trial of Nplate given to 72 patients with thrombocytopenia-related MDS, 8 (11.1%) patients were reported as having possible disease progression, of which 3 (4.2%) had confirmation of AML during follow-up. Epub 2019 Jun 21. Obrador E, Salvador-Palmer R, Villaescusa JI, Gallego E, Pellicer B, Estrela JM, Montoro A. Antioxidants (Basel). Nplate is not for use in people with a precancerous condition called myelodysplastic syndrome (MDS), or low platelet count caused by any condition other than ITP. development via the same pathway as eTPO.1,3. Verify that the syringe contains the correct dosage. The effectiveness of Nplate for this use was only studied in animals, because it could not be studied in people. 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]. Watch this instructional video to learn how Nplate. See What is the most important information I should know about Nplate?. Yang BB, Doshi S, Arkam K, Franklin J, Chow AT. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. IP: 34.210.113.179. The reconstituted Nplate solution should be clear and colorless. Adjust the dose as follows for adult patients: The initial dose of Nplate is 1 mcg/kg. Nplate is a prescription medicine also used to treat people including newborns who have been exposed to high levels of radiation (acute radiation syndrome). Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to romiplostim are unknown. 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. This Medication Guide has been approved by the U.S. Food and Drug Administration. Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate therapy at the maximum weekly dose of 10 mcg/kg [see WARNINGS AND PRECAUTIONS]. Revised: Jan 2021. Nplate, detailed in a Healthline report, is a thrombopoietin mimetic. Nplate therapy may increase the risk of reticulin fiber formation within the bone marrow. The median age of the patients was 10 years (range 1 to 17 years) and 27.3% of patients were female. Npl-law.com.This domain provided by networksolutions.com at 2003-06-10T19:49:19Z (19 Years, 45 Days ago), expired at 2023-06-10T19:49:19Z (0 Years, 319 Days left). Keyword Research; Domain By Extension; Hosting; . Efficacy studies of Nplate could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. official website and that any information you provide is encrypted Study 3 was a single-arm, open-label study designed to assess the safety and efficacy of Nplate in adult patients who had an insufficient response (platelet count 30 x 109/L) to first-line therapy. Prior ITP treatments included corticosteroids, immunoglobulins and anti-D immunoglobulins. 10 Things People With Depression Wish You Knew, Calculated Patient Dose (mcg) = Weight (kg) x Prescribed dose (mcg/kg). 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. 2016 Sep;55(9):1045-58. doi: 10.1007/s40262-016-0382-7. Table 3. Overall, the median platelet count was 14 109/L at study entry. Multiply the patients weight (kg) by the prescribed dose to obtain the Calculated Patient Dose. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate. Two vial presentations are available, which contain a sufficient amount of active ingredient to provide either 250 mcg or 500 mcg of deliverable romiplostim, respectively. Long-term treatment with According to the HHS statement, the government supply would be held separately to the doses available in the commercial market. Symptoms of ARS injuries include impaired blood clotting as a result of low platelet counts, which can lead to uncontrolled and life-threatening bleeding. 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]. In another ITP clinical study, no accumulation in serum concentrations was observed (n = 4) after six weekly doses of Nplate (3 mcg/kg). 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]. If needed, unopened Nplate vials may be stored in the original carton at room temperature up to a maximum of 25C (77F) for a single period of up to 30 days. Use the lowest dose of Nplate to achieve and maintain a platelet count 50 x 109/L as necessary to reduce the risk for bleeding. This site needs JavaScript to work properly. are not meant to imply clinical efficacy. Kaushansky K. The molecular mechanisms that control Each single-dose 500 mcg vial of Nplate contains the following: 625 mcg romiplostim, 50 mg mannitol, 25 mg sucrose, 1.9 mg L-histidine, 0.05 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0 [see DOSAGE AND ADMINISTRATION]. 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. 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. Actual body weight at initiation of treatment should always be used when calculating the initial dose. 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 . In addition, in 3 (4.2%) patients, increased peripheral blood blast cell counts decreased to baseline after discontinuation of Nplate. 1.2 Patients with Hematopoietic Syndrome of Acute Radiation Syndrome Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed . Tell your healthcare provider about any bruising or bleeding that occurs during treatment with Nplate. Round volume to the nearest hundredth mL. Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate therapy at the maximum weekly dose of 10 mcg/kg Generally, dissolution of Nplate takes less than 2 minutes. between antibody activity and clinical effectiveness or safety.1,4, Review Nplate safety profile in adults with newly After a single subcutaneous dose of 1 to 10 mcg/kg Nplate in patients with ITP, the peak platelet count was 1.3 to 14.9 times greater than the baseline platelet count over a 2-to 3-week period. 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). Adjust the dose as follows for pediatric patients: The recommended dose of Nplate is 10 mcg/kg administered once as a subcutaneous injection. development via the same pathway as eTPO.1,3. 2020 Sep;96(9):1125-1134. doi: 10.1080/09553002.2020.1787546. Nplate. Reconstituted and further diluted product with 0.9% Sodium Chloride Injection, USP can be held in a syringe at room temperature 25C (77F) or in the original vial refrigerated at 2C to 8C (36F to 46F) for no longer than 4 hours prior to administration. While it has been available on the commercial market for some time, Amgen told Newsweek this is the first time it has supplied Nplate to the government, which purchased it under the 2004 Project Bioshield Act. Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP. Federal government websites often end in .gov or .mil. Do not freeze. In the same study, an exploratory cohort of n=40 animals received Nplate (5mg/kg) on day 1 and pegfilgrastim (0.3mg/kg) on days 1 and 8 post-irradiation. Nineteen confirmed pediatric patients were included in the postmarketing registry study. Similar to adults with ITP, romiplostim pharmacokinetics are highly variable in pediatric patients with ITP. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. To detect antibody formation, submit blood samples to Amgen (1-800-772-6436). 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. 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