Food and Drug Administration. Tracking platelet counts weekly can help you see changes. Amgen scores pediatric FDA approval for Nplate in immune thrombocytopenia Single Dose Vial; Discard unused portion Do not freeze. 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. ITP is a disease where the immune system is confused and attacks the platelet cells in the blood, destroying . With 5-years of follow-up, 29 (11.6%) patients showed progression to AML, including 20/168 (11.9%) patients in the Nplate arm versus 9/82 (11.0%) patients in the placebo arm (HR [95% CI] = 1.06 [0.48, 2.33]). Single Dose Vial; Discard unused portion A randomized, double-blind, placebo-controlled trial enrolling adult patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS was terminated due to more cases of AML observed in the Nplate arm. 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 (6.3)]. The effectiveness of Nplate for this use was only studied in animals, because it could not be studied in people. PDF Quick Guide to Home Administration of Nplate Last updated on Feb 1, 2022. Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Reconstitute Nplate with Sterile Water for Injection, USP. nplate - UpToDate 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. Overview "Nplate (romiplostim)Romiplate - Drug Insight and Market Forecast - 2030" report outlays comprehensive insights of the product indicated for the treatment of its approved condition.New York, Aug. 26, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Nplate (romiplostim)Romiplate - Drug Insight and Market Forecast - 2030" - https://www.reportlinker . F*l[Ti\f3C8oH cUZmQBkj"ycOpJ UlQwFGSGGKGe l@A W($88'iA D2,Ln$gKOAq(-xUf`& (Va`kE@:H[30d@1 3. Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. The 2021-2023 Strategic Plan describes our work and expected outcomes to accomplish the mission. Next: are breastfeeding or plan to breastfeed. Due to the potential for serious adverse reactions in a breastfed child from Nplate, advise women not to breastfeed during treatment with Nplate. Previous. Please know that the sponsors of this site are not responsible for content on the website you are entering. Increased reticulin fiber formation was reported for 18.5% (5 of 27) of patients in cohort 1 and 47.2% (17 of 36) of patients in cohort 2, with a maximum grade of 2. Please see full Prescribing Information and Medication Guide. Nplate is the trade name for the drug romiplostim, approved by the U.S. Food and Drug Administration (FDA) in January 2021 for the treatment of blood cell injuries that result from acute radiation syndrome. Based on cohort assignment at the time of study enrollment, 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. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate. The US Food and Drug Administration (FDA) has specifically approved Nplate for the following reasons: In 2019 the American Society of Hematology (ASH) and the International Consensus Report (ICR) released updates to their guidelines for ITP treatment. This formation may improve upon discontinuation of Nplate . first speak to your healthcare provider and understand the benefits and risks of Nplate. Use the lowest dose of Nplate to achieve and maintain a platelet count 50 109/L as necessary to reduce the risk for bleeding. For Subcutaneous Use Only Summary of Efficacy Endpoints for Long-term Use of Nplate (Study 7) - With Number of Patients With Bleeding Events, Number of Subjects With Rescue Medication Use, Number of Subjects on Treatment, Median Platelet Counts During the Treatment Period, Advise the patient to read the FDA-approved patient labeling (, Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) that efficacy studies of Nplate for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals. Table 3 presents adverse drug reactions from Studies 1 and 2 with a 5% higher patient incidence in Nplate versus placebo. Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The carcinogenic potential of romiplostim has not been evaluated. responses occurring as early The median time from ITP diagnosis to study enrollment was 2.2 months (range 0.1 to 6.6). The incidence of binding antibody post treatment was 16% (3/19) to romiplostim, of which 5.3% (1/19) were positive for neutralizing antibodies to romiplostim. Do not administer more than one dose from a vial. Billing and Coding: Complex Drug Administration Coding Blood Adv. Administer Nplate regardless of whether a complete blood count (CBC) can be obtained. with Nplate is a prescription medicine used to treat low platelet counts that can lead to bleeding in people with chronic immune thrombocytopenic purpura (ITP). Data on file, Amgen; Clinical Study Report 20080435; 2014. To prepare your Nplate injection your healthcare provider will reconstitute the Nplate powder which comes in a vial. In a long-term, single arm, open label pediatric safety study, headache occurred in 78/203 patients (38%); the incidence rates of other adverse reactions were similar to those reported in the placebo-controlled studies. Visually inspect the reconstituted solution for particulate matter and/or discoloration. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. The use of Nplate to increase survival in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation is based on efficacy studies conducted in adult animals. During the study, the median weekly Nplate dose was 3 mcg/kg (25th-75th percentile: 2-4 mcg/kg). Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). of patients achieved The recommended dose of Nplate is 10 mcg/kg administered once as a subcutaneous injection. For injection: 125 mcg, 250 mcg or 500 mcg of Nplate as a sterile, lyophilized, solid white powder in single-dose vials. Use the lowest dose of Nplate to achieve and maintain a platelet count 50 109/L as necessary to reduce the risk for bleeding. For those patients receiving Nplate, 14 (48%) of headaches were mild, 9 (31%) were moderate, and 6 (21%) were severe. Romiplostim is a thrombopoietin receptor agonist (TPO-RA). Amgen, based in Thousands Oaks, California, developed Nplate for ARS with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), as well as the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. During treatment for ITP, your healthcare provider will closely monitor your Nplate dose and platelet counts. hb```,,( The accumulation at higher doses of romiplostim is unknown. Nplate Dosage and Administration | Healthgrades | (romiplostim 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. Nplate (romiplostim) is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines . 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). This Medication Guide has been approved by the U.S. Food and Drug Administration. Reconstitute Nplate with Sterile Water for Injection, USP. Blood Adv. The patient showed a transient antibody response for neutralizing antibodies against TPO, with a negative result at the patient's last timepoint tested within the study period after discontinuation of Nplate. 06/22. The initial dose of Nplate is 1 mcg/kg. Reconstitute with 1.2 mL Sterile Water Prescribing Information and Medication Guide. Platelet responses were excluded for 4 weeks after receiving rescue medications. Only patients who demonstrate the ability to reconstitute and self-administer Nplate are allowed to continue doing so. ITP patient on Nplate, ITP experts Adrian Newland & Ivy Altomare discuss remission data WITH NPLATE. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations, Romiplostim is a thrombopoietin receptor agonist (TPO-RA). Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. 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. 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. One patient in each group had undergone splenectomy. Search our database for licensed Seattle businesses. Single Dose Vial; Discard unused portion Reconstitution and Dilution of Nplate Single-Dose Vials. Nplate (romiplostim) Now Approved For Earlier Use In Adults With Apply for a Seattle business license or renew existing licenses. A durable platelet response was defined as achieving at least 6 weekly platelet counts 50 109/L during weeks 18 through 25 of treatment. Do not shake. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to romiplostim are unknown. The medication comes in a powder inside vials that contain: 125 micrograms (mcg) 250 mcg 500 mcg Your doctor will mix Nplate. You may have a higher risk of getting a blood clot if your platelet count becomes high during treatment with Nplate. Adult patients who lacked response or lost response to Nplate or a non-US approved romiplostim product were enrolled. A postmarketing registry study involving patients with thrombocytopenia on Nplate or a non-US approved romiplostim product was conducted to assess the long-term consequences of the anti-romiplostim antibodies. An Nplate preparation mat Gives you a place on which to prepare your injection. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate. Provan D, Arnold DM, Bussel JB, et al. Avoid excess or vigorous agitation: Calculated Dose greater than or equal to 23, In patients with ITP, to minimize the risk for thrombotic/thromboembolic complications, do not use Nplate in an attempt to normalize platelet counts. Readmore, even if platelet counts drop during taper, Delay splenectomy until 1 year to 2 years, Access the full ICR Guidelines. Available data with Nplate use in pregnant women are insufficient to draw conclusions about any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Romiplostim has no amino acid sequence homology to endogenous TPO. As a result, for a given dose, patients with high platelet counts are associated with low serum concentrations and vice versa. U.S. Stockpiles $290 Million in NIH-Funded Radiation Sickness Drug One Amgen Center Drive Nplate (Romiplostim) is a medication used to treat low platelet levels in people with immune (idiopathic) thrombocytopenic purpura (ITP). FDA Approves Nplate (Romiplostim) For Use In Pediatric - Amgen From the total of 169 patients enrolled in the 3 cohorts, 132 (78%) patients were evaluable for bone marrow collagen fibrosis and 131 (78%) patients were evaluable for bone marrow reticulin formation. Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count 50 109/L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. Nplate (Romiplostim) belongs to a class of medications called thrombopoiesis-stimulating proteins. Nplate should not be used in an attempt to normalize platelet counts, Hypersensitivity reactions including angioedema and anaphylaxis, Nplate therapy is administered to achieve and maintain a platelet count 50 10. Nplate should not be used in an attempt to normalize platelet counts. The median age of the patients was 10 years (range 1 to 17 years) and 27.3% of patients were female. 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. Romiplostim was designated an orphan drug by the U.S. Food and Drug Administration (FDA) in 2003, as the chronic ITP population in the USA is under 200,000 . Nplate is not used to make your platelet count normal. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with Nplate. 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). Approximately 58% of patients had a baseline count 20 x 109/L, which was similar between treatment arms. Be sure to. Long-term safety in the same population using Nplate for a median duration of 3 years was also evaluated in a single arm, open-label study [see Adverse Reactions (6.1), Clinical Studies (14.2)]. Dosage form: injection, powder, lyophilized, for solution A transient platelet response was the achievement of any weekly platelet counts 50 109/L for any 4 weeks during the treatment period without a durable platelet response. In clinical studies, Nplate was discontinued in four of the 271 patients because of bone marrow reticulin deposition. No apparent correlation was observed between antibody activity and clinical effectiveness or safety. Patients received single weekly SC injections of Nplate, with individual dose adjustments to maintain platelet counts (50 109/L to 200 109/L). Reconstitute with 0.72 mL Sterile Water tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take. 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]). HV]o:+\V+@[V[ZAV*MP3v/33I`_ pf2-9lk% B'p@ENq|VtM%0psCiG.$xf3}KAa' Y[x"s'\H;K:`x1-;dwLo6oM7U+xo9kk%bBAzkMh.1pstbSV4[ce Z%vl{)dnliW:b jl>-K,wiRxV W S4U^ The Kaplan-Meier estimate of the median time to first platelet response was 2.1 weeks (95% CI: 1.1, 3.0). It is not known if Nplate works or if it is safe in people under the age of 1. Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. %PDF-1.6 % Your doctor will give Nplate to you as an injection under your skin. The safety of Nplate for the acute radiation syndrome setting was assessed based on the clinical experience in patients with ITP [see Adverse Reactions (6)] and from a study with healthy volunteers. Reconstitution with 0.44 mL of Sterile Water for Injection provides a resulting concentration of 125 mcg/0.25 mL. Six patients in the Nplate group and 2 patients in the placebo group had undergone splenectomy. If you have ITP, you may be at risk of serious, life-threatening bleeding. TK Drem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. The appearance of Nplate can differ based on the dosing. The patients were randomized 2:1 to treatment with Nplate or placebo (167 Nplate, 83 placebo). In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. PDF HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. Please be aware that sponsors of this site are not responsible for content on the site you are about to enter. Based on findings from animal reproduction studies, Nplate may cause fetal harm when administered to a pregnant woman. Nplate for ITP is given by your healthcare provider as an injection under the skin (subcutaneous) one time each week. Nplate may pass into your breast milk and harm your baby. Rhesus monkeys were randomized to either a control (n = 40) or treated (n = 40) cohort. Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. After that, you will need to get blood tests every month. 2. Only administer subcutaneously [see Overdosage (10)]. Discard any unused portion. Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) has been observed in adult clinical trials with Nplate. Do not administer Nplate if particulate matter and/or discoloration is observed. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Nplate, detailed in a Healthline report, is a . Your Nplate dose will be adjusted based on how your platelets respond to treatment if you are an adult. The dose is adjusted slowly until a platelet count of 50x109/L is achieved and maintained. The modified Bauermeister grading scale was used for both assessments. "Nplate is a thrombopoietin mimetic, it helps in stimulating . Use in combination with your Step-by-step guide and Self-administration diary A Step-by-step guide to preparation and administration of the Nplate injection An illustrated guide to self-administration, to help ensure you follow the steps correctly and in the The Biden administration has placed an order for $290 million worth of a drug that can be used to treat 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. The pharmacokinetics of romiplostim is not available in patients acutely exposed to myelosuppressive doses of radiation. To reduce radiation-induced bleeding, Nplate stimulates the body's production of platelets. Watch Experts Discuss Study Results With Early Nplate, 2019 ITP TREATMENT GUIDELINES RECOMMENDATIONS, Dr Adrian Newland & Dr Ivy Altomare discuss treatment-free remission data withNPLATE, Learn about the 2019 ASH & ICR ITP Treatment Guidelines, Dr Steven Fein DISCUSSES a It works by stimulating your bone marrow to make more platelets. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. The main objective of the study was to look at how platelet count responded to Nplate. Rescue therapies (i.e., corticosteroids, IVIG, platelet transfusions, anti-D immunoglobulin, dapsone, danazol, and azathioprine) were permitted. Nplate should be used only in patients with ITP whose degree of thrombocytopenia These updates are based on a critical review of relevant articles published over the last 10 years.7,8, Recent evidence suggests that ITP is often managed with prolonged steroid use, exposing patients to side effects that may have long-term implications.7, is preferred vs prolonged, continuous use, Access the full ASH Guidelines. Indications and Marketing. Approximately 82% of patients had a baseline count 20 x 109/L, which was similar between treatment arms. Immune Thrombocytopenia (ITP) Treatment | Nplate (romiplostim) This formation may improve upon discontinuation of Nplate . Guide to each patient. 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. Too much Nplate may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications. *Remission was a secondary objective in the Nplate clinical study. 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. Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous use. Studies of long-term treatment with romiplostim in rats have not been conducted; therefore, it is not known if the fibrosis of the bone marrow is reversible in rats after long-term treatment. The following adverse reactions have been identified during post approval use of Nplate. Estimate a patient's absorbed whole body radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics. People with developmental disabilities and their families are valued citizens of the . Patients eligible for self-administration of Nplate should be trained in these procedures. In January, the Food and Drug Administration approved the use of romiplostim (trade name Nplate) to increase survival of adults and children, including newborns, who are acutely exposed to high doses of radiation that damage the bone marrow. Please see Prescribing Information and Medication Guide for more information about Nplate on Nplate.com. NPLATE (romiplostim injection, powder, lyophilized, for solution) comes in different strengths and amounts. This formation may improve upon discontinuation of Nplate . What is Nplate used for and how does it work? Why U.S. purchase of radiation sickness drug Nplate is no cause for alarm The following clinically significant adverse reactions are discussed in greater detail in other sections: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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