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Your Nplate dose will be adjusted based on how your platelets respond to treatment if you are an adult. Drug class: Platelet-stimulating agents. Of the 24 patients who achieved treatmentfree remission, 20 (83%) discontinued Nplate based on this regimen during the 52-week treatment period; 4 patients (17%) tapered Nplate at the end of the 52-week treatment period using a different dosage adjustment approach per the study protocol.13. Advise the patient to read the FDA-approved patient labeling (Medication Guide). NPLATE (romiplostim injection, powder, lyophilized, for solution) comes in different strengths and amounts. are pregnant or plan to become pregnant. Do not administer more than one dose from a vial. Nplate is a prescription medicine used to treat low platelet counts that can lead to bleeding in people with chronic immune thrombocytopenic purpura (ITP). The samples from patients that tested positive for binding antibodies were further evaluated for neutralizing capacity using a cell-based bioassay. thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. with 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 . Nplate is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in: adults with immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough. Administer . This video provides a step-by-step guide for adult patients on the preparation and self-administration of the correct dose of Nplate (romiplostim). Two percent (2/132) of patients (both from cohort 3) developed Grade 4 findings (presence of collagen). There is insufficient evidence to establish a relationship between maximum platelet threshold and risk of thrombotic/thromboembolic complications. These changes may improve if you stop taking Nplate. Administer Nplate as a once-weekly subcutaneous injection with dose adjustments based upon the platelet count response. for Injection, USP for a concentration of The data described below reflect Nplate exposure to 271 adult patients with ITP, aged 18 to 88, of whom 62% were female. Food and Drug Administration. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Newland A, Godeau B, Priego V, et al. The effectiveness of Nplate for this use was only studied in animals, because it could not be studied in people. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. 2 DOSAGE AND ADMINISTRATION 2.1 Patients with Immune Thrombocytopenia (ITP) Use the lowest dose of Nplate to achieve and maintain a platelet count 50 109/L as necessary to reduce the risk for bleeding. Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody). Nplate should be injected once per week in order to keep your platelet counts up. The maximum weekly dose is 10 mcg per kg. Click "Yes, I am" to enter if you are a U.S. healthcare professional. Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Maternal IgG is known to be present in human milk. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy, Advise women not to breastfeed during treatment with Nplate, Injection of too much Nplate may cause a dangerous increase in your blood platelet count and serious side effects. Your healthcare provider may need to check your bone marrow for this problem during treatment with Nplate. Nplate is supplied as either 125 mcg per vial, 250 mcg per vial or 500 . Adjustments were made following the recommended dosage regimen (Section 2.1 of the Nplate Prescribing Information). Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous use. Nplate should not be used in an attempt to normalize platelet counts. The drug is an artificial protein that promotes the production of platelets or blood-clotting cells in the human body. Following Nplate discontinuation in Studies 1 and 2, seven patients maintained platelet counts of 50 109/L. To reduce radiation-induced bleeding, Nplate stimulates the body's production of platelets. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125268s168lbl.pdf, https://www.nplate.com/platelet-booster#getting-nplate. Available from: Nplate. 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. Nplate is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in: 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 immune thrombocytopenia (ITP). It works by stimulating your bone marrow to make more platelets. Reconstituted product with Sterile Water for Injection, USP may be held in a syringe at room temperature 25C (77F) for a maximum of 4 hours following reconstitution. Patients were screened for immunogenicity to romiplostim using a BIAcore-based biosensor immunoassay. 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]). Administer Nplate only using a syringe with 0.01 mL graduations for accurate dosage. An Nplate preparation mat Gives you a place on which to prepare your injection. Protect from light. children 1 year of age and older with ITP for at least 6 months when certain medicines or surgery to remove your spleen have not worked well enough. The platelet counts were above 50 10, Reduction/Discontinuation of Baseline Concurrent ITP Medical Therapy, Figure 1. Nplate is also approved for adult and pediatric patients with immune thrombocytopenia, a blood disorder resulting in low platelet counts. Approximately 58% of patients had a baseline count 20 x 109/L, which was similar between treatment arms. K How is Nplate stored? Nplate (romiplostim) 101. In Studies 1 and 2, nine patients reported a serious bleeding event [five (6%) Nplate, four (10%) placebo]. Due to the potential for serious adverse reactions in a breastfed child from Nplate, advise women not to breastfeed during treatment with Nplate. Nplate. Romiplostim ( Nplate) is administered as a once-weekly subcutaneous injection. What are the possible side effects of Nplate? You may have a higher risk of getting a blood clot if your platelet count becomes high during treatment with Nplate. The information provided in this section is intended expressly for healthcare professionals in the United States. romiplostim injection, powder, lyophilized, for solution. DO NOT SHAKE reconstituted solution, 250 mcg/vial What are the possible side effects of Nplate? 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. AdministerNplate only . pain in mouth and throat (oropharyngeal pain), These are not all the possible side effects of Nplate, If you have any questions about this information, be sure to discuss with your doctor. From the total of 79 patients enrolled in the 2 cohorts, 27 (90%) patients in cohort 1 and 36 (73.5%) patients in cohort 2 had evaluable on-study bone marrow biopsies. Store Nplate vials in the refrigerator at 2C to 8C (36F to 46F) in the original carton to protect from light. Approval for this indication was based on efficacy studies conducted in animals, Nplate's effect on platelet count in healthy human volunteers and on data supporting Nplate's effect on thrombocytopenia in patients with ITP and insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate administration increases the risk for development or progression of reticulin fiber deposition within the bone marrow. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. A durable platelet response was defined as achieving at least 6 weekly platelet counts 50 109/L during weeks 18 through 25 of treatment. based on the recommended dosage regimen in the Nplate, including Nplate, as a second-line therapy, At the end of the 52-week treatment period, patients who had not entered remission, were still receiving Nplate, In patients achieving treatment-free remission, median weekly Nplate, Dose reductions are described for platelet counts > 200 x 10, 84% of patients (n = 63/75) reported treatment-emergent adverse events, Serious treatment-related adverse events were reported in 3 patients: gastritis, increased transaminases,* and reversible ischemic neurologic deficit (1 patient each), Any bleeding event occurred in 31% of patients (n = 23/75), Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate, To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate, Hyporesponsiveness or failure to maintain a platelet response with Nplate, To detect antibody formation, submit blood samples to Amgen (, In the placebo-controlled trials of adult ITP patients, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate, The most common adverse reactions experienced by 5% of patients receiving Nplate, In pediatric patients of age 1 year receiving Nplate. 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. Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay used in detection and may be influenced by several factors, including sample handling, concomitant medications, and underlying disease. This formation may improve upon discontinuation of Nplate . During the dose adjustment phase of therapy, your healthcare provider will check your platelet count before each injection to determine the dose of Nplate you need. 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. 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 . 7. If MDS worsens to become acute leukemia you may die sooner from the acute leukemia. 2019;3(22):3780-3817. Sixty percent of patients had ITP duration < 3 months and 40% had ITP duration 3 months. 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. Nplate may pass into your breast milk and harm your baby. Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Talking with your doctor is key to managing ITP. Tracking platelet counts weekly can help you see changes. Reconstitution with 0.72 mL of Sterile Water for Injection provides a resulting concentration of 250 mcg/0.5 mL. The incidence of new binding antibody development was 3.8% (7/184) to romiplostim and 2.2% (4/184) were positive for binding, non-neutralizing antibodies to TPO; two patients were positive for binding antibodies to both romiplostim and TPO. Bleeding events that were Grade 2 severity or higher occurred in 15% of patients treated with Nplate and 34% of patients treated with placebo. Of the seven patients with positive binding antibodies to romiplostim, one patient (0.5%; 1/184) was positive for neutralizing antibodies to romiplostim only. This formation may improve upon discontinuation. 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 the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. Nplate is supplied in single-dose vials as a sterile, preservative-free, white lyophilized powder that must be reconstituted as outlined in Table 1 and administered using a syringe with 0.01 mL graduations. Rescue medications (i.e., corticosteroids, platelet transfusions, IVIG, azathioprine, anti-D immunoglobulin, and danazol) were permitted. Visit. Br J Haematol. To detect antibody formation, submit blood samples to Amgen (1-800-772-6436). Nplate (romiplostim) prescribing information, Amgen. 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 [see Clinical Studies (14.3)]. Animals were administered a single subcutaneous dose of blinded treatment (control article [sterile saline] or Nplate [5mg/kg]) 24 hours post-irradiation. The drug can be used to treat adults and children. 2015 0 obj <>/Filter/FlateDecode/ID[<5949F21F6A858243A73A756CCBE358D7>]/Index[1996 40]/Info 1995 0 R/Length 88/Prev 144093/Root 1997 0 R/Size 2036/Type/XRef/W[1 2 1]>>stream and clinical condition increase the risk for bleeding. Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. ITP patient on Nplate, 20/24 patients entered remission during the 52-week treatment period, Dr Steven Fein DISCUSSES a A durable platelet response was the achievement of a weekly platelet count 50 109/L for any 6 of the last 8 weeks of the 24-week treatment period in the absence of rescue medication at any time. The efficacy of Nplate in this trial was measured by the proportion of patients receiving Nplate achieving a durable platelet response and the proportion of patient achieving an overall platelet response. Nplate is supplied as either 125 mcg per vial, 250 mcg per vial or 500 mcg per vial of romiplostim and requires reconstitution with Sterile Water for Injection to obtain a concentration of 500 mcg/mL. The primary efficacy endpoint was survival. The drug which can be used on kids as well as adults is "approved to treat blood . There was no detectable bone marrow collagen in one patient on repeat testing 12 weeks after discontinuation of romiplostim. Reconstitution and Dilution of Nplate Single-Dose Vials. Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody). 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. Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) has been observed in adult clinical trials with Nplate. It will then be injected under your skin (subcutaneously) at one of three recommended injection sites including the: Your healthcare provider will use a syringe that has 0.01ml graduations to inject Nplate because the dose you need may be very small. Use aseptic technique. Six additional patients had reticulin observed upon bone marrow biopsy. F*l[Ti\f3C8oH cUZmQBkj"ycOpJ UlQwFGSGGKGe l@A W($88'iA D2,Ln$gKOAq(-xUf`& (Va`kE@:H[30d@1 Nplate should be used only in patients with ITP whose degree of thrombocytopenia Search our database for licensed Seattle businesses. The US has bought $290 million in anti-radiation drugs amid heightened Russian threats of nuclear war. Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Multiply the patients weight (kg) by the prescribed dose to obtain the Calculated Patient Dose. 250 mcg/0.5 mL. Animals received medical management consisting of intravenous or subcutaneous fluids, anti-ulcer medication, anti-emetic medication, analgesics, antimicrobials, and other support as required. All 10 patients with bone Reconstitution with 1.2 mL of Sterile Water for Injection provides a resulting concentration of 500 mcg/mL. NPlate (10 mcg per kg) is also administered as a one-off treatment to increase survival in people acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, HS-ARS). Nplate was administered weekly for up to 3 years by subcutaneous injection starting at a dose of 1 mcg/kg with weekly increments to a maximum dose of 10 mcg/kg to reach a target platelet count between 50 109/L and 200 109/L. Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. 2008-2022 Amgen Inc. All rights reserved. Following discontinuation of Nplate, thrombocytopenia and risk of bleeding may develop that is worse than that experienced prior to the Nplate therapy. 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 median age of the patients was 9.5 years (range 3 to 17) and 57% were female. Gently swirl and invert the vial to reconstitute. For Subcutaneous Use Only For pediatric patients (including term neonates), extrapolation was based on data supporting Nplate's effect on thrombocytopenia in patients with ITP and an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The open-label long-term study also evaluated changes in bone marrow reticulin and collagen formation. 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). Romiplostim has no amino acid sequence homology to endogenous TPO. See Dosage and Administration (2.1) for dosing recommendations for pediatric patients 1 year and older. Worsening of a precancerous blood condition to a blood cancer (leukemia). 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 . Package insert / prescribing information Available from. Overdoses due to medication errors have been reported in patients receiving Nplate. 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%). Reassessment of body weight is recommended every 12 weeks. The dose is adjusted slowly until a platelet count of 50x109/L is achieved and maintained. Platelet responses were excluded for 4 weeks after receiving rescue medications. ITP is a disease where the immune system is confused and attacks the platelet cells in the blood, destroying . In pediatric studies, data on antibody formation was collected from 282 patients (20 from early phase studies, 59 from phase 3 studies with duration of 6 months and 203 from a long-term study with median duration of 3 years). Administer Nplate only with a syringe that contains 0.01 mL graduations. Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. 1 Adult patients: Actual body weight at initiation of therapy should always be used when calculating the dose. 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. 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). Your doctor will give Nplate to you as an injection under your skin. Overall, the median platelet count was 19 109/L at study entry. Find ways to get help online and in-person. 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. Each single-dose 250 mcg vial of Nplate contains the following: 250 mcg romiplostim, L-histidine (1.2 mg), mannitol (30 mg), polysorbate 20 (0.03 mg), sucrose (15 mg), and sufficient HCl to adjust the pH to a target of 5. The median age of the patients was 10 years (range 1 to 17 years) and the median and maximum duration of treatment were 156 weeks and 163 weeks, respectively. The median time since ITP diagnosis for Studies 1 and 2 was 2.1 years (range 0.1 to 31.6) and 8 years (range 0.6 to 44.8), respectively. Only patients who demonstrate the ability to reconstitute and self-administer Nplate are allowed to continue doing so. Use the lowest dose of Nplate to achieve and maintain a platelet count 50 109/L as necessary to reduce the risk for bleeding. Last updated on April 19, 2021. 0 Blood Adv. Revised: 01/2021, inflammation of the sinuses (sinusitis), pain in mouth and throat (oropharyngeal pain). 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. 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.. Do not exceed maximum weekly dose of 10 mcg/kg. What is the most important information I should know about Nplate? Six patients in the Nplate group and 2 patients in the placebo group had undergone splenectomy. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. Read More Dosage and Administration (2.1, 2.2, 2.3) 12/2018 In some patients with MDS, Nplate increases blast cell counts and -----INDICATIONS AND USAGE----- increases the risk of progression to acute myelogenous leukemia. 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. If you have ITP, you may be at risk of serious, life-threatening bleeding. Your doctor may change the dosage and prescription of Nplate to get you the best results possible. This Medication Guide has been approved by the U.S. Food and Drug Administration. Protect from light. Dispense the enclosed Medication 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. Do not reconstitute or dilute with Bacteriostatic Water for Injection, USP or dilute with Bacteriostatic Sodium Chloride Injection, USP. This may affect your liver function. Study 1 and 2 outcomes are shown in Table 5. 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 (5.3)]. Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Be sure to. For the administration of a drug using an On-Body Injector bill with CPT code 96377. 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. 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. ''H~B RITUXAN (rituximab) full Prescribing Information, Genentech, Inc. 6. The following adverse reactions have been identified during post approval use of Nplate. Reconstituted Nplate can be kept at room temperature (25C/77F) or refrigerated at 2 to 8C (36 to 46F) for up to 24 hours prior to administration. We currently administer over 80 Taft-Hartley and Public Trust Funds which cover benefits for Health and Welfare, Disability and Time Loss, Dental, Vision, Defined Contribution, Defined . Verify that the syringe contains the correct dosage. 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. Data on file, Amgen; Clinical Study Report 20080435; 2014. Romiplostim is a thrombopoietin receptor agonist (TPO-RA). 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 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. See What are the possible side effects of Nplate? for other side effects of Nplate. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. 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. When you stop receiving Nplate, you will need blood tests for at least 2 weeks to check if your platelet count drops too low. In pediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight. Romiplostim (Nplate TM, Amgen, Inc., Thousand Oaks, CA) was approved by the Food and Drug Administration (FDA) on August 22, 2008 for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
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