The most common side effects of romiplostim in adults include: The most common side effects of romiplostim in children 1 year of age and older include: People who take romiplostim may have an increased risk of developing new or worsening changes in the bone marrow called increased reticulin. The risk or severity of peripheral neuropathy can be increased when Romiplostim is combined with Vindesine. Romiplostim 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. Do not freeze. 267639-76-9 - romiplostim. 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 (the chronic adult ITP population in the USA is thought to be around 60,000, with women outnumbering men by a factor of two). tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. The drug can be used to treat adults and children. And remember there were 2 studies, and this will get back a little bit to what we were talking about before. However, a dose dependent-increase in platelet counts have been observed in clinical trials. Accumulation does not occur after six weekly doses of 3 mcg/kg romiplostim. Anyway, on both platelets as well as on megakaryocytes. Last updated on Apr 14, 2022. Romiplostim is produced by recombinant DNA technology in Escherichia coli. Jean A. Ridgeway Lenn Fechter Cindy Murray geriatric nursing, Assessment Classification Therapeutic: antithrombocytopenics Pharmacologic: thrombopoietin receptor agonists Indications Treatment of thrombocytopenia associated with chronic immune (idiopathic) thrombocytopenic purpura that has not responded to corticosteroids, immunoglobulins, or splenectomy where there is risk of bleeding. Discontinuation of romiplostim must be approached with great caution, as a rapid decrease in the platelet count may occur, possibly leading to bleeding diathesis. AHFS Patient Medication Information. Romiplostim can cause serious side effects, including: See What are the side effects of romiplostim? below for other side effects of romiplostim. 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. [2] 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 (the chronic adult ITP population in the USA is thought to be around 60,000, with women outnumbering men by a factor of two). 2 Clarke DriveSuite 100Cranbury, NJ 08512. After your treatment with romiplostim injection ends, your platelet level may drop lower than it was before you began your treatment with romiplostim injection. Easily compare up to 40 drugs with our drug interaction checker. It is also important information to carry with you in case of emergencies. Romiplostim belongs to a class of drugs called TPO (thrombopoietin) peptide mimetics. How should this medicine be used? Romiplostim has been found to be generally well tolerated. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Many other medications may also interact with romiplostim, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Romiplostim works by mimicking the action of your own natural TPO, which is a hormone produced by your liver and kidneys that regulates how many platelets you produce. The thrombopoietic growth factors (TGFs) are a novel class of compounds for the treatment of chronic immune thrombocytopenia (ITP). Inactive ingredients: L-histidine, mannitol, polysorbate 20, sucrose, and hydrochloric acid, Romiplostim is manufactured under the brandname Nplate by Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799, No, Nplate is not a chemotherapy (cancer) drug, it is a prescription medicine used to treat low platelet counts that can lead to bleeding in people with chronic immune thrombocytopenic purpura (ITP). Store romiplostim vials in the refrigerator at 2C to 8C (36F to 46F) in the original carton to protect from light. Vd, 0.3 g/kg = 122 mL/kg Romiplostim is a prescription medicine also used to treat people including newborns who have been exposed to high levels of radiation (acute radiation syndrome). We thus tested if the addition of romiplostim to the clinically applied conditioning chemotherapy regimen cyclophosphamide and busulfan leads to increased efficacy of the chemotherapeutic regimen. Romiplostim is a fusion protein thrombopoietin (TPO) peptide analog that increases platelet counts by binding to and activating the human TPO receptor. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). Romiplostim is an Fc-peptide fusion protein (peptibody) that interacts with the TPO receptor to trigger downstream signal cascades that ultimately stimulate platelet production by promoting proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. Once stored at room temperature, do not place back in the refrigerator. Build, train, & validate predictive machine-learning models with structured datasets. [1][5], Romiplostim treatment is generally administered at weekly intervals via subcutaneous injection. Mezrich JD et al., 2012, SU5416, a VEGF receptor inhibitor and ligand of the AHR, represents a new alternative for immunomodulation., PLoS One ROMIPLOSTIM MPL It works by causing the cells in the bone marrow to produce more platelets. All Rights Reserved. GN5XU2DXKV - ROMIPLOSTIM. Call your doctor right away if you are unable to keep an appointment to receive a dose of romiplostim injection. Headache was the most commonly reported adverse reaction that did not occur at 5% higher patient incidence in Nplate versus placebo. 2020;96(1):145-154. doi:10.1080/09553002.2019.1605465, Romiplostim is a prescription medicine used to treat low blood platelet counts (. Find information on Romiplostim (Nplate) in Davis's Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. Tell your doctor if you are pregnant or plan to become pregnant. Do not breastfeed during treatment with romiplostim. If your platelet level does not increase enough after you have received romiplostim injection for some time, your doctor will stop giving you the medication. [7] "To reduce radiation-induced bleeding, Nplate stimulates the bodys production of platelets. This medication is used to treat a certain blood disorder (idiopathic thrombocytopenia purpura - ITP) in which the blood does not clot properly due to a lack of platelets. American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. thrombopoietin receptor agonists. Ivy Altomare, MD: Youre talking about romiplostim. SNOMED-CT. 439122000 - Romiplostim (substance) Next: Usage Decision Support Cross-check . Romiplostim works by causing the cells in the bone marrow to produce more platelets. 2007 Dec;47(12):1489-97. Romiplostim is a prescription medication used for the treatment of chronic immune thrombocytopenia and hematopoietic syndrome associated with acute radiation syndrome. . And the results were that between 80% and 90% of patients had a sustained response. The goal of treatment is to maintain the count above 50,000 per cubic millimeter (mm3) of blood, not to achieve a normal countdefined as 150,000450,000 per mm3 in most healthy individuals. GET PRICE Romiplostim Dosage [4], On August 22, 2008, the FDA approved romiplostim as a long-term treatment for chronic ITP in adults who have not responded to other treatments, such as corticosteroids, intravenous immunoglobulin, Rho(D) immune globulin or splenectomy. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. After reconstitution, a deliverable volume of 0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL). After that, you will need to get blood tests every month. These data, if confirmed in larger study or real-world experience, are very important, could change practice and also add validity to the class effect of TPO-RA in refractory AA. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Pharmaceutical Form: Vials containing 250 g romiplostim powder for solution for injection. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine. Duplication for commercial use must be authorized by ASHP. "[7], Experimental treatment of acute radiation syndrome, chronic idiopathic (immune) thrombocytopenic purpura, "FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP", "US splashes $290m on anti-radiation drugs after Putin ups nuclear threats", Tetragalacturonic acid hydroxymethylester, Methoxy polyethylene glycol-epoetin beta (CERA/Mircera), Granulocyte macrophage colony-stimulating factor, Interferon alpha (interferon alfa, IFN-), FMS-like tyrosine kinase 3 ligand (FLT3L), Leukemia/leukocyte inhibitory factor (LIF), https://en.wikipedia.org/w/index.php?title=Romiplostim&oldid=1115304045, Chemicals that do not have a ChemSpider ID assigned, Drugboxes which contain changes to verified fields, Drugboxes which contain changes to watched fields, Articles with unsourced statements from December 2021, Creative Commons Attribution-ShareAlike License 3.0, This page was last edited on 10 October 2022, at 20:15. The risk or severity of peripheral neuropathy can be increased when Romiplostim is combined with Vincristine. [, Krzyzanski W, Sutjandra L, Perez-Ruixo JJ, Sloey B, Chow AT, Wang YM: Pharmacokinetic and pharmacodynamic modeling of romiplostim in animals. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Information from one mother-infant pair indicates that no short-term adverse effects occurred in the infant after . Target-based classification of drugs [BR:br08310] Cytokines and receptors Cytokine receptors CSF and other factor receptors MPL (TPOR, CD110) Romiplostim is a fusion protein thrombopoietin (TPO) peptide analog that increases platelet counts by binding to and activating the human TPO receptor. Romiplostim is in a class of medications called thrombopoietin receptor agonists. Romiplostim is given by your healthcare provider as an injection under the skin once for exposure to high levels of radiation. [1] During development and clinical trials the drug was called AMG531. thrombopoietin receptor agonists. B02BX04 Romiplostim D08990 Romiplostim (USAN/INN) <JP/US> USP drug classification [BR:br08302] Blood Products and Modifiers Blood Products and Modifiers, Other . antithrombocytopenics. Your doctor may also order blood tests to find out why romiplostim injection did not work for you. The new expiration date must be written in the space provided on the carton. binding to c-Mpl receptors (dominant mode of clearance at low doses), Immune thrombocytopenia patients, subQ = 3.5 days (median) (range 1-34 days). What special dietary instructions should I follow? The drug was developed in 2 parallel identically designed, multinational double-blind, double-dummy studies. numbness, burning, or tingling in the arms or legs, difficulty falling asleep or staying asleep, runny nose, congestion, cough, or other cold symptoms, swelling, pain, tenderness, warmth or redness in one leg, pain in the chest, arms, back, neck, jaw, or stomach. Romiplostim 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. 2022 MJH Life Sciences and OncLive - Clinical Oncology News, Cancer Expert Insights. Romiplostim decreases your risk of bleeding by increasing the number of platelets. And all of the trials are done with all of these agents used as the target platelet count of 50,000 or higher because thats considered the safe platelet count at which point patients generally dont bleed unless you invade them. ROMIPLOSTIM belongs to the class of 'platelet-stimulating agents' primarily used to treat chronic immune thrombocytopenia in adults who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. If MDS worsens to become acute leukemia you may die sooner from the acute 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 . Res. [citation needed], Romiplostim may be used to treat acute radiation syndrome. The first of these agents to receive regulatory approval, romiplostim and eltrombopag, have demonstrated impressive efficacy and tolerability in randomized controlled trials and open-label extension studies of several years duration and stand poised to . There's more to see -- the rest of this topic is available only to . Keep all appointments with your doctor and the laboratory. It is usually injected once a week. 2022 MJH Life Sciences and OncLive - Clinical Oncology News, Cancer Expert Insights. romiplostim (Rx) Brand and Other Names: Nplate Classes: Hematopoietic Growth Factors; Thrombopoietic Agents Dosing & Uses AdultPediatric Dosage Forms & Strengths injection, lyophilized powder for. Romiplostim is the first available drug in a recently developed class of agents that work through stimulation of the thrombopoietin (TPO) receptor (c-Mpl) to increase platelet production. Call your doctor for medical advice about side effects. Romiplostim injection does not work for everybody. adults with immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough. 2012;72(3):415-435. doi:10.2165/11208260-000000000-00000, Bunin DI, Bakke J, Green CE, Javitz HS, Fielden M, Chang PY. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Romiplostim may pass into your breast milk and harm your baby. Epub 2012 Dec 19. If a count of 200,000 or higher is achieved for two consecutive weeks a reduced dose is administered or treatment is suspended until the count decreases below 200,000. There's more to see -- the rest of this topic is available only to . Romiplostim pregnancy and breastfeeding warnings, National Library of Medicine Nplate Product Label, Keating GM. Avoid life-threatening adverse drug events & improve clinical decision support. 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