In healthy volunteers, non-linear decrease in Vd with increase IV dose of romiplostim which indicates . Romiplostim. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Romiplostim acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). . Your doctor will monitor you carefully for 2 weeks after your treatment ends. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. Use the lowest dose of Nplate to achieve and maintain a platelet count 50 109/L as necessary to reduce the risk for bleeding. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Romiplostim in chronic immune thrombocytopenic purpura. tell your doctor if you are breast-feeding. ROMIPLOSTIM helps your body make more platelets. Patients in Cohort 2 had a median initial dose of 4.5 mcg/kg/week. If you log out, you will be required to enter your username and password the next time you visit. Romiplostim 1 mcg/kg (actual body weight) subcutaneous injection, Once Weekly Example: Patient weight of 150 lbs. View More . = 68 kg, therefore the dose would be 68 mcg subcutaneously once weekly The dose should be increased slowly (example: increase by 1 mcg/kg per week) to prevent the platelet count from increasing too much, but to achieve a platelet . Careers. Romiplostim injection may cause your platelet level to increase too much. Conclusions: The safety and efficacy profiles of romiplostim in this study suggested that weekly subcutaneous administration of 750 g romiplostim is an appropriate starting dose for future clinical studies in patients with MDS and thrombocytopenia. If you experience any of these symptoms, call your doctor immediately: Romiplostim injection may cause changes in your bone marrow. Although not all of these side effects may occur, if they do occur they may need medical attention. NOTES: This medication must be used under close medical supervision so your blood counts can be monitored. Romiplostim is an investigational Fc-peptide fusion protein (peptibody) that has demonstrated the ability to increase platelet counts over prolonged periods in thrombocytopenic patients with chronic ITP. Most Disclaimer, National Library of Medicine tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. It is usually injected once a week. The presence of other medical problems may affect the use of this medicine. The following side effects are common (occurring in greater than 30%) for patients taking romiplostim: Headache fatigue Coughing up blood These side effects are less common side effects (occurring in about 10-29%) of patients receiving romiplostim: Joint pain (arthralgia) Dizziness Insomnia Muscle pain (myalgia) Pain in extremity Abdominal pain Nplate (romiplostim) Product Information Page 3 of 40 Nplate Product Information Method of administration For subcutaneous use. This will continue until your healthcare provider decides that your dose of Nplate can stay the same. Use the lowest dose of Romiplostim to achieve and maintain a platelet count 50 x 10 9 /L as necessary to reduce the risk for bleeding. (One . Romiplostim injection is used to treat low blood platelet counts (thrombocytopenia) and help prevent bleeding in patients with a blood disorder called immune thrombocytopenia (ITP). This site needs JavaScript to work properly. Some romiplostim side effects are more common than others. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Background/rationale: MeSH Epub 2014 Jan 12. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents. 2022 Apr;13(3):337-340. doi: 10.6004/jadpro.2022.13.3.32. Individual plans may vary Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. romiplostim 0.5 MG Injection: SCD - Semantic Clinical Drug Ingredient + Strength + Dose Form: Concept ID (RxCUI): 1728097: romiplostim 500 MCG Injection: SY - Synonym Synonym of another TTY, given for clarity. Bone marrow problems (eg, myelodysplastic syndrome or MDS)Use with caution. It is usually injected once a week. Romiplostim injection does not work for everybody. Le but de cette tude est d'valuer l'innocuit et l'efficacit du dosage long terme de l'AMG 531 chez des sujets japonais thrombocytopniques . Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. This was a retrospective, single-center, cohort study including hospitalized adults with corticosteroid- and intravenous immunoglobulin-refractory immune thrombocytopenia. commonly, these are "non-preferred" brand drugs or specialty ICH GCP. official website and that any information you provide is encrypted Appropriate studies on the relationship of age to the effects of romiplostim injection have not been performed in newborns with acute radiation syndrome. This drug is available at a higher level co-pay. The initial dose is 1 mcg/ kg, and the maximum dose is 10 mcg/kg. It will not be stored at home. Epub 2015 Sep 4. Symptoms of overdose may include: signs of blood clots to the leg/lung/heart/brain such as pain/swelling/warmth in the groin/calf, sudden shortness of breath, coughing up blood, sudden dizziness/fainting, chest/jaw/left arm pain, trouble speaking, weakness on one side of the body, vision problems/changes. https://www.mayoclinic.org/drugs-supplements/romiplostim-subcutaneous-route/proper-use/drg-20072281, Advertising and sponsorship opportunities. ICH GCP. dizziness from alcohol and Romiplostim. This medicine is used to treat low platelets caused by chronic idiopathic thrombocytopenic purpura (ITP) or a bone marrow syndrome caused by radiation sickness. Be sure to keep all medical/lab appointments.Your risk of bleeding may increase when you stop using romiplostim. You may report side effects to the FDA at 1-800-FDA-1088. To view formulary information first create a list of plans. Your doctor will order blood tests (platelet counts) to find the right dose for you. Publication types Clinical Trial, Phase II Copyright(c) 2022 First Databank, Inc. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. You may report side effects to FDA at 1-800-FDA-1088. A: Generally acceptable. continue to avoid activities that may cause injury and bleeding during your treatment with romiplostim injection. While it may be prescribed for children as young as newborns for selected conditions, precautions do apply. Your doctor will probably start you on a low dose of romiplostim injection and adjust your dose, not more than once every week. - If needed, unopened 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. Tarantino MD, Bussel JB, Blanchette VS, Beam D, Roy J, Despotovic J, Raj A, Carpenter N, Mehta B, Eisen M. Haematologica. Romiplostim works by stimulating the bone marrow to produce more platelets. Keep all medical/lab test appointments. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. Always ask your health care professional for complete information about this product and your specific health needs. Access your plan list on any device mobile or desktop. All rights reserved. Romiplostim injection comes as a powder to be mixed with liquid to be injected subcutaneously (under the skin) by a doctor or nurse in a medical office. Along with its needed effects, a medicine may cause some unwanted effects. Romiplostim is a thrombopoietin receptor agonist recommended as a second-line therapy for immune thrombocytopenia. All content, product and service are for informational purpose only. Accessibility Laboratory and/or medical tests (such as blood and platelet counts) should be performed before you start treatment, weekly when first starting, and then monthly to monitor your progress or check for side effects. Romiplostim is in a class of medications called thrombopoietin receptor agonists. The prescribed Nplate dose may consist of a very small volume (e.g., 0.15 mL). 125mcg 250mcg 500mcg. ROMIPLOSTIM (roe mi PLOE stim) helps your body make more platelets. A single copy of these materials may be reprinted for noncommercial personal use only. See Privacy Policy for more information. vial. The prescribed Romiplostim dose may consist of a very small volume (eg, 0.15 mL). Typical dosing for Nplate (romiplostim) This medication must be given by a healthcare provider. 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 . restrictions. Estudo de segurana e eficcia do romiplostim para tratar trombocitopenia imune (PTI) em pacientes peditricos Um estudo de fase 3, randomizado, duplo-cego, controlado por placebo para determinar a segurana e eficcia do romiplostim em peditricos trombocitopnicos com trombocitopenia imune (ITP) Intact Vials. Fusion antibody-peptide that is a thrombopoietin receptor agonist; stimulates proliferation, differentiation, and activity of monocytes, neutrophils, eoxinophils, and macrophages, Administer using syringe with 0.01 mL graduations, Round volume to nearest hundredth mL and verify dose, Discard any unused portion; do not pool unused portions from the vials; do not administer more than 1 dose from each vial. Platelets help clot the blood. The https:// ensures that you are connecting to the Romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) in order to decrease the risk of bleeding in people who have chronic idiopathic thrombocytopenic purpura (chronic ITP; an ongoing condition that may cause easy bruising or bleeding due to an abnormally low number of platelets in the blood). Romiplostim is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood. Nplate is given as an injection under the skin (subcutaneous) one time each week by your healthcare provider. Be extra careful to avoid injuries. They need to know if you have any of these conditions: This medicine is injected under the skin. This is a decision you and your doctor will make. romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) in order to decrease the risk of bleeding in adults who have immune thrombocytopenia (itp; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding due to an abnormally low number of platelets in the USES: 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. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Canada residents can call a provincial poison control center. Romiplostim injection may cause other side effects. It is also important information to carry with you in case of emergencies. Liver disease (including cirrhosis), chronicUse with caution. These side effects may go away during treatment as your body adjusts to the medicine. Coming to a Cleveland Clinic location?Visitation, mask requirements and COVID-19 information. Administer Nplate as a once-weekly subcutaneous injection with dose adjustments based upon the platelet count response. Your doctor will monitor your platelet level carefully during your treatment with romiplostim injection. Romiplostim - Get up-to-date information on Romiplostim side effects, uses, dosage, overdose, pregnancy, alcohol and more. Children and Adolescents: SubQ: Initial: 1 mcg/kg/dose once weekly; adjust dose by 1 mcg/kg/week increments to achieve platelet count 50,000/mm 3 and to reduce the risk of bleeding; maximum dose: 10 mcg/kg/week Dosage adjustment recommendations: Adjust dose based on platelet count response: romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) in order to decrease the risk of bleeding in adults who have immune thrombocytopenia (itp; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding due to an abnormally low number of platelets in the Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. PMC This medicine is to be given only by or under the direct supervision of your doctor. A review of electronic medical records and descriptive statistics generated findings. Portal vein thrombosis (a blood clotting problem in the liver) may occur in patients receiving this medicine, usually in those who have low platelet counts caused by chronic liver disease (eg, cirrhosis). 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. Before Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. Also tell them if you smoke, drink alcohol, or use illegal drugs. It is important not to miss your dose. It is given as a shot under your skin once a week for patients with ITP or once for every exposure to high levels of radiation. eCollection 2019. if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving romiplostim injection. Tell your doctor right away if you develop any bleeding/bruising.When used for an extended period, this medication may not work as well and may require different dosing. You are being redirected to eCollection 2018. Long-term treatment with romiplostim and treatment-free platelet responses in children with chronic immune thrombocytopenia. Romiplostim is for use in adults and children who are at least 1 year old. This information is not individual medical advice and does not substitute for the advice of your health care professional. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Deciphering predictive factors for choice of thrombopoietin receptor agonist, treatment free responses, and thrombotic events in immune thrombocytopenia. Compare formulary status to other drugs in the same class. Objective: Call your health care provider if you are unable to keep an appointment. 2020 Apr 28;11:2040620720912992. doi: 10.1177/2040620720912992. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, or stomach, chest pain, trouble breathing, loss of sensation, confusion, or problems with muscle control or speech. Efficacy and safety of the thrombopoietin receptor agonist romiplostim in patients aged 65 years with immune thrombocytopenia. Romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) in order to decrease the risk of bleeding in people who have chronic idiopathic thrombocytopenic purpura (chronic ITP; an ongoing condition that may cause easy bruising or bleeding due to an abnormally low number of platelets in the blood). The median hospital length of stay was shorter in Cohort 2 (13.5 vs. 20 days). Please confirm that you would like to log out of Medscape. In children, fever, mouth/throat pain, diarrhea, easy bruising, or swelling hands/ankles/feet may also occur. Patients who have a stable platelet count 50 x 109/L for at least 4 weeks without dose adjustment may, at the discretion of the supervising experienced healthcare provider, self- Romiplostim decreases your risk of bleeding by increasing the number of platelets. Table 1.Current radiation countering medicinals within space vehicle's emergency medical kit # If your platelet level is too high, your doctor may decrease your dose or may not give you the medication at all. NOTE: This sheet is a summary. The lowest GoodRx price for the most common version of Nplate is around $17,519.92, 37% off the average retail price of $27,972.76. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. Blood tests will be needed to check for unwanted effects. The primary objective of this study was to compare the time to platelet 10 109/L between patients who received an initial romiplostim dose of 2 mcg/kg/week compared to the standard initial dose of 1 mcg/kg/week. Our study suggests that higher initial romiplostim doses may be safe for hospitalized patients with treatment-refractory immune thrombocytopenia. Michel M, Wasser J, Godeau B, Aledort L, Cooper N, Tomiyama Y, Khellaf M, Wang X. Ann Hematol. The 4 T's of ITP: Tailoring Therapies to Treat Thrombocytopenia. If you receive this medicine and you have a bone marrow problem called myelodysplastic syndromes (MDS), it may worsen and become an acute leukemia (white blood cell cancer).Talk to your doctor if you have concerns about this. An initial dose of 1 mcg/kg/week subcutaneously with weekly 1 mcg/kg dose escalation is recommended per package labeling. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. It may harm an unborn baby. Your doctor may increase your dose if your platelet level is too low. If you have any questions, consult your doctor or pharmacist.This medication is injected under the skin by a health care professional, usually once a week.Dosage is based on your medical condition, weight, and response to treatment. Stay away from rough sports or other situations where you could be bruised, cut, or injured. sharing sensitive information, make sure youre on a federal - Store in original carton until use. The weekly dose is adjusted in increments of until the platelet count is 50 10 9 /L or Conclusion: For injection: 250 mcg or 500 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder in single-dose vials. Do not exceed maximum weekly dose of 10 mcg/kg. the convention on the rights of the child; yarp direct forwarding; primary key not found entity framework core More patients in Cohort 2 achieved a platelet 30 109/L (42.9% vs. 25%) and platelet 50 109/L (28.6% vs. 25%). However, safety and efficacy have not been established in children younger than 1 year of age with ITP. It may not cover all possible information. Romiplostim is given by subcutaneous injection. It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Use the lowest dose of romiplostim 250 MCG Injection to achieve and maintain a platelet count greater than or equal to 50 x 10^9/L as necessary to reduce the risk for bleeding. J Adv Pract Oncol. Call your doctor or pharmacist for instructions. Most All rights reserved. For your first injection, the usual dose of Nplate for adults is 1 mcg of drug per kilogram (kg) of body weight. and formulary information changes. This may increase the risk that you will develop a blood clot, which may spread to the lungs, or cause a heart attack or a stroke. 2014 May;22(5):1217-22. doi: 10.1007/s00520-013-2074-2. The prescribed Nplate dose may consist of a very small volume (eg, 0.15 mL). Most A dose-ranging study gave romiplostim to 24 patients with previously treated immune thrombocytopenic purpura. Bethesda, MD 20894, Web Policies Epub 2022 May 23. Klinikai vizsglatok nyilvntartsa. Romiplostim injection should only be used in adults and children 1 year of age or older who cannot be treated or have not been helped by other treatments, including other medications or surgery to remove the spleen. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). The goal of treatment is to maintain the count above 50,000 per cubic millimeter (mm . The role of romiplostim for pediatric patients with immune thrombocytopenia. Compared to Food and Drug Administration-approved dosing, higher initial doses may shorten time to platelet responses and hospital length of stay. This drug is available at a middle level co-pay. Ther Adv Hematol. May make these conditions worse. During treatment for ITP, your healthcare provider will closely monitor your romiplostim dose and platelet counts. lowest dose of Nplate to achieve and maintain a platelet count 50 x 10. Initial dose: 1 mcg/kg subcutaneous injection once a week based on actual body weight; adjust the weekly dose by increments of 1 mcg/kg until the patients achieves a platelet count of 50 x 10 (9)/L or greater Maintenance dose: Use the lowest dose to achieve and maintain a platelet count of 50 x 10 (9)/L or greater as needed to reduce bleeding risk. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvbnBsYXRlLXJvbWlwbG9zdGltLTM0MjE3Nw==, View explanations for tiers and Alcohol or marijuana (cannabis) can make you more dizzy. Do not stop receiving this medicine without checking first with your doctor. It is usually injected once a week. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of romiplostim injection in children 1 year of age and older with ITP for at least 6 months. Myelosuppression is a bone marrow problem that can lead to a decrease in blood cell counts. Concept ID (RxCUI): 1728099: Nplate 500 MCG Injection: PSN - Prescribable Name Your doctor will probably start you on a low dose of romiplostim injection and adjust your dose, not more than once every week. 9 /L as necessary to reduce the risk for bleeding. Most ding. Platelets ( platelets ) are the cells in the blood that help to close wounds and form blood clots. The .gov means its official. Romiplostim is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood. Some people may also experience more euphoria, depression, irritability or all three. Immune Thrombocytopenia (ITP) Treatment | Nplate (romiplostim) 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. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Drgwhy. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving romiplostim injection. Romiplostim injection may cause side effects. The initial dose of romiplostim (Nplate) is 1 mcg/kg with future dose adjustments based on changes in platelet counts only. By clicking send, you acknowledge that you have permission to email the recipient with this information. US residents can call their local poison control center at 1-800-222-1222. Drugs. Romiplostim injection is given to decrease the risk that you will experience severe bleeding, but there is still a risk that bleeding may occur. Thrombocytopenia caused by myelodysplastic syndrome (MDS) or conditions other than ITPShould not be used in patients with this condition. Some items may interact with your medicine. Indications and dose Chronic immune (idiopathic) thrombocytopenic purpura in patients refractory to other treatments (such as corticosteroids or immunoglobulins) (under expert supervision) FOIA Romiplostim injection comes as a powder to be mixed with liquid to be injected subcutaneously (under the skin) by a doctor or nurse in a medical office. Read More Nplate (romiplostim) dosage forms. Calculated Patient Dose (mcg) = Weight (kg) x Prescribed dose (mcg/kg) Reconstitution And Dilution Of Nplate Single-Dose Vials Reconstitute Nplate with Sterile Water for Injection, USP. prescription products. ICH GCP. Romiplostim injection is also used to treat acute radiation syndrome in patients who have been exposed to high levels (myelosuppressive doses) of radiation. Your condition will be monitored carefully while you are receiving this medicine. Manage and view all your plans together even plans in different states. If you notice any other effects, check with your healthcare professional. How To Use Many people using this medication do not have serious side effects.This medication may rarely cause serious problems from blood clots to the heart, brain or lung (such as pulmonary embolism, stroke, heart attack), especially if your platelet counts are too high. Patients were stratified by their initial romiplostim dose into Cohort 1 (1 mcg/kg/week) and Cohort 2 (2 mcg/kg/week).
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