use of romiplostim was recently approved in pediatric patients in the united states and the european union, and use in adults has been extended to include those with newly diagnosed itp. Talk with your doctor if you have concerns about this risk. To submit feedback about this web page, please enter your comments, suggestions, compliments or questions in the form below. Prescription Hope can obtain Nplate for individuals at the set price of $50.00 per month. (2.1), Do not shake during reconstitution; protect reconstituted Romiplostim from light; administer reconstituted Romiplostim within 24 hours. This medicine is used to treat low platelets caused by chronic idiopathic thrombocytopenic purpura (ITP) or a bone marrow syndrome caused by radiation sickness. During the 58-week study period, progression to AML occurred in 10 (6.0%) subjects in the Romiplostim arm and 4 (4.8%) subjects in the placebo arm (hazard ratio [95%CI] = 1.20 [0.38, 3.84]). Romiplostim injection is used to treat low blood platelet counts (thrombocytopenia) and. Nplate (romiplostim) is injected under the skin weekly mainly to treat low platelet counts in people whose immune system attacks their platelets. Keep all medical/lab test appointments. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. upper respiratory tract infection. This may affect your liver function. Your healthcare provider will check your platelet count every week and change your dose of Romiplostim as needed. It's used to increase platelets in people with IPT. (3) NPLATE If you become pregnant while receiving romiplostim injection, call your doctor. Do not pool unused portions from the vials. Romiplostim may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. Romiplostim Injection. Study 1 and 2 outcomes are shown in Table 3. Patients received single weekly SC injections of Romiplostim, with individual dose adjustments to maintain platelet counts (50 x 109/L to 200 x 109/L). You can call 8-1-1 (or 7-1-1 for the deaf and the hard of hearing) to talk to a pharmacist about your medication questions. Ask your doctor or pharmacist if you are unsure. You will need frequent blood tests. DO NOT SHAKE reconstituted solution. Romiplostim(Nplate) generic is a thrombopoietin (TPO) mimetic protein, prescribed for low platelets (thrombocytopenia). 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. As the injection volume may be very small, use a syringe with graduations to 0.01 mL. Physical activity related questions will be answered by one of HealthLink BCs qualified exercise professionals. Next, calculate the volume of Romiplostim solution that is given to the patient by dividing the microgram dose by the concentration of the reconstituted Romiplostim solution (500 mcg/mL). Talk to your doctor about the risks of receiving romiplostim injection. Romiplostim is in a class of medications called thrombopoietin receptor agonists. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. The incidence of new binding antibody development was 3% (5/186) to Romiplostim and 1% (2/186) to TPO. Your doctor will discuss this with you. Always ask your health care professional for complete information about this product and your specific health needs. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Romiplostim [see Warnings and Precautions ( 5.4 )]. (5.2), If severe thrombocytopenia develops during Romiplostim treatment, assess patients for the formation of neutralizing antibodies. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Overdoses due to medication errors have been reported in patients receiving Romiplostim. Patients who lacked response or lost response to Romiplostim or a non-US approved romiplostim product were enrolled. Always use this medicine exactly as your doctor has told you. FDA pregnancy category C. It is not known whether romiplostim 500 MCG Injection will harm an unborn baby. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. If you would like more information, talk with your healthcare provider. Consent is required to receive a reply. Talk to your doctor, pharmacist, or nurse before using Nplate. In Canada - Call your doctor for medical advice about side effects. Romiplostim works by causing the cells in the bone marrow to produce more platelets. In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. Background: Romiplostim is a peptibody protein that augments thrombopoiesis by activating the thrombopoietin receptor. See What are the possible side effects of Romiplostim? for other side effects of Romiplostim. . I was told that I had an allergic reaction to penicillin when I was a child. Please take note of such effect most especially when taking Primosa capsule. The information was verified by Dr. Vishal Pawar, MD Pharmacology, Contact|Privacy Policy You should consult a doctor about the dosage before using this medicine! Romiplostim is not a cure for ITP and it will not make your platelet. Even with Romiplostim therapy, patients should continue to avoid situations or medications that may increase the risk for bleeding. Do not use this medicine after the expiry date which is stated on the vial label after EXP. Prolonged use of Nplate can cause changes in thebone marrow. To obtain prescription medications, Prescription Hope works directly with . Your doctor will probably start you on a low dose of romiplostim injection and adjust your dose, not more than once every week. Your condition can cause complications in a medical emergency. No apparent correlation was observed between antibody activity and clinical effectiveness or safety. Of the patients with positive binding antibodies that developed to Romiplostim or to TPO, five patients had neutralizing activity to Romiplostim and none had neutralizing activity to TPO. 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It works by causing the cells in the bone marrow to produce more platelets. "NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]". For questions about food and nutrition, please click onEmail a HealthLinkBC Dietitian. Romiplostim is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. No further bone marrow evaluations were available. The doctor will set the Nplatedoseso that the platelet count does not become too high. 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 VRS, visit Video Relay Services to sign up and give them the number 604-215-5101 to call us. For injection: 250 mcg or 500 mcg of deliverable Romiplostim as a sterile, lyophilized, solid white powder in single-dose vials. It may harm an unborn baby. Canada residents can call a provincial poison control center. The safety and efficacy of Romiplostim were assessed in two double-blind, placebo-controlled clinical studies and in an open-label extension study. It is usually injected once a week. Use a syringe with graduations to 0.01 mL. It works by causing the cells in the bone marrow to produce more platelets. Therefore, if your doctor suspects that you have been given too little Nplate, it is recommended that you be monitored for signs or symptoms ofside effectsand that you receive appropriate treatment immediately. Detection of peripheral blood cell abnormalities may necessitate a bone marrow examination. 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. Tell your doctor if your condition (bleeding/bruising) persists or worsens. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). Allopathic Romiplostim 250 mcg, For Clinical, Packaging Size: One Injection Per Box. Your wellbeing is how you manage the ups and downs of day-to-day life. The patients had been diagnosed with ITP for approximately 8 years and had received a median of six prior ITP treatments. If you experience any of these symptoms, call your doctor immediately: swelling, pain, tenderness, warmth or redness in one leg, pain in the chest, arms, back, neck, jaw, or stomach. In a single-arm trial of Romiplostim given to 72 subjects with thrombocytopenia-related MDS, 8 (11.1%) subjects were reported as having possible disease progression, of which 3 (4.2%) had confirmation of AML during follow-up. 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. It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. Romiplostim is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP. Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS) 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. Consult your doctor before breast-feeding. Using romiplostim 500 MCG Injection long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. Revised: 4/2016. The samples from patients that tested positive for binding antibodies were further evaluated for neutralizing capacity using a cell-based bioassay. Content provided by: AHFS Patient Medication Information. Each single-dose 250 mcg vial of Romiplostim contains the following: 375 mcg Romiplostim, 30 mg mannitol, 15 mg sucrose, 1.2 mg L-histidine, 0.03 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0. 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 . Romiplostim is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Your doctor will decide if you should stop taking Nplate. Copyright, 2021. What other drugs will affect romiplostim 500 MCG Injection? The information was verified by Dr. Rachana Salvi, MD Pharmacology. Generally, dissolution of Romiplostim takes less than 2 minutes. The serum concentration peaks after a median of 14 hours and the median half-life is 3.5 days. The following serious adverse reactions are discussed in greater detail in other sections: The most common adverse reactions ( 5% higher patient incidence in Romiplostim versus placebo) are arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, and paresthesia. It is very important that you prepare Nplate correctly and that you take the correctdose(see section 7, Instructions forreconstitutionandinjectionof Nplate, at the end of this leaflet). Discard any unused portion. This information does not assure that this product is safe, effective, or appropriate for you. Your doctor will monitor your platelet level carefully during your treatment with romiplostim injection. 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. Verify that the syringe contains the correct dosage. (5.3). It is unknown if this drug passes into breast milk. Do not freeze. Know the medicines you take. Staff. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Romiplostim [ see Dosage and Administration ( 2.1 ) ]. Do not administer more than one dose from a vial. trouble sleeping; stomach pain, indigestion, nausea, vomiting, diarrhea; cough, wheezing, chest tightness, trouble breathing; stuffy nose, sneezing, sinus pain; or. Romiplostim injection may cause changes in your bone marrow. Your doctor will tell you how much you need to take. All Rights Reserved, Number of Weeks With Platelet Counts 50 x 10, Patients Who Had > 25% Dose Reduction in Concurrent Therapy, n (%), Patients Who Discontinued Baseline Therapy, n (%), Romiplostim is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP, Romiplostim should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding, Romiplostim should not be used in an attempt to normalize platelet counts. What side effects can this medication cause? Before receiving Romiplostim, tell your healthcare provider about all your medical conditions, including if you: Pregnancy Surveillance Program: Women who become pregnant during Romiplostim treatment are encouraged to enroll in Amgens Pregnancy Surveillance Program. (2.2), Discard any unused portion of the single-dose vial. * Total vial content includes overfill to ensure delivery of 250 mcg or 500 mcg. In general, dose adjustment for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Following Romiplostim discontinuation in Studies 1 and 2, seven patients maintained platelet counts of 50 x 109/L. Patients were administered romiplostim by SC injection once weekly for up to 3 years. In some cases, it always advisable to stop the intake of some medicines gradually because of the rebound effect of the medicine. The peptibody molecule has two identical single-chain subunits, each one is made up of 269 amino acid residues. Call your doctor for medical advice about side effects. General information about the safe and effective use of Romiplostim. Otherwise, call a poison control center right away. Reconstituted Romiplostim 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. As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein. Can You Take A Z-Pak If You Have A Penicillin Allergy. You may report side effects to Health Canada at 1-866-234-2345. Addictive Medicine is categorically called Controlled substances by the government. Romiplostim injection is used to increase the number of platelets enough to lower the risk of bleeding, but it is not used to increase the number of platelets to a normal level. 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