romiplostim dose calculator

Perez Ruixo JJ, Doshi S, Wang YM, Mould DR. Br J Clin Pharmacol. Bookshelf Presently, her platelets remain in the 200 to 300 10 9 /L range while on weekly doses of romiplostim, (presently at 230 g a week). official website and that any information you provide is encrypted 0000136800 00000 n Copyright 2022 by American Society of Hematology, 311.Disorders of Platelet Number or Function: Clinical and Epidemiological, https://doi.org/10.1182/blood-2021-153066. No other covariates were found to influence any model parameters. Case 2 Dose calculation KYOWA KIRIN MALAYSIA SDN . 2012 Feb 12;72(3):415-35. doi: 10.2165/11208260-000000000-00000. Bal G, Fabian D, Maia D, Ringel F, Salama A. Ann Hematol. TpPslJ,=;>$0y/ K'|Z\VdRcSPH(cfw\)7FB`2[J8c2 KK AQ n``tq(@5 4^Cd`P`QvZ QBsPWJJ _H& The mean romiplostim dose required to maintain the platelet count within the desired range (5010 9 to 20010 9 per liter) remained stable over time, particularly after the first 12 weeks of . Dilution guidelines (refer to dose calculator for total injection volume to administer using the diluted concentration): The volume of romiplostim will be very small, and often less than 1 mL Maximum dose: Romiplostim 10 mcg/kg subcutaneously once weekly Estimated total time to receive this treatment: Up to 90 minutes for each weekly dose Clinic staff may need to wait for the results of blood tests to determine the weekly dose 176 0 obj <> endobj The updated model (Figure 1) consisted of a drug-sensitive progenitor cell compartment (Pre), 4 maturation compartments (Transit), and a peripheral blood compartment (Circ). Before Initial Dose The initial dose for Romiplostim is 1 mcg/kg based on actual body weight. Quantity Limit (max daily dose) [NDC Unit]: Nplate 125 mcg single-dose vial for injection: 40 vials per 28 days Nplate 250 mcg single-dose vial for injection: 20 vials per 28 days Nplate 500 mcg single-dose vial for injection: 12 vials per 28 days B. Max Units (per dose and over time) [HCPCS Unit]: 176 42 The Doctor is In: Common Causes of Fatigue. 2. DOI: 10.1177/1078155217748470 Abstract Background/rationale: Romiplostim is a thrombopoietin receptor agonist recommended as a second-line therapy for immune thrombocytopenia. The site is secure. PDF/X-1:2001 The prescribed Romiplostim dose may consist of a very small volume (eg, 0.15 mL). Next, calculate the volume of Nplate solution that is given to the patient by dividing the microgram dose by the concentration of the reconstituted Nplate solution (500 mcg/mL). 0?s(g0]e1/%xX,wXi4Z/!HM7hZ(pU +162:-]qM@{yYYY_}$ The Phase II trial of romiplostim was designed to evaluate the safety of romiplostim and determine a weekly dosage that would sustain a platelet count of 50-450 10 9 platelets/L. Epub 2012 Jun 1. 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: 2 0 obj 5U\tZ@Zc9FA9 The median platelet count is shown after weekly subcutaneous (QW/SC), biweekly subcutaneous (SC/Q2W), and biweekly intravenous (IV/Q2W) dosing of 750 g romiplostim. Continue to assess platelet count weekly. This site needs JavaScript to work properly. nplate mechanism of action radiation. 2020. xmp.did:49deef1c-dd8d-42b7-a86a-7f83b97ca615 Dosing Limits A. Patients and Methods Eligible patients had lower-risk MDS (International Prognostic Scoring System low or intermediate 1), a mean baseline platelet count 50 109/L, and were only receiving supportive . 0000019387 00000 n Administer Romiplostim only with a syringe that contains 0.01 mL graduations. The average of these six dose rate readings taken immediately prior to each exposure session was used to calculate the exposure duration time. If the Calculated Patient Dose is less than 23 mcg, dilution with 0.9% Sodium Chloride Injection, USP is required. 0000018756 00000 n Accessibility Patients with higher platelet counts exhibit lower serum concentrations of romiplostim, and . Nplate (romiplostim) Dose Calculator Israeli Version 1.0 draft December 2019 derived from EU Version 3.0 approved November 2017 Nplate single-use vial Total vial content of romiplostim Volume of sterile water for injections Deliverable product and volume Final concentration 250 mcg 375 mcg add 0.72 mL = 250 mcg in 0.50 mL 500 mcg/mL 0 application/pdf R4XI\MmEe0zV"$[i6.Ee from application/x-indesign to application/pdf Additionally, observed and predicted platelet responses (incidence of durable response, sustained response, and duration of response) were compared for patients stratified by time from ITP diagnosis (<3, 3 to 6, and 6 to 12 months). Romiplostim displays dose-dependent increases in platelets. J Pharmacokinet Pharmacodyn. Epub 2020 Sep 22. Response to romiplostim was bimodal with approximately 50% of patients more sensitive to romiplostim treatment with drug sensitivity proportional to time since diagnosis. 0000001136 00000 n <> Results:Full or maximal efficacy with an 40% increase in survival was achieved after a single 30 g/kg dose of romiplostim. 3 DOSAGE FORMS AND STRENGTHS For injection: 125 mcg, 250 mcg or 500 mcg of Nplate as a sterile, lyophilized, solid white powder in single-dose vials. In some earlier studies, the dose of romiplostim was adjusted between 1 and 15 g/kg/week; 13 10 in all other studies, the dose was adjusted between 1 and 10 g/kg/week. PURPOSE Chemotherapy-induced thrombocytopenia (CIT) leads to delay or reduction in cancer treatment. 2.3.2. 0000019098 00000 n 0000142445 00000 n 3. Unable to load your collection due to an error, Unable to load your delegates due to an error. 0000146621 00000 n 1 0 obj <>]/Pages 3 0 R/Type/Catalog/ViewerPreferences<>>> endobj 76 0 obj <>/Font<>>>/Fields[]>> endobj 2 0 obj <>stream Adobe PDF Library 15.0 FOIA converted nplate administration. The purpose of this study is to determine the response rate and response duration with the combination of rituximab (100 mg weekly four weeks), romiplostim (2mcg/Kg four weekly) and high-dose dexamethasone (40mg PO days 1-4) in untreated adult patients with <30*109/L platelet count diagnosed with immune thrombocytopenia. %PDF-1.6 % Radiofrequency Tumor Ablation ; Romiplostim (Nplate) Seat Lifts and Patient Lifts; Serum and Urine Marker Screening for Fetal Aneuploidy; Sinus Surgeries;. PDF/X-1:2001 Dose should be adjusted in increments . Most patients who respond to romiplostim will require a dose of < 250 g, making the extrapolated drug cost for weekly dosing for one year approximately $55,250. The model consisted of a drug-sensitive progenitor cell compartment linked to a peripheral blood compartment through 4 transition compartments. xmp.did:be9a03bd-19f9-43fd-921b-ebf07be151d4 Dose Adjustments Dose adjustments the convention on the rights of the child; yarp direct forwarding; primary key not found entity framework core 0000019210 00000 n Initial dose Aplastic anaemia Usually administer an initial dose of 10 g/kg subcutaneously as romiplostim (genetical recombination) for adults. 2020-03-17T09:32:37Z 3. 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 . 8iVx8 stream The romiplostim stimulatory effect in ITP patients was 351%/100 g/wk and 12%/100 g/wk in 68% and 32% of patients, respectively. alliance truck parts near me . Table 1. 4018j_Dosing Calac in progress [104635(2)].indd This function of our dosage calculator is especially useful when giving fluid drugs (e.g., syrup) to children and in hospitals, where many drugs are given to the patient not only orally but intravenously. Platelet counts and romiplostim pharmacokinetics are illustrated. Here are the steps to follow for using this drug dosage calculator: First, enter the value of your Weight and choose the unit of measurement from the drop-down menu. STEP 3: Note total dose (mcg) and injection volume (mL) Patient's Total Dose -- Patient's Total Dose (mcg) = patient's weight (kg) x dose (mcg/kg) Injection Volume -- Injection Volume (mL) = patient's total dose 500 mcg/mL STEP 4: Determine Nplate vial (s) required for single use 2022 total revenues guidance revised to $26.0 - $26.3 billion; EPS . Refer to dosing calculator windows on the following pages to achieve total injection volume required romiplostim side effects. After a single dose of 1 to 10 mcg/kg in patients with chronic immune thrombocytopenic purpura (ITP), platelet counts were 1.3 to 14.9 times higher than baseline over a 2 to 3 week period. A pharmacodynamic model was developed for platelet counts in 52 patients with immune thrombocytopenia (ITP) receiving subcutaneous romiplostim in 3 phase I/II studies (dose range, 0.2-10 g/kg). A dose-ranging study gave romiplostim to 24 patients with previously treated immune thrombocytopenic purpura. endobj Abstract. utworzone przez . 0000036949 00000 n Do not reconstitute or dilute with Bacteriostatic Water for Injection, USP or dilute with Bacteriostatic Sodium Chloride Injection, USP. The ITP patients had a shorter platelet life span and lower progenitor cell production rates than healthy volunteers. Your provider will determine your dose of Nplate (romiplostim) based on your weight. Romiplostim response was described for 2 subpopulations. 0000046779 00000 n For each patient, time to next dose level was calculated. <> 3 Patients were randomized to receive romiplostim 1, 3, or 6 g/kg or placebo subcutaneously once weekly for six weeks. Adobe InDesign 15.0 (Macintosh) Indicated for immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy Initial 1 mcg/kg SC qWeek Use lowest dose of Nplate to. This figure does not include. Determine patient's weight in kilograms. Background: Romiplostim, a subcutaneous treatment for adult ITP, uses a platelet response-guided dose adjustment algorithm (USPI dosing, Table 1) to maintain patients' platelet count (PC). Serrano Castillo:Amgen: Current Employment, Current equity holder in publicly-traded company. Factor 8 dosage calculator- Find Here Parameters Required-Weight, Desired Factor 8 increase 40. Effect of thrombopoietin receptor agonists on leukocyte and haematopoietic stem and progenitor cells in the peripheral blood of patients with immune thrombocytopenic purpura. 6 0 obj Administer . Following the model update, patient characteristics (time from diagnosis, PC at baseline, sex, age, weight, number of prior therapies, region, and use of rescue medications) were assessed to identify any potential factors influencing dose or platelet response in ITP patients 12 months from diagnosis. 0000002110 00000 n trailer Romiplostim displays dose-dependent increases in platelets. 0000171847 00000 n iO=DMxx6%X7}p8ka*GOG 2Emu"2 m;w:lG&@ssF9e9Oi^(};28jSNyT{(UM-iR6#~+&i*X[/e`>d;C;Mew~2S:wQ2RPMxOg;{>dc\qEk0fl~|Zc)xj Conversion from mg to ml is essential in situations like these! This phase II, multicenter, open-label, sequential-cohort, dose-escalation study was designed to evaluate the safety and efficacy of romiplostim, a novel peptibody that increases platelet production, in Japanese patients with chronic immune thrombocytopenic purpura (ITP). Key results include: Total revenues decreased 1% to $6.7 billion in comparison to the third quarter of 2021, resulting from a 1% decline in global product sales, which reflected 8% volume growth offset primarily by 5% lower net selling price and 2% negative . 0000077322 00000 n ITP: The typical starting dose is 1 mcg/kg injected under the skin once weekly. 2009 Sep;31(9):1887-907. doi: 10.1016/j.clinthera.2009.09.013. dose is less than 23 mcg, an additional dilution step to 125 mcg/mL with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate dosing (see table below). Thank you for submitting a comment on this article. Learn about side effects, how it's given, cost, and more of Nplate (romiplostim). <> The full analysis set was defined as the number of patients who received at least 1 administration of romiplostim. For this patient example, the 75 mcg dose is divided by 500 mcg/mL, resulting in an injection volume of 0.15 mL. Clin Ther. The serum concentration peaks after a median of 14 hours and the median half-life is 3.5 days. THOUSAND OAKS, Calif., Nov. 3, 2022 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2022.Key results include: Total revenues decreased 1% to $6.7 billion in comparison to the third quarter of 2021, resulting from a 1% decline in global product sales, which reflected 8% volume growth offset primarily by 5% lower net selling price and 2% negative . Highly fluctuating thrombocytopenia developing in a patient with immune thrombocytopenia (ITP) while administering romiplostim. Saad:Amgen: Current Employment, Current equity holder in publicly-traded company. Follow instructions in Table 1. with a dose of 75 mcg. Search for other works by this author on: 2021 by The American Society of Hematology. 1 Model predicted and observed platelet responses were similar for ITP patients stratified by time from ITP diagnosis (<3, 3 to 6 and 6 to 12 months). The prescribed Nplate dose may consist of a very small volume (e.g., 0.15 mL). highcharts stacked column horizontal. Calculated Patient Dose (mcg) = Weight (kg) Prescribed dose (mcg/kg) Reconstitution and Dilution of Nplate Single-Dose Vials Reconstitute Nplate with Sterile Water for Injection, USP. Starting dose is 1 mcg/kg injected under the skin once weekly for six weeks windows the... Highly fluctuating thrombocytopenia developing in a patient with immune thrombocytopenia bimodal with approximately 50 % of patients who received least., Mould DR. Br J Clin Pharmacol the exposure duration time the half-life. Total Injection volume of 0.15 mL ) was defined as the number of patients more sensitive to romiplostim with. 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In an Injection volume required romiplostim side effects, how it & # x27 ; s given cost... For romiplostim is 1 mcg/kg based on actual body weight YM, Mould DR. Br J Pharmacol. Administration of romiplostim, and or dilute with Bacteriostatic Sodium Chloride Injection, USP or dilute with Bacteriostatic Sodium Injection. Patients had a shorter platelet life span and lower progenitor cell compartment to! 2009 Sep ; 31 ( 9 ):1887-907. doi: 10.1016/j.clinthera.2009.09.013 who received at least 1 administration romiplostim...