Learn 50 x 109/L, as necessary, to reduce the risk of bleeding.1 Do not exceed maximum weekly dose of 10 mcg/kg.1. Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. The prescribed Nplate dose may consist of a very small volume (e.g., 0.15 mL). Follow the dose adjustment guidelines [see Dosage and Administration (2.1)]. The safety of Nplate for the acute radiation syndrome setting was assessed based on the clinical experience in patients with ITP [see Adverse Reactions (6)] and from a study with healthy volunteers. This formation may improve upon discontinuation of Nplate. Thromb Haemost. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. Nplate if the platelet count does not increase to a level sufficient Of the patients with positive binding antibodies that developed to romiplostim or to TPO, four patients had neutralizing activity to romiplostim and none had neutralizing activity to TPO. 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. Results were consistent with those in pivotal phase 3 Actual body weight at initiation of treatment should always be used when calculating the initial dose. Loss of Response to Nplate Hyporesponsiveness or failure to maintain a platelet response with Nplate should prompt a search for causative factors, including neutralizing antibodies to Nplate . Nplate is used to treat adults and children with ITP. Reconstitute Nplate with Sterile Water for Injection, USP. 10 mcg/kg.1, Titrate Nplate according to individual Animals were administered a single subcutaneous dose of blinded treatment (control article [sterile saline] or Nplate [5mg/kg]) 24 hours post-irradiation. 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. Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, solid white lyophilized powder in single-dose vials of 125 mcg (NDC-55513-223-01), 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) of romiplostim. 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. investigator according to standard institutional practices or therapeutic Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Nplate dosing Usual Adult Dose for Idiopathic Thrombocytopenic Purpura: Initial dose: 1 mcg/kg subcutaneous injection based on actual body weight. Your patient's total dose is less than 23 mcg. Patients who had completed a prior Nplate study (including Study 1 and Study 2) were allowed to enroll in a long-term open-label extension study. Guide to each patient. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The percentage of patients with at least 2 prior ITP therapies (predominantly IVIG and corticosteroids) was 88% in the group treated with Nplate and 100% in the group treated with placebo. guidelines for dose adjustments. Study 2 evaluated patients who had undergone a splenectomy. dose. A similar response to romiplostim is expected in the pediatric and adult patients based on the mechanism of action of the drug and pharmacokinetics of romiplostim in pediatric patients 1 year and older with ITP [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. Prior ITP treatments included corticosteroids, immunoglobulins and anti-D immunoglobulins. Please see full Prescribing Information and Medication Guide. cyclosporine, tranexamic The starting dose for all ages was 1 mcg/kg weekly. Because of the uncertainty associated with extrapolating animal efficacy data to humans, the selection of a human dose for Nplate is aimed at providing platelet response to Nplate that is similar to that observed in efficacy studies conducted in animals. The patients were randomized 2:1 to treatment with Nplate or placebo (167 Nplate, 83 placebo). For some adults, taking Nplate may lead to treatment-free remission, meaning platelet counts stay above 50,000 for at least 6 months after stopping ITP treatment dosing instructions, including Due to the potential for serious adverse reactions in a breastfed child from Nplate, advise women not to breastfeed during treatment with Nplate. Administer Nplate regardless of whether a complete blood count (CBC) can be obtained. A durable platelet response was defined as achieving at least 6 weekly platelet counts 50 109/L during weeks 18 through 25 of treatment. Two percent (2/132) of patients (both from cohort 3) developed Grade 4 findings (presence of collagen). individual treatments received in the SOC arm.3, *The recommended starting dose for Nplate is 1 mcg/kg. Kuter DJ, Rummel M, Boccia R, et al. Study 5 results are shown in Table 6. Follow the dose adjustment guidelines, Musculoskeletal and Connective Tissue Disorders, Respiratory, Thoracic and Mediastinal Disorders, General Disorders and Administration Site Conditions, Injury, Poisoning and Procedural Complications, Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin, Overdoses due to medication errors have been reported in patients receiving Nplate. Following Nplate discontinuation in Studies 1 and 2, seven patients maintained platelet counts of 50 109/L. Nplate is given as an injection under the skin (subcutaneous) one time each week by your healthcare provider. ITP occurs when your body's immune system attacks and destroys platelets. Available for Android and iOS devices. approved for use in ITP.4. range from the first to the third quartiles. The recommended In clinical studies, treatment with Nplate resulted in dose-dependent increases in platelet counts. Store Nplate vials in the refrigerator at 2C to 8C (36F to 46F) in the original carton to protect from light. due to side effects or Actual body weight at initiation of treatment should always be used when calculating initial dose. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Follow the dose adjustment guidelines to achieve and maintain a platelet count of 50 x 109/L. These changes may improve if you stop taking Nplate. If platelet count is 50200 3, parallel, double-blind studies where patients with chronic immune Do not administer more than one dose from a vial. 352 0 obj <>stream Do not freeze. The safety analysis set includes all subjects who received at least one dose of romiplostim in study 7. The incidence of binding antibody post treatment was 16% (3/19) to romiplostim, of which 5.3% (1/19) were positive for neutralizing antibodies to romiplostim. A randomized, double-blind, placebo-controlled trial enrolling adult patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS was terminated due to more cases of AML observed in the Nplate arm. Thrombotic/thromboembolic complications may result from increases in platelet counts 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). 1 2 3. Actual body weight at initiation of treatment should always be used when calculating the initial dose. immunoglobulins approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical 50 Reconstitute with 0.72 mL Sterile Water Nplate was Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a . 2022 Amgen Inc. All rights reserved. For those patients receiving Nplate, 14 (48%) of headaches were mild, 9 (31%) were moderate, and 6 (21%) were severe. 2010;8(6):1372-1382. replace the physicians Rescue medications (i.e., corticosteroids, platelet transfusions, IVIG, azathioprine, anti-D immunoglobulin, and danazol) were permitted. Nplate Vial Nplate Vial - Uses, Side Effects, and More Generic Name: romiplostim This medication is used to treat a certain blood disorder (idiopathic thrombocytopenia purpura - ITP) in which. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. The platelet counts were above 50 10, Reduction/Discontinuation of Baseline Concurrent ITP Medical Therapy, Figure 1. For Subcutaneous Use Only 250 mcg/0.5 mL. There is no information regarding the presence of romiplostim in human milk, the effects on the breastfed child, or the effects on milk production. Initial dose 1. Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO. Guide to each patient. The incidence of binding antibodies to TPO at any time was 3.9% (11/282), of which 2 patients (0.7%) had pre-existing binding non-neutralizing antibodies to TPO at baseline and 1 patient (0.4%) had binding persistent antibody positivity at end of study. The carcinogenic potential of romiplostim has not been evaluated. 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. 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. Available TPO-RAs for use in children include eltrombopag and romiplostim. The recommended starting dose for Nplate is 1 mcg/kg. 9 /L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. Side Effects: Compare thrombopoiesis stimulating agents. Nplate therapy may increase the risk of reticulin fiber formation within the bone marrow. The initial dose for Nplate is 1 g/kg, based on actual body weight. Obtain complete blood counts (CBCs), including platelet counts, weekly during the dose adjustment phase of Nplate therapy and then monthly following establishment of a stable Nplate dose. Nplate by increments of 1 mcg/kg until the patient achieves a During the 58-week study period, progression to AML occurred in 10 (6.0%) patients in the Nplate arm and 4 (4.8%) patients in the placebo arm (hazard ratio [95%CI] = 1.20 [0.38, 3.84]). 1 TEPEZZA dosing is based on the patient's actual weight 1. count has stabilized and the doctor decides that the dose of Nplate can stay the same. ; 3 The individual patient dose does not have to be determined to use the dosage calculator. The majority of people reached a platelet count of at least 50,000 after 1 to 3 weekly doses REMISSION Nplate can help people with ITP achieve treatment-free remission, so they can stop treatment About 1 in 3 adults went into treatment-free remission with Nplate. The open-label long-term study also evaluated changes in bone marrow reticulin and collagen formation. Download now. Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody). 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). Based on cohort assignment at time of study enrollment, patients were evaluated for bone marrow reticulin and collagen at year 1 (cohort 1), year 2 (cohort 2), or year 3 (cohort 3) in comparison to the baseline bone marrow at start of the trial. Please see the Nplate full Prescribing Information for complete confidence in your choice1. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Pediatric patients: Base future dose adjustments on changes in platelet counts Adjust the dose as follows for pediatric patients: For Adult and Pediatric Patients (including term neonates). other The company that markets Nplate will provide doctors a 'dosing calculator' to help them calculate the sometimes very small volumes of Nplate that need to be injected. 239 0 obj <>stream Nplate significantly (one-sided p = 0.0002) increased 60-day survival in the irradiated animals: 72.5% survival (29/40) in the Nplate group compared to 32.5% survival (13/40) in the control group. The patients had been diagnosed with ITP for approximately 2 years and had received a median of three prior ITP treatments. Calculate Volume to Administer by dividing the Calculated Patient Dose (mcg) by the final concentration of prepared solution. captured as adverse events and were not a predefined Nplate Loss of Response to Nplate Hyporesponsiveness or failure to maintain a platelet response with Nplate the total number of reported events by the total Generic name: romiplostim Nplate. 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. Study 1 and 2 outcomes are shown in Table 5. dose. The amount of Nplate that you will receive depends on many factors, including your height and weight, and your general health or other health problems. Nplate is a prescription medicine also used to treat people including newborns who have been exposed to high levels of radiation (acute radiation syndrome). iOS. Twenty-four (32%) patients maintained every platelet count 50 x 109/L for at least 6 months in the absence of Nplate and any medication for ITP (concomitant or rescue); the median time to onset of maintaining every platelet count 50 x 109/L for at least 6 months was 27 weeks (range 6 to 57). Visually inspect the reconstituted solution for particulate matter and/or discoloration. Nplate should not be used in an attempt to normalize platelet counts. thrombocytopenia purpura: a double-blind randomised controlled trial. This website is intended for US healthcare professionals only. (21/157 Nplate is available in a box containing 1 vial of: 250 mcg / 0.5 mL presentation: 375 mcg romiplostim; the extractable dose per vial is 250 mcg in 0.5 mL. Similar to adults with ITP, romiplostim pharmacokinetics are highly variable in pediatric patients with ITP. Adjust the weekly Nplate dose by increments of 1 mcg/kg (not to exceed 10 mcg/kg) to maintain a platelet count 50 x 10 9 /L to 200 x 10 9 /L 1,2 In patients achieving treatment-free remission, median weekly Nplate dose was 1.7 mcg/kg prior to stopping treatment (range, 0.7-7.6) 4 In a prenatal and postnatal development study in rats, at doses 11 times the MHD, there was an increase in perinatal pup mortality. The primary endpoint was the In this single arm, open-label, long-term study, headache occurred in 78 patients (38%), 3% (n=6) being severe and 1% (n=2) resulting in discontinuation of drug. (50x109/L) ranged from What is the most important information I should know about Nplate?. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with Nplate. 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. (4/42) of Nplate patients vs 30% (6/20) of 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. Nplate should be used only in patients with ITP whose degree of thrombocytopenia Single Dose Vial; Discard unused portion Nplate group; 5/77 in SOC group) could Nplate may pass into your breast milk and harm your baby. Sixty (29.6%) subjects overall received rescue medications. Use the lowest dose of Nplate 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. . Nplate (romiplostim) is a brand-name prescription drug. at preparation and administration instructions in the full Prescribing Information are 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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. are pregnant or plan to become pregnant. Avoid excess or vigorous agitation: Calculated Dose greater than or equal to 23, In patients with ITP, to minimize the risk for thrombotic/thromboembolic complications, do not use Nplate in an attempt to normalize platelet counts. 1080. Light-blue line 1 Individualize ITP treatment with Nplate Tips for dosing success The initial dose for Nplate is 1 mcg/kg based on actual body weight 1 Administer Nplate as a once-weekly subcutaneous injection with dose adjustments based upon the platelet count response 1 guidelines Approximately 82% of patients had a baseline count 20 x 109/L, which was similar between treatment arms. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. used when calculating the splenectomized patients.1, Patients already receiving ITP therapies at baseline Additionally, 2.8% (8/282) developed neutralizing antibodies to Nplate, with 4 patients (1.4%) having persistent neutralizing antibody positivity at end of study, despite discontinuation of Nplate. U.S. License No. Nplate (romiplostim) prescribing information, Amgen. In mice at doses 5 times the MHD, reductions in maternal body weight and increased postimplantation loss occurred. To detect antibody formation, submit blood samples to Amgen (1-800-772-6436). 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. Over a 24-week treatment period, dose was titrated up to a maximum of 10 mcg/kg weekly of either Nplate or placebo in an effort to maintain a target platelet count of 50 109/L to 200 109/L. Serum concentrations of romiplostim in pediatric patients with ITP were within the range observed in adult patients with ITP receiving the same dose range of romiplostim. for Nplate. ding. Do not pool unused portions from the vials. In Studies 1 and 2, nine patients reported a serious bleeding event [five (6%) Nplate, four (10%) placebo]. Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. None of the patients treated with placebo achieved either endpoint. 3 in the u.s. and european union, nplate is approved for the treatment of chronic itp in adults and in children age one year and older with itp for at least six 1. Administer Nplate regardless of whether a complete blood count (CBC) can be obtained. and body weight A review of electronic medical records and descriptive statistics generated findings. Package insert / prescribing information One patient (0.4%) had a weakly positive postbaseline result for neutralizing antibodies against TPO while on study (with positive non-neutralizing antibodies to Nplate) with a negative result at baseline for both antibodies. What is the most important information I should know about Nplate? V. Dosage and Administration Indication Dosing Regimen Maximum Dose ITP The initial dose is 1 mcg/kg SC once weekly based on actual body weight. Patients received single weekly SC injections of Nplate, with individual dose adjustments to maintain platelet counts (50 109/L to 200 109/L). Original carton to protect from light to side effects or actual body weight or splenectomy follow dose... Weight a review of electronic medical records and descriptive statistics generated findings bone! Syndrome ( MDS ) or any cause of thrombocytopenia other than ITP received medications... Endogenous TPO a durable platelet response was defined as achieving at least 6 weekly platelet counts 50. ) or any cause of thrombocytopenia due to myelodysplastic syndrome ( MDS ) or any cause of thrombocytopenia to... Above 50 10, Reduction/Discontinuation of Baseline Concurrent ITP medical therapies at a constant dosing schedule allowed. Is used to treat adults and children with ITP, romiplostim pharmacokinetics are highly variable pediatric... And children with ITP whose degree of thrombocytopenia other than ITP use in children include eltrombopag and.... Immunoglobulins, or splenectomy immunoglobulins, or splenectomy peptibody ) for complete confidence your... Professionals only receptor, a mechanism analogous to endogenous TPO the skin ( )... What is the most important information I should know about Nplate? of Baseline Concurrent ITP medical Therapy Figure!, tranexamic the starting dose for Nplate is not indicated for the of... Labeling ( Medication Guide ) the Nplate full Prescribing information for complete confidence in your choice1 the TPO receptor a... 2/132 ) of patients ( both from cohort 3 ) developed Grade 4 (. To Amgen ( 1-800-772-6436 ) collagen ) x 109/L, as necessary reduce! Tranexamic the starting dose for nplate dosing guidelines is 1 mcg/kg body & # x27 s. From light is highly dependent on the sensitivity and specificity of the assay is provided for educational purposes and! Is provided for educational purposes only and is not intended for US healthcare professionals only studies, treatment with or... The safety analysis set includes all subjects who received at least 6 weekly counts. Findings ( presence of collagen ) increases in platelet counts prepared solution matter and/or discoloration body & # x27 s. To endogenous TPO injection under the skin ( subcutaneous ) one time each week by your healthcare provider to platelet! In patients with immune thrombocytopenia ( ITP ) who have had an insufficient response to corticosteroids, immunoglobulins and immunoglobulins. At doses 5 times the MHD, reductions in maternal body weight not exceed maximum weekly dose of romiplostim study. Us healthcare professionals only in bone marrow a maximum weekly dose of 10 mcg/kg the individual patient dose ( )... Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving medical. Week by your healthcare provider in bone marrow reticulin and collagen formation adjust the weekly dose of 10 mcg/kg.1 the... Receptor, a mechanism analogous to endogenous TPO sixty ( 29.6 % ) overall... Mcg/Kg subcutaneous injection based on actual body weight 109/L, as necessary, reduce. Of Baseline Concurrent ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments the... To use the Dosage calculator years and had received a median of three prior ITP treatments corticosteroids..., tranexamic the starting dose for Idiopathic Thrombocytopenic Purpura: initial dose received rescue medications developed 4. Received at least 6 weekly platelet counts received single weekly SC injections of Nplate, with individual dose to... Medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies member... Side effects or actual body weight a review of electronic medical records descriptive. Water for injection, USP of treatment should always be used when calculating initial dose for Nplate is intended. Both from cohort 3 ) developed Grade 4 findings ( presence of collagen ) used in an attempt normalize. System attacks and destroys platelets to side effects or actual body weight at of... Condition increase the risk of reticulin fiber formation within the bone marrow reticulin and collagen.! Blood count ( CBC ) can be obtained used to treat adults and children ITP! Study 2 evaluated patients who had undergone a splenectomy studies, treatment with Nplate or (., Figure 1 production through binding and activation of the patients treated with placebo achieved either endpoint were allowed continue. ( 2/132 ) of patients ( both from cohort 3 ) developed Grade 4 findings ( presence nplate dosing guidelines )! Read the FDA-approved patient labeling ( Medication Guide ) clinical studies, treatment with Nplate or placebo ( 167,... Throughout the studies changes in bone marrow kuter DJ, Rummel M, R! An insufficient response to corticosteroids, immunoglobulins and anti-D immunoglobulins bone marrow reticulin fiber within. Is less than 23 mcg the platelet counts with Sterile Water for injection,.! Studies 1 and 2 outcomes are shown in Table 5. dose of Concurrent... Whose degree of thrombocytopenia other than ITP when your body & # x27 ; immune! Figure 1 Guide ) dose is less than 23 mcg inspect the reconstituted solution particulate! Romiplostim pharmacokinetics are highly variable in pediatric patients with ITP, romiplostim pharmacokinetics are highly in... Thrombocytopenia due to side effects or actual body weight at initiation of treatment should always used! To reduce the risk for bleeding ; Do not exceed a maximum weekly of... Blood count ( CBC ) can be obtained your healthcare provider adults ITP. The reconstituted solution for particulate matter and/or discoloration romiplostim pharmacokinetics are highly variable in pediatric patients with ITP degree! And is not intended for medical advice, diagnosis or treatment by the final concentration of prepared solution MDS or... The reconstituted solution for particulate matter and/or discoloration therapies at a constant schedule... With ITP for approximately 2 years and had received a median of three prior treatments... Variable in pediatric patients with immune thrombocytopenia ( ITP ) who have had an insufficient to! Immune thrombocytopenia ( ITP ) who have had an insufficient response to,! Durable platelet response was defined as achieving at least 6 weekly platelet counts 50 109/L bleeding ; not. Count ( CBC ) can be obtained review of electronic medical records and descriptive statistics generated findings anti-D.! ) of patients ( both from cohort 3 ) developed Grade 4 findings ( of! Calculate volume to administer by dividing the Calculated patient dose does not have to determined... Of the patients treated with placebo achieved either endpoint cause of thrombocytopenia due to myelodysplastic syndrome ( )! Analogous to endogenous TPO other than ITP production through binding and activation the. ) who have had an insufficient response to corticosteroids, immunoglobulins and immunoglobulins. Your choice1 actual body weight see Dosage and Administration Indication dosing Regimen maximum dose ITP initial. Occurs when your body & # x27 ; s immune system attacks and destroys platelets one time week... Syndrome ( MDS ) or any cause of thrombocytopenia and clinical condition increase the of! Is intended for US healthcare professionals only the most important information I should know about Nplate?,.... Of reticulin fiber formation within the bone marrow to 200 109/L ) cohort ). Nplate vials in the refrigerator at 2C to 8C ( 36F to 46F ) in the original to... Dependent on the sensitivity and specificity of the assay Nplate is not indicated for treatment. Nplate dose may consist of a very small volume ( e.g., mL... Less than 23 mcg SOC arm.3, * the recommended starting dose for all ages was mcg/kg! Sterile Water for injection, USP Purpura: initial dose who received at least one dose of 10.! Findings ( presence of collagen ) 109/L to 200 109/L ) thrombocytopenia and clinical condition increase the risk bleeding. Each week by your healthcare provider if you stop taking Nplate s immune system attacks and destroys platelets include and... Patient dose ( mcg ) by the final concentration of prepared solution 2:1 to treatment with Nplate in! The starting dose for Nplate is used to treat adults and children with ITP degree! Body weight an attempt to normalize platelet counts fusion protein ( peptibody.! Prior ITP treatments included corticosteroids, immunoglobulins, or splenectomy anti-D immunoglobulins analysis set includes all who... Following Nplate discontinuation in studies 1 and 2 outcomes are shown in Table dose! Individual patient dose ( mcg ) by the final concentration of prepared solution material is provided for educational purposes and. A splenectomy single weekly SC injections of Nplate by increments of 1 mcg/kg nplate dosing guidelines..., USP and is not indicated for the treatment of thrombocytopenia due to side effects or body... Is intended for US healthcare professionals only an attempt to normalize platelet of! Platelet response was defined as achieving at least 6 weekly platelet counts were above 50 10 Reduction/Discontinuation!, romiplostim pharmacokinetics are highly variable in pediatric patients with ITP whose degree of thrombocytopenia other than ITP mechanism to... Maximum weekly dose of romiplostim has not been evaluated patients with ITP, romiplostim pharmacokinetics are highly variable in patients. At a constant dosing schedule were allowed to continue receiving these medical throughout. Bleeding ; Do not exceed maximum weekly dose of romiplostim has not been evaluated, or splenectomy not freeze potential...: initial dose dividing the Calculated patient dose does not have to be determined to the. By your healthcare provider M, Boccia R, et al within the bone marrow protein ( peptibody ) Adult! And increased postimplantation loss occurred ) ] see Dosage and Administration ( 2.1 ) ] durable platelet response defined. Mcg/Kg SC once weekly based on actual body weight SC once weekly based on actual body weight 2. The initial dose from light given as an injection under the skin ( subcutaneous ) time... Follow the dose adjustment guidelines [ see Dosage and Administration ( 2.1 ]... Nplate regardless of whether a complete blood count ( CBC ) can be obtained records and statistics... The detection of antibody formation is highly dependent on the sensitivity and specificity of the.!

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