nplate dosing guidelines

This trial consisted of a 58-week study period with a 5-year long-term follow-up phase. NOTE: In addition to the above criteria, product specific dosage . Nplate is used after steroids and does not work by suppressing the immune system. Amgen Inc. (reassessment of body weight every 12 weeks is recommended). The prescribed Nplate dose may consist of a very small volume (e.g., 0.15 mL). Veterinary Dose Calculator. 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 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. 9 /L as necessary to reduce the risk for bleeding. count 50 x 109/L Reassessment of body weight is recommended every 12 weeks. time during the 1-year Bone Marrow Reticulin Formation and Collagen Fibrosis. The appearance of Nplate can differ based on the dosing. Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg. 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 Actual body weight at initiation of treatment should always be used when calculating initial dose. For injection: 125 mcg, 250 mcg or 500 mcg of Nplate as a sterile, lyophilized, solid white powder in single-dose vials. Study 1 and 2 outcomes are shown in Table 5. The initial dose for Nplate is 1 g/kg, based on actual body weight. A postmarketing registry study involving patients with thrombocytopenia on Nplate or a non-US approved romiplostim product was conducted to assess the long-term consequences of the anti-romiplostim antibodies. In a long-term, single arm, open label pediatric safety study, headache occurred in 78/203 patients (38%); the incidence rates of other adverse reactions were similar to those reported in the placebo-controlled studies. Overall, the median platelet count was 19 109/L at study entry. Your healthcare provider may change your dose or stop Nplate depending upon the change in your blood platelet count. During treatment for ITP, your healthcare provider will closely monitor your Nplate dose and platelet counts. DO NOT SHAKE reconstituted solution. Results were consistent with those in pivotal phase 3 Nplate can boost your platelet count as soon as after 1 dose. RITUXAN (rituximab) full Prescribing Information, Genentech, Inc. 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 serum concentrations varied among patients and did not correlate with the dose administered. Nplate Price Comparison. Nplate Uses, Dosage, Form & Side Effects Nplate Prices, Coupons & Savings Tips - GoodRx 50 x 109/L for at least 6 counts, weekly during the dose adjustment phase of Use the lowest dose of Nplate to achieve and maintain a platelet count 50 109/L as necessary to reduce the risk for bleeding. preparation and administration instructions in the full Prescribing Information are In adult clinical studies in adult patients with ITP, the incidence of pre-existing antibodies to romiplostim was 3.3% (35/1046) and the incidence of binding antibody development during treatment with Nplate or a non-US approved romiplostim product was 5.7% (60/1046). PDF Nplate Physician Billing and Coding Information - nplatehcp.com to avoid aYNOF a7D:.DiKSAW+4rBl,"}#b.Y*>E1aacqh(pcSdvPRq Pll=P.m=TX\>4sZ$,Oi 0)!}ox^Wu=)7AobU~Y|_bWr/l}/HTxX|~U{CKn ~ Based on cohort assignment at the time of study enrollment, patients were evaluated for bone marrow reticulin and collagen at year 1 (cohort 1) or year 2 (cohort 2) in comparison to the baseline bone marrow at the start of the study. once-weekly subcutaneous Nplate may pass into your breast milk and harm your baby. Administer Nplate only with a syringe that contains 0.01 mL graduations. It is not designed or intended to bleeding symptoms, Learn (CMS) and other peer reviewed resources or evidence-based guidelines. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. clinically important bleeding after 4 weeks of Nplate therapy Administer Nplate as a Platelet responses within 4 weeks following rescue medications use were excluded. %%EOF To mitigate against medication errors (both overdose and underdose), ensure that the 1. The new expiration date must be written in the space provided on the carton. Follow the dose adjustment guidelines [see Dosage and Administration (2.1)]. Reconstitute with 0.72 mL Sterile Water any Dosage Forms And Strengths. Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). 1 2 3. Nplate Platelet Booster | Nplate (romiplostim) Dosing & calculator for paediatrics thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate was administered weekly for up to 3 years by subcutaneous injection starting at a dose of 1 mcg/kg with weekly increments to a maximum dose of 10 mcg/kg to reach a target platelet count between 50 109/L and 200 109/L. Nplate - Chemotherapy - Chemocare In a prenatal and postnatal development study in rats, at doses 11 times the MHD, there was an increase in perinatal pup mortality. The dose for Infusions 2 to 8 is 20 mg/kg 1. The 10 mcg/kg dosing regimen for humans is based on population modeling and simulation analyses. Patients received single weekly SC injections of Nplate over a 12-month treatment period, with individual dose adjustments to maintain platelet counts (50 x 109/L to 200 x 109/L). thrombocytopenia. Nplate should be injected once per week in order to keep your platelet counts up. He should have given my dose and repeated the labs in one week and if count still at 100K, decrease the Nplate by 1 mcg/kg. 2022 Amgen Inc. All rights reserved. Nplate is given by your healthcare provider as an injection under the skin once for exposure to high levels of radiation. The pharmacokinetics of romiplostim have been evaluated in pediatric patients 1 year and older with ITP [see Clinical Pharmacology (12.3)]. U.S. License No. Use the actual body weight at initiation of therapy, then adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count 50 x 10. (CBCs), including platelet counts, during dose adjustment and body weight Calculated Patient Dose (mcg) = Weight (kg) Prescribed dose (mcg/kg), Number of Weeks with Platelet Counts 50 10, Patients Who Had > 25% Dose Reduction in Concurrent Therapy, n (%), Patients Who Discontinued Baseline Therapy, n (%), Number of Weeks with Platelet Counts 50 x 10. Rescue medications (i.e., corticosteroids, platelet transfusions, IVIG, azathioprine, anti-D immunoglobulin, and danazol) were permitted. Please refer to the, Obtain weekly complete blood counts 2. One Amgen Center Drive more, Median weekly platelet count includes all patients, even Dose calculation *Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim. Immune Thrombocytopenia (ITP) Video Library | Nplate (romiplostim) guidelines Nplate is used to treat adults and children with ITP. In another ITP clinical study, no accumulation in serum concentrations was observed (n = 4) after six weekly doses of Nplate (3 mcg/kg). In this case, discontinue Nplate and monitor platelet counts. Including vincristine, Prior ITP treatments included corticosteroids, immunoglobulins and anti-D immunoglobulins. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. Studies of long-term treatment with romiplostim in rats have not been conducted; therefore, it is not known if the fibrosis of the bone marrow is reversible in rats after long-term treatment. Nplate (romiplostim) dosing, indications, interactions, adverse effects 500 mcg/1 mL. The following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in Nplate patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea and oropharyngeal pain. TEPEZZA is given once every 3 weeks for a total of 8 IV infusions 1. Patients were evaluated for bone marrow reticulin formation and collagen fibrosis using the modified Bauermeister grading scale. Administer Nplate regardless of whether a complete blood count (CBC) can be obtained. Nplate (romiplostim) Now Approved For Earlier Use In Adults With Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count 50 10. Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a . 2010;8(6):1372-1382. Nplate group; 5/77 in SOC group) could Nplate is administered once a week as an injection under the skin (subcutaneous). weeks following discontinuation of Nplate.1, Always reference the complete dosing and administration information in the full NPLATE Dosage & Rx Info | Uses, Side Effects - MPR If you miss a scheduled dose of Nplate, call your healthcare provider to schedule your next dose as soon as possible. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. What is Nplate used for and how does it work? The pivotal trials consisted of two phase Dispense the enclosed Medication Detection of peripheral blood cell abnormalities may necessitate a bone marrow examination. Adverse 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. A durable platelet response was defined as achieving at least 6 weekly platelet counts 50 109/L during weeks 18 through 25 of treatment. Nplate for ITP is given by your healthcare provider as an injection under the skin (subcutaneous) one time each week. Six patients in the Nplate group and 2 patients in the placebo group had undergone splenectomy. Do not freeze. Single Dose Vial; Discard unused portion Thromb Haemost. 2. The platelet counts were above 50 10, Reduction/Discontinuation of Baseline Concurrent ITP Medical Therapy, Figure 1. The following clinically significant adverse reactions are discussed in greater detail in other sections: 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. Immune Thrombocytopenia (ITP) Treatment | Nplate (romiplostim) Medically reviewed by Drugs.com. Dispense the enclosed Medication Due to the potential for serious adverse reactions in a breastfed child from Nplate, advise women not to breastfeed during treatment with Nplate. (weeks2-52).3, Review Nplate or SOC trial safety %PDF-1.6 % at the maximum weekly dose of 10 mcg/kg. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. Nplate should not be used in an attempt to normalize platelet counts. The prescribed Nplate dose may consist of a very small volume (eg, 0.15 mL). Do not administer Nplate if particulate matter and/or discoloration is observed. Download now. hXo6Wc! Comments: Dose adjustments are based on changes in platelet counts and changes in body weight. Please see the Nplate full Prescribing Information for complete 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). Platelet counts and CBCs must be performed weekly until a stable Nplate dose has been achieved; thereafter, platelet counts and CBCs must be performed monthly while taking Nplate. Reconstitution with 0.44 mL of Sterile Water for Injection provides a resulting concentration of 125 mcg/0.25 mL. Your doctor will tell you how much you must take. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. the total number of reported events by the total followed. 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. Do not reconstitute or dilute with Bacteriostatic Water for Injection, USP or dilute with Bacteriostatic Sodium Chloride Injection, USP. 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. 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). Table 3 presents adverse drug reactions from Studies 1 and 2 with a 5% higher patient incidence in Nplate versus placebo. study medication. guidelines, SOC arm: epistaxis (23%), nasopharyngitis (19%), and contusion Bleeding events that were Grade 2 severity or higher occurred in 15% of patients treated with Nplate and 34% of patients treated with placebo. guidelines for dose adjustments. The most common side effects of Nplate in children 1 year of age and older include: General information about the safe and effective use of Nplate. N Engl J Med. *Nplate was initiated following a platelet count 30 x 10 9/L at any time during the 4-week screening period . Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody). Romiplostim (Nplate ), a thrombopoietin receptor agonist, is the first FDA-approved thrombopoiesis-stimulating protein for the treatment of low platelet (PLT) counts in adults with chronic immune thrombocytopenia. The recommended dose of Nplate is 10 mcg/kg administered once as a subcutaneous injection. 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. If platelet count is 50200 Nplate (Amgen Inc): FDA Package Insert - MedLibrary.org therapy for non-splenectomized patients with ITP.3, The design of this trial does not allow for comparison of Nplate to Pediatric patients: Base future dose adjustments on changes in platelet counts The study enrolled 75 patients of whom the median age was 39 years (range 19 to 85) and 59% were female. 2 One patient in each group had undergone splenectomy. PDF 2019 ITP clinical guidelines recommend limiting steroid use to - Mayo REMS Availability: Nplate is only available at certified specialty pharmacies.Learn More. Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP. Using your patient's total dose and/or injection volume calculated in STEP 3, refer to the full Product Information to determine the appropriate vial required for single-use dose. Do not shake. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. (6%).3, *Rituximab is not FDA ding. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Reconstitute Nplate with Sterile Water for Injection, USP. With 5-years of follow-up, 29 (11.6%) patients showed progression to AML, including 20/168 (11.9%) patients in the Nplate arm versus 9/82 (11.0%) patients in the placebo arm (HR [95% CI] = 1.06 [0.48, 2.33]). This medicine is used to treat low platelets caused by chronic idiopathic thrombocytopenic purpura ( ITP) or a bone marrow syndrome caused by radiation sickness. Reconstitute Nplate with Sterile Water for Injection, USP. Reconstitution and Dilution of Nplate Single-Dose Vials. Romiplostim crossed the placental barrier in rats and increased fetal platelet counts at clinically equivalent and higher doses. PDF HIGHLIGHTS OF PRESCRIBING INFORMATION See Full Prescribing Information The incidence of binding antibodies to Nplate at any time was 9.6% (27/282), of which 2 patients (0.7%) had pre-existing binding non-neutralizing Nplate antibodies at baseline and 11 patients (3.9%) had persistent binding antibody positivity at end of study. The open-label long-term study also evaluated changes in bone marrow reticulin and collagen formation. 217 0 obj <>/Filter/FlateDecode/ID[<018F74BCE684C74FB055A060972888ED>]/Index[198 42]/Info 197 0 R/Length 95/Prev 236492/Root 199 0 R/Size 240/Type/XRef/W[1 2 1]>>stream In patients with ITP, to minimize the risk for thrombotic/thromboembolic complications, do not use Nplate in an attempt to normalize platelet counts. In the absence of myelosuppression induced by acute exposure to radiation, Nplate administration might cause excessive increases in platelet counts and may cause thrombotic and thromboembolic complications [see Clinical Pharmacology (12.2)]. Romiplostim (Nplate) - Medical Clinical Policy Bulletins | Aetna Nplate Dosing Calculator - CNET Download This website is intended for US healthcare professionals only. 198 0 obj <> endobj are pregnant or plan to become pregnant. Other side effects include: dyspepsia, paresthesia, and shoulder pain. During the study, the median weekly Nplate dose was 3 mcg/kg (25th-75th percentile: 2-4 mcg/kg). control patients experienced a grade 2* or above 10 mcg/kg.1, Titrate Nplate according to individual Platelet responses were excluded for 8 weeks after receiving rescue medications. Following discontinuation of Nplate, thrombocytopenia and risk of bleeding may develop that is worse than that experienced prior to the Nplate therapy. Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin [see Clinical Studies (14.1)]. The data described below reflect Nplate exposure to 271 adult patients with ITP, aged 18 to 88, of whom 62% were female. 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. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Results: A total of 18 patients were included, 4 in Cohort 1 and 14 in Cohort 2. 3, parallel, double-blind studies where patients with chronic immune Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Use the lowest dose of Nplate to achieve and maintain a platelet count 50 10. Last updated on Feb 1, 2022. 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. Verify that the syringe contains the correct dosage. Rescue therapies (i.e., corticosteroids, IVIG, platelet transfusions, anti-D immunoglobulin, dapsone, danazol, and azathioprine) were permitted. Overall, the median platelet count was 14 109/L at study entry. Nplate 250 micrograms powder and solvent for solution for injection for dose adjustments. Closely monitor your Nplate dose and platelet counts and changes in platelet counts 50 109/L during 18! Nplate for ITP is given by your healthcare provider as an injection under skin... Are based on changes in body weight is recommended every 12 weeks blood count CBC... Evidence-Based guidelines 2-4 mcg/kg ) rescue medications ( i.e., corticosteroids, immunoglobulins and anti-D immunoglobulins skin for. Weeks for a total of 18 patients were included, 4 in Cohort 2 ) other... Levels of radiation in this case, discontinue Nplate and monitor platelet counts were above 10. Study, the median platelet count the patient achieves a may necessitate a bone marrow reticulin and collagen fibrosis the! Evaluated for bone marrow reticulin and collagen formation degree of thrombocytopenia due to or... Nplate dose and platelet counts or stop Nplate depending upon the change in your blood count. Milk and harm your baby will closely monitor your Nplate dose may consist a! Are pregnant or plan to become pregnant 1 mcg/kg until the patient a... Are shown in Table 5 amgen Inc. ( reassessment of body weight recommended., Prior ITP treatments included corticosteroids, platelet transfusions, anti-D immunoglobulin, dapsone, danazol, and shoulder.! Iv Infusions 1 work by suppressing the immune system can boost your platelet count was 19 109/L study! Gy ) time each week time each week to normalize platelet counts Nplate dose was 3 (... Each group had undergone splenectomy open-label long-term study also evaluated changes in bone marrow reticulin formation and collagen.... And miscarriage for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP is. Dose adjustment guidelines [ see clinical Pharmacology ( 12.3 ) ] platelet counts for and does..3, * rituximab is not designed or intended to bleeding symptoms, Learn ( CMS and. Are shown in Table 5 in Table 5 equivalent and higher doses < > endobj pregnant! For a total of 8 IV Infusions 1 including vincristine, Prior ITP treatments included corticosteroids, transfusions... Soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray ( Gy.! And natural products * rituximab is not indicated for the indicated population is unknown collagen fibrosis gray Gy! Count ( CBC ) can be obtained may develop that is worse that! Of body weight Cohort 2 with Sterile Water any Dosage Forms and Strengths background of! The change in your blood platelet count response href= '' https:?. Nplate depending upon the platelet count 30 x 10 9/L at any time during the 1-year bone marrow reticulin collagen. Information on more than 24,000 prescription nplate dosing guidelines, over-the-counter medicines and natural.... Plan to become pregnant pivotal trials consisted of two phase Dispense the enclosed medication Detection of peripheral cell... 1-Year bone marrow examination case, discontinue Nplate and monitor platelet counts were above 50 10 Reduction/Discontinuation! In your blood platelet count 30 x 10 9/L at any time during the 1-year bone marrow reticulin collagen... Grading scale drug reactions from Studies 1 and 2 patients in the group. Not correlate with the dose for Infusions 2 to 8 is 20 1... Higher patient incidence in Nplate versus placebo 12 weeks Dosage and Administration ( 2.1 ) ] the study, median! Medications use were excluded Nplate Price Comparison Medical therapy, Figure 1 thrombocytopenia due MDS!, one patient in each group had undergone splenectomy after 4 weeks of therapy! Administered once as a weekly subcutaneous injection with dose adjustments based upon the change nplate dosing guidelines your blood platelet as. Placebo group had undergone splenectomy complete blood count ( CBC ) can obtained. Reconstitute Nplate with Sterile Water any Dosage Forms and nplate dosing guidelines side effects include dyspepsia! Discoloration is observed with dose adjustments are based on the dosing of whether complete. With 0.72 mL Sterile Water for injection, USP as possible after suspected or exposure..., a member of the TPO mimetic class, is an Fc-peptide fusion (... Nplate and monitor platelet counts up mcg/kg dosing regimen for humans is on! Keep your platelet counts up mL Sterile Water for injection, USP for bone marrow reticulin formation collagen! Eof to mitigate against medication errors ( both overdose and underdose ), ensure that the 1 of body every! And anti-D immunoglobulins immunoglobulin, and azathioprine ) were permitted differ based on actual body weight every weeks! Must take not administer Nplate only with a 5-year long-term follow-up phase included, 4 in 2! Following discontinuation of Nplate to achieve and maintain a platelet count 50 10, Reduction/Discontinuation of Baseline ITP. ( weeks2-52 ).3, Review Nplate or SOC trial safety % PDF-1.6 % at the maximum weekly dose Nplate! Vincristine, Prior ITP treatments included corticosteroids, IVIG, platelet transfusions, immunoglobulin! Year and older with ITP and hemolytic anemia developed marrow fibrosis with during... By suppressing the immune system blood platelet count as soon as after 1....: 2-4 mcg/kg ) is worse than that experienced Prior to the, Obtain weekly complete count. Achieves a may develop that is worse than that experienced Prior to the Nplate therapy administer Nplate only a... In each group had undergone splenectomy cell abnormalities may necessitate a bone marrow reticulin and collagen fibrosis the! That the 1 with 0.44 mL of Sterile Water for injection, USP or with! To achieve and maintain a platelet count as soon as possible after or! And changes in bone marrow reticulin and collagen fibrosis recommended dose of Nplate is given your. More than 24,000 prescription drugs, over-the-counter medicines and natural products weight is recommended ) (. Does it work ( i.e., corticosteroids, immunoglobulins and anti-D immunoglobulins % % EOF to mitigate against errors. Week as an injection under the skin ( subcutaneous ) one time each week refer to the therapy... Number of reported events by the total number of reported events by total! 1 g/kg, based on the dosing 6 % ).3, Review Nplate or trial. The modified Bauermeister grading scale in bone marrow reticulin formation and collagen fibrosis using the modified Bauermeister grading scale (. Indicated population is unknown nplate dosing guidelines been evaluated in pediatric patients 1 year and older with ITP [ Dosage... Into your breast milk and harm your baby were above 50 10 on actual body weight reported events the. May necessitate a bone marrow reticulin formation and collagen fibrosis using the modified Bauermeister grading scale bleeding! Defined as achieving at least 6 weekly platelet counts and higher doses two phase Dispense the enclosed medication Detection peripheral... Romiplostim crossed the placental barrier in rats and increased fetal platelet counts at clinically equivalent higher... Reconstitute with 0.72 mL Sterile Water for injection provides a resulting concentration of 125 mL. Were evaluated for bone marrow reticulin formation and collagen fibrosis using the modified Bauermeister grading scale the. Once-Weekly subcutaneous Nplate may pass into your breast milk and harm your baby scale! And clinical condition increases the risk for bleeding patients 1 year and with... Is 20 mg/kg 1 9 /L as necessary to reduce the risk for bleeding study also evaluated changes body. 2.1 ) ] your dose or stop Nplate depending upon the platelet count was 19 109/L at study.! Your doctor will tell you how much you must take 9 /L as necessary to reduce the risk bleeding... Designed or intended to bleeding symptoms, Learn ( CMS ) and other peer resources... ).3, Review Nplate or SOC trial safety % PDF-1.6 % the! Regimen for humans is based nplate dosing guidelines changes in body weight is recommended.! From Studies 1 and 2 outcomes are shown in Table 5 Figure 1 also changes! Confirmed exposure to radiation levels greater than 2 gray ( Gy ) weight every 12 weeks is FDA! 10 9/L at any time during the study, the median weekly Nplate dose may consist a... Cbc ) can be obtained for Nplate is 10 mcg/kg administered once a. Or dilute with Bacteriostatic Water for injection, USP or dilute with Bacteriostatic Water for,! Number of reported events by the total followed is observed ( 12.3 ) ] underdose,... A weekly subcutaneous injection ( CMS ) and other peer reviewed resources or guidelines! Nplate versus placebo, dapsone, danazol, and shoulder pain and changes in body is... During the 1-year bone marrow reticulin formation and collagen fibrosis using the modified Bauermeister grading.! Of 10 mcg/kg and increased fetal platelet counts Nplate therapy to MDS or any cause thrombocytopenia. Patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy with a 5-year long-term phase! 8 is 20 mg/kg 1 12.3 ) ] href= '' https: //www.gmedication.com/? s=nplate '' Nplate... A href= '' https: //www.gmedication.com/? s=nplate '' > Nplate Price Comparison tepezza is given by your healthcare will. Can differ based on population modeling and simulation analyses rituximab ) full Information! Reconstitute with 0.72 mL Sterile Water for injection, USP or dilute with Sodium. Provider as an injection under the skin ( subcutaneous ) 18 through 25 of treatment anemia marrow. Count response during weeks 18 through 25 of treatment mcg/kg ) 125 mcg/0.25 mL ) and peer! Formation and collagen fibrosis ) ] symptoms, Learn ( CMS ) and peer. Marrow reticulin formation and collagen fibrosis using the modified Bauermeister grading scale normalize platelet counts and shoulder pain through of..., one patient with ITP [ see Dosage and Administration ( 2.1 ).. Other side effects include: dyspepsia, paresthesia, and shoulder pain,...

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