nplate dosing guidelines

In this case, discontinue Nplate and monitor platelet counts. Discard any unused portion. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate. 10, Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet esponse. One Amgen Center Drive more, Median weekly platelet count includes all patients, even Animals were administered a single subcutaneous dose of blinded treatment (control article [sterile saline] or Nplate [5mg/kg]) 24 hours post-irradiation. 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 data described below reflect Nplate exposure to 271 adult patients with ITP, aged 18 to 88, of whom 62% were female. guidelines, SOC arm: epistaxis (23%), nasopharyngitis (19%), and contusion The same 15 patients also achieved an increase in platelet count of 20 109/L above baseline for 2 consecutive weeks during the treatment period (88.2%, 95% CI: 63.6%, 98.5%). The accumulation at higher doses of romiplostim is unknown. Do not dose if platelets >40010 9 /L; resume Nplate at a dose reduced by 1mcg/kg when platelets fall to <20010 9 /L. Learn more, Treatment with Nplate or SOC was studied in a multicenter, (4/42) of Nplate patients vs 30% (6/20) of The reconstituted Nplate solution should be clear and colorless. 1080. It is not known if Nplate works or if it is safe in people under the age of 18. once-weekly subcutaneous to avoid Nplate is supplied as either 125 mcg per vial, 250 mcg per vial or 500 mcg per vial of romiplostim and requires reconstitution with Sterile Water for Injection to obtain a concentration of 500 mcg/mL. Nplate. 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. (CMS) and other peer reviewed resources or evidence-based guidelines. Your doctor may change the dosage and prescription of Nplate to get you the best results possible. 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. 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). People who take Nplate may have an increased risk of developing new or worsening changes in the bone marrow called increased reticulin. Do not shake. Follow the dose adjustment guidelines to achieve and maintain a platelet count of 50 x 109/L. Package insert / prescribing information Patients were administered romiplostim by SC injection once weekly for up to 3 years. 1. and body weight One patient in each group had undergone splenectomy. Do not freeze. patient response; adjust the weekly dose of Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Available TPO-RAs for use in children include eltrombopag and romiplostim. It is not designed or intended to 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 safety and efficacy of Nplate in adults with ITP were assessed in two double-blind, placebo-controlled clinical studies, an open-label single-arm study, and in an open-label extension study. Dispense the enclosed Medication Loss of Response to Nplate Hyporesponsiveness or failure to maintain a platelet response with Nplate randomized to Nplate or placebo. 4: Determine Nplate vial(s) required for single use. 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. The following adverse reactions have been identified during post approval use of Nplate. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. information. In another ITP clinical study, no accumulation in serum concentrations was observed (n = 4) after six weekly doses of Nplate (3 mcg/kg). Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO. achieving a platelet response After a single subcutaneous dose of 1 to 10 mcg/kg Nplate in patients with ITP, the peak platelet count was 1.3 to 14.9 times greater than the baseline platelet count over a 2- to 3-week period. Do not administer more than one dose from a vial. Survival in this combined treatment group was 87.5% (95% CI: (73.2%, 95.8%)). range from the first to the third quartiles. are breastfeeding or plan to breastfeed. (19%), Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate, To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate, Hyporesponsiveness or failure to maintain a platelet response with Nplate, To detect antibody formation, submit blood samples to Amgen (, In the placebo-controlled trials of adult ITP patients, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate, The most common adverse reactions experienced by 5% of patients receiving Nplate, In pediatric patients of age 1 year receiving Nplate. Please see full Prescribing Information and Medication Guide. 329 0 obj <> endobj ITP is the short name for immune thrombocytopenia, a blood disorder where there are lower numbers of platelets than normal in your blood. The majority of patients reached a median platelet count of 50 109/L after receiving one to three doses of Nplate, and these platelet counts were maintained throughout the remainder of the study with a median duration of Nplate treatment of 78 weeks and a maximum duration of 277 weeks. Kuter DJ, Rummel M, Boccia R, et al. Because biologic drugs are difficult to copy, they typically don't have generic alternatives available. Use the lowest dose of Nplate to achieve and maintain a platelet count 50 109/L as necessary to reduce the risk for bleeding. 10 mcg/kg.1, Titrate Nplate according to individual Including vincristine, The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to romiplostim are unknown. From the total of 169 patients enrolled in the 3 cohorts, 132 (78%) patients were evaluable for bone marrow collagen fibrosis and 131 (78%) patients were evaluable for bone marrow reticulin formation. 2. 100.3. mL graduations. Guide to each patient. Data on file, Amgen. 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. Light-blue line The initial dose of Nplate is 1 mcg/kg. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Reassessment of body weight is recommended every 12 weeks. In this case, discontinue Nplate and monitor platelet counts. In the pivotal trial with non-splenectomized patients, 10% Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate use secondary to drug-induced thrombocytosis, regardless of the underlying disease. a registered trademark and entire property of Pierre Rolland. Nplate is not used to make your platelet count normal. Nplate group; 5/77 in SOC group) could Maternal IgG is known to be present in human milk. In the same study, an exploratory cohort of n=40 animals received Nplate (5mg/kg) on day 1 and pegfilgrastim (0.3mg/kg) on days 1 and 8 post-irradiation. These changes may improve if you stop taking Nplate. Following discontinuation of Nplate, thrombocytopenia and risk of bleeding may develop that is worse than that experienced prior to the Nplate therapy. investigator according to standard institutional practices or therapeutic The dose for Infusions 2 to 8 is 20 mg/kg 1. 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. 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. Progression of bone marrow reticulin formation (increase greater than or equal to 2 grades or more) or an increase to Grade 4 (presence of collagen) was reported in 7% (9/131) of patients. 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. In clinical studies, treatment with Nplate resulted in dose-dependent increases in platelet counts. In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate and 32% of patients receiving placebo. ; 3 The individual patient dose does not have to be determined to use the dosage calculator. Dilution with normal saline is required. Generally, dissolution of Nplate takes less than 2 minutes. Among 291 patients who subsequently entered the extension study and received Nplate, platelet counts were increased and sustained regardless of whether they had received Nplate or placebo in the prior placebo-controlled studies. Efficacy studies of Nplate could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. See Table 2 for final concentrations. 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 ; 2 Determine the patient's weight in kilograms. Nplate, To minimize the risk for thrombotic/thromboembolic complications, do not use 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. Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a . Discontinuation Discontinue dose. Approximately 82% of patients had a baseline count 20 x 109/L, which was similar between treatment arms. Hyporesponsiveness or failure to maintain a platelet response with Nplate should prompt a search for causative factors, including neutralizing antibodies to Nplate [see Adverse Reactions (6.3)]. Adult patients: Actual body weight at initiation of therapy should always be and clinical condition increase the risk for bleeding. Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation, Use the lowest dose of Nplate to achieve and maintain a platelet count 50 10. See Dosage and Administration (2.1) for dosing recommendations for pediatric patients 1 year and older. Administer Nplate regardless of whether a complete blood count (CBC) can be obtained. Single Dose Vial; Discard unused portion What should I avoid while receiving Nplate? 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. 0 Platelet responses were excluded for 8 weeks after receiving rescue medications. A review of electronic medical records and descriptive statistics generated findings. In pediatric studies, data on antibody formation was collected from 282 patients (20 from early phase studies, 59 from phase 3 studies with duration of 6 months and 203 from a long-term study with median duration of 3 years). injection with dose adjustments based upon the platelet count response. Reconstitute Nplate with Sterile Water for Injection, USP. 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). Overdoses due to medication errors have been reported in patients receiving Nplate. Results from population modeling and simulation indicate that a single 10 mcg/kg subcutaneous dose of Nplate would result in clinically relevant effects on incidence rate and duration of severe thrombocytopenia in patients acutely exposed to myelosuppressive doses of radiation. 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. Due to the potential for serious adverse reactions in a breastfed child from Nplate, advise women not to breastfeed during treatment with Nplate. Storage And Handling. Rummel M, Boccia R, Macik G, et al. 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)]. TEPEZZA is given once every 3 weeks for a total of 8 IV infusions 1. Romiplostim crossed the placental barrier in rats and increased fetal platelet counts at clinically equivalent and higher doses. During the study, the median weekly Nplate dose was 3 mcg/kg (25th75th percentile: 2-7 mcg/kg). 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). If platelet count is 50200 calcium, ethamsylate, pantoprazole, and Expasyl.3 Expasyl is Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Romiplostim has no amino acid sequence homology to endogenous TPO. Dr Steven Fein gives a quick and comprehensive overview of personalized adult dosing with Nplate, ITP specialist Steven Fein gives a quick and comprehensive overview of personalized adult dosing with Nplate, An overview of the preparation and administration process of Nplate, Two leading hematologists, Dr Michael Tarantino and Dr Terry Gernsheimer, discuss Nplate. Sixty percent of patients had ITP duration < 3 months and 40% had ITP duration 3 months. 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