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. 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 . Do not freeze.DO NOT SHAKE reconstituted solution, 250 mcg/vialReconstitute with 0.72 mL Sterile Waterfor Injection, USP for a concentration of250 mcg/0.5 mL.For Subcutaneous Use OnlySingle Dose Vial; Discard unused portionDispense the enclosed MedicationGuide to each patient.Protect from light. If you have question, please e-mail Allevaire Indian Team or call Allevaire India on +91-9818274099 (Mr. Kamal Kaushal)/ (Mr. Sanjeev) for further details. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Administer the dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation. In patients with ITP the recommended initial dose of romiplostim is 1 mcg/kg once weekly as a subcutaneous injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Table 1. Mobile : 9140551027 / 9794360370WhatsApp: +91-9555306364E: info@lucknowpharma.comWebsite: www.lucknowpharma.com, Breast cancer, Prostate cancer, Skin cancer (melanoma), Colon cancer, Lung cancer, Leukemia, Lymphoma etc. Summary of Efficacy Endpoints for Long-term Use of NPLATE (Study 7) - With Number of Patients With Bleeding Events, Number of Subjects With Rescue Medication Use, Number of Subjects on Treatment, Median Platelet Counts During the Treatment Period. Advise patients to avoid situations that may increase the risk of bleeding. The efficacy of Nplate in this trial was measured by the proportion of patients receiving Nplate achieving a durable platelet response and the proportion of patient achieving an overall platelet response. There may be other drugs that can interact with romiplostim 250 MCG Injection. Administer SC Safety and efficacy have not been established in patients younger than 1 year with immune thrombocytopenia (ITP). It was developed and marketed as Nplate by Amgen (also marketed as Romiplate by Kyowa Hakko Kirin). Reconstitution with 0.72 mL of Sterile Water for Injection provides a resulting concentration of 250 mcg/0.5 mL. Romiplostim 250 MCG Injection is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood. People with liver-related problems. Si la dosis individual calculada del paciente es < 23 mcg, para asegurar una dosis exacta, se requiere una dilucin con solucin inyectable de NaCl 9 mg/ml (0,9%) estril y sin conservantes. Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS) The recommended dose of Nplate is 10 mcg/kg administered once as a subcutaneous injection in adults and pediatrics (including term . Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody). Nplate-rm.de.Site is running on IP address 195.30.228.106, host name www.leben-mit-knochenmetastasen.de ( Germany) ping response time 7ms Excellent ping.. Last updated on 2022/07/02 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 is always better to check the credential of the whole-seller/supplier/exporter before buying the product. SHARE THIS. In animal reproduction and developmental toxicity studies, romiplostim crossed the placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality(see Data). The following people avoid the administration of Romiplostim: Allergic to the ingredients of the medicine. Indications and dose Chronic immune (idiopathic) thrombocytopenic purpura in patients refractory to other treatments (such as corticosteroids or immunoglobulins) (under expert supervision) (3) 4 CONTRAINDICATIONS None. Use aseptic technique. 1 4/2/2018. View Labeling Archives, Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy, Advise women not to breastfeed during treatment with Nplate, Injection of too much Nplate may cause a dangerous increase in your blood platelet count and serious side effects. The carcinogenic potential of romiplostim has not been evaluated. The primary efficacy endpoint was survival. The dose should be adjusted based on platelet response. See Table2 for final concentrations. Site is running on IP address 34.210.113.179, host name ec2-34-210-113-179.us-west-2.compute.amazonaws.com (Boardman United States) ping response time 18ms Good ping.Current Global rank is 3,561,113, site estimated value 600$ Do not use bacteriostatic water for injection. Actual body weight at initiation of treatment should always be used when calculating initial dose. Each single-dose 250 mcg vial of Nplate contains the following: 250 mcg romiplostim, L-histidine (1.2 mg), mannitol (30 mg), polysorbate 20 (0.03 mg), sucrose (15 mg), and sufficient HCl to adjust the pH to a target of 5. Romiplostim should protect from light and retain in the original carton until use. Use: Treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; use only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. 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. An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered. Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Reassessment of body weight is recommended every 12 weeks. Study 5 results are shown in Table 6. Overall, the median platelet count was 14 109/L at study entry. 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. 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)]. Romiplostim has no amino acid sequence homology to endogenous TPO. Of the seven patients with positive binding antibodies to romiplostim, one patient (0.5%; 1/184) was positive for neutralizing antibodies to romiplostim only. The safety and efficacy of Nplate in pediatric patients younger than 1 year with ITP have not been established. Files, Presentations Instructions. Did you experience any side effects after consuming the medication? Of the 271patients who received Nplate in ITP clinical studies, 55(20%) were age65 and over, and 27(10%) were 75 and over. (, In some patients with MDS, Nplate increases blast cell counts and increases the risk of progression to acute myelogenous leukemia. Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO. Warnings and Precautions 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. Nplate is given by your healthcare provider as an injection under the skin once for exposure to high levels of radiation. No overall differences in safety or efficacy have been observed between older and younger patients in the placebo-controlled studies, but greater sensitivity of some older individuals cannot be ruled out. Romiplostim Injection side effects Most common side effects of Romiplostim are Joint pain, difficulty in sleeping, dizziness, Muscle pain, Pain in extremity, Abdominal pain, Indigestion, headache and tingling or pricking sensation. Please ask your doctor, nurse or pharmacist for the correct places on your body where this . https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=c45f9a58-37c1-4f76-8e36-97d38c577037, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. ITP (Immune Thrombocytopenia Purpura) is an autoimmune blood disorder which leads to low platelet counts. It also works similarly to thrombopoietin (TPO), an endogenous glycoprotein hormone that regulates the production of platelets in the bone marrow. Reconstitution with 1.2 mL of Sterile Water for Injection provides a resulting concentration of 500 mcg/mL. The patients were randomized 2:1 to treatment with Nplate or placebo (167 Nplate, 83 placebo). For pediatric patients (including term neonates), extrapolation was based on data supporting Nplate's effect on thrombocytopenia in patients with ITP and an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 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. Rotate injection sites. Labels, All Index Files, All Mapping The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response.The prescribed Nplate dose may consist of a very small volume (eg, 0.15 mL). Prior ITP treatments in both study groups included corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, and azathioprine. 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! Inform patients that the risks associated with long-term use of this drug are unknown. 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. Who should not take romiplostim 250 MCG Injection? Talk with your doctor if you have concerns about this risk. No apparent correlation was observed between antibody activity and clinical effectiveness or safety. The recommended initial dose of the drug is 1 mcg/kg once weekly based on actual body weight, as a subcutaneous injection. We are NOT ONLINE store and We do not sell Narcotics and Sedatives. 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. ITP is a disorder in which the body's immune system destroys its own platelets, the blood cells which help seal cuts and form blood cuts. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy. This formation may improve upon discontinuation of Nplate. Thousand Oaks, CA; Amgen Inc; February 2021. (, For injection: 125mcg,250mcg or 500mcg of romiplostim as a lyophilized powder in single-dose vials. Following discontinuation of Nplate, thrombocytopenia and risk of bleeding may develop that is worse than that experienced prior to the Nplate therapy. romiplostim 250 MCG Injection is available only under a special program called romiplostim 250 MCG Injection NEXUS. Reconstitute with only preservative free SWFI (add 0.72 mL to 250 mcg) This is to track the outcome of the pregnancy and to evaluate any effects of romiplostim 250 MCG Injection on the baby. Maximum dose: 10 mcg/kg/week Idiopathic (Immune) Thrombocytopenic Purpura. Maintenance dose: Use the lowest dose to achieve and maintain a platelet count of 50 x 10(9)/L or greater as needed to reduce bleeding risk. Females with childbearing potential must be advised to avoid becoming pregnant while on Romiplostim. Generally, dissolution of Nplate takes less than 2minutes. Please visit your doctor for a recommendation as such case requires special attention. Nplate.com.This domain provided by markmonitor.com at 2008-01-12T19:51:35Z (14 Years, 176 Days ago), expired at 2024-01-12T19:51:35Z (1 Year, 189 Days left). Sixty (29.6%) subjects overall received rescue medications. Reassessment of body weight is recommended every 12 weeks. The median time from ITP diagnosis to study enrollment was 2.2 months (range 0.1 to 6.6). It is not known whether romiplostim 250 MCG Injection passes into breast milk or if it could harm a nursing baby. 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. Amgen Inc, US Food and Drug Administration, [ Revised on Dec 2018] [ Accessed on 31st Dec 2021]. What is the most important information I should know about Nplate?. Reconstituted and further diluted product with 0.9% Sodium Chloride Injection, USP can be held in a syringe at room temperature 25C (77F) or in the original vial refrigerated at 2C to 8C (36F to 46F) for no longer than 4 hours prior to administration. Over a 24-week treatment period, dose was titrated up to a maximum of 10mcg/kg weekly of either Nplate or placebo in an effort to maintain a target platelet count of 50 109/L to 200 109/L. 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). 250-mcg vial (actual content is 375 mcg): Reconstitute with 0.72 mL sterile water 500-mcg vial (actual content is 625 mcg): Reconstitute with 1.2 mL sterile water Note: Actual vial. HEMABATE 250 MCG/ML 1 ML X 10 VIAL SERECOR LP 300 MG 60 CAPS. ), More about getting RSS News & Updates from DailyMed, 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. Most common side effects of Romiplostim are Joint pain, difficulty in sleeping, dizziness, Muscle pain, Pain in extremity, Abdominal pain, Indigestion, headache and tingling or pricking sensation. After a single subcutaneous dose of 1 to 10mcg/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. Safety and effectiveness have been established in pediatric patients age 1 year and older with ITP for at least 6 months evaluated in two randomized, placebo-controlled studies. 7/18/2014. Your healthcare provider may need to check your bone marrow for this problem during treatment with Nplate. 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. Nplate stimulates certain bone marrow cells to make platelets and increases the risk of progression to acute myelogenous leukemia in patients with myelodysplastic syndromes. This drug should not be used in an attempt to normalize platelet counts. NPLATE. The modified Bauermeister grading scale was used for both assessments. from any authorized whole-seller after getting a prescription from a qualified doctor. 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. The pharmacokinetics of romiplostim have been evaluated in pediatric patients 1 year and older with ITP [see Clinical Pharmacology (12.3)]. Romiplostim 125 microgram. There was no detectable bone marrow collagen in one patient on repeat testing 12weeks after discontinuation of romiplostim. To be sold by retail on prescription of a registered oncologist only (rituximab) injection, for intravenous use. Protect product from light. Worsening of a precancerous blood condition to a blood cancer (leukemia). Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment. Reconstitution with 0.44 mL of Sterile Water for Injection provides a resulting concentration of 125 mcg/0.25 mL. Nplate was studied in two randomized, placebo-controlled, double-blind studies that were identical in design, with the exception that Study 1 evaluated nonsplenectomized patients with ITP and Study 2 evaluated splenectomized patients with ITP. How is romiplostim 250 MCG Injection given? Overall, Nplate was administered to 114patients for at least 52weeks and 53patients for at least 96weeks. of romiset . 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 . 3,100/ Piece Get Latest Price Romiplostim injection is used to increase the number of platelets (cells that help the blood to clot in order to decrease the risk of bleeding in adults who have immune thrombocytopenia (ITP; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding View Complete Details 1080. ITP is a disorder in which the body's immune system destroys its own platelets, the blood cells which help seal cuts and form blood cuts. Nplate is a prescription medicine also used to treat people including newborns who have been exposed to high levels of radiation (acute radiation syndrome). The safety and efficacy of Nplate in pediatric patients 1 year and older with ITP for at least 6 months were assessed in two double-blind, placebo-controlled clinical trials. Nplate is supplied as sterile solution (250 mcg and 500 mcg) designed for subcutaneous administration. Be sure to. (, See Full Prescribing Information for instructions on reconstitution, preparation, and administration. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. What are the possible side effects of Nplate? For additional information: www.fda.gov/REMS You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication. Romiplostim is a subcutaneous injection into the skin; It is supplied in 250 mcg and 500 mcg vials. 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. 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. Two percent (2/132) of patients (both from cohort 3) developed Grade 4findings (presence of collagen). What is NPLATE (Romiplostim) Tablets? Patients can simply fill the order form or can send mail at info@lucknowpharma.com. Overall, the median platelet count was 19 109/L at study entry. Protect product from light. Va SC. There were no antibodies detected to TPO. The starting dose for all ages was 1mcg/kg weekly. Increased reticulin fiber formation was reported for 18.5% (5 of 27) of patients in cohort 1 and 47.2% (17 of 36) of patients in cohort 2, with a maximum grade of 2. Patients must be closely monitored with weekly platelet counts and CBCs for at least 2weeks following Nplate discontinuation. 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. A postmarketing registry study involving patients with thrombocytopenia on Nplate or a non-US approved romiplostimproduct was conducted to assess the long-term consequences of the anti-romiplostim antibodies. Reconstituted and further diluted product with 0.9% Sodium Chloride Injection, USP can be held in a syringe at room temperature (25C [77F]) or in the original vial refrigerated at 2C to 8C (36F to 46F) for no longer than 4 hours prior to administration. 250 mcg or 500 mcg of deliverable romiplostim in single-use vials ( 3) . 1 1 7/18/2014. Do not freeze.DO NOT SHAKE reconstituted solution, 125 mcg/vialReconstitute with 0.44 mL Sterile Waterfor Injection, USP for a concentration of125 mcg/0.25 mL.For Subcutaneous Use OnlySingle Dose Vial; Discard unused portionDispense the enclosed MedicationGuide to each patient.Protect from light. Sixty percent of patients had ITP duration < 3 months and 40% had ITP duration 3 months. Study 3 was a single-arm, open-label study designed to assess the safety and efficacy of Nplate in adult patients who had an insufficient response (platelet count 30 x 109/L) to first-line therapy. No patients in either cohort developed collagen fibrosis (defined as grade 4) or a bone marrow abnormality that was inconsistent with an underlying diagnosis of ITP. Usually dissolves within 2 minutes, Storage Absorption Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4weeks at the highest weekly dose of 10mcg/kg. Your healthcare provider may change your dose or stop Nplate depending upon the change in your blood platelet count. are breastfeeding or plan to breastfeed. References 1. 1 12/12/2016. In some cases, it always advisable to stop the intake of some medicines gradually because of the rebound effect of the medicine. Gently swirl and invert the vial to reconstitute. Study 1 and 2 outcomes are shown in Table 5. As the injection volume may be very small, use a syringe with graduations to 0.01 mL. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. Nplate J2796, injection, romiplostim, 10 mcg Nplate is supplied in single-use vials containing 125 mcg, 250 mcg and 500 mcg deliverable romiplostim The NDC numbers for Nplate, in the 11-digit format, are as follows: - 125-mcg vial: 55513-0223-01 - 250-mcg vial: 55513-0221-01 - 500-mcg vial: 55513-0222-01 Administration 96372, therapeutic . Calculate Volume to Administer by dividing the Calculated Patient Dose (mcg) by the final concentration of prepared solution. 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. The median age of the patients was 10 years (range 1 to 17 years) and the median and maximum duration of treatment were 156 weeks and 163 weeks, respectively. Follow the dose adjustment guidelines [see Dosage and Administration (2.1)]. romiPLOStim 250 MCG Injection: Description of concept identifier: Term Type (TTY) PSN: Term type in source with name and description: Term Type Name: Prescribable Name: Name of term type in source: Term Type Description: Synonym of another TTY, given for clarity and for display purposes in electronic prescribing applications. Romiplostim Therapeutic Classification Anticoagulants and Antiplatelets. The safety analysis set includes all subjects who received at least one dose of romiplostim in study 7. Seller Information Manufactured By. Do not pool unused portions from the vials. For injection: 250 mcg or 500 mcg of deliverable Romiplostim as a lyophilized powder in single-dose vials. *** Add 0.9% Sodium Chloride Injection, USP directly to the vial. Reconstitute Nplate with Sterile Water for Injection, USP. You must have blood platelet counts done before you start, during, and after Nplate therapy is stopped (. Romiplostim 250 MCG /0.5ML. In addition, in 3 (4.2%) patients, increased peripheral blood blast cell counts decreased to baseline after discontinuation of 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. The 10 mcg/kg dosing regimen for humans is based on population modeling and simulation analyses. It is always better to check the credential of the whole-seller/supplier/exporter before buying the product. Among 291adultpatients with ITP who received Nplate in the single-arm extension study, the incidence rates of the adverse reactions occurred in a pattern similar to those reported in the placebo-controlled clinical studies. Intact Vials. Validating our sources through stringent internal procedure and adopting measures to ensure the genuineness of the medicines is our speciality. The new expiration date must be written in the space provided on the carton. ROMY 250MCG INJECTIONMfr: INTAS PHARMACEUTICAL, ROMISET 250MCG/6ML INJECTIONMfr: ALKEM LABORATORIES LTD. We ensure the surety of getting the genuine medicine by sourcing the medicine only from the company or company authorized super distributors. In rat and rabbit embryo-fetal development toxicity studies, no evidence of fetal harm was observed at romiplostim doses up to 11times (rats) and 82times (rabbits) the maximum human dose (MHD) based on systemic exposure (AUC). Protect reconstituted product from light. river cruise restaurant. Detection of peripheral blood cell abnormalities may necessitate a bone marrow examination. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. View NDC Code(s)NEW! Country of Origin . Romiplostim Injection 250 mcg. Registered under GST Act. Round volume to the nearest hundredth mL. Patients can also send WhatsApp messages to +91-9555306364 We will reply ASAP with the details of the Romiplostim Injection price as well as procurement procedure. During the study, the median weekly Nplate dose was 3mcg/kg (25th-75th percentile: 2-4mcg/kg). Each single-dose 500 mcg vial of Nplate contains the following: 500 mcg romiplostim, L-histidine (1.9 mg), mannitol (50 mg), polysorbate 20 (0.05 mg), sucrose (25 mg), and sufficient HCl to adjust the pH to a target of 5. 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. Active Pharmaceutical Ingredient Romiplostim 250 mcg. FDA Safety Recalls, 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)]. The new expiration date must be written in the space provided on the carton 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. It is used to treat immune primary thrombocytopenia (called ITP). Do not freeze "Nplate (romiplostim) injection, powder, lyophilized, for solution [amgen inc]". Rescue therapies (i.e., corticosteroids, IVIG, platelet transfusions, anti-D immunoglobulin, dapsone, danazol, and azathioprine) were permitted. Last updated on Feb 1, 2021. - Usually dissolves within 2 minutes. 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. It's wise to get in touch with your doctor as a professional advice is needed in this case regarding your health, medications and further recommendation to give you a stable health condition. Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. Dissolution usually takes less than 2 min. Study 2 evaluated patients who had undergone a splenectomy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Adverse Reactions Identified inTwo Placebo-Controlled Studies, Musculoskeletal and Connective Tissue Disorders, Table 4. Patients were administered romiplostim by SC injection once weekly for up to 3years. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Injection volume may be very small; use syringe with graduations to 0.01 mL. Medically reviewed by Drugs.com.
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