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Return to previous pageNplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune... Read more
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy... Read more
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.
When should I prescribe Nplate® for my patients with adult chronic immune thrombocytopenia (ITP)?
How is Nplate® administered or dosed?
How quickly does Nplate® work, and when may a platelet response become apparent?
Is financial assistance available for patients on treatment with Nplate®?
Who should I contact if I have a question about Nplate® or would like to report an adverse event?
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
1Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.
1Review the Nplate® pivotal trials dataNplate® is administered once weekly by subcutaneous injection. The initial dose for Nplate® is 1 mcg/kg based on the patient's actual body weight at initiation.
1 Please refer to the full Prescribing Information for complete dosing and administration information including reconstitution, dose adjustments, and monitoring requirements. 1Full Prescribing InformationIndividual responses on Nplate® will vary from patient to patient.
In the two parallel, double-blind, phase 3 trials, patients with ITP who had completed at least one prior treatment and had a platelet count of ≤ 30 x 109/L prior to study entry were randomized (2:1) to 24 weeks of Nplate® (1 mcg/kg subcutaneous) or placebo.
, 1,7Dose adjustments were based on platelet counts. Patients could have doses of concurrent ITP medications adjusted only during the first 12 weeks.
, 1,7Weeks 0-3 platelet counts across two 6-month pivotal trials
50% of patients achieved median platelet counts of ≥ 50 x 109/L within 2-3 weeks. 7
Durable platelet response
61% of non-splenectomized patients achieved a durable platelet response during the last 8 weeks of the study. , 1,7
Overall platelet response
Nplate® restored stability for 8 out of 10 patients during the study. ,*1,7,*
In the long-term extension study
The majority of patients reached a platelet count of ≥ 50 x 109/L after receiving 1 to 3 doses. ,†1,†
*Based on Overall Platelet Response (88%) in non-splenectomized patients.
, 1,7†Interim analysis: included patients from the two pivotal trials (n = 100).
1‡Final analysis: includes patients from the two pivotal trials and additional studies (n = 291).
8Review the Nplate® pivotal trials dataIf a patient misses their scheduled dose of Nplate®, they should call their healthcare provider to arrange for their next dose as soon as possible.
If a patient plans to travel, the patient or their healthcare provider can call Nplate® Navigator in advance at 1-855-7Nplate (1‑800‑772‑6436). An Nplate® Navigator patient support specialist will access a list of board-certified physicians who may be able to give the patient their Nplate® injection at their destination.
Please note that Amgen does not endorse or recommend any healthcare provider. In consultation with their healthcare provider, the patient should make his or her own decision regarding their treatment options.
Learn more about Nplate® Navigator67% of patients pay $0 out-of-pocket (OOP) for Nplate®.
9,*Amgen Assist 360™ provides your patients access to support for Nplate®.
Contact Amgen Assist 360™ at 1-888-4ASSIST (1-888-427-7478) or visit AmgenAssist360.com for more information.
*Data based on IMS Remit Data for 2016 for all payors, including commercial and government. Claims included in this analysis were categorized according to patient OOP costs for Nplate®. The majority of patients who do have OOP costs pay between $0 and $300 dollars.
9Learn more about Amgen Assist 360™If you have a clinical question about Nplate® or would like to report an adverse event related to Nplate®, please contact Amgen Medical Information. Amgen healthcare professionals can be accessed 24/7.
Call 1‑800‑77‑AMGEN (1‑800‑772‑6436) or access Amgen Medical Information online.
Connect with AmgenWomen who become pregnant during Nplate® treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1‑800‑77‑AMGEN (1‑800‑772‑6436) to enroll.
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.
Please see full Prescribing Information and Medication Guide.
Women who become pregnant during Nplate® treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1‑800‑77‑AMGEN (1‑800‑772‑6436) to enroll.
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.
Please see full Prescribing Information and Medication Guide.
References: 1. Nplate® (romiplostim) prescribing information, Amgen. 2. Cines DB, McMillan R. Management of adult idiopathic thrombocytopenic purpura. Annu Rev Med. 2005;56:425-442. 3. Cines DB, Blanchette VS. Immune thrombocytopenic purpura. N Engl J Med. 2002;346:995-1008. 4. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115:168-186. 5. Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117:4190-4207. 6. Wang B, Nichol JL, Sullivan JT. Pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoietin receptor ligand. Clin Pharmacol Ther. 2004;76:628-638. 7. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008;371:395-403. 8. Kuter DJ, Bussel JB, Newland A, et al. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013;161:411-423. 9. Data on file, Amgen.
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