Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient corticosteroids, immunoglobulins, or splenectomy.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® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than 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.
Nplate® is the once-weekly, in-office treatment that offers:
No new safety signals observed up to 5 years of continuous treatment1
No need to remember to take a pill every day2-5
No liver monitoring, and no known drug interactions or dietary restrictions2,6
Pivotal Trials (Pooled)
The Safety Profile of Nplate® Was Consistent Across Clinical Trial Results
Nplate® vs SOC trial: adverse event summary7
ADVERSE EVENTS | NPLATE® (n = 154) |
CONTROL (n = 75) |
---|---|---|
Serious adverse events, % | 23 | 37 |
Treatment-related serious adverse events, % | 5 | 8 |
Total deaths (none treatment related*), n | 1 | 5 |
Thrombotic events, number of events (rate) | 11 | 2 |
Hematologic malignancy, number of events | 0 | 2 |
Lymphoma | 0 | 1 |
Myelodysplastic syndrome | 0 | 1 |
Rate = adverse event rate per 100 patient-weeks on study medication. Nplate® total patient-weeks = 7,294; SOC total patient-weeks = 3,050.7
Nplate® vs SOC trial: Most common adverse events8
*Not considered treatment related by investigators.7
SOC, standard-of-care.
Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy.
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® 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® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than 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. Kuter DJ, Bussel JB, Newland A. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013;161(3):411-423. 2. Nplate® (romiplostim) prescribing information, Amgen. 3. Promacta® (eltrombopag) full Prescribing Information, Novartis. 4. Doptelet® (avatrombopag) full Prescribing Information, Sobi. 5. Tavalisse® (fostamatinib disodium hexahydrate) full Prescribing Information, Rigel. 6. Data on file, Amgen; Clinical Study Report 20080435; 2014. 7. Kuter DJ, Rummel M, Boccia R, et al. Romiplostim or standard of care in patients with immune thrombocytopenia. N Engl J Med. 2010;363(20):1889-1899. 8. Rummel M, Boccia R, Macik G, et al. Efficacy and safety of romiplostim versus medical standard of care as chronic therapy for nonsplenectomized patients with immune thrombocytopenia (ITP). Haematologica. 2009;94(suppl 2):424.