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
Adult Remission Data
The Side Effect Profile Was Consistent With the Known Profile of Nplate®
No new safety signals were observed. Most adverse events were mild to moderate in severity7
Most common adverse events during the treatment period (N = 75)7
ADVERSE EVENT | n (%) |
---|---|
Headache | 12 (16) |
Arthralgia | 11 (15) |
Nasopharyngitis | 9 (12) |
Hematoma | 8 (11) |
Cough | 7 (9) |
Most common (≥ 5%) bleeding events during the treatment period (N = 75)7
BLEEDING EVENT | n (%) |
---|---|
Hematoma | 8 (11) |
Petechiae | 7 (9) |
Epistaxis | 6 (8) |
*Led to discontinuation of Nplate®.
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. Newland A, Godeau B, Priego V, et al. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016;172(2):262-273.