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.
Reasons to choose Nplate® first at 2L,
the brand you know—proven:1
CLINICAL STUDIES DEMONSTRATED:
Rapid Efficacy That Lasts2,3
Nplate® is the only approved immune thrombocytopenia (ITP) therapy with treatment-free remission in the label2,3
Lasting stability: 61% of patients achieved a response for ≥ 11 months (n = 46/75)3
*Platelet response was defined as a platelet count ≥ 50 x 109/L during 12-month treatment period.2
†95% CI: 1.1, 3.0; 5.56%, 47.22%, and 61.11% of patients responded by weeks 1, 2, and 3, respectively.2,5
‡Rituximab is not FDA-approved for use in ITP.7
Choose Nplate® first when your ITP patient needs second-line treatment.3
See the study data on rapid and lasting efficacy
Established Safety Profile Without Food Restrictions
Nplate® is the once-weekly, in-office, subcutaneous injection that offers:
*Long-term safety data: Based on an open-label, single-arm, extension study of 291 adults with chronic ITP who had at least one dose of Nplate®. Subjects could enter any time during the 277-week period. Mean treatment duration was 110 weeks. Study results: AEs did not increase in frequency or type with longer Nplate® drug exposure. Primary assessment/incidence: Serious treatment-related AEs, 8% (24/291); thrombotic events, 6.5% (19/291); bone marrow reticulin increase, 1.4% (4/291); neutralizing antibody formation, < 1% (2/291); and deaths, 5% (16/291).2,9
AFTER THE CLINICAL DECISION HAS BEEN MADE, CONSIDER THAT:
Nplate® Has the Highest Percentage of Patient Claims With $0 OOP Costs vs Oral Agents* and Broad Coverage13,14
$0 OOP costs for Nplate®13
$0 OOP costs for
oral ITP medications13
*Analysis from 2020 to 2021 for Commercial and Medicare patient claims combined. Data based on IQVIA LAAD claims data. Oral OOP percent is a weighted average of claims for eltrombopag, avatrombopag, and fostamatinib disodium hexahydrate.13
2L, second line; AE, adverse event; ASH, American Society of Hematology; CI, confidence interval; OOP, out-of-pocket; TPO-RA, thrombopoietin receptor agonist.
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. Lozano ML, Mingot-Castellano ME, Perera MM, et al. Deciphering predictive factors for choice of thrombopoietin receptor agonist, treatment free responses, and thrombotic events in immune thrombocytopenia. Sci Rep. 2019;9(1):16680. 2. Nplate® (romiplostim) prescribing information, Amgen. 3. 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. 4. Data on file, Amgen; Clinical Study Report 20080435; 2014. 5. Data on file, Amgen; Time to Onset, biostatistical analysis; 2019. 6. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866. 7. Rituxan® (rituximab) full Prescribing Information, Genentech. 8. 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(Suppl):1-4. 9. 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(3):411-423. 10. Promacta® (eltrombopag) full Prescribing Information, Novartis. 11. Doptelet® (avatrombopag) full Prescribing Information, Sobi. 12. Tavalisse® (fostamatinib disodium hexahydrate) full Prescribing Information, Rigel. 13. Data on file, Amgen; Nplate® IQVIA LAAD 2020 and 2021 OOP Cost Analysis Medicare Commercial Combined ALL; 2022. 14. Data on file, Amgen; Nplate® - coverage from MMIT; 2022.