Difference between revisions of "Romiplostim (Nplate)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 8/22/2008: Initial | + | * 8/22/2008: Initial approval |
* 12/14/2018: Approved for pediatric patients 1 year of age and older with [[Immune thrombocytopenia|immune thrombocytopenia (ITP)]] for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. | * 12/14/2018: Approved for pediatric patients 1 year of age and older with [[Immune thrombocytopenia|immune thrombocytopenia (ITP)]] for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. | ||
| − | + | ==History of changes in EMA indication== | |
| + | *2/4/2009: Initial authorization | ||
==Also known as== | ==Also known as== | ||
*'''Brand name:''' Nplate | *'''Brand name:''' Nplate | ||
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[[Category:FDA approved in 2008]] | [[Category:FDA approved in 2008]] | ||
| + | [[Category:EMA approved in 2008]] | ||
Revision as of 13:56, 31 December 2022
General information
Class/mechanism: Thrombopoietin (TPO/cMpl) receptor agonist. Romiplostim is an Fc-peptide fusion protein (peptibody) that interacts with the TPO receptor to trigger downstream signal cascades that ultimately stimulate platelet production by promoting proliferation and differentiation of megakaryocytes from bone marrow progenitor cells.[1][2][3]
Route: SC
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Romiplostim (Nplate) package insert[1]
- Romiplostim (Nplate) patient drug information (Chemocare)[4]
- Romiplostim (Nplate) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 8/22/2008: Initial approval
- 12/14/2018: Approved for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
History of changes in EMA indication
- 2/4/2009: Initial authorization
Also known as
- Brand name: Nplate