Difference between revisions of "Romiplostim (Nplate)"
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==General information== | ==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.<ref name="insert">[http://pi.amgen.com/ | + | 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.<ref name="insert">[http://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/nplate/nplate_pi_hcp_english.ashx Romiplostim (Nplate) package insert]</ref><ref>[[:File:Romiplostim.pdf|Romiplostim (Nplate) package insert (locally hosted backup)]]</ref><ref>[https://www.nplate.com/ Nplate manufacturer's website]</ref> |
<br>Route: SC | <br>Route: SC | ||
<br>Extravasation: n/a | <br>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. | + | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | + | *[[Aplastic anemia]] | |
| − | *[[ | + | *[[Immune thrombocytopenia]] |
==Patient drug information== | ==Patient drug information== | ||
| − | *[http://pi.amgen.com/ | + | *[http://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/nplate/nplate_pi_hcp_english.ashx Romiplostim (Nplate) package insert]<ref name="insert"></ref> |
*[http://chemocare.com/bio/romiplostim.asp Romiplostim (Nplate) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/romiplostim.asp Romiplostim (Nplate) patient drug information (Chemocare)]</ref> | *[http://chemocare.com/bio/romiplostim.asp Romiplostim (Nplate) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/romiplostim.asp Romiplostim (Nplate) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/romiplostim-patient-drug-information Romiplostim (Nplate) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/romiplostim-patient-drug-information Romiplostim (Nplate) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/romiplostim-patient-drug-information Romiplostim (Nplate) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/romiplostim-patient-drug-information Romiplostim (Nplate) patient drug information (UpToDate)]</ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | * 2008-08-22: Initial approval | ||
| + | * 2018-12-14: 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== | ||
| + | *2009-02-04: Initial authorization | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2019-06-18: New indication and a new dosage for the treatment of [[aplastic anemia]] in patients who have not responded sufficiently to conventional treatments. | ||
| + | |||
| + | ==Also known as== | ||
| + | *'''Brand name:''' Nplate | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drugs]] | ||
| + | [[Category:Subcutaneous medications]] | ||
| + | |||
| + | [[Category:Hematopoietic growth factors]] | ||
| + | [[Category:Megakaryocyte growth factors]] | ||
| + | |||
| + | [[Category:Hematology medications]] | ||
| + | [[Category:Aplastic anemia medications]] | ||
| + | [[Category:Immune thrombocytopenia medications]] | ||
| + | |||
| + | [[Category:FDA approved in 2008]] | ||
| + | [[Category:EMA approved in 2009]] | ||
Latest revision as of 01:48, 11 June 2023
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
- 2008-08-22: Initial approval
- 2018-12-14: 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
- 2009-02-04: Initial authorization
History of changes in PMDA indication
- 2019-06-18: New indication and a new dosage for the treatment of aplastic anemia in patients who have not responded sufficiently to conventional treatments.
Also known as
- Brand name: Nplate