Difference between revisions of "Eltrombopag (Promacta)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Thrombopoietin (TPO) receptor agonist; interacts with the transmembrane domain of 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">[ | + | Class/mechanism: Thrombopoietin (TPO) receptor agonist; interacts with the transmembrane domain of 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">[https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/promacta.pdf Eltrombopag (Promacta) package insert]</ref><ref>[[:File:Eltrombopag.pdf | Eltrombopag (Promacta) package insert (locally hosted backup)]]</ref><ref>[https://www.hcp.novartis.com/products/promacta Promacta manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<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 or the prescribing information.<ref name="insert"></ref> |
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Aplastic anemia]] | ||
| + | *[[Immune thrombocytopenia]] | ||
==Patient drug information== | ==Patient drug information== | ||
| + | *[https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/promacta.pdf Eltrombopag (Promacta) package insert]<ref name="insert"></ref> | ||
*[http://www.uptodate.com/contents/eltrombopag-patient-drug-information Eltrombopag (Promacta) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/eltrombopag-patient-drug-information Eltrombopag (Promacta) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/eltrombopag-patient-drug-information Eltrombopag (Promacta) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/eltrombopag-patient-drug-information Eltrombopag (Promacta) patient drug information (UpToDate)]</ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | * 2008-11-20: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129214.htm Initial approval] for treatment of thrombocytopenia in patients with [[Immune_thrombocytopenia | chronic immune (idiopathic) thrombocytopenia (ITP)]] who have had an insufficient response to [[:Category:Steroids|corticosteroids]], immunoglobulins, or splenectomy. | ||
| + | * 2012-11-19: Approved for treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ''(Non-hematologic indication)'' | ||
| + | * 2014-08-26: Approved for patients with [[Aplastic anemia | severe aplastic anemia]] who have had an insufficient response to immunosuppressive therapy. | ||
| + | * 2015-08-24: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm459467.htm Approved] for the treatment of thrombocytopenia in pediatric patients 1 year and older with [[Immune_thrombocytopenia |chronic immune (idiopathic) thrombocytopenia (ITP)]] who have had an insufficient response to [[:Category:Steroids|corticosteroids]], immunoglobulins, or splenectomy. | ||
| + | ==History of changes in EMA indication== | ||
| + | *2010-03-11: Initial authorization as Revolade | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2017-08-25: New additional indication and a new dosage for the treatment of [[aplastic anemia]]. | ||
| + | ==Also known as== | ||
| + | *'''Code name:''' SB-497115-GR | ||
| + | *'''Generic name:''' eltrombopag olamine | ||
| + | *'''Brand names:''' Eltrom, Promacta, Revolade | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drugs]] | ||
| + | [[Category:Oral medications]] | ||
| + | [[Category:Hematopoietic growth factors]] | ||
| + | [[Category:Megakaryocyte growth factors]] | ||
| + | |||
| + | [[Category:Aplastic anemia medications]] | ||
| + | [[Category:Immune thrombocytopenia medications]] | ||
| + | |||
| + | [[Category:FDA approved in 2008]] | ||
| + | [[Category:EMA approved in 2010]] | ||
Latest revision as of 00:58, 29 June 2024
General information
Class/mechanism: Thrombopoietin (TPO) receptor agonist; interacts with the transmembrane domain of 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: PO
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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Eltrombopag (Promacta) package insert[1]
- Eltrombopag (Promacta) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 2008-11-20: Initial approval for treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
- 2012-11-19: Approved for treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. (Non-hematologic indication)
- 2014-08-26: Approved for patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
- 2015-08-24: Approved for the treatment of thrombocytopenia in pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
History of changes in EMA indication
- 2010-03-11: Initial authorization as Revolade
History of changes in PMDA indication
- 2017-08-25: New additional indication and a new dosage for the treatment of aplastic anemia.
Also known as
- Code name: SB-497115-GR
- Generic name: eltrombopag olamine
- Brand names: Eltrom, Promacta, Revolade