Difference between revisions of "Eltrombopag (Promacta)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 11/20/2008: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129214.htm Initial FDA approval] for treatment of "thrombocytopenia in patients with | + | * 11/20/2008: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129214.htm Initial FDA approval] for treatment of "thrombocytopenia in patients with [[Autoimmune thrombocytopenic purpura (ITP) | chronic immune (idiopathic) thrombocytopenia (ITP)]] who have had an insufficient response to [[:Category:Steroids|corticosteroids]], immunoglobulins, or splenectomy." |
* 11/19/2012: FDA approved for treatment of "thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy." | * 11/19/2012: FDA approved for treatment of "thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy." | ||
* 8/26/2014: FDA approved for "patients with [[Aplastic anemia | severe aplastic anemia]] who have had an insufficient response to immunosuppressive therapy." | * 8/26/2014: FDA approved for "patients with [[Aplastic anemia | severe aplastic anemia]] who have had an insufficient response to immunosuppressive therapy." | ||
| + | * 8/24/2015: FDA approved for "the treatment of thrombocytopenia in pediatric patients 1 year and older with [[Autoimmune thrombocytopenic purpura (ITP) |chronic immune (idiopathic) thrombocytopenia (ITP)]] who have had an insufficient response to [[:Category:Steroids|corticosteroids]], immunoglobulins, or splenectomy." | ||
==Also known as== | ==Also known as== | ||
Revision as of 17:54, 24 August 2015
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), 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
- 11/20/2008: Initial FDA approval for treatment of "thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy."
- 11/19/2012: FDA approved for treatment of "thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy."
- 8/26/2014: FDA approved for "patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy."
- 8/24/2015: FDA 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."
Also known as
Revolade, SB-497115-GR.