Difference between revisions of "Nivolumab (Opdivo)"
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| − | = | + | ==General information== |
| − | + | Class/mechanism: PD-1 receptor antibody. Nivolumab is an IgG4 kappa human monoclonal antibody which binds to the PD-1 (programmed death receptor-1) receptor and binds its interaction with the ligands PD-L1 and PD-L2. Normally, PD-L1 and PD-L2 binding to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production, which can impede immune system surveillance of tumors. By interfering with the binding of PD-L1 and PD-L2 to the PD-1 receptor, nivolumab can cause upregulation of the anti-tumor immune response.<ref name=insert>[http://packageinserts.bms.com/pi/pi_opdivo.pdf Nivolumab (Opdivo) package insert]</ref><ref>[[Media:Nivolumab.pdf | Nivolumab (Opdivo) package insert (locally hosted backup)]]</ref><ref>[http://www.opdivo.com/ Opdivo manufacturer's website]</ref> | |
| + | <br>Route: IV | ||
| + | <br>Extravasation: no information | ||
| − | = | + | 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> |
| − | ==[[Hodgkin lymphoma]]== | + | ==Diseases for which it is used== |
| + | *[[Melanoma]] | ||
| + | |||
| + | ==Preliminary data== | ||
| + | |||
| + | ===[[Hodgkin lymphoma]]=== | ||
# Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 Blockade with Nivolumab in Relapsed or Refractory Hodgkin's Lymphoma. N Engl J Med. 2014 Dec 6. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1411087 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/25482239 PubMed] | # Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 Blockade with Nivolumab in Relapsed or Refractory Hodgkin's Lymphoma. N Engl J Med. 2014 Dec 6. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1411087 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/25482239 PubMed] | ||
| − | == | + | ==Patient drug information== |
| − | + | *[http://packageinserts.bms.com/pi/pi_opdivo.pdf Nivolumab (Opdivo) package insert]<ref name="insert"></ref> | |
| − | + | ||
| − | + | ==History of changes in FDA indication== | |
| + | *12/22/2014: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm427716.htm FDA approved] "for the treatment of patients with unresectable or metastatic [[melanoma]] and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor." | ||
| + | |||
| + | ==Also known as== | ||
| + | BMS-936558, MDX-1106. | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drug index]] | [[Category:Drug index]] | ||
| − | + | [[Category:Chemotherapy]] | |
| − | [[Category: | ||
| − | |||
[[Category:Antibody medications]] | [[Category:Antibody medications]] | ||
[[Category:Anti-PD-1 antibodies]] | [[Category:Anti-PD-1 antibodies]] | ||
| Line 22: | Line 34: | ||
[[Category:Melanoma medications]] | [[Category:Melanoma medications]] | ||
| − | [[Category: | + | [[Category:Drugs FDA approved in 2014]] |
Revision as of 06:53, 23 December 2014
General information
Class/mechanism: PD-1 receptor antibody. Nivolumab is an IgG4 kappa human monoclonal antibody which binds to the PD-1 (programmed death receptor-1) receptor and binds its interaction with the ligands PD-L1 and PD-L2. Normally, PD-L1 and PD-L2 binding to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production, which can impede immune system surveillance of tumors. By interfering with the binding of PD-L1 and PD-L2 to the PD-1 receptor, nivolumab can cause upregulation of the anti-tumor immune response.[1][2][3]
Route: IV
Extravasation: no information
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
Preliminary data
Hodgkin lymphoma
- Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 Blockade with Nivolumab in Relapsed or Refractory Hodgkin's Lymphoma. N Engl J Med. 2014 Dec 6. [Epub ahead of print] link to original article PubMed
Patient drug information
History of changes in FDA indication
- 12/22/2014: FDA approved "for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor."
Also known as
BMS-936558, MDX-1106.