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NIVOLUMAB
DIR Classification
Classification:Most-DIR concern
Severity Score:4
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- Other Immune-Mediated Adverse Reactions
- OPDIVO can cause other clinically significant and potentially fatal immune-mediated adverse reactions. Immune-mediated adverse reactions may occur after discontinuation of OPDIVO therapy. For any suspected immune-mediated adverse reactions, exclude other causes. Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and if appropriate, initiate hormone-replacement therapy. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider restarting OPDIVO after completion of corticosteroid taper based on the severity of the event [see DOSAGE AND ADMINISTRATION (2.10)].
- Across clinical trials of OPDIVO administered as a single agent or in combination with ipilimumab, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in less than 1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, and myasthenic syndrome.
- If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO or OPDIVO in combination with ipilimumab and may require treatment with systemic steroids to reduce the risk of permanent vision loss.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
60
42852
Other ADRs
14736
14102543
Odds Ratio = 1.34
Drug Property Information
ATC Code(s):
- L01XC17 - nivolumab
- L01XC - Monoclonal antibodies
- L01X - OTHER ANTINEOPLASTIC AGENTS
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:nivolumab
Active Ingredient UNII:31YO63LBSN
Drugbank ID:DB09035
PubChem Compound:N/A
CAS Number:946414-94-4
Dosage Form(s):injection
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure: 
SMILE Code:
-
-
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: A Case of Nivolumab-Induced Severe Mononeuropathy Multiplex and Rhabdomyolysis.
[Sakai Katsuya,Mochizuki Hitoshi,Mochida Kosuke,Shiomi Kazutaka,Amano Masahiro,Nakazato Masamitsu]Case Rep Med.2017;2017:1093858. doi: 10.1155/2017/1093858. Epub 2017 Oct 22. PMID: 29312452
2: PD-1 Inhibitor-associated Myopathies: Emerging Immune-mediated Myopathies.
[Liewluck Teerin,Kao Justin C,Mauermann Michelle L]J Immunother.2017 Dec 1. doi: 10.1097/CJI.0000000000000196. [Epub ahead of print] PMID: 29200081
3: Smoldering myocarditis following immune checkpoint blockade.
[Norwood Timothy G,Westbrook Brian C,Johnson Douglas B,Litovsky Silvio H,Terry Nina L,McKee Svetlana B,Gertler Alan S,Moslehi Javid J,Conry Robert M]J Immunother Cancer.2017 Nov 21;5(1):91. doi: 10.1186/s40425-017-0296-4. PMID: 29157297
4: Fatal myocarditis and rhabdomyolysis induced by nivolumab during the treatment of type B3 thymoma.
[Chen Qiang,Huang Dang-Sheng,Zhang Li-Wei,Li Yuan-Qing,Wang Hong-Wei,Liu Hong-Bin]Clin Toxicol (Phila).2017 Nov 10:1-5. doi: 10.1080/15563650.2017.1401079. [Epub ahead of print] PMID: 29126352
5: Fulminant Myocarditis with Combination Immune Checkpoint Blockade.
[Johnson Douglas B,Balko Justin M,Compton Margaret L,Chalkias Spyridon,Gorham Joshua,Xu Yaomin,Hicks Mellissa,Puzanov Igor,Alexander Matthew R,Bloomer Tyler L,Becker Jason R,Slosky David A,Phillips Elizabeth J,Pilkinton Mark A,Craig-Owens Laura,Kola Nina,Plautz Gregory,Reshef Daniel S,Deutsch Jonathan S,Deering Raquel P,Olenchock Benjamin A,Lichtman Andrew H,Roden Dan M,Seidman Christine E,Koralnik Igor J,Seidman Jonathan G,Hoffman Robert D,Taube Janis M,Diaz Luis A,Anders Robert A,Sosman Jeffrey A,Moslehi Javid J]N Engl J Med.2016 Nov 3;375(18):1749-1755. PMID: 27806233
6: Acute rhabdomyolysis with severe polymyositis following ipilimumab-nivolumab treatment in a cancer patient with elevated anti-striated muscle antibody.
[Bilen Mehmet Asim,Subudhi Sumit K,Gao Jianjun,Tannir Nizar M,Tu Shi-Ming,Sharma Padmanee]J Immunother Cancer.2016 Jun 21;4:36. doi: 10.1186/s40425-016-0139-8. eCollection 2016. PMID: 27330809
7: Acetylcholine receptor binding antibody-associated myasthenia gravis and rhabdomyolysis induced by nivolumab in a patient with melanoma.
[Shirai Takushi,Sano Tasuku,Kamijo Fuminao,Saito Nana,Miyake Tomomi,Kodaira Minori,Katoh Nagaaki,Nishie Kenichi,Okuyama Ryuhei,Uhara Hisashi]Jpn J Clin Oncol.2016 Jan;46(1):86-8. doi: 10.1093/jjco/hyv158. Epub 2015 Oct 21. PMID: 26491202
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