Dermatology Made Easy is based on the most popular topics from DermNet NZ's vast array of material. The book combines the essential focus of the ‘Made Easy’ book series with the authority and knowledge base of DermNet NZ's unparalleled resources.
Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand; Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2015.
Nivolumab (OPDIVO®, Bristol Myers Squibb, New Jersey, USA) is a human programmed death receptor-1 (PD-1)-blocking antibody, approved in Japan and the USA for treatment of advanced melanoma.
In December 2014, the US Food and Drug Administration (FDA) approved the use of nivolumab in:
In October 2015, nivolumab was approved for use in combination with ipilimumab for improved response in advanced melanoma (unresectable or metastatic disease). In January 2016, it was also approved in untreated BRAF-wild type melanoma.
In the European Union, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application for Nivolumab in advanced melanoma. The application has also been granted accelerated assessment by the EMA’s CHMP (Committee for Medicinal Products for Human Use). Nivolumab is available in New Zealand, and funded by PHARMAC for some cases of metastatic and unresectable advanced melanoma.
No formal pharmacokinetic drug-drug interaction studies have been conducted with nivolumab.
Other clinically important adverse events occurring at an incidence of 1–10% have included:
A clinical trial of the combination of nivolumab and ipilimumab had 36% dropout due to side effects, mainly diarrhoea and elevated liver function tests.
Skin complications are common in patients treated with nivolumab, with about 40% of patients experiencing these, with mean onset of rash being about 10 months into the course of treatment. Reported reactions include:
Darkening of hair has been reported in a few patients taking PD-1 inhibitors for non-small cell lung cancer .
The safety and effectiveness of nivolumab has not been established in paediatric patients.
Clinical studies of nivolumab did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients.
Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with renal impairment.
Based on a population pharmacokinetic analysis, no dose adjustment is recommended for patients with mild hepatic impairment. Nivolumab has not been studied in patients with moderate or severe hepatic impairment.
Feldstein SI, Patel F, Larsen L, Kim E, Hwang S, Fung MA. Eruptive keratoacanthomas arising in the setting of lichenoid toxicity after programmed cell death 1 inhibition with nivolumab. J Eur Acad Dermatol Venereol. 2017 Aug 3. doi: 10.1111/jdv.14503. [Epub ahead of print] PubMed PMID: 28776778. PubMed.
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