Nivolumab

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK); Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2015.

What is nivolumab?

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.

What is nivolumab used for?

In December 2014, the US Food and Drug Administration (FDA) approved the use of nivolumab:

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.

How does nivolumab work?

How is nivolumab administered?

Dosage modifications

Withhold medication for any of the following conditions

Permanently discontinue in any of the following conditions

Link to key clinical-trial evidence about nivolumab

Potential drug interactions with nivolumab

No formal pharmacokinetic drug-drug interaction studies have been conducted with nivolumab.

What are the adverse effects of 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.

Cutaneous adverse effects of nivolumab

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:

Use of nivolumab in pregnancy

Use of nivolumab in nursing mothers

Paediatric use of nivolumab

The safety and effectiveness of nivolumab has not been established in paediatric patients.

Geriatric use of nivolumab

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.

Renal impairment and nivolumab

Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with renal impairment.

Hepatic impairment and nivolumab

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.

New Zealand approved datasheets are the official source of information for these prescription medicines, including approved uses and risk information. Check the individual New Zealand datasheet on the Medsafe website.

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