Description
IV Administration
– Administer as an IV infusion over 60 minutes through a line with a sterile, nonpyrogenic, low protein binding 0.2 to 1.2 micrometer in-line filter
– Do not administer other medications through the same IV line
– Flush IV line at the end of the infusion
Combination Therapy with Ipilimumab
– When administered in combination with ipilimumab, infuse nivolumab first followed by ipilimumab on the same day
– Use separate infusion bags and filters for each infusion
– If nivolumab therapy is withheld, ipilimumab should also be withheld
Storage
Intact Vials
– Store intact vials at 2°C to 8°C (36°F to 46°F)
– Do not freeze
– Protect from light
– Do not shake
IV Infusion Solution
– After preparation in NS or D5W, store the infusion solution at room temperature for no more than 8 hours (including infusion time) or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours (including infusion time)
– Infusion must be completed within 24 hours of preparation
– Do not freeze solutions prepared for infusion.
Monitoring
– Hepatic and renal function tests (baseline and periodic)
– Thyroid function (baseline and periodically [at treatment day 1 and every 6 weeks])
– Blood glucose
– Monitor for signs/symptoms of adrenal insufficiency, hypophysitis, thyroid disorders, immune-mediated colitis, pneumonitis, rash/dermatologic toxicity, encephalitis (changes in neurologic function)
– Monitor for infusion reactions.