Description
IV Administration
β 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
β Do not administer other medications through the same IV line
β Flush IV line at the end of the infusion
Combination Therapy with Ipilimumab
β When administered in combination with ipilimumab, infuse nivolumab first followed by ipilimumab on the same day
β Use separate infusion bags and filters for each infusion
β If nivolumab therapy is withheld, ipilimumab should also be withheld
Storage
Intact Vials
β Store intact vials at 2Β°C to 8Β°C (36Β°F to 46Β°F)
β Do not freeze
β Protect from light
β Do not shake
IV Infusion Solution
β 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 2Β°C to 8Β°C (36Β°F to 46Β°F) for up to 24 hours (including infusion time)
β Infusion must be completed within 24 hours of preparation
β Do not freeze solutions prepared for infusion.
Monitoring
β Hepatic and renal function tests (baseline and periodic)
β Thyroid function (baseline and periodically [at treatment day 1 and every 6 weeks])
β Blood glucose
β Monitor for signs/symptoms of adrenal insufficiency, hypophysitis, thyroid disorders, immune-mediated colitis, pneumonitis, rash/dermatologic toxicity, encephalitis (changes in neurologic function)
β Monitor for infusion reactions.