Warnings and Precautions

Question 1

Immune-mediated pneumonitis

Answer 1

Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis.

Question 2

Immune-mediated colitis

Answer 2

Withhold OPDIVO (nivolumab) when given as a single agent for moderate or severe and permanently discontinue for life-threatening colitis. Withhold OPDIVO when given with ipilimumab for moderate and permanently discontinue for severe or life-threatening colitis.

Question 3

Immune-mediated hepatitis

Answer 3

Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation.

Question 4

Immune-mediated endocrinopathies

Answer 4

Withhold for moderate or severe and permanently discontinue for life-threatening hypophysitis. Withhold for moderate
and permanently discontinue for severe or life-threatening adrenal insufficiency. Monitor for changes in thyroid function. Initiate thyroid hormone replacement as needed. Monitor for hyperglycemia. Withhold for severe and permanently discontinue for life-threatening hyperglycemia.

Question 5

Immune-mediated nephritis and renal dysfunction

Answer 5

Monitor for changes in renal function. Withhold for moderate or severe and permanently discontinue for life-threatening serum creatinine elevation.

Question 6

Immune-mediated rash

Answer 6

Withhold for severe and permanently discontinue for

life-threatening rash.

Question 7

Immune-mediated encephalitis

Answer 7

Monitor for changes in neurologic function. Withhold for new-onset moderate to severe neurological signs or symptoms and permanently
discontinue for immune-mediated encephalitis.

Question 8

Infusion reactions

Answer 8

Discontinue OPDIVO for severe and life-threatening infusion
reactions. Interrupt or slow the rate of infusion in patients with mild or moderate
infusion reactions.

Question 9

Complications of allogeneic HSCT after OPDIVO

Answer 9

Monitor for hyperacute graft-versushost-
disease (GVHD), grade 3-4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions.
Transplant-related mortality has occurred.

Question 10

Embryo-fetal toxicity

Answer 10

Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.