Keytruda Patient Counseling Information

Immune-Mediated Adverse Reactions: Inform patients of the risk of immune-mediated adverse reactions that may be severe or fatal, may occur after discontinuation of treatment, and may require corticosteroid treatment and interruption or discontinuation of KEYTRUDA. These reactions may include the following [see Precautions].
Pneumonitis: Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath.
Colitis: Advise patients to contact their healthcare provider immediately for diarrhea or severe abdominal pain.
Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, or easy bruising or bleeding.
Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of adrenal insufficiency, hypophysitis, hypothyroidism, hyperthyroidism, or Type 1 diabetes mellitus.
Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis.
Severe skin reactions: Advise patients to contact their healthcare provider immediately for any signs or symptoms of severe skin reactions, SJS or TEN.
Other immune-mediated adverse reactions: Advise patients that immune-mediated adverse reactions can occur and may involve any organ system, and to contact their healthcare provider immediately for any new or worsening signs or symptoms.
Advise patients of the risk of solid organ transplant rejection and to contact their healthcare provider immediately for signs or symptoms of organ transplant rejection.
Infusion-Related Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Precautions].
Complications of Allogeneic HSCT: Advise patients of the risk of post-allogeneic hematopoietic stem cell transplantation complications [see Precautions].
Embryo-Fetal Toxicity: Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Precautions and Use in Pregnancy & Lactation].
Advise females of reproductive potential to use effective contraception during treatment with KEYTRUDA and for 4 months after the last dose [see Precautions and Use in Pregnancy & Lactation].
Lactation: Advise women not to breastfeed during treatment with KEYTRUDA and for 4 months after the last dose [see Use in Pregnancy & Lactation].
Laboratory Tests: Advise patients of the importance of keeping scheduled appointments for blood work or other laboratory tests [see Precautions].