Yervoy

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related colitis, hepatitis (with or without tumor involvement), dermatologic reactions, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), pneumonitis, nephritis/renal dysfunction, myocarditis, neurological toxicities, ophthalmologic, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain clinical chemistries including LFTs, creatinine, ACTH levels, and thyroid function at baseline and before each dose. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Monitor for infusion-related reactions; discontinue if severe or life-threatening; interrupt or slow infusion rate if mild or moderate. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease) and manage promptly. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after final dose. Pregnancy (esp. during 2^nd & 3^rd trimesters): exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related colitis, hepatitis (with or without tumor involvement), dermatologic reactions, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), pneumonitis, nephritis/renal dysfunction, myocarditis, neurological toxicities, ophthalmologic, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain clinical chemistries including LFTs, creatinine, ACTH levels, and thyroid function at baseline and before each dose. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Monitor for infusion-related reactions; discontinue if severe or life-threatening; interrupt or slow infusion rate if mild or moderate. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease) and manage promptly. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after final dose. Pregnancy (esp. during 2^nd & 3^rd trimesters): exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related colitis, hepatitis (with or without tumor involvement), dermatologic reactions, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), pneumonitis, nephritis/renal dysfunction, myocarditis, neurological toxicities, ophthalmologic, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain clinical chemistries including LFTs, creatinine, ACTH levels, and thyroid function at baseline and before each dose. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Monitor for infusion-related reactions; discontinue if severe or life-threatening; interrupt or slow infusion rate if mild or moderate. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease) and manage promptly. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after final dose. Pregnancy (esp. during 2^nd & 3^rd trimesters): exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related colitis, hepatitis (with or without tumor involvement), dermatologic reactions, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), pneumonitis, nephritis/renal dysfunction, myocarditis, neurological toxicities, ophthalmologic, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain clinical chemistries including LFTs, creatinine, ACTH levels, and thyroid function at baseline and before each dose. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Monitor for infusion-related reactions; discontinue if severe or life-threatening; interrupt or slow infusion rate if mild or moderate. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease) and manage promptly. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after final dose. Pregnancy (esp. during 2^nd & 3^rd trimesters): exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).