Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for YERVOY:

In combination with nivolumab for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

Adult:

Give by IV infusion over 30mins. 1mg/kg (given after nivolumab 3mg/kg on the same day) every 3 weeks for 4 doses, then followed by nivolumab 240mg every 2 weeks or 480mg every 4 weeks (as single agent) until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Boxed Warning:

Immune-mediated adverse reactions.

Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Permanently discontinue therapy and initiate systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions. Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5mg prednisone or equivalent per day. Monitor for enterocolitis, bowel perforation, corticosteroid-refractory colitis (reevaluate if occurs), hepatitis, dermatitis, neuropathy, endocrinopathy, pneumonitis, nephritis, encephalitis, and others including ocular manifestations; perform clinical chemistries including LFTs, ACTH levels, and thyroid tests at baseline and before each dose. Monitor for infusion-related reactions; discontinue if severe or life-threatening; interrupt or slow infusion rate if mild or moderate. Give steroid eye drops if uveitis, iritis, or episcleritis develops (may need systemic treatment if a Vogt-Koyanagi-Harada-like syndrome develops); permanently discontinue if unresponsive to local therapy. Monitor for GVHD (may be fatal or serious) before or after allogeneic HSCT and treat 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. Nursing mothers: not recommended (during and for 3 months after final dose).

Pharmacologic Class:

Cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody.

Adverse Reactions:

Fatigue, diarrhea, pruritus, rash, colitis, headache, weight loss, nausea, pyrexia, decreased appetite, vomiting, insomnia; immune-mediated reactions, CMV infection/reactivation; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea, dizziness, hypothyroidism, adrenal insufficiency; also with platinum-doublet chemotherapy: constipation.

Note:

To enroll pregnant patients in the Pregnancy Safety Surveillance Study, call (844) 593-7869.

Generic Availability:

NO

How Supplied:

Single-use vial (50mg, 200mg)—1

Colorectal and other GI cancers:

Indications for YERVOY:

In combination with nivolumab for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) in patients ≥12yrs who has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. In combination with nivolumab for the treatment of hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.

Adult:

Give by IV infusion over 30mins. CRC: 1mg/kg (given after nivolumab on the same day) every 3 weeks. HCC: 3mg/kg (given after nivolumab on the same day) every 3 weeks. Both: administer for up to 4 doses or until disease progression or unacceptable toxicity. After completing 4 doses of the combination, give nivolumab as a single agent. Dose modifications: see full labeling.

Children:

Not established.

Boxed Warning:

Immune-mediated adverse reactions.

Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Permanently discontinue therapy and initiate systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions. Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5mg prednisone or equivalent per day. Monitor for enterocolitis, bowel perforation, corticosteroid-refractory colitis (reevaluate if occurs), hepatitis, dermatitis, neuropathy, endocrinopathy, pneumonitis, nephritis, encephalitis, and others including ocular manifestations; perform clinical chemistries including LFTs, ACTH levels, and thyroid tests at baseline and before each dose. Monitor for infusion-related reactions; discontinue if severe or life-threatening; interrupt or slow infusion rate if mild or moderate. Give steroid eye drops if uveitis, iritis, or episcleritis develops (may need systemic treatment if a Vogt-Koyanagi-Harada-like syndrome develops); permanently discontinue if unresponsive to local therapy. Monitor for GVHD (may be fatal or serious) before or after allogeneic HSCT and treat 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. Nursing mothers: not recommended (during and for 3 months after final dose).

Pharmacologic Class:

Cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody.

Adverse Reactions:

Fatigue, diarrhea, pruritus, rash, colitis, headache, weight loss, nausea, pyrexia, decreased appetite, vomiting, insomnia; immune-mediated reactions, CMV infection/reactivation; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea, dizziness, hypothyroidism, adrenal insufficiency; also with platinum-doublet chemotherapy: constipation.

Note:

To enroll pregnant patients in the Pregnancy Safety Surveillance Study, call (844) 593-7869.

Generic Availability:

NO

How Supplied:

Single-use vial (50mg, 200mg)—1

Melanoma and other skin cancers:

Indications for YERVOY:

Treatment of unresectable or ­metastatic melanoma in patients ≥12yrs. Adjuvant treatment of cutaneous melanoma in patients with pathologic involvement of regional lymph nodes >1mm who have undergone complete resection, including total lymphadenectomy.

Adult:

Give by IV infusion over 90mins. Unresectable, metastatic: 3mg/kg every 3 weeks for a maximum of 4 doses; may delay doses if toxicity occurs, but all treatment must be given within 16 weeks of the first dose. Adjuvant: 10mg/kg every 3 weeks for 4 doses, followed by 10mg/kg every 12 weeks for up to 3 years; may omit doses if toxicity occurs. Dose modifications: see full labeling.

Children:

Not established.

Boxed Warning:

Immune-mediated adverse reactions.

Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Permanently discontinue therapy and initiate systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions. Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5mg prednisone or equivalent per day. Monitor for enterocolitis, bowel perforation, corticosteroid-refractory colitis (reevaluate if occurs), hepatitis, dermatitis, neuropathy, endocrinopathy, pneumonitis, nephritis, encephalitis, and others including ocular manifestations; perform clinical chemistries including LFTs, ACTH levels, and thyroid tests at baseline and before each dose. Monitor for infusion-related reactions; discontinue if severe or life-threatening; interrupt or slow infusion rate if mild or moderate. Give steroid eye drops if uveitis, iritis, or episcleritis develops (may need systemic treatment if a Vogt-Koyanagi-Harada-like syndrome develops); permanently discontinue if unresponsive to local therapy. Monitor for GVHD (may be fatal or serious) before or after allogeneic HSCT and treat 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. Nursing mothers: not recommended (during and for 3 months after final dose).

Pharmacologic Class:

Cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody.

Adverse Reactions:

Fatigue, diarrhea, pruritus, rash, colitis, headache, weight loss, nausea, pyrexia, decreased appetite, vomiting, insomnia; immune-mediated reactions, CMV infection/reactivation; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea, dizziness, hypothyroidism, adrenal insufficiency; also with platinum-doublet chemotherapy: constipation.

Note:

To enroll pregnant patients in the Pregnancy Safety Surveillance Study, call (844) 593-7869.

Generic Availability:

NO

How Supplied:

Single-use vial (50mg, 200mg)—1

Respiratory and thoracic cancers:

Indications for YERVOY:

In combination with nivolumab for first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations, as determined by an FDA-approved test. In combination with nivolumab and 2 cycles of platinum-doublet chemotherapy for first-line treatment of metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations.

Adult:

Give by IV infusion over 30mins. ≥18yrs: 1mg/kg every 6 weeks with nivolumab 3mg/kg every 2 weeks (metastatic NSCLC with PD-L1 expression) or nivolumab 360mg every 3 weeks and histology-based platinum doublet chemotherapy every 3 weeks for 2 cycles (metastatic or recurrent NSCLC). Continue until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression. Dose modifications: see full labeling.

Children:

Not established.

Boxed Warning:

Immune-mediated adverse reactions.

Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Permanently discontinue therapy and initiate systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions. Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5mg prednisone or equivalent per day. Monitor for enterocolitis, bowel perforation, corticosteroid-refractory colitis (reevaluate if occurs), hepatitis, dermatitis, neuropathy, endocrinopathy, pneumonitis, nephritis, encephalitis, and others including ocular manifestations; perform clinical chemistries including LFTs, ACTH levels, and thyroid tests at baseline and before each dose. Monitor for infusion-related reactions; discontinue if severe or life-threatening; interrupt or slow infusion rate if mild or moderate. Give steroid eye drops if uveitis, iritis, or episcleritis develops (may need systemic treatment if a Vogt-Koyanagi-Harada-like syndrome develops); permanently discontinue if unresponsive to local therapy. Monitor for GVHD (may be fatal or serious) before or after allogeneic HSCT and treat 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. Nursing mothers: not recommended (during and for 3 months after final dose).

Pharmacologic Class:

Cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody.

Adverse Reactions:

Fatigue, diarrhea, pruritus, rash, colitis, headache, weight loss, nausea, pyrexia, decreased appetite, vomiting, insomnia; immune-mediated reactions, CMV infection/reactivation; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea, dizziness, hypothyroidism, adrenal insufficiency; also with platinum-doublet chemotherapy: constipation.

Note:

To enroll pregnant patients in the Pregnancy Safety Surveillance Study, call (844) 593-7869.

Generic Availability:

NO

How Supplied:

Single-use vial (50mg, 200mg)—1