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 Dosage:

Give by IV infusion over 30mins. ≥18yrs: 1mg/kg (given after nivolumab on the same day) every 3 weeks; after completing 4 doses of the combination, give nivolumab (as a single agent) until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children Dosage:

<18yrs: not established.

YERVOY Warnings/Precautions:

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 2nd & 3rd trimesters): exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).

YERVOY Classification:

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; CMV infection/reactivation; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea, dizziness, hyperthyroidism, hypothyroidism, hypophysitis, adrenal insufficiency; also with platinum-doublet chemotherapy: constipation.

Note:

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

Generic Drug 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 Dosage:

Give by IV infusion over 30mins. ≥12yrs: CRC: 1mg/kg (given after nivolumab on the same day) every 3 weeks. ≥18yrs: HCC: 3mg/kg (given after nivolumab on the same day) every 3 weeks. Both: after completing 4 doses of the combination, give nivolumab (as a single agent) until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children Dosage:

CRC: <12yrs: not established. HCC: <18yrs: not established.

YERVOY Warnings/Precautions:

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 2nd & 3rd trimesters): exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).

YERVOY Classification:

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; CMV infection/reactivation; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea, dizziness, hyperthyroidism, hypothyroidism, hypophysitis, adrenal insufficiency; also with platinum-doublet chemotherapy: constipation.

Note:

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

Generic Drug Availability:

NO

How Supplied:

Single-use vial (50mg, 200mg)—1

Melanoma and other skin cancers:

Indications for: YERVOY

As a single agent or in combination with nivolumab for the treatment of unresectable or ­metastatic melanoma. Adjuvant treatment of cutaneous melanoma in patients with pathologic involvement of regional lymph nodes >1mm who have undergone complete resection, including total lymphadenectomy.

Adult Dosage:

Give by IV infusion over 90mins. ≥12yrs: Single agent: 3mg/kg every 3 weeks for a maximum of 4 doses. In combination with nivolumab: 3mg/kg every 3 weeks (given after nivolumab on the same day) for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier; after completing 4 doses of the combination, give nivolumab (as a single agent) until disease progression or unacceptable toxicity. ≥18yrs: 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 Dosage:

Unresectable, metastatic melanoma: <12yrs: not established. Adjuvant treatment: <18yrs: not established.

YERVOY Warnings/Precautions:

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 2nd & 3rd trimesters): exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).

YERVOY Classification:

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; CMV infection/reactivation; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea, dizziness, hyperthyroidism, hypothyroidism, hypophysitis, adrenal insufficiency; also with platinum-doublet chemotherapy: constipation.

Note:

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

Generic Drug 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. In combination with nivolumab for first-line treatment of unresectable malignant pleural mesothelioma.

Adult Dosage:

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

Children Dosage:

<18yrs: not established.

YERVOY Warnings/Precautions:

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 2nd & 3rd trimesters): exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).

YERVOY Classification:

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; CMV infection/reactivation; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea, dizziness, hyperthyroidism, hypothyroidism, hypophysitis, adrenal insufficiency; also with platinum-doublet chemotherapy: constipation.

Note:

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

Generic Drug Availability:

NO

How Supplied:

Single-use vial (50mg, 200mg)—1