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YERVOY
Bladder, kidney, and other urologic cancers
Colorectal and other GI cancers
Melanoma and other skin cancers
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Drug Name:

YERVOY Rx

Generic Name and Formulations:
Ipilimumab 5mg/mL; soln for IV infusion; preservative-free.

Company:
Bristol-Myers Squibb

Therapeutic Use:

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, hepatitis, dermatitis, neuropathy, endocrinopathy, and others including ocular manifestations; perform clinical chemistries including LFTs, ACTH levels, and thyroid tests at baseline and before each dose. Monitor for infusion 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. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for 3 months after final dose. Pregnancy. Nursing mothers: not recommended (during and for 3 months after final dose).

Pharmacological 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; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea.

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


Data provided by MPR.

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.

Adult:

Give by IV infusion over 30mins. 1mg/kg (given after nivolumab on the same day) every 3 weeks for 4 doses or 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, hepatitis, dermatitis, neuropathy, endocrinopathy, and others including ocular manifestations; perform clinical chemistries including LFTs, ACTH levels, and thyroid tests at baseline and before each dose. Monitor for infusion 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. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for 3 months after final dose. Pregnancy. Nursing mothers: not recommended (during and for 3 months after final dose).

Pharmacological 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; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea.

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


Data provided by MPR.

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, hepatitis, dermatitis, neuropathy, endocrinopathy, and others including ocular manifestations; perform clinical chemistries including LFTs, ACTH levels, and thyroid tests at baseline and before each dose. Monitor for infusion 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. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for 3 months after final dose. Pregnancy. Nursing mothers: not recommended (during and for 3 months after final dose).

Pharmacological 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; also with nivolumab: musculoskeletal pain, abdominal pain, cough, arthralgia, dyspnea.

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


Data provided by MPR.

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