Bristol-Myers Squibb




Bristol-Myers Squibb
Concise Prescribing Info
Unresectable or metastatic melanoma. Intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC) in combination w/ nivolumab.
Dosage/Direction for Use
Unresectable or metastatic melanoma 3 mg/kg IV over 90 min every 3 wk for a total of 4 doses. RCC In combination w/ nivolumab: 3 mg/kg nivolumab as IV infusion over 30 min followed by 1 mg/kg Yervoy IV infusion over 30 min on the same day, every 3 wk for 4 doses. After completing 4 doses of the combination, administer nivolumab as single agent for 3 mg/kg every 2 wk or 480 mg every 4 wk as IV infusion over 30 min until disease progression or unacceptable toxicity. Dose modification: Patient w/ complete or partial resolution of AR & are receiving prednisone <7.5 mg or equiv/day Resume Yervoy at 3 mg/kg every 3 wk until complete 4 planned doses or 16 wk from 1st dose.
Special Precautions
Severe & fatal immune-mediated reactions. Monitor patients for signs & symptoms of enterocolitis & bowel perforation; liver function tests & hepatotoxicity prior to therapy; dermatitis eg, rash & pruritus; motor or sensory neuropathy eg, unilateral or bilateral weakness, sensory alterations or paresthesia; hypophysitis, adrenal insufficiency (including adrenal crisis), & hyper- or hypothyroidism, thyroid function test & clinical chemistries; signs w/ radiographic imaging & symptoms of pneumonitis; for elevated serum creatine prior to & periodically during treatment. Concomitant use w/ vemurafenib. Patient who has previously experienced a severe or life-threatening skin adverse reaction on a prior cancer immune stimulatory therapy. Withhold use in moderate enterocolitis, in patients w/ grade 2 hepatotoxicity; moderate to severe dermatitis; moderate neuropathy (not interfering w/ daily activities); moderate to severe signs & symptoms of pneumonitis & nephritis; new-onset moderate to severe neurologic signs or symptoms. Permanently discontinue use in patients w/ severe enterocolitis; grade 3-5 hepatotoxicity; Stevens-Johnson syndrome; toxic epidermal necrolysis or rash; severe neuropathy eg, Guillain-Barré-like syndromes; clinically significant or severe immune-mediated adverse reaction; immune-mediated ocular disease unresponsive to local immunosuppressive therapy; who develops diabetes; life-threatening (Grade 4) pneumonitis, increased serum creatinine; immune-mediated encephalitis. Discontinue use in patients w/ severe or life-threatening infusion reactions. Females should be advised to use effective contraception during treatment & for 3 mth following the last dose. Moderate or severe hepatic impairment. Pregnancy & lactation. Childn <12 yr.
Adverse Reactions
Fatigue, diarrhea, pruritus, rash & colitis; decreased appetite; nausea, vomiting; inj site reaction, pyrexia. Tumor pain; anaemia, lymphopenia; hypopituitarism (including hypophysitis), hypothyroidism; dehydration, hypokalemia; confusional state; peripheral sensory neuropathy, dizziness, headache, lethargy; blurred vision, eye pain; hypotension, flushing, hot flush; dyspnea, cough; GI haemorrhage, colitis, constipation, GERD, abdominal pain; abnormal hepatic function; dermatitis, erythema, vitiligo, urticaria, alopecia, night sweats, dry skin; arthralgia, myalgia, musculoskeletal pain, muscle spasms; amenorrhea; chills, asthenia, oedema, pain, influenza-like illness (symptoms); increased ALT & AST, increased blood bilirubin, increased blood alkaline phosphatase, decreased wt.
ATC Classification
L01XC11 - ipilimumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Yervoy infusion 50 mg/10 mL
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