Yervoy

Ipilimumab

Unresectable or metastatic melanoma. In combination w/ nivolumab for previously untreated advanced renal cell carcinoma (RCC) in intermediate or poor risk patients; for 1st-line treatment of adults w/ unresectable malignant pleural mesothelioma.

Unresectable or metastatic melanoma 3 mg/kg IV infusion over 90 min every 3 wk for total of 4 doses. Advanced RCC In combination w/ nivolumab: 1 mg/kg every 3 wk + nivolumab 3 mg/kg as IV infusion over 30 min for 4 doses. After completing 4 doses of combination therapy, administer nivolumab as single agent either 3 mg/kg every 2 wk or 480 mg every 4 wk until disease progression or unacceptable toxicity. Malignant pleural mesothelioma 1 mg/kg IV infusion over 30 min every 6 wk + nivolumab 360 mg every 3 wk or 3 mg/kg every 2 wk as IV infusion over 30 min until disease progression, unacceptable toxicity, or up to 2 yr if w/o disease progression.

Hypersensitivity.

Permanently discontinue in patients w/ severe enterocolitis; immune-mediated colitis, rash, pneumonitis, nephritis & renal dysfunction; Grade 3-5 hepatotoxicity; SJS, TEN or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; severe neuropathy (interfering w/ daily activities) eg, Guillain-Barré-like syndromes; hypophysitis, adrenal insufficiency; life-threatening (Grade 4) pneumonitis; Grade 4 increased serum creatinine; immune-mediated encephalitis; clinically significant or severe immune-mediated adverse reactions; immune-mediated ocular disease unresponsive to local immunosuppressive therapy. Discontinue in patients w/ severe or life-threatening infusion-related reactions. Interrupt or slow infusion rate in patients w/ mild or moderate infusion-related reactions. Withhold in patients w/ moderate enterocolitis; Grade 2 hepatotoxicity; moderate to severe signs & symptoms of SJS, TEN or rash, immune-mediated pneumonitis, or nephritis & renal dysfunction; moderate neuropathy (not interfering w/ daily activities); symptoms of immune-mediated endocrinopathies; new-onset moderate to severe neurologic signs or symptoms of immune-mediated encephalitis; type I DM. Cytomegalovirus infection/reactivation in patients w/ corticosteroid-refractory immune-related colitis. Increased risk of rejection in solid organ transplant recipients. Patient who previously experienced severe or life-threatening skin adverse reaction on prior cancer immune stimulatory therapy. Monitor patients for signs & symptoms of enterocolitis & bowel perforation; LFTs & hepatotoxicity before each dose; dermatitis eg, rash & pruritus; motor or sensory neuropathy eg, unilateral or bilateral weakness, sensory alterations or paresthesia; hypophysitis, adrenal insufficiency (including adrenal crisis), & hyper-/hypothyroidism; thyroid function tests & clinical chemistries at start of treatment, before each dose, & as clinically indicated based on symptoms; signs w/ radiographic imaging & symptoms of pneumonitis; for elevated serum creatinine prior to & periodically during treatment. Administer anti-diarrheal treatment & initiate systemic corticosteroids if moderate enterocolitis persists for >1 wk; topical or systemic corticosteroids in mild to moderate dermatitis if no improvement in symptoms w/in 1 wk; corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis. Perform stool infection work-up upon presentation of diarrhea or colitis. Concomitant use w/ vemurafenib. Moderate or severe hepatic impairment. Females of reproductive potential should use effective contraception during treatment & for 3 mth after last dose. Not recommended during pregnancy or in women of childbearing potential not using effective contraception. Discontinue breastfeeding during treatment & for 3 mth following final dose. May cause fetal harm. Ped patients <12 yr.

Decreased appetite; diarrhoea, vomiting, nausea; rash, pruritus; fatigue, inj site reaction, pyrexia. Tumour 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, flu-like illness (symptoms); increased ALT, AST, blood bilirubin & blood alkaline phosphatase, decreased wt. TEN including SJS.

Cancer Immunotherapy

L01FX04 - ipilimumab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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