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| Site | Signs and symptoms | Management
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| GI | Assess patients for changes in bowel habits and for the following signs and symptoms: diarrhea, abdominal pain, blood or mucus in stool with or without fever, peritoneal signs consistent with bowel perforation, and ileus. | Low-grade events: symptomatic management (dietary modifications and loperamide).
High-grade events: corticosteroid therapy may be required.
>7 stools/day over baseline, signs consistent with perforation, or patients with a fever: administer 1-2 mg/kg prednisone or equivalent and then move forward with ensuring differential diagnosis.
Withhold ipilimumab for moderate reactions until improvement to mild severity or complete resolution; for severe reactions, discontinue ipilimumab. |
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| Skin | Evaluate patients for signs and symptoms of pruritus, vitiligo, or maculopapular rash. | Mild to moderate: symptomatic management. Topical moisturizers and oatmeal baths may help relieve mild cases.
Moderate to severe: topical and/or systemic corticosteroids may be required.
Withhold ipilimumab dosing in patients with moderate to severe signs and symptoms.
Permanently discontinue ipilimumab in patients with Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations. |
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| Liver | Run liver function tests before each infusion or more frequently if possible.
Monitor patients for any signs of hepatitis. | Moderate AST or ALT >2.5 times but ≤5 times ULN, or moderate total bilirubin elevation >1.5 times but ≤3 times ULN: withhold ipilimumab dose.
Severe AST or ALT elevations of >5 times ULN; total bilirubin elevations of >3 times ULN; or failure to complete full treatment course within 16 weeks from administration of first dose: permanently discontinue ipilimumab.
Grade ≥3 hepatitis: consider corticosteroid therapy. |
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| Endocrine | Nonspecific symptoms include fatigue, headache, changes in mental status, abdominal pain, unusual bowel habits, and hypotension.
Undertake appropriate blood work. | Moderate reactions or symptomatic endocrinopathy: withhold ipilimumab until complete resolution or stable on hormone replacement therapy.
Patients unable to have their corticosteroid dose reduced to 7.5 mg prednisone or equivalent per day: permanently discontinue ipilimumab.
Consider long-term hormone replacement therapy as necessary. |
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| Neurologic | Encourage patient report of changes in muscle weakness or sensory alternations. | New onset or worsening symptoms: may require permanent discontinuation of ipilimumab. |
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| Ocular | Assess patients for uveitis, iritis, or episcleritis. | Administer corticosteroid drops. |
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