Ipilimumab Disease Interactions

Ipilimumab can cause immune-mediated colitis, which may be fatal. CMV infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis; repeating infectious workup should be considered in these patients to exclude alternative etiologies. Ipilimumab should be withheld or permanently discontinued depending on severity of colitis.

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Ipilimumab can cause immune-mediated rash or dermatitis (including bullous and exfoliative dermatitis, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], and drug rash with eosinophilia and systemic symptoms [DRESS]). Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Ipilimumab should be withheld for suspected SJS, TEN, or DRESS and permanently discontinued for confirmed SJS, TEN, or DRESS.

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Immune-mediated endocrinopathies, including severe to life-threatening cases, have occurred with ipilimumab therapy. It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including adrenocorticotropic hormone [ACTH] level and thyroid function) should be evaluated at baseline and before each dose. Medical management should be started promptly, including specialty consultation as appropriate. Ipilimumab should be withheld or permanently discontinued depending on severity of endocrinopathies.

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Ipilimumab can cause immune-mediated adverse reactions, which may be severe or fatal. Immune-mediated hepatitis has occurred with ipilimumab therapy. It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including liver enzymes) should be evaluated at baseline and before each dose. Ipilimumab should be withheld or permanently discontinued depending on severity of hepatitis.

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Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive ipilimumab either before or after allogeneic hematopoietic stem cell transplantation (HSCT). These complications may occur despite intervening therapy between cytotoxic T-lymphocyte antigen 4 (CTLA-4) receptor blocking antibody and allogeneic HSCT. It is recommended to monitor patients closely for evidence of GVHD and intervene promptly. The benefit versus risks of treatment with ipilimumab after allogeneic HSCT should be considered.

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Ipilimumab can cause immune-mediated adverse reactions, which may be severe or fatal. Immune-mediated adverse reactions can occur in any organ system or tissue. Care should be exercised when using ipilimumab in patients with preexisting immune system disorders (e.g., ulcerative colitis, Crohn's disease, lupus). It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including liver enzymes, creatinine, adrenocorticotropic hormone [ACTH] level, and thyroid function) should be evaluated at baseline and before each dose. Medical management should be started promptly, including specialty consultation as appropriate. Ipilimumab should be withheld or permanently discontinued depending on severity.

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Ipilimumab can cause immune-mediated adverse reactions, which may be severe or fatal. It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Ipilimumab should be permanently discontinued for a Grade 2, 3, or 4 ophthalmologic adverse reaction that does not improve to Grade 1 within 2 weeks while receiving topical therapy or if systemic therapy is required.

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Care should be exercised when using ipilimumab in patients with moderate (total bilirubin greater than 1.5 to 3 times the upper limit of normal [1.5 to 3 x ULN] and any AST) or severe (total bilirubin greater than 3 x ULN and any AST) liver dysfunction as ipilimumab has not been studied in these patients. Mild liver dysfunction (total bilirubin greater than 1 to 1.5 x ULN or AST greater than ULN) had no clinically significant effect on the clearance of ipilimumab.

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Solid organ transplant rejection has been reported during postmarketing experience with ipilimumab. Care should be exercised when using ipilimumab in patients who have received a solid organ transplant.

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Ipilimumab can cause immune-mediated pneumonitis. Care should be exercised when using ipilimumab in patients with preexisting pulmonary impairment. Ipilimumab should be withheld or permanently discontinued depending on severity of pneumonitis.

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