<p><strong>Immune-mediated pneumonitis</strong>: Withhold for moderate, and permanently discontinue for severe, life-threatening or recurrent moderate pneumonitis.<br />
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<strong>Immune-mediated colitis</strong>: Withhold for moderate or severe, and permanently discontinue for life-threatening colitis.<br />
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<strong>Immune-mediated hepatitis (Pembrolizumab) and hepatotoxicity (Pembrolizumab in combination with axitinib)</strong>: Monitor for changes in hepatic function. Based on severity of liver enzyme elevations, withhold or discontinue Pembrolizumab, axitinib, or Pembrolizumab and axitinib. Consider corticosteroid therapy.<br />
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Immune-mediated endocrinopathies:</p>

<ul>
	<li><strong>Adrenal insufficiency</strong>: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening adrenal insufficiency.</li>
	<li><strong>Hypophysitis</strong>: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening hypophysitis.</li>
	<li><strong>Thyroid disorders</strong>: Monitor for changes in thyroid function. Withhold or permanently discontinue for severe or life-threatening hyperthyroidism.</li>
	<li><strong>Type 1 diabetes mellitus</strong>: Monitor for hyperglycemia. Withhold Pembrolizumab in cases of severe hyperglycemia.</li>
</ul>

<p><strong>Immune-mediated nephritis</strong>: Monitor for changes in renal function. Withhold for moderate, and permanently discontinue for severe or life-threatening nephritis.<br />
<br />
<strong>Immune-mediated skin adverse reactions including, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)</strong>: Withhold for severe and permanently discontinue for life-threatening skin reactions.<br />
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<strong>Other immune-mediated adverse reactions</strong>: In organ transplant recipients, consider the benefit of treatment with Pembrolizumab versus the risk of possible organ rejection.<br />
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<strong>Infusion-related reactions</strong>: Stop infusion and permanently discontinue Pembrolizumab for severe or life-threatening infusion reactions.<br />
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<strong>Complications of allogeneic HSCT</strong>: Allogeneic HSCT after treatment with Pembrolizumab: Monitor for hepatic veno-occlusive disease, grade 3-4 acute GVHD including hyperacute GVHD, steroid-requiring febrile syndrome, and other immune-mediated adverse reactions. Transplant-related mortality has occurred. Allogeneic HSCT prior to treatment with Pembrolizumab: In patients with a history of allogeneic HSCT, consider the benefit of treatment with Pembrolizumab versus the risk of GVHD.<br />
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Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.<br />
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<strong>Embryo-Fetal toxicity</strong>: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective method of contraception.</p>