The majority of patients with hypothyroidism required long-term thyroid hormone replacement. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%).None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). Withhold or permanently discontinue KEYTRUDA depending on severity. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Hypothyroidism can follow hyperthyroidism. Thyroiditis can present with or without endocrinopathy. KEYTRUDA can cause immune-mediated thyroid disorders.All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2–4, n=116), ALT resolved to Grades 0–1 in 94%. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. Consider monitoring more frequently as compared to when the drugs are administered as single agents. Monitor liver enzymes before initiation of and periodically throughout treatment. KEYTRUDA in combination with axitinib can cause hepatic toxicity.Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) KEYTRUDA, as a single agent, is indicated for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non–small cell lung cancer (NSCLC). Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. stage III where patients are not candidates for surgical resection or definitive chemoradiation, or.KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with non–small cell lung cancer (NSCLC) expressing programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and is: KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein‑bound, is indicated for the first‑line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
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