Keytruda

Keytruda Adverse Reactions

pembrolizumab

Manufacturer:

Merck Sharp & Dohme

Distributor:

Merck Sharp & Dohme
Full Prescribing Info
Adverse Reactions
Clinical Trials Experience: The safety of Pembrolizumab (KEYTRUDA) was evaluated in 2799 patients in controlled and uncontrolled studies. The median treatment duration was 4.2 months (range 1 day to 30.4 months) including 1153 patients treated for greater than or equal to six months and 600 patients treated for greater than or equal to one year. Pembrolizumab (KEYTRUDA) was discontinued for treatment-related adverse reactions in 5% of patients. Treatment-related serious adverse events (SAEs) reported up to 90 days after the last dose occurred in 10% of patients receiving Pembrolizumab (KEYTRUDA). Of these treatment-related SAEs, the most common were pneumonitis, colitis, diarrhea, and pyrexia.
Immune-mediated adverse reactions (see Precautions): Immune-mediated adverse reactions are presented based on 2799 patients with melanoma and NSCLC. The safety profile was generally similar for patients with melanoma and NSCLC. Table 14 presents the incidence of immune-mediated adverse reactions by Grade that occurred in patients receiving Pembrolizumab (KEYTRUDA). (See Table 14.)

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Endocrinopathies: The median time to onset of hypophysitis was 3.7 months (range 1 day to 11.9 months). The median duration was 4.7 months (range 8+ days to 12.7+ months). Hypophysitis led to discontinuation of Pembrolizumab (KEYTRUDA) in 4 (0.1%) patients. Hypophysitis resolved in 7 patients. The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 21.9 months). The median duration was 2.1 months (range 3 days to 15.0+ months). Hyperthyroidism led to discontinuation of Pembrolizumab (KEYTRUDA) in 2 (<0.1%) patients. Hyperthyroidism resolved in 71 patients. The median time to onset of hypothyroidism was 3.5 months (range 1 day to 18.9 months). The median duration was not reached (range 2 days to 27.7+ months). One (<0.1%) patient discontinued Pembrolizumab (KEYTRUDA) due to hypothyroidism.
Pneumonitis: The median time to onset of pneumonitis was 3.3 months (range 2 days to 19.3 months). The median duration was 1.5 months (range 1 day to 17.2+ months). Pneumonitis led to discontinuation of Pembrolizumab (KEYTRUDA) in 36 (1.3%) patients. Pneumonitis resolved in 55 patients.
Colitis: The median time to onset of colitis was 3.5 months (range 10 days to 16.2 months). The median duration was 1.3 months (range 1 day to 8.7+ months). Colitis led to discontinuation of Pembrolizumab (KEYTRUDA) in 15 (0.5%) patients. Colitis resolved in 41 patients.
Hepatitis: The median time to onset of hepatitis was 1.3 months (range 8 days to 21.4 months). The median duration was 1.8 months (range 8 days to 20.9+ months). Hepatitis led to discontinuation of Pembrolizumab (KEYTRUDA) in 6 (0.2%) patients. Hepatitis resolved in 15 patients.
Nephritis: The median time to onset of nephritis was 5.1 months (range 12 days to 12.8 months). The median duration was 3.3 months (range 12 days to 8.9+ months). Nephritis led to discontinuation of Pembrolizumab (KEYTRUDA) in 3 (0.1%) patients. Nephritis resolved in 5 patients.
Other adverse events: Melanoma: Table 15 summarizes the adverse events that occurred in at least 10% of patients with melanoma treated with Pembrolizumab (KEYTRUDA) in KEYNOTE-006. The most common adverse events (reported in at least 15% of patients) were arthralgia and cough. (See Table 15.)

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Table 16 summarizes the adverse events that occurred in at least 10% of patients with melanoma treated with Pembrolizumab (KEYTRUDA) at the recommended dose in KEYNOTE-002. The most common adverse event (reported in at least 20% of patients) was pruritus. (See Table 16.)

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Overall, the safety profile was similar across all doses and between patients previously treated with ipilimumab and patients naive to treatment with ipilimumab.
Non-Small Cell Lung Carcinoma: Monotherapy: Table 17 summarizes the adverse events that occurred in at least 10% of previously treated patients with NSCLC receiving Pembrolizumab (KEYTRUDA) in KEYNOTE-010. The most common adverse event (reported in at least 15% of patients) was cough. Adverse events occurring in previously untreated patients with NSCLC receiving Pembrolizumab (KEYTRUDA) in KEYNOTE-024 were generally similar to those occurring in patients in KEYNOTE-010. (See Table 17.)

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Combination Therapy: Table 18 summarizes the adverse events that occurred in at least 20% of patients treated with Pembrolizumab (KEYTRUDA) combination therapy in KEYNOTE-021. (See Table 18.)

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Other Cancers: Adverse events occurring in patients with HNSCC, cHL, urothelial carcinoma and gastric cancer were generally similar to those occurring in patients with melanoma or NSCLC.
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