Keytruda

Keytruda Special Precautions

pembrolizumab

Manufacturer:

Merck Sharp & Dohme

Distributor:

Merck Sharp & Dohme
Full Prescribing Info
Special Precautions
Immune-mediated adverse reactions: Immune-mediated adverse reactions occurred in patients receiving Pembrolizumab (KEYTRUDA). In clinical trials, most immune-mediated adverse reactions were reversible and managed with interruptions of Pembrolizumab (KEYTRUDA), administration of corticosteroids and/or supportive care. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously.
For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold Pembrolizumab (KEYTRUDA) and consider administration of corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Restart Pembrolizumab (KEYTRUDA) if the adverse reaction remains at Grade 1 or less following corticosteroid taper. If another episode of a severe adverse reaction occurs, permanently discontinue Pembrolizumab (KEYTRUDA). (See Dosage & Administration and Adverse Reactions.)
Immune-mediated pneumonitis: Pneumonitis (including fatal cases) has been reported in patients receiving Pembrolizumab (KEYTRUDA) (see Adverse Reactions). Monitor patients for signs and symptoms of pneumonitis. If pneumonitis is suspected, evaluate with radiographic imaging and exclude other causes. Administer corticosteroids for Grade 2 or greater events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper), withhold Pembrolizumab (KEYTRUDA) for moderate (Grade 2) pneumonitis, and permanently discontinue Pembrolizumab (KEYTRUDA) for severe (Grade 3), life-threatening (Grade 4) or recurrent moderate (Grade 2) pneumonitis. (See Dosage & Administration and Immune-mediated adverse reactions mentioned previously.
Immune-mediated colitis: Colitis has been reported in patients receiving Pembrolizumab (KEYTRUDA) (see Adverse Reactions). Monitor patients for signs and symptoms of colitis and exclude other causes. Administer corticosteroids for Grade 2 or greater events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper), withhold Pembrolizumab (KEYTRUDA) for moderate (Grade 2) or severe (Grade 3) colitis, and permanently discontinue Pembrolizumab (KEYTRUDA) for life-threatening (Grade 4) colitis. (See Dosage and Administration and Immune-mediated adverse reactions mentioned previously.)
Immune-mediated hepatitis: Hepatitis has been reported in patients receiving Pembrolizumab (KEYTRUDA) (see Adverse Reactions). Monitor patients for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis and exclude other causes. Administer corticosteroids (initial dose of 0.5-1 mg/kg/day [for Grade 2 events] and 1-2 mg/kg/day [for Grade 3 or greater events] prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, withhold or discontinue Pembrolizumab (KEYTRUDA). (See Dosage and Administration and Immune-mediated adverse reactions mentioned previously.)
Immune-mediated nephritis: Nephritis has been reported in patients receiving Pembrolizumab (KEYTRUDA) (see Adverse Reactions). Monitor patients for changes in renal function and exclude other causes. Administer corticosteroids for Grade 2 or greater events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper), withhold Pembrolizumab (KEYTRUDA) for moderate (Grade 2), and permanently discontinue Pembrolizumab (KEYTRUDA) for severe (Grade 3) or life-threatening (Grade 4) nephritis. (See Dosage and Administration and Immune-mediated adverse reactions mentioned previously.)
Immune-mediated endocrinopathies: Hypophysitis has been reported in patients receiving Pembrolizumab (KEYTRUDA) (see Adverse Reactions). Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and secondary adrenal insufficiency) and exclude other causes. Administer corticosteroids to treat secondary adrenal insufficiency and other hormone replacement as clinically indicated, withhold Pembrolizumab (KEYTRUDA) for moderate (Grade 2), withhold or discontinue Pembrolizumab (KEYTRUDA) for severe (Grade 3) or life-threatening (Grade 4) hypophysitis. (See Dosage and Administration and Immune-mediated adverse reactions mentioned previously.)
Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving Pembrolizumab (KEYTRUDA) (see Adverse Reactions). Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold Pembrolizumab (KEYTRUDA) in cases of severe hyperglycemia until metabolic control is achieved.
Thyroid disorders, including hyperthyroidism, hypothyroidism and thyroiditis, have been reported in patients receiving Pembrolizumab (KEYTRUDA) and can occur at any time during treatment; therefore, monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders. Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids. Hyperthyroidism may be managed symptomatically. Withhold or discontinue Pembrolizumab (KEYTRUDA) for severe (Grade 3) or life-threatening (Grade 4) hyperthyroidism. (See Dosage and Administration, Immune-mediated adverse reactions mentioned previously and Adverse Reactions.)
For patients with severe (Grade 3) or life-threatening (Grade 4) endocrinopathy that improves to Grade 2 or lower and is controlled with hormone replacement, continuation of Pembrolizumab (KEYTRUDA) may be considered.
Severe skin reactions: Immune-mediated severe skin reactions have been reported in patients treated with Pembrolizumab (KEYTRUDA). Monitor patients for suspected severe skin reactions and exclude other causes. Based on the severity of the adverse reaction, withhold or permanently discontinue Pembrolizumab (KEYTRUDA) and administer corticosteroids (see Dosage and Administration).
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some with fatal outcome, have been reported in patients treated with Pembrolizumab (KEYTRUDA). For signs or symptoms of SJS or TEN, withhold Pembrolizumab (KEYTRUDA) and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue Pembrolizumab (KEYTRUDA). (See Dosage and Administration.)
Other immune-mediated adverse reactions: The following additional clinically significant, immune-mediated adverse reactions were reported in less than 1% of patients treated with Pembrolizumab (KEYTRUDA) in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010: uveitis, myositis, Guillain-Barré syndrome, pancreatitis, encephalitis, sarcoidosis and myasthenic syndrome/myasthenia gravis (including exacerbation). Eye disorders: Vogt-Koyanagi-harada syndrome. The following was reported in other clinical studies with Pembrolizumab (KEYTRUDA) or in post-marketing use: myocarditis.
Cases of these immune-mediated adverse reactions, some of which were severe, have been reported in clinical trials or in post-marketing use.
Transplant-related adverse reactions: Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with Pembrolizumab (KEYTRUDA). Treatment with Pembrolizumab (KEYTRUDA) may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment with Pembrolizumab (KEYTRUDA) versus the risk of possible organ rejection in these patients.
Acute graft-versus-host-disease (GVHD) after treatment with Pembrolizumab (KEYTRUDA) has been reported in patients with a history of allogeneic hematopoietic stem cell transplant (HSCT). Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after treatment with Pembrolizumab (KEYTRUDA). Consider the benefit of treatment with Pembrolizumab (KEYTRUDA) versus the risk of possible GVHD in patients with a history of allogeneic HSCT.
Increased mortality in patients with multiple myeloma when Pembrolizumab (KEYTRUDA) is added to a thalidomide analogue and dexamethasone: In two randomized clinical trials in patients with multiple myeloma, the addition of Pembrolizumab (KEYTRUDA) to a thalidomide analogue plus dexamethasone, a use for which no PD-1 or PD-L1 blocking antibody is indicated, resulted in increased mortality. 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.
Infusion-related reactions: Severe infusion reactions, including hypersensitivity and anaphylaxis, have been reported in 6 (0.2%) of 2799 patients receiving Pembrolizumab (KEYTRUDA) in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010. For severe infusion reactions, stop infusion and permanently discontinue Pembrolizumab (KEYTRUDA) (see Dosage and Administration). Patients with mild or moderate infusion reaction may continue to receive Pembrolizumab (KEYTRUDA) with close monitoring; premedication with antipyretic and antihistamine may be considered.
Combination Therapy: Incidences of immune-mediated adverse reactions and infusion-related reactions with Pembrolizumab (KEYTRUDA) in combination with pemetrexed and carboplatin were consistent with those observed with Pembrolizumab (KEYTRUDA) as monotherapy (see Adverse Reactions).
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