Pembrolizumab

The UK SPC for KEYTRUDA 25 mg/mL concentrate for solution for infusion (eMC product 2498) has since been recovered. It is the right product for this page: the page names brand Keytruda, category PD-1 immune checkpoint inhibitor, and route 'Intravenous infusion (over 30 minutes)' — which this SPC states verbatim — and the fetched §4.2 explicitly names urological regimens (cisplatin-ineligible MIBC with enfortumab vedotin; adjuvant RCC). SCOPE CAVEAT: §4.1 (therapeutic indications) was NOT part of the fetch, so the precise licensed wording for advanced urothelial carcinoma is not quoted here; the dose above is the SPC's own across-indication adult dose, and the indication-specific course lengths above are only those §4.2 itself sets out. PD-L1 AND MSI/MMR TESTING: if specified in the indication, patient selection based on tumour PD-L1 expression, or on MSI-H/dMMR tumour status, should be confirmed by a validated test. FORMULATION SWITCHING: patients receiving subcutaneous pembrolizumab can switch to intravenous pembrolizumab at their next scheduled dose, and vice versa. ATYPICAL RESPONSES: an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage has been observed; it is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until progression is confirmed. TOXICITY MANAGEMENT (Table 1, selected): withhold for Grade 2 pneumonitis and permanently discontinue for Grade 3 or 4 or recurrent Grade 2; withhold for Grade 2 or 3 colitis and permanently discontinue for Grade 4 or recurrent Grade 3; withhold for Grade 2 nephritis with creatinine above 1.5 to 3 times ULN and permanently discontinue for Grade 3 or above with creatinine above 3 times ULN; withhold for Grade 2 hepatitis with AST/ALT above 3 to 5 times ULN or total bilirubin above 1.5 to 3 times ULN and permanently discontinue at Grade 3 or above (AST/ALT above 5 times ULN or bilirubin above 3 times ULN); permanently discontinue for Grade 3 or 4 infusion-related reactions. If treatment-related toxicity does not resolve to Grades 0-1 within 12 weeks after the last dose, or if corticosteroid dosing cannot be reduced to 10 mg prednisone or equivalent per day or less within 12 weeks, KEYTRUDA should be permanently discontinued. Hypothyroidism may be managed with replacement therapy without treatment interruption. RESTARTING: pembrolizumab may be restarted within 12 weeks after the last dose if the adverse reaction recovers to Grade 1 or less and the corticosteroid dose has been reduced to 10 mg prednisone or equivalent per day or less. PATIENT CARD: patients treated with KEYTRUDA must be given the patient card and be informed about the risks. ELDERLY: no dose adjustment is necessary in patients 65 years and over. PAEDIATRIC — NO PAEDIATRIC DOSE IS PUBLISHED ON THIS PAGE: 'The safety and efficacy of KEYTRUDA in children below 18 years of age have not been established except in paediatric patients with melanoma or cHL.' The SPC's paediatric figure (2 mg/kg bodyweight, up to a maximum of 200 mg, every 3 weeks) belongs ONLY to monotherapy for classical Hodgkin lymphoma aged 3 years and older and melanoma aged 12 years and older — different indications from this urological page — so it is deliberately not carried into paedDose. Some sections of the product information we used were incomplete — check the full SPC.