Short Prescribing Information KEYTRUDA® (pembrolizumab)

KEYTRUDA®: C: pembrolizumab. I: adults: monotherapy for unresectable or metastatic melanoma and adjuvant treatment of completely resected melanoma stage III. Temporary approval: monotherapy for adjuvant treatment of completely resected melanoma stage IIB or IIC. Po: adults: 200 mg i.v. 30 min. every 3 weeks or
400 mg i.v. 30 min. every 6 weeks; treatment until disease progression or recurrence, or until unacceptable toxicity; maximum course of treatment in adj. melanoma 12 mos. For further indications and the corresponding dosages for adults and pediatric patients, please refer to the prescribing information. CI: hypersensitivity to active substance/excipients. Pr: immune-mediated adverse reactions: e.g. pneumonitis, colitis, hepatitis, nephritis, endocrinopathies (including hypophysitis, type 1 diabetes mellitus, thyroid disorders; in TNBC monitor blood cortisol), hemophagocytic Lymphohistiocytosis (HLH), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome), other immune-mediated adverse reactions; patients with pre-existing autoimmune disease; transplantation / stem cell transplantation (HSCT): graft-versus-host-disease (GvHD) and hepatic vein-occlusive disease (VOD); adjuvant therapy in melanoma IIB/IIC and NSCLC IB/II/IIIA: OS analysis pending; adjuvant treatment following neoadjuvant therapy associated with additional toxicity; influence on subsequent administration of anti-PD-(L)1-based systemic therapies including resistance in the event of a recurrence has not been investigated; elevated liver enzymes when KEYTRUDA® is combined with axitinib (liver enzymes to be monitored before initiation of and throughout treatment); myocardial infarction in combination of KEYTRUDA® with lenvatinib in RCC; multiple myeloma: increased mortality when adding KEYTRUDA® to thalidomide analogue and dexamethasone; combination with trastuzumab in gastric cancer, see trastuzumab’s prescribing information; for gastric and GEJ carcinoma, previous immune checkpoint inhibitor therapy excluded from study; infusion-related reactions (including hypersensitivity and anaphylaxis); patients were excluded from clinical studies (see prescribing information for details). IA: none known / not investigated. P/L: not recommended, contraception. UE (very common): respiratory tract infections, urinary tract infection, anaemia, neutrophil count decreased, neutropenia, thrombocytopenia, leukopenia, hypothyroidism, decreased appetite, hypokalaemia, weight decreased, hypomagnesemia, insomnia, headache, neuropathy peripheral, dysgeusia, hypertension, hemorrhage, dyspnoea, cough, dysphonia, diarrhoea, abdominal pain, nausea, vomiting, constipation, lipase increased, oral inflammation, stomatitis, alanine aminotransferase increased, aspartate aminotransferase increased, rash, rash maculo-papular, pruritus, alopecia, palmar-plantar erythrodysaesthesia syndrome, musculoskeletal pain, arthralgia, myositis, pain in extremity, proteinuria, blood creatinine increased, fatigue/asthenia, oedema, pyrexia. P: 2 vial/s with 100mg / 4ml. DC: A. MAH: MSD Merck Sharp & Dohme AG, Werftestrasse 4, 6005 Lucerne, Switzerland. (V27.0); CH-KEY-00084.

Before prescribing please consult the full prescribing information published on the homepage of Swissmedic www.swissmedicinfo.ch.