SELECTED SAFETY INFORMATION

KEYTRUDA® (Pembrolizumab) | Selected Safety Information (SSI)

CONTRAINDICATIONS

KEYTRUDA is contraindicated in patients with hypersensitivity to pembrolizumab or any inactive ingredients, and should not be used during pregnancy and lactation.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Safety and efficacy not established in children <18 years except for paediatric patients with melanoma or classical Hodgkin Lymphoma (cHL). No dose adjustments needed for elderly patients (≥65 years) or mild-to-moderate renal/hepatic impairment. Use caution in severe renal/hepatic impairment (not studied). No formal pharmacokinetic drug interaction studies exist/ have been conducted. Avoid corticosteroids/immunosuppressants before treatment. Poses fetal risks—use contraception during and 4 months post-treatment. Avoid breastfeeding.

SIDE EFFECTS (UNDESIRABLE EFFECTS)

Pembrolizumab commonly triggers immune-mediated adverse reactions, most resolving with appropriate treatment or discontinuation. The adverse events were assessed across tumour types. Monotherapy (7,631 patients, 8.5 months median observation): Very common adverse reactions included Blood and lymphatic system disorders: anaemia; Endocrine disorders: hypothyroidism; Metabolism and nutrition disorders: decreased appetite; Nervous system disorders: headache; Respiratory, thoracic and mediastinal disorders: dyspnoea, cough; Gastrointestinal disorders: diarrhoea, abdominal pain, nausea, vomiting, constipation; Skin and subcutaneous tissue disorders: pruritus, rash; Musculoskeletal and connective tissue disorders: musculoskeletal pain, arthralgia; General disorders and administration site conditions: fatigue, asthenia, oedema, pyrexia. Mostly Grades 1 or 2 in severity. Severe adverse reactions included immune-mediated and severe infusion-related reactions. Combination with Chemotherapy or chemoradiotherapy (CRT) (6,093 patients): Very common adverse reactions included: Blood and lymphatic system disorders: anaemia, neutropenia, thrombocytopenia; Endocrine disorders: hypothyroidism; Metabolism and nutrition disorders: hypokalaemia, decreased appetite; Psychiatric disorders: insomnia; Nervous system disorders: neuropathy peripheral, headache, dizziness; Respiratory, thoracic and mediastinal disorders: dyspnoea, cough; Gastrointestinal disorders: diarrhoea, nausea, vomiting abdominal pain, constipation; Skin and subcutaneous tissue disorders: alopecia, pruritus, rash; Musculoskeletal and connective tissue disorders: musculoskeletal pain, arthralgia; General disorders and administration site conditions: fatigue, asthenia, pyrexia, oedema; Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased. Combination with tyrosine kinase inhibitor (TKI) (1,456 patients): Very common adverse reactions include: Infections and Infestations: urinary tract infection; Blood and lymphatic system disorders: anaemia; Endocrine disorders: hypothyroidism; Metabolism and nutrition disorders: decreased appetite; Nervous system disorders: headache, dysgeusia; Vascular disorders: hypertension; Respiratory, thoracic and mediastinal disorders: dyspnoea, cough; Gastrointestinal disorders: diarrhoea, vomiting abdominal pain, nausea, constipation; Skin and subcutaneous tissue disorders: rash, pruritus; Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, myositis, pain in extremity; General disorders and administration site conditions: fatigue, asthenia, oedema, pyrexia; Investigations: lipase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased. Immune-mediated adverse reactions across various doses reported included pneumonitis, colitis, hepatitis, nephritis, endocrinopathies and Severe skin reactions. Other immune-mediated adverse reactions reported in less than 1 % of patients treated included uveitis, myositis, Guillain-Barré syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis (including exacerbation), myelitis vasculitis, hypoparathyroidism, gastritis, haemolytic aneamia and pericarditis. Immune-mediated adverse reactions reported in post-marketing use included myocarditis, sclerosing cholangitis, optic neuritis and exocrine pancreatic insufficiency.

For full prescribing information refer to the professional information approved by the Medicines Regulatory Authority.

KEYTRUDA legals:
S4 KEYTRUDA® Solution for Infusion. Reg. No. 50/30.1/0957. Each vial contains 100 mg pembrolizumab in 4 ml solution (25 mg/ml). Contains 280 mg sucrose.

Report any suspected adverse events or product quality complaints to DPOC South Africa: dpoc.zaf@msd.com.

ZA-KEY-01204 Date updated: 21 August 2025