Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Keytruda

KEYTRUDA 25 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 19–20

HOS-131809 · Präparat HOS-097138

19  MedDRA SOC Monotherapy In combination with In combination with and frequency chemotherapy, axitinib or lenvatinib category radiation therapy or chemoradiotherapy Uncommon psoriasis, lichenoid psoriasis, lichenoid eczema, lichenoid keratosis⁎, papule, keratosis⁎, vitiligo⁎, keratosis⁎, psoriasis, hair colour changes papule vitiligo⁎, papule, hair colour changes Rare Stevens-Johnson Stevens-Johnson toxic epidermal syndrome, erythema syndrome, erythema necrolysis, nodosum, toxic nodosum, hair colour Stevens-Johnson epidermal necrolysis changes syndrome Musculoskeletal and connective tissue disorders Very common musculoskeletal arthralgia, arthralgia, pain⁎, arthralgia musculoskeletal pain⁎ musculoskeletal pain⁎, myositis⁎¶, pain in extremity Common myositis⁎¶, pain in myositis⁎¶, pain in arthritis⁎ extremity, arthritis⁎ extremity, arthritis⁎ Uncommon tenosynovitis⁎ tenosynovitis⁎ tenosynovitis⁎ Rare Sjogren’s syndrome Sjogren’s syndrome Sjogren’s syndrome Renal and urinary disorders Common acute kidney injury nephritis⁎ Uncommon nephritis⁎ nephritis⁎, cystitis noninfective Rare cystitis noninfective cystitis noninfective General disorders and administration site conditions Very common fatigue, asthenia, fatigue, asthenia, pyrexia, fatigue, asthenia, oedema⁎, pyrexia oedema⁎ oedema⁎, pyrexia Common influenza-like influenza-like illness, influenza-like illness, illness, chills chills chills Investigations Very common alanine aminotransferase lipase increased, increased, aspartate alanine aminotransferase aminotransferase increased increased, aspartate aminotransferase increased, blood creatinine increased Common alanine blood bilirubin increased, amylase increased, aminotransferase blood alkaline blood bilirubin increased, aspartate phosphatase increased, increased, blood aminotransferase blood creatinine alkaline phosphatase increased, blood increased, increased, alkaline phosphatase hypercalcaemia hypercalcaemia increased, hypercalcaemia, blood bilirubin increased, blood creatinine increased Uncommon amylase increased amylase increased † Adverse reaction frequencies presented in Table 2 may not be fully attributable to pembrolizumab alone but may contain contributions from the underlying disease or from other medicinal products used in a combination. ‡Based upon a standard query including bradyarrhythmias and tachyarrhythmias. ¶ Myocarditis, myositis, myasthenia gravis can occur simultaneously (as myocarditis-myositis-myasthenia gravis overlap syndrome). ⁎The following terms represent a group of related events that describe a medical condition rather than a single event:

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.