Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Torisel

Torisel 30 mg concentrate and solvent for solution for infusion · Abschnitt 4.8 · PDF-Seite 14–15

HOS-209005 · Präparat HOS-154221

14  System Frequency Adverse reactions All grades Grade organ class n (%) 3&4 n (%) Skin and Very common Rash (including rash, pruritic rash, 138 (43.0) 16 (5.0) subcutaneous maculo-papular rash, rash, generalised tissue disorders rash, macular rash, papular rash) Pruritus (including pruritus 69 (21.5) 4 (1.2) generalised) Dry skin 32 (10.0) 1 (0.3) Common Dermatitis 6 (1.9) 0 (0.0) Exfoliative rash 5 (1.6) 0 (0.0) Acne 15 (4.7) 0(0.0) Nail disorder 26 (8.1) 0 (0.0) Ecchymosis*** 5 (1.6) 0 (0.0) Petechiae*** 4 (1.2) 0 (0.0) Musculoskeletal Very common Arthralgia 50 (15.6) 2 (0.6) and connective Back pain 53 (16.5) 8 (2.5) tissue disorders Common Myalgia 19 ( 5.9) 0 (0.0) Renal and urinary Common Renal failurea 5 (1.6) 0 (0.0) disorders General disorders Very common Fatigue 133 (41.4) 31 (9.7) and administration Oedema (including generalised 122 (38.0) 11 (3.4) site conditions oedema, facial oedema, peripheral oedema, scrotal oedema, genital oedema) Astheniaa 67 (20.9) 16 (5.0) Mucosal inflammation 66 (20.6) 7 (2.2) Pyrexia 91 (28.3) 5 (1.6) Pain 36 (11.2) 7 (2.2) Chills 32 (10.0) 1 (0.3) Chest pain 32 (10.0) 1 (0.3) Uncommon Impaired wound healing 2 (0.6) 0 (0.0) Investigations Very common Blood creatinine increased 35 (10.9) 4 (1.2) Common Increased aspartate aminotransferase 27 (8.4) 5 (1.6) Common Increased alanine aminotransferase 17 (5.3) 2 (0.6) a: One fatal case b: One pleural effusion fatal event occurred in the low-dose (175/25 mg) arm of the MCL study *Most NCI-CTC Grade 3 and above reactions observed in clinical trials of temsirolimus for MCL ** Most NCI-CTC all grades reactions observed in clinical trials of temsirolimus for MCL *** All NCI-CTC Grade 1 and 2 reactions observed in clinical trials of temsirolimus for MCL ****Interstitial lung disease is defined by a cluster of related Preferred Terms: interstitial lung disease (n = 6), pneumonitisa (n = 7), alveolitis (n = 1), alveolitis allergic (n = 1), pulmonary fibrosis (n = 1) and eosinophilic pneumonia (n = 0).

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