Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Retsevmo

Retsevmo 40 mg film-coated tablets Retsevmo 80 mg film-coated tablets Retsevmo 120 mg film-coated tablets Retsevmo 160 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 49–51

HOS-146926 · Präparat HOS-099572

49  MedDRA system MedDRA preferred Frequency of all Frequency of Grade ≥ 3 organ class term Grades# Immune system disordersc Hypersensitivityd Very common Common Endocrine disorders Hypothyroidism e Very common - Metabolism and nutrition Decreased appetite Common - disorders Nervous system Headache Very common - disorders Dizziness Very common - Cardiac disorders Electrocardiogram QT Very common Common prolongedf Vascular disorders Haemorrhageg Very common - Hypertension Common Common Gastrointestinal Diarrhoeah Very common Common disorders Nausea Very common Common Abdominal pain i Very common - Vomiting Very common Common Constipation Very common Common Stomatitis Very common - Dry Mouth Common - Chylous ascites Common - Skin and subcutaneous Rashj Very common - tissue disorders Musculoskeletal and Musculoskeletal paink Very common - connective tissue disorders Epiphysiolysis of the Common Common femoral head Reproductive system and Erectile dysfunctionl Very common Common breast disorders General disorders and Pyrexia Very common - administration site Fatigue m Very common - conditions Oedeman Very common - Weight increased Very common Very common Investigationso Calcium decreased Very common Very common ALT increased Very common Common Albumin decreased Very common - AST increased Very common Common Alkaline phosphatase Very common - increased White blood cell count Very common Common decreased Neutrophil count Very common Common decreased Haemoglobin decreased Very common Very common Total bilirubin increased Very common Common Magnesium decreased Very common Common Platelets decreased Very common Common Lymphocyte count Very common Very common decreased Potassium decreased Very common Common Creatinine increased Very common Common Sodium decreased Very common - # Among the 36 patients in LIBRETTO-121, 31 patients were less than 18 years of age, and 5 patients were between 18 and 21 years of age. 50 a Urinary tract infections include urinary tract infection and cystitis. b Pneumonia includes pneumonia and pneumonia respiratory syncytial viral. c Hypersensitivity reactions were characterized by a maculopapular rash often preceded by a fever with associated arthralgias/myalgias during the patient’s first cycle of treatment (typically between Days 7-21). d Hypersensitivity includes drug hypersensitivity and hypersensitivity. e Hypothyroidism includes hypothyroidism, blood thyroid stimulating hormone increased and thyroglobulin increased. f Electrocardiogram QT prolonged includes electrocardiogram QT prolonged and electrocardiogram QRS complex prolonged. g Haemorrhage includes epistaxis, haematuria, activated partial thromboplastin time prolonged, anal haemorrhage, blood urine present, haemoptysis, menorrhagia and mouth haemorrhage. h Diarrhoea includes diarrhoea and anal incontinence. i Abdominal pain includes abdominal pain, abdominal pain upper and abdominal discomfort. j Rash includes rash maculo-papular, rash, rash erythematous and urticaria. k Musculoskeletal pain includes arthralgia, pain in extremity, back pain, non-cardiac chest pain, bone pain, musculoskeletal chest pain, musculoskeletal pain and neck pain. l Erectile dysfunction in male patients treated with selpercatinib. Denominator adjusted due to gender-specific event for males (n=19) m Fatigue includes fatigue, asthenia and malaise. n Oedema includes face oedema, oedema peripheral, periorbital oedema, generalised oedema, localised oedema and swelling. o Based on laboratory assessments. Percentage is calculated based on the number of patients with baseline assessment and at least one post-baseline assessment as the denominator.

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