Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Retsevmo

Retsevmo 40 mg hard capsules Retsevmo 80 mg hard capsules · Abschnitt 4.8 · PDF-Seite 12–13

HOS-146857 · Präparat HOS-099572

12  MedDRA system MedDRA preferred term Frequency of all Frequency of Grade organ class Grades ≥3 Haemoglobin decreased Very common Common Magnesium decreased Very common Common Potassium decreased Very common Common a Urinary tract infections includes urinary tract infection, cystitis, urosepsis, escherichia urinary tract infection, escherichia pyelonephritis, kidney infection, nitrite urine present, pyelonephritis, urethritis, urinary tract infection bacterial and urogenital infection fungal. b Pneumonia includes pneumonia, lung infection, pneumonia aspiration, empyema, lung consolidation, pleural infection, pneumonia bacterial, pneumonia staphylococcal, atypical pneumonia, lung abscess, pneumocystis jirovecii pneumonia, pneumonia pneumococcal, pneumonia respiratory syncytial viral, infectious pleural effusion, and pneumonia viral. c Hypersensitivity reactions were characterised 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 Headache includes headache, sinus headache and tension headache. f Dizziness includes dizziness, vertigo, presyncope and dizziness postural. g Electrocardiogram QT prolonged includes electrocardiogram QT prolonged and Electrocardiogram QT interval abnormal. h Hypertension includes hypertension and blood pressure increased. i Haemorrhage includes epistaxis, haemoptysis, contusion, haematuria, rectal haemorrhage, vaginal haemorrhage, cerebral haemorrhage, traumatic haematoma, blood urine present, conjunctival haemorrhage, ecchymosis, gingival bleeding, haematochezia, petechiae, blood blister, spontaneous haematoma, abdominal wall haematoma, anal haemorrhage, angina bullosa haemorrhagica, disseminated intravascular coagulation, eye haemorrhage, gastric haemorrhage, gastrointestinal haemorrhage, haemorrhage intracranial, haemorrhage subcutaneous, haemorrhoidal haemorrhage, hepatic haematoma, intra-abdominal haemorrhage, mouth haemorrhage, oesophageal haemorrhage, pelvic haematoma, periorbital haematoma, periorbital haemorrhage, pharyngeal haemorrhage, pulmonary contusion, purpura, retroperitoneal haematoma, skin haemorrhage, subarachnoid haemorrhage, diverticulum intestinal haemorrhagic, eye haematoma, haematemesis, haemorrhage, haemorrhagic stroke, hepatic haemorrhage, laryngeal haemorrhage, lower gastrointestinal haemorrhage, melaena, menorrhagia, occult blood positive, post procedural haemorrhage, postmenopausal haemorrhage, retinal haemorrhage, scleral haemorrhage, subdural haemorrhage, traumatic haemothorax, tumour haemorrhage, upper gastrointestinal haemorrhage, uterine haemorrhage, vessel puncture site haematoma, haemarthrosis and haematoma. j Interstitial lung disease/pneumonitis includes interstitial lung disease, pneumonitis, radiation pneumonitis, restrictive pulmonary disease, acute respiratory distress syndrome, alveolitis, bronchiolitis, langerhans’ cell histiocytosis, pulmonary radiation injury, cystic lung disease, lung infiltration and lung opacity. k Diarrhoea includes diarrhoea, anal incontinence, defaecation urgency, frequent bowel movements and gastrointestinal hypermotility. l Dry mouth includes dry mouth and mucosal dryness. m Abdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower and gastrointestinal pain. n Vomiting includes vomiting, retching and regurgitation. o Stomatitis includes stomatitis, mouth ulceration, mucosal inflammation and oral mucosal blistering. p Chylous ascites includes chylous ascites and ascites chylous (MedDRA LLTs). q Rash includes rash, rash maculo-papular, dermatitis, skin exfoliation, rash macular, rash erythematous, urticaria, dermatitis allergic, exfoliative rash, rash papular, rash morbilliform, rash pruritic, rash vesicular, butterfly rash, rash follicular, rash generalised, rash pustular and skin reaction. r From post-marketing data. s Epiphysiolysis of the femoral head has been commonly observed (6.4%) in paediatric patients (<18 years of age) treated with selpercatinib (n=47). t Erectile dysfunction has been very commonly observed (12.4%) in male patients treated with selpercatinib in clinical trials (n=986)

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