Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Nulojix

NULOJIX 250 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8–9

HOS-213621 · Präparat HOS-155150

8 Table 2: Adverse reactions in newly transplanted patient clinical trials Infections and infestations Very Common urinary tract infection, upper respiratory infection, cytomegalovirus infection*, bronchitis Common sepsis, pneumonia, influenza, gastroenteritis, herpes zoster, sinusitis, herpes simplex, oral candidiasis, pyelonephritis, onychomycosis, BK virus infection, respiratory tract infection, candidiasis, rhinitis, cellulitis, wound infection, localised infection, herpes virus infection, fungal infection, fungal skin infection Uncommon progressive multifocal leukoencephalopathy*, cerebral fungal infection, cytomegalovirus (CMV) colitis, polyomavirus-associated nephropathy, genital herpes, staphylococcal infection, endocarditis, tuberculosis*, bronchiectasis, osteomyelitis, strongyloidiasis, blastocystis infection, giardiasis, lymphangitis Neoplasms, benign, malignant and unspecified (incl cysts and polyps)* Common squamous cell carcinoma of skin, basal cell carcinoma, skin papilloma Uncommon EBV associated lymphoproliferative disorder**,lung cancer, rectal cancer, breast cancer, sarcoma, kaposi's sarcoma, prostate cancer, cervix carcinoma, laryngeal cancer, lymphoma, multiple myeloma, transitional cell carcinoma Blood and lymphatic system disorders Very Common anaemia, leukopenia Common thrombocytopenia, neutropenia, leukocytosis, polycythaemia, lymphopenia Uncommon monocytopenia, pure red cell aplasia, agranulocytosis, haemolysis, hypercoagulation Immune system disorders Common blood immunoglobulin G decreased, blood immunoglobulin M decreased Uncommon hypogammaglobulinaemia, seasonal allergy Endocrine disorders Common cushingoid Uncommon adrenal insufficiency Metabolism and nutrition disorders Very Common hypophosphataemia, hypokalaemia, dyslipidaemia, hyperkalaemia, hyperglycaemia, hypocalcaemia Common weight increase, diabetes mellitus, dehydration, weight decrease, acidosis, fluid retention, hypercalcaemia, hypoproteinaemia Uncommon diabetic ketoacidosis, diabetic foot, alkalosis, decreased appetite, vitamin D deficiency Psychiatric disorders Very Common insomnia, anxiety Common depression Uncommon abnormal dreams, mood swings, attention deficit/hyperactivity disorder, libido increased Nervous system disorders Very Common headache Common tremor, paraesthesia, cerebrovascular accident, dizziness, syncope, lethargy, neuropathy peripheral Uncommon encephalitis, Guillain-Barré syndrome*, brain oedema, intracranial pressure increased, encephalopathy, convulsion, hemiparesis, demyelination, facial palsy, dysgeusia, cognitive disorder, memory impairment, migraine, burning sensation, diabetic neuropathy, restless leg syndrome

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