Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Nulojix

NULOJIX 250 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10–11

HOS-213623 · Präparat HOS-155150

10 Reproductive system and breast disorders Uncommon epididymitis, priapism, cervical dysplasia, breast mass, testicular pain, vulval ulceration, atrophic vulvovaginitis, infertility, scrotal oedema Congenital, familial and genetic disorders Common hydrocele Uncommon hypophosphatasia General disorders and administration site conditions Very Common oedema peripheral, pyrexia Common chest pain, fatigue, malaise, impaired healing Uncommon infusion related reaction*, irritability, fibrosis, inflammation, disease recurrence, feeling hot, ulcer Investigations Common c-reactive protein increased, blood parathyroid hormone increased Uncommon pancreatic enzymes increased, troponin increased, electrolyte imbalance, prostate- specific antigen increased, blood uric acid increased, urine output decreased, blood glucose decreased, CD4 lymphocytes decreased Injury, poisoning and procedural complications Very Common graft dysfunction Common chronic allograft nephropathy (CAN), incisional hernia Uncommon transplant failure, transfusion reaction, wound dehiscence, fracture, tendon rupture, procedural hypotension, procedural hypertension, post-procedural haematoma, procedural pain, procedural headache, contusion * See section “Description of selected adverse reactions”. ** Includes all events reported over a median of 3.3 years in the newly transplanted patient Phase 3 studies, and a median of approximately 7 years in the newly transplanted patient Phase 2 study.

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