Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Nivestim

Nivestim 12 MU/0.2 ml solution for injection/infusion Nivestim 30 MU/0.5 ml solution for injection/infusion Nivestim 48 MU/0.5 ml solution for injection/infusion · Abschnitt 4.8 · PDF-Seite 14–15

HOS-122626 · Präparat HOS-095547

14  MedDRA Adverse reactions system organ Very common Common Uncommon Rare class (≥ 1/10) (≥ 1/100 to (≥ 1/1 000 to (≥ 1/10 000 to < 1/10) < 1/100) < 1/1 000) Skin and Alopeciaa Rasha Rash maculo- Cutaneous vasculitisa subcutaneous papular Erythema Sweets syndrome tissue disorders (acute febrile neutrophilic dermatosis) Musculoskeletal Musculoskeletal Muscle Osteoporosis Bone density and connective painc spasms decreased tissue disorders Exacerbation of rheumatoid arthritis Renal and Dysuria Proteinuria Glomerulonephritis urinary Haematuria Urine abnormality disorders General Fatiguea Chest paina Injection site disorders and reaction Mucosal Paina administration inflammationa site conditions Astheniaa Pyrexia Malaisee Oedema peripherale Injury, Transfusion poisoning and reactione procedural complications a. See section c (Description of selected adverse reactions). b. There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c). c. Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain. d. Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or PBPC mobilisation. e. Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy.

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