Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Tevagrastim

Tevagrastim 30 MIU/0.5 mL solution for injection/infusion Tevagrastim 48 MIU/0.8 mL solution for injection/infusion · Abschnitt 4.8 · PDF-Seite 13–14

HOS-209174 · Präparat HOS-154265

13  MedDRA Adverse reactions system Very common Common Uncommon Rare organ class (≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1,000 to (≥ 1/10,000 to < 1/100) < 1/1,000) Hepato- Hepatomegaly Aspartate biliary Blood alkaline aminotransferase disorders phosphatase increased increased Gamma-glutamyl transferase increased Skin and Alopeciaa Rasha Rash Cutaneous sub- Erythema maculopapular vasculitisa cutaneous Sweets syndrome tissue (acute febrile disorders neutrophilic dermatosis) Musculo- Musculoskeletal Muscle spasms Osteoporosis Bone density c skeletal pain decreased and Exacerbation of connective rheumatoid arthritis tissue disorders Renal and Dysuria Proteinuria Glomerulonephritis urinary Haematuria Urine abnormality disorders General Fatiguea Chest paina Injection site disorders Mucosal Paina reaction and ad- inflammationa Astheniaa ministratio Pyrexia Malaisee n site Oedema peripherale conditions Injury, Transfusion poisoning reactione and procedural complicatio ns 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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