Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · MabThera

MabThera 1600 mg solution for subcutaneous injection · Abschnitt 4.8 · PDF-Seite 87

HOS-087723 · Präparat HOS-083527

During the development programme, the safety profile of MabThera subcutaneous formulation was comparable to that of the intravenous formulation with the exception of local cutaneous reactions. Local cutaneous reactions including injection site reactions were very common in patients receiving MabThera subcutaneous formulation. In the NHL phase 3 trial SABRINA (BO22334), local cutaneous reactions were reported in up to 20% of patients receiving subcutaneous MabThera. The most common local cutaneous reactions in the MabThera subcutaneous arm were injection site erythema (13%), injection site pain (7%), and injection site oedema (4%). Events seen following subcutaneous administration were mild or moderate, apart from one patient who reported a local cutaneous reaction

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