Nebenwirkungen · MabThera
MabThera 1600 mg solution for subcutaneous injection · Abschnitt 4.8 · PDF-Seite 88
HOS-087726 · Präparat HOS-083527
The risk of acute administration-related reactions associated with the subcutaneous formulation of MabThera was assessed in three clinical trials: SparkThera and SABRINA (the two trials in NHL)and SAWYER the CLL trial. In trial SABRINA, severe administration-related reactions (grade≥ 3) were reported in two patients (2%) following administration of MabThera subcutaneous formulation. These events were Grade 3 injection site rash and dry mouth. In trial SparkThera, no severe administration-related reactions were reported. In SAWYER (BO25341), severe administration--related reactions (Grade ≥ 3) were reported in four patients (5%) following MabThera subcutaneous administration. These events were Grade 4 thrombocytopenia and Grade 3 anxiety, injection-site erythema and urticaria.
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