Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Degarelix Accord

Degarelix Accord 80 mg powder and solvent for solution for injection Degarelix Accord 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-151012 · Präparat HOS-100434

The injection site adverse reactions reported were mainly pain and erythema, reported in 28% and 17% of patients, respectively, less frequently reported were swelling (6%), induration (4%) and nodule (3%). These events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, the incidence of these events pr 100 injections was: 3 for pain and <1 for erythema, swelling, nodule and induration. The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (< 1%). Serious injection site reactions were very rarely reported such as injection site infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage.

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