Nucala Adverse Reactions

Clinical trial experiences: Severe Eosinophilic Asthma: The safety of NUCALA was studied in a clinical development program in adolescents and adults with severe eosinophilic asthma which included 3 randomised, placebo-controlled, multicentre studies (n=1327). Subjects received either subcutaneous (SC) or intravenous (IV) mepolizumab or placebo during clinical studies of 24-52 weeks duration. Adverse reactions associated with NUCALA 100 mg administered subcutaneously (n=263) are presented in the table as follows. The safety profile of NUCALA in severe asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000). (See Table 7.)

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Eosinophilic Granulomatosis with Polyangiitis (EGPA): In a double-blind placebo-controlled study in subjects with EGPA (300 mg NUCALA n=68, placebo n=68) no additional adverse reactions were identified to those reported for the severe asthma studies.
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): In a randomised, double-blind placebo-controlled 52-week study in subjects with CRSwNP (NUCALA 100 mg n= 206, placebo n= 201), no additional adverse reactions were identified to those reported for the severe asthma studies.