Nucala Adverse Reactions

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Full Prescribing Info

Adverse Reactions

Severe asthma: The safety of NUCALA was studied in a clinical development program in severe eosinophilic asthma which included 3 randomized, placebo-controlled, multicenter 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 (≥1/10000 to <1/1000). (See Table 3.)

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Post-marketing data: (See Table 4.)

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Nucala Adverse Reactions

mepolizumab

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma