Ilumya Adverse Reactions

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Full Prescribing Info

Adverse Reactions

Summary of the safety profile: The most common adverse reactions are upper respiratory tract infections (12.6%), headache (4.0%), diarrhoea (1.6%), gastroenteritis (1.5%), back pain (1.5%), nausea (1.3%) and injection site pain (1.3%).
Tabulated list of adverse reactions: Adverse reactions from clinical studies (Table 1) are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. (See Table 3.)

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Long-term Safety: The safety profile of tildrakizumab observed during the long-term extensions periods of reSURFACE 1 and reSURFACE 2 was consistent with that of the double-blind periods.

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Ilumya Adverse Reactions

tildrakizumab

Manufacturer:

Vetter Pharma

Distributor:

DKSH

Marketer:

Ranbaxy