Staquis Adverse Reactions

The most common adverse drug reactions from completed STAQUIS clinical trials (Trials 1 and 2) were application site reactions (5.6% and 3.6% for STAQUIS and vehicle groups, respectively) and most were classified as mild. Of these drug-related application site reactions, application site pain (e.g., burning or stinging) was the only adverse drug reaction that showed a clinically relevant difference in rates between the treatment groups (4.4% and 1.2% for STAQUIS and vehicle groups, respectively). Generally, application site pain was noted early in the treatment period and was transient in nature, resolving spontaneously.
Treatment-emergent adverse events reported by ≥1% of subjects from either treatment group, based on the pooled safety population (Trial 1 and Trial 2) are listed in Table 5. (See Table 5.)

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Uncommon (<1%) adverse reactions in subjects treated with STAQUIS included contact urticaria (see Precautions).
The safety profile from a completed STAQUIS open-label clinical trial (Trial 3) in which STAQUIS was applied intermittently in 28-day treatment courses for up to 48 weeks was consistent with that of Trial 1 and Trial 2 (see Pharmacology: Pharmacodynamics under Actions). (See Table 6.)

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In Trial 4, the adverse drug reactions observed during the twice daily treatment open-label period for up to 8 weeks were consistent with the known safety profile of twice daily STAQUIS. During the double-blind maintenance period in Trial 4 through Week 52, no cases of application site pain in the once daily STAQUIS-treated group were reported compared to 1.5% (2/135 subjects) in the once daily vehicle-treated group (see Pharmacology: Pharmacodynamics under Actions).
Pediatric clinical trial: In a multicenter, open-label, uncontrolled trial, 137 pediatric subjects aged 3 months to less than 2 years were treated with STAQUIS twice daily for 4 weeks. Overall, the safety profile of STAQUIS in this age group was consistent with that of Trials 1 and 2 in subjects 2 years of age and older.
Post-market reported adverse reactions: The following adverse reactions have been identified during post-approval use of STAQUIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Application site reactions.