TACTUPUMP FORTE

Adverse Drug Reaction Overview Treatment-related adverse reactions typically associated with use of TACTUPUMP or TACTUPUMP FORTE include mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging.

These reactions usually occur early in the treatment, and tend to gradually lessen over time (see WARNINGS AND PRECAUTIONS). Local adverse reactions during the treatment period were more pronounced with TACTUPUMP compared to adapalene or benzoyl peroxide alone.

Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. During clinical trials, 2077 subjects were exposed to TACTUPUMP or TACTUPUMP FORTE Topical Gel formulations.

A total of 1470 patients with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months. TACTUPUMP and TACTUPUMP FORTE efficacy and safety were assessed in subjects 12 years of age or older presenting with acne vulgaris.

In these studies, TACTUPUMP and TACTUPUMP FORTE and their comparators were applied once daily over a treatment period of 12 weeks. In two 12-week studies, related adverse events that were reported in at least 1% in any treatment group of 564 patients treated with TACTUPUMP Topical Gel are captured in Table 1.

Related adverse events reported in at least 1% of patients 12 years and older, in a 12-week study conducted with TACTUPUMP FORTE Topical Gel or TACTUPUMP Topical Gel are summarized in Table 2. 2) a Drug-related adverse events do not include known local adverse events (local tolerability) of retinoids.

b Multiple occurrences of a Preferred Term by a subject were counted once per Preferred Term. c A subject was counted once even if the subject experienced more than one AE during the study. 9) 0 0 a Drug-related adverse events do not include known local adverse events (local tolerability) of retinoids.

In the two 12-week studies conducted with TACTUPUMP Topical Gel, local tolerability evaluations were conducted at each study visit by assessment of erythema, scaling, dryness and stinging/burning. Analysis over the 12-week period showed that local tolerability scores peaked at Week 1 of therapy and subsided thereafter.