Clinical Studies Experience

The safety profile of ALTABAX was assessed in 2,115 adult and pediatric patients ≥9 months who used at least one dose from a 5-day, twice a day regimen of retapamulin ointment. Control groups included 819 adult and pediatric patients who used at least one dose of the active control (oral cephalexin), 172 patients who used an active topical comparator (not available in the US), and 71 patients who used placebo.

Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of patients treated with retapamulin ointment, 6.6% (54/819) of patients receiving cephalexin, and 2.8% (2/71) of patients receiving placebo. The most common drug-related adverse events (≥1% of patients) were application site irritation (1.4%) in the retapamulin group, diarrhea (1.7%) in the cephalexin group, and application site pruritus (1.4%) and application site paresthesia (1.4%) in the placebo group.

Because clinical studies are conducted under varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Adults: The adverse events, regardless of attribution, reported in at least 1% of adults (18 years of age and older) who received ALTABAX are listed in Table 1.

Pediatrics: The adverse events, regardless of attribution, reported in at least 1% of pediatric patients aged 9 months to 17 years who received ALTABAX are listed in Table 2.

Table 2. Adverse Events Reported by ≥1% in Pediatric Patients Aged 9 Months to 17 Years Treated With ALTABAX in Phase 3 Clinical Studies

Other Adverse Events: Application site pain, erythema, and contact dermatitis were reported in less than 1% of patients in clinical studies.

Co-administration of oral ketoconazole 200 mg twice daily increased retapamulin geometric mean AUC_(0-24) and Cmax by 81% after topical application of retapamulin ointment, 1% on the abraded skin of healthy adult males. Due to low systemic exposure to retapamulin following topical application in patients, dosage adjustments for retapamulin are unnecessary when co-administered with CYP3A4 inhibitors, such as ketoconazole. Based on in vitro P450 inhibition studies and the low systemic exposure observed following topical application of ALTABAX, retapamulin is unlikely to affect the metabolism of other P450 substrates.

The effect of concurrent application of ALTABAX and other topical products to the same area of skin has not been studied.

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