Clinical Studies Experience
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.
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.
The adverse events, regardless of attribution, reported in at least 1% of adults (18 years of age and older) who received ALTABAX or comparator are presented in Table 1.
Table 1: Adverse Events Reported by ≥ 1% of Adult
Patients Treated With ALTABAX or Comparator in Phase 3 Clinical Studies
N = 1,527
N = 698
|Application site irritation||1.6||< 1.0|
|Creatinine phosphokinase increased||< 1.0||1.0|
The adverse events, regardless of attribution, reported in at least 1% of pediatric patients aged 9 months to 17 years who received ALTABAX are presented 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
N = 588
N = 121
N = 64
|Application site pruritus||1.9||0||0|
Other Adverse Events
In addition to reports in clinical trials, the following events have been identified during postmarketing use of ALTABAX. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Disorders and Administration Site Conditions
Application site burning.
Immune System Disorders
Hypersensitivity including angioedema.
Read the Altabax (retapamulin) Side Effects Center for a complete guide to possible side effects
Coadministration 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 adults and pediatric patients 2 years of age and older, dosage adjustments for retapamulin are unnecessary in these patients when coadministered 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.
Concomitant administration of retapamulin and CYP3A4 inhibitors, such as ketoconazole, has not been studied in pediatric patients. In pediatric patients 2 to 24 months of age, systemic exposure of retapamulin was higher compared with patients > 2 years of age after topical application [see Pharmacokinetics]. Based on the higher exposure of retapamulin, it is not recommended to coadminister ALTABAX with strong CYP3A4 inhibitors in patients younger than 24 months of age.
The effect of concurrent application of ALTABAX and other topical products to the same area of skin has not been studied.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/28/2013
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