General This product is for otic use only and not approved for ophthalmic use. This product is not approved for injection. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, were reported in patients receiving treatment based on systemically administered quinolones.
Serious acute hypersensitivity reactions may require immediate emergency treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.
Carcinogenesis and Mutagenesis Carcinogenic potential of finafloxacin has not been studied. Finafloxacin was shown to be genotoxic and clastogenic in reverse mutation assay, mouse lymphoma cell forward mutation assay, and micronucleus assay in vitro.
Susceptibility/Resistance Development of Drug Resistant Bacteria Prescribing XTORO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of resistant organisms.
Potential for Microbial Overgrowth As with other antibacterial preparations, prolonged use may lead to overgrowth of resistant organisms, including yeast and fungi. If the infection has not improved after one week of treatment, this treatment should be discontinued and cultures should be obtained to guide further treatment.
If such infections occur, discontinue use and institute alternative therapy.
Special Populations Pregnant Women:
Teratogenic Effects: Finafloxacin was shown to be teratogenic following intravenous administration in rabbits. In the rabbit, the maternal NOEL was 3 mg/kg and fetal toxicity was observed at the lowest dose, 1 mg/kg. Fetal toxicity at 1 mg/kg was characterized by paw hyperflexure, exencephaly, decreased brain tissue, enlarged fontanel, and skeletal effects.
Finafloxacin administered to male and female rats at oral doses of 100 mg/kg/day, approximately 60,000 times higher than the clinical dose (based on a 30 μL drop size, 4 drop per dose, BID, and a 50 kg person), resulted in no changes in the fertility index and implantation rate.
3%) Page 5 of 20 500mg/kg/day. Since there are no adequate and well- controlled studies in pregnant women, this drug should not be used in pregnant women unless the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Nursing Women:
Finafloxacin has been identified in the milk of nursing rats following oral administration. It is not known whether topical otic administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk.
Nevertheless, caution should be exercised when finafloxacin is administered to a nursing mother.
Pediatrics (> 1 year and older):
The safety and efficacy of XTORO in infants below one year of age have not been established.
Geriatrics (≥ 65 years of age):
No overall differences in safety and effectiveness have been observed between elderly and younger patients. ADVERSE REACTIONS Adverse Drug Reaction Overview A total of 618 patients were treated with XTORO in two Phase 3 clinical trials.
No serious adverse reactions were reported. 5% included ear pruritus and dizziness. 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. 0) presented by System Organ Class. 1%) reported treatment-emergent adverse events in the Vehicle group.
0% during the Phase 3 efficacy and safety studies (C-10-018 and C-10- 019). 0%: Ear and labyrinth disorders: ear pruritus, cerumen impaction, hypoacusis Gastrointestinal disorders: nausea Infections and infestations: ear infection fungal, otitis externa candida Nervous system disorders: dizziness, headache Abnormal Hematologic and Clinical Chemistry Findings XTORO had no clinically relevant treatment-related effect upon laboratory parameters.
DRUG INTERACTIONS Overview Specific drug interaction studies have not been conducted with XTORO. Given the low systemic concentration of finafloxacin following topical otic administration of the product, drug interactions are unlikely to occur.
3%). Given the low systemic concentration of […]