Benaliv

Benaliv™ 0.05% (levocabastine hydrochloride ophthalmic suspension) is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

SHAKE WELL BEFORE USING. The usual dose is one drop instilled in affected eyes four times per day.

This product is contraindicated in persons with known or suspected hypersensitivity to any of its components. It should not be used while soft contact lenses are being worn.

WARNINGS

For topical use only. Not for injection.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Levocabastine was not carcinogenic in male or female rats or in male mice when administered in the diet for up to 24 months. In female mice, levocabastine doses of 5,000 and 21,500 times the maximum recommended ocular human use level resulted in an increased incidence of pituitary gland adenoma and mammary gland adenocarcinoma possibly produced by increased prolactin levels.

The clinical relevance of this finding is unknown with regard to the interspecies differences in prolactin physiology and the very low plasma concentrations of levocabastine following ocular administration.

Mutagenic potential was not demonstrated for levocabastine when tested in Ames' Salmonella reversion test or in Escherichia coli, Drosophila melanogaster, a mouse Dominant Lethal Assay or in rat Micronucleus test.

In reproduction studies in rats, levocabastine showed no effects on fertility at oral doses of 20 mg/kg/day (8,300 times the maximum recommended human ocular dose).

Pregnancy

Teratogenic Effects - Pregnancy Category C

Levocabastine has been shown to be teratogenic (polydactyly) in rats when given in doses 16,500 times the maximum recommended human ocular dose. Teratogenicity (polydactyly, hydrocephaly, brachygnathia), embryotoxicity, and maternal toxicity were observed in rats at 66,000 times the maximum recommended ocular human dose. There are no adequate and well-controlled studies in pregnant women. Levocabastine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Based on determinations of levocabastine in breast milk after ophthalmic administration of the drug to one nursing woman, it was calculated that the daily dose of levocabastine in the infant was about 0.5 μg.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

The most frequent adverse experiences reported with the use of Benaliv™ 0.05% (levocabastine hydrochloride ophthalmic suspension) were mild, transient stinging and burning (29%) and headache (5%).

Other adverse experiences reported in approximately 1-3% of patients treated with Benaliv™ were visual disturbances, dry mouth, fatigue, pharyngitis, eye pain/dryness, somnolence, red eyes, lacrimation/discharge, cough, nausea, rash/erythema, eyelid edema, and dyspnea.

No information provided.