Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma thymidine kinase (tk) assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay.
Patient Counseling Information
Instruct the patient to shake the bottle for one to two seconds before using.
Risk of Contamination
Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the suspension.
Risk of Secondary Infection
If pain develops, or redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician.
Contact Lens Wear
Advise patients that the preservative in Inveltys may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of Inveltys and may be reinserted after 15 minutes following administration.
Kala Pharmaceuticals, Inc.
Waltham, MA 02453
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Patented. See www.kalarx.com/patents
© 2018 Kala Pharmaceuticals, Inc. All rights reserved.
Part # 2003R02