Indications: RESTASIS® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Dosing: Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of RESTASIS® ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS® can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products. Discard vial immediately after use.
Supplied: HOW SUPPLIED DOSAGE FORMS AND STRENGTHS Ophthalmic emulsion containing cyclosporine 0.5 mg/mL
STORAGE AND HANDLING RESTASIS® ophthalmic emulsion is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial; 30 or 60 vials are packaged in a polypropylene tray with an aluminum peelable lid. The entire contents of each tray (30 vials or 60 vials) must be dispensed intact.
30 Vials 0.4 mL each - NDC 0023-9163-30 60 Vials 0.4 mL each - NDC 0023-9163-60
STORAGE Store at 15°-25 °C (59°-77 °F).
Efficacy: MECHANISM OF ACTION Cyclosporine is an immunosuppressive agent when administered systemically.
In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.
CLINICAL STUDIES Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS® demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of RESTASIS® ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Precautions/Warnings: PRECAUTIONS POTENTIAL FOR EYE INJURY AND CONTAMINATION Be careful not to touch the vial tip to your eye or other surfaces to avoid potential for eye injury and contamination.
USE WITH CONTACT LENSES RESTASIS® should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS® ophthalmic emulsion.
NONCLINICAL TOXICOLOGY CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY CARCINOGENESIS Systemic carcinogenicity studies were conducted in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.
In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 80 times greater (normalized to body surface area) than the daily recommended human dose of one drop (approximately 28 mcL) of 0.05% RESTASIS® twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed.
MUTAGENESIS Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitro gave indication of a positive effect (i.e., induction of SCE).
IMPAIRMENT OF FERTILITY No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 2,000 times the human daily dose of 0.001 mg/kg/day normalized to body surface area) for 9 weeks (male) and 2 weeks (female) prior to mating.
No increase in bacterial or fungal ocular infections was reported following administration of RESTASIS®.
Indications: LACRISERT (cellulose) is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT (cellulose) is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions.
LACRISERT (cellulose) is also indicated for patients with:
Dosing: One LACRISERT (cellulose) ophthalmic insert in each eye once daily is usually sufficient to relieve the symptoms associated with moderate to severe dry eye syndromes. Individual patients may require more flexibility in the use of LACRISERT (cellulose) ; some patients may require twice daily use for optimal results.
Clinical experience with LACRISERT (cellulose) indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.
LACRISERT (cellulose) is inserted into the inferior cul-de-sac of the eye beneath the base of the tarsus, not in apposition to the cornea, nor beneath the eyelid at the level of the tarsal plate. If not properly positioned, it will be expelled into the interpalpebral fissure, and may cause symptoms of a foreign body. Illustrated instructions are included in each package. While in the licensed practitioner's office, the patient should read the instructions, then practice insertion and removal of LACRISERT (cellulose) until proficiency is achieved.
NOTE: Occasionally LACRISERT (cellulose) is inadvertently expelled from the eye, especially in patients with shallow conjunctival fornices. The patient should be cautioned against rubbing the eye(s) containing LACRISERT (cellulose) , especially upon awakening, so as not to dislodge or expel the insert. If required, another LACRISERT (cellulose) ophthalmic insert may be inserted. If experience indicates that transient blurred vision develops in an individual patient, the patient may want to remove LACRISERT (cellulose) a few hours after insertion to avoid this. Another LACRISERT (cellulose) ophthalmic insert maybe inserted if needed.
If LACRISERT (cellulose) causes worsening of symptoms, the patient should be instructed to inspect the conjunctival sac to make certain LACRISERT (cellulose) is in the proper location, deep in the inferior cul-de-sac of the eye beneath the base of the tarsus. If these symptoms persist, LACRISERT (cellulose) should be removed and the patient should contact the practitioner. Precautions/Warnings: PRECAUTIONS GENERAL If improperly placed, LACRISERT (cellulose) may result in corneal abrasion (see DOSAGE AND ADMINISTRATION).
INFORMATION FOR PATIENTS Patients should be advised to follow the instructions for using LACRISERT (cellulose) which accompany the package.
Because this product may produce transient blurring of vision, patients should be instructed to exercise caution when operating hazardous machinery or driving a motor vehicle.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Feeding of hydroxypropyl cellulose to rats at levels up to 5% of their diet produced no gross or histopathologic changes or other deleterious effects.
PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.
GERIATRIC USE No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Supplied: LACRISERT (cellulose) , a sterile, translucent, rod-shaped, water-soluble, ophthalmic insert made of hydroxypropyl cellulose, 5 mg, is supplied as follows:
NDC 25010-805-68 in packages containing 60 unit doses (each wrapped in an aluminum blister), two reusable applicators, and a plastic storage container to store the applicators after use.
STORAGE Store below 30°C (86°F). WARNINGS Instructions for inserting and removing LACRISERT (cellulose) should be carefully followed.
Efficacy: PHARMACODYNAMICS LACRISERT (cellulose) acts to stabilize and thicken the precorneal tear film and prolong the tear film breakup time which is usually accelerated in patients with dry eye states. LACRISERT (cellulose) also acts to lubricate and protect the eye.
LACRISERT (cellulose) usually reduces the signs and symptoms resulting from moderate to severe dry eye syndromes, such as conjunctival hyperemia, corneal and conjunctival staining with rose bengal, exudation, itching, burning, foreign body sensation, smarting, photophobia, dryness and blurred or cloudy vision. Progressive visual deterioration which occurs in some patients may be retarded, halted, or sometimes reversed.
Indications: Xiidra™ (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
Dosing: Instill one drop of Xiidra twice daily (approximately 12 hours apart) into each eye using a single-use container. Discard the single-use container immediately after using in each eye.
Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration.
Supplied: Xiidra contains Active: lifitegrast 50 mg/mL; Inactives: sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection.
DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing lifitegrast 5% (50 mg/mL).
STORAGE AND HANDLING Xiidra (lifitegrast ophthalmic solution) 5% (50 mg/mL) is supplied in a foil pouch containing 5 low density polyethylene 0.2 mL single-use containers.
NDC 54092-606-01; Carton of 60 single-use containers.
STORAGE Store at 20-25°C (68-77°F). Store single-use containers in the original foil pouch.
MECHANISM OF ACTION Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in dry eye disease is not known.
CLINICAL STUDIES The safety and efficacy of lifitegrast for the treatment of dry eye disease were assessed in a total of 1181 patients (1067 of which received lifitegrast 5%) in four 12-week, randomized, multi-center, double-masked, vehicle-controlled studies. Patients were randomized to Xiidra or vehicle (placebo) in a 1:1 ratio and dosed twice a day. Use of artificial tears was not allowed during the studies. The mean age was 59 years (range, 19–97 years). The majority of patients were female (76%). Enrollment criteria included, minimal signs (i.e., Corneal Fluorescein Staining (CFS) and non-anesthetized Schirmer Tear Test (STT)) and symptoms (i.e., Eye Dryness Score (EDS) and Ocular Discomfort Score (ODS)) severity scores at baseline.
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