Restasis MultiDose

RESTASIS MULTIDOSE- cyclosporine emulsion
Allergan, Inc.

1 INDICATIONS AND USAGE

RESTASIS MULTIDOSE TM 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.

2 DOSAGE AND ADMINISTRATION

Instill one drop of RESTASIS MULTIDOSE TM ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS MULTIDOSE TM can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products. Contact lenses should be removed prior to the administration of RESTASIS ® MULTIDOSE TM and may be reinserted 15 minutes following administration.

2.1 Preparation for First-Time Use

Step 1: Pull off the clear shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSE TM if shipping cover or pull tab are damaged or missing.

Pull off the clear shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSETM if shipping cover or pull tab are damaged or missing.

Step 2: Remove the pull tab on the olive green colored protective cap by pulling the end of the pull tab away from the bottle then winding it counterclockwise. Throw away the pull tab.

Remove the pull tab on the olive green colored protective cap by pulling the end of the pull tab away from the bottle then winding it counterclockwise.  Throw away the pull tab.

Step 3: Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap.

Remove the olive green colored protective cap by pulling it straight up.  Keep the colored protective cap.

Step 4: Prime the bottle for first-time use by squeezing two drops onto a tissue. Do not let the bottle tip touch the tissue.

Prime the bottle for first-time use by squeezing two drops onto a tissue.  Do not let the bottle tip touch the tissue.

Step 5: The bottle is now ready for use. After use, recap the bottle with the olive green colored protective cap by pushing it straight down onto the bottle.

The bottle is now ready for use.  After use, recap the bottle with the olive green colored protective cap by pushing it straight down onto the bottle.

2.2 Preparation for Use

Step 6: Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well.

Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well.

Step 7: Instill one drop in the affected eye. Replace the olive green colored protective cap.

3 DOSAGE FORMS AND STRENGTHS

Ophthalmic emulsion containing cyclosporine 0.5 mg/mL

4 CONTRAINDICATIONS

RESTASIS MULTIDOSE TM is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5. 1 Potential for Eye Injury and Contamination

Be careful not to touch the bottle tip to your eye or other surfaces to avoid potential for eye injury and contamination.

5.2 Use with Contact Lenses

RESTASIS MULTIDOSE™ 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 MULTIDOSE™ ophthalmic emulsion.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion, 0.05% was ocular burning (17%).

Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).

6.2 Post-marketing Experience

The following adverse reactions have been identified during post approval use of cyclosporine ophthalmic emulsion, 0.05%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the bottle tip touching the eye during administration).

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary
Clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see Clinical Pharmacology (12.3)] , and maternal use is not expected to result in fetal exposure to the drug. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data].

Data
Animal Data
At maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (USP) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose.

An oral dose of 45 mg/kg/day cyclosporine administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. This dose is 7,000 times greater than the daily recommended human dose. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose).

8.2 Lactation

Risk Summary
Cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. Although blood concentrations are undetectable following topical administration of cyclosporine ophthalmic emulsion 0.05% [see Clinical Pharmacology (12.3)] , caution should be exercised when RESTASIS MULTIDOSE TM is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RESTASIS MULTIDOSE TM and any potential adverse effects on the breast-fed child from cyclosporine.

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