Reward Yourself for Rewarding Your Eyes

Transcription

1 RESTASIS My Tears, My Rewards Guide When tear production is reduced by inflammation due to chronic Dry Eye Reward Yourself for Rewarding Your Eyes Please see Important Safety Information inside.

2 The My Tears, My Rewards Program In addition to the continued clinical benefits that can be achieved with continued use of RESTASIS, you can enjoy the savings and support of the My Tears, My Rewards Program. Enroll in this free program and receive A personal organizer to help guide you through the My Tears, My Rewards Program Access to your online My Tears, My Rewards Program tracker REFRESH OPTIVE Lubricant Eye Drops» 90-day supply program receives 3 bottles» 30-day supply program receives 1 bottle Your Health in Sight newsletter When you fill your prescription and refill it over time, valuable offers follow Discounts off of every refill Free RESTASIS at program completion Automatic program re-enrollment upon program completion For more information about the My Tears, My Rewards Program Call Visit MyTearsMyRewards.com Important Safety Information RESTASIS should not be used by patients with active eye infections and has not been studied in patients with a history of herpes viral infections of the eye.

3 The Convenience of the Card Saving with the My Tears, My Rewards Program is now even easier with the convenience of the RESTASIS My Tears, My Rewards Program card. Enjoy instant savings, not only with the first fill of your prescription, but with every refill of your RESTASIS prescription, with just a swipe of a card Savings are processed with your mail order submission, so there s no waiting for rebate checks You can even choose to start on the 30-day supply program, allowing you to fill your prescription and start treatment today, then switch to the 90-day supply program to enjoy the benefits of mail-order pharmacies Activate your RESTASIS My Tears, My Rewards Program card now Call Important Safety Information (continued) RESTASIS should not be used while wearing contact lenses. If contact lenses are worn, they should be removed prior to use.

4 Enjoying the Benefits 30-Day Supply* $25 off 1st prescription $15 off each of your next 5 prescriptions 90-Day Supply Save up to $690 $45 off 1st prescription $45 off of your next prescription FREE gift card upon 4th prescription FREE gift card upon 2nd prescription 7th prescription is FREE 3rd prescription is FREE Up to $300 saved on co-pays and free RESTASIS alone Up to $690 saved on co-pays and free RESTASIS alone Automatic program re-enrollment upon program completion, for continued savings *Two trays for 30 days. Six trays for 90 days. NOTE: Savings cannot exceed out-of-pocket co-pay cost. Prescription must be written for a minimum of a 30-day supply (2 trays per patient). Not valid for residents of Massachusetts, patients participating in Medicare, Medicaid, or any other federal- or state-funded benefits program and where prohibited by law. Under certain state laws, you may need to disclose your acceptance of offers to your third-party payer (insurer). Important Safety Information (continued) The most common side effect is a temporary burning sensation.

5 Using the Program Card 30-Day Supply* 1 Present card, along with your prescription, to the pharmacist 90-Day Supply Contact your mail-order pharmacy to verify they will accept the RESTASIS My Tears, My Rewards Program card (If they don t, see enclosed instructions for independent rebate redemption) 2 Upon successful claim adjudication, the card will be funded with the program benefit amount Make a copy of the front and back of your card 3 To receive payment, swipe the card or enter the 16-digit card number on the credit card terminal Mail the copy of the card along with your prescription and any other forms required by your mail-order pharmacy 4 The dollar amount funded to the card will be automatically deducted from the amount due You will need to pay the difference (if any) between your co-pay and the first 90-day prescription maximum benefit of $45 *Two trays for 30 days. Six trays for 90 days. NOTE: For subsequent mail orders, contact your mail-order pharmacy to determine if they have retained your card information. If so, they will be able to process your card without any further action on your part. If not, it may be necessary to send another copy of your card. Important Safety Information (continued) Other side effects include eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision.

6 Save Time and Money With Mail Order Filling prescriptions through your mail-order pharmacy provides you with multiple benefits. Ask for a 90-day Mail-Order Prescription Save money Many medications are available through mail-order at a discounted cost Save time Having RESTASIS delivered right to your door may mean more free time for you Fewer refills Mail-order pharmacies will often fill a 90-day prescription, meaning less frequent refills Most healthcare plans partner with a mail-order pharmacy. To learn more about your mail-order options, discuss them with your insurer or employer benefits administrator. You can also look for the toll-free phone number of your prescription drug plan on your prescription drug card or healthcare plan ID card. Call and ask how you can order your RESTASIS refills through the mail. Important Safety Information RESTASIS should not be used by patients with active eye infections and has not been studied in patients with a history of herpes viral infections of the eye.

7 Pharmacy Comparison Plans will vary, but the example listed below shows a typical benefit of refilling RESTASIS through your mail-order pharmacy. Retail pharmacy One retail prescription delivers a 30-day supply of RESTASIS * Retail = Mail-order pharmacy One mail-order prescription often delivers a 90-day supply of RESTASIS * Mail order = + + *Individual plans may vary. Important Safety Information (continued) RESTASIS should not be used while wearing contact lenses. If contact lenses are worn, they should be removed prior to use. The most common side effect is a temporary burning sensation.

8 RESTASIS helps you make more of your own real tears, for benefits that continue with continued use RESTASIS SUPPORT CENTER RESTASIS Ophthalmic Emulsion helps increase your eyes natural ability to produce tears, which may be reduced by inflammation due to chronic Dry Eye. RESTASIS did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs. Important Safety Information RESTASIS should not be used by patients with active eye infections and has not been studied in patients with a history of herpes viral infections of the eye. RESTASIS should not be used while wearing contact lenses. If contact lenses are worn, they should be removed prior to use. The most common side effect is a temporary burning sensation. Other side effects include eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Please see full Product Information enclosed. To get the REAL story, please visit RESTASIS.com Allergan, Inc., Irvine, CA and marks owned by Allergan, Inc. APC13VE10

9 RESTASIS (cyclosporine ophthalmic emulsion) 0.05% Sterile, Preservative-Free DESCRIPTION RESTASIS (cyclosporine ophthalmic emulsion) 0.05% contains a topical immunomodulator with anti-inflammatory effects. Cyclosporine s chemical name is Cyclo[[(E )-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl- N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-Lleucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure: Structural Formula Formula: C62H111N11O12 Mol. Wt.: Cyclosporine is a fine white powder. RESTASIS appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mosmol/kg and a ph of Each ml of RESTASIS ophthalmic emulsion contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer 1342; purified water and sodium hydroxide to adjust the ph. CLINICAL PHARMACOLOGY 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. Pharmacokinetics Blood cyclosporin A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of RESTASIS 0.05%, BID, in humans for up to 12 months, were below the quantitation limit of 0.1 ng/ml. There was no detectable drug accumulation in blood during 12 months of treatment with RESTASIS ophthalmic emulsion. Clinical Evaluations Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1200 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. No increase in bacterial or fungal ocular infections was reported following administration of RESTASIS. INDICATIONS AND USAGE 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. CONTRAINDICATIONS RESTASIS is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. WARNING RESTASIS ophthalmic emulsion has not been studied in patients with a history of herpes keratitis. PRECAUTIONS General: For ophthalmic use only. Information for Patients The emulsion from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration. Do not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. 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. Carcinogenesis, Mutagenesis, and Impairment of Fertility Systemic carcinogenicity studies were carried out 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 1000 and 500 times greater, respectively, than the daily human dose of one drop (28 µl) of 0.05% RESTASIS BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Cyclosporine has not been found 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 DNArepair 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). 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 15,000 times the human daily dose of mg/kg/day) for 9 weeks (male) and 2 weeks (female) prior to mating. Pregnancy-Teratogenic effects Pregnancy category C. Teratogenic Effects: No evidence of teratogenicity was observed in rats or rabbits receiving oral doses of cyclosporine up to 300 mg/kg/day during organogenesis. These doses in rats and rabbits are approximately 300,000 times greater than the daily human dose of one drop (28 µl) 0.05% RESTASIS BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Non-Teratogenic Effects: Adverse effects were seen in reproduction studies in rats and rabbits only at dose levels toxic to dams. At toxic doses (rats at 30 mg/kg/day and rabbits at 100 mg/kg/day), cyclosporine oral solution, USP, was embryo- and fetotoxic as indicated by increased pre- and postnatal mortality and reduced fetal weight together with related skeletal retardations. These doses are 30,000 and 100,000 times greater, respectively than the daily human dose of one-drop (28 µl) of 0.05% RESTASIS BID 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 at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively, during organogenesis. These doses in rats and rabbits are approximately 17,000 and 30,000 times greater, respectively, than the daily human dose. Offspring of rats receiving a 45 mg/kg/day oral dose of cyclosporine from Day 15 of pregnancy until Day 21 post partum, a maternally toxic level, exhibited an increase in postnatal mortality; this dose is 45,000 times greater than the daily human topical dose, mg/kg/day, assuming that the entire dose is absorbed. No adverse events were observed at oral doses up to 15 mg/kg/day (15,000 times greater than the daily human dose). There are no adequate and well-controlled studies of RESTASIS in pregnant women. RESTASIS should be administered to a pregnant woman only if clearly needed. Nursing Mothers Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of RESTASIS ophthalmic emulsion, caution should be exercised when RESTASIS is administered to a nursing woman. Pediatric Use The safety and efficacy of RESTASIS ophthalmic emulsion have not been established in pediatric patients below the age of 16. Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients. ADVERSE REACTIONS The most common adverse event following the use of RESTASIS was ocular burning (17%). Other events 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). DOSAGE AND ADMINISTRATION 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 artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use. HOW SUPPLIED RESTASIS ophthalmic emulsion is packaged in single use vials. Each vial contains 0.4 ml fill in a 0.9 ml LDPE vial; 30 vials are packaged in a polypropylene tray with an aluminum peelable lid. The entire contents of this tray (30 vials) must be dispensed intact. RESTASIS is also provided in a 60 count (2 x 30) package (one month supply) that must be dispensed intact. 30 Vials 0.4 ml each - NDC (2 x 30) Vials 0.4 ml each - NDC Storage: Store RESTASIS ophthalmic emulsion at C (59-77 F). KEEP OUT OF THE REACH OF CHILDREN. Rx Only Revised 02/ Allergan, Inc. Irvine, CA 92612, U.S.A. marks owned by Allergan, Inc. APC76FT10 U.S. Patent 5,474,979 Made in the U.S.A.