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Mercy continued from page 57 July 2011 Grace Flight is a Texas-based or- ganization providing free air trans- portation for patients with medical needs exceeding the abilities of their hometown care. These patients are usually too ill to drive or fly com- mercially and often financially strapped; transportation costs are not typically covered by insurance. Multiple days in a car would be very difficult on someone going through chemotherapy, and security lines at major airports can be a challenge for a young, sick child, for example. "Our volunteer pilots donate their time and pay for the fuel and all the operating costs of the air- craft," said Tim Dammon, executive director, Grace Flight of America. "It's a tremendous sacrifice on their part. We have some volunteers who fly on a regular basis. Some fly every month, others a few times a year. It's whatever they can do." Dr. Ellman has been working with Grace Flight for just over a year and has about 10 flights logged. "For some of these patients, be- sides the illness preventing them from working, the burden of travel- ing back and forth becomes ex- tremely difficult," said Dr. Ellman. "It's nice we're able to help them re- lieve some of that burden." Even if no pilots are available, they will do- nate frequent flyer points or buy tickets for patients to fly commercial. The most common route Grace Flight has in Texas is from El Paso to the University of Texas MD Anderson Cancer Center in Hous- ton; these have about 750 miles or 12 hours by car between them. Be- cause most of the pilots fly small, single-engine planes that don't travel as fast as commercial jets, Grace Flight will break up longer trips between two or even three avi- ators from similar agencies around the country if the destination re- quires it. "We try to work with people to get them where they need to go," said Mr. Dammon. "If that means partnering with other agencies then that's what we do." Dr. Ellman frequents the El Paso to Houston route, usually stopping halfway at a small airport in San Angelo, Texas, where another Grace Flight pilot completes the trip. "I try to combine trips as much as I can," said Dr. Ellman. "If I know I'm flying somewhere, I'll see if Grace Flight has anyone that needs a lift as well." Dr. Ellman became interested in flying while in medical school, but it wasn't until he moved to El Paso and opened his own practice, South- west Eye Institute, that he took to the skies. He began taking lessons in December 2006 and received his pilot's license in March 2007. "Flying is a very intensive activ- ity," he said. "You're concentrating on the different systems, but at the same time, you're not thinking about anything else—you're just fly- ing the airplane. So even though it's very intense, it's a stress reliever." Dr. Ellman's aircraft is the only commercially made plane with a built-in parachute, but he's not too worried about needing it. "It can be a dangerous activity, but most of the things that kill pi- lots are preventable, such as flying into bad weather or running out of gas," he said. "There's always that small risk of an engine failure, but that's actually quite rare. You just need to practice good decision mak- ing, which starts before you even take off by checking the weather and the airplane carefully." Flying has been nothing but smooth for Dr. Ellman, who is al- ways looking for additional passen- gers on his trips, including patients for Grace Flight. For more informa- tion on Grace Flight and to learn how to volunteer or donate, visit www.graceflight.org. EW Contact information Ellman: ellman@southwesteye.com Dammon: tdammon@graceflight.org RESTASIS ® (cyclosporine ophthalmic emulsion) 0.05% Sterile, Preservative-Free 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 produc tion 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 micronu cleus 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). 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 0.001 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 tox icity 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, 0.001 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). Rx Only Based on package insert 71876US14B Revised February 2010 ©2010 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. APC80OW11 U.S. Patent 5,474,979 Made in the U.S.A. 315-25995 Bleed: XX.XX" x XX.XX" Trim: 2.125" x 12.5" Live: XX.XX" x XX.XX" CLIENT NAME: Abelson Taylor JOB#: VW120 DESC: Restasis OPERATOR: DL ROUND: 1 DATE: 02/14/2011 FILE NAME: VW120_b01.indd QC Check __________ __________ __________ Marisela Munoz (center), with her husband (left) and Marc Ellman, M.D. (right), is a breast cancer survivor and Grace Flight passenger Source: Marc Ellman, M.D.

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