The Salina Journal from Salina, Kansas on April 15, 2001 · Page 56
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The Salina Journal from Salina, Kansas · Page 56

Salina, Kansas
Issue Date:
Sunday, April 15, 2001
Page 56
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HYLAN G-F 20 ms SUMMMY OF PRESCRIBING INFORMATION Tliis Summary describes Synvisc, a prescription formulation of hylan 6-F 20 for knee pain due to osteoarthrilis. Please road it carefully. Only your doctor has (he training necessary to weish the twnoSIs and risks of Synvisc therapy for you. Contact your doctor if you have any quesllorB. WHATISSYNVISC7 Synvisc Is a viscous and clastic sterile mixture that is made up of hylan A fluid, hylan B gel. and salt water. The two hylans are manufactured from hyaiuronan (sodium hyaluronate) that comes from chicken combs. HyaluFonan Is a natural chemical found in the body and Is present In a particularly high amount In ioint tissues and in the fluid that fills the loint The body's own hyaiuronan acts like a lubricant and a shock absorter In the ]olnt. and is needed lor the joint to operate propofly In osteoarthritis, there may not be enough hyaiuronan, and there may be a change In (he quality of the hyaiuronan in joint fluid and tissues. Synvisc has comparable viscous and clastic properties to synovial fluid of 1 a- to 27-year-old healthy human knees. Synvisc is given by a series of injections directly into your knee. WHAT IS SYNVISC USED FOR? Synvisc is used to relieve knee pain due to osteoarthritis. It is used for patients v»ho do not get adequate relief from simple painkillers or hom exsrdse and physical therapy. The most pain relief and the greatest amount of treatment success occurred 8 to 12 weeks after Synvisc treahnent began. HOW CAN I GET MORE INFORMATION ABOUT SYNVISC? If you have any questions or would like to find out more about Synvisc, you may call Wyeth-Ayerst Pharmaceuticals, at 1 -800-99-WYETH. CONTRAINDICATIONS • Do not administer to patients with known hypersensitivity (allergy) to hyaiuronan (sodium hyaluronate) preparations. • Do not Inject Synvisc In the knees of patients having knee joint Infections or skin diseases or Infections in the area of the Injection site. WARNINGS • Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaiuronan can precipitate In their presence. • Do not inject Synvisc extra-artculariy, or Into the synovial tissues and capsule. Local and systemic adverse events, generally In the area oi the injection, have occuned folkiwing extra-arllcular Injection of Synvisc. • intrayascular Injections of Synvisc may cause systemic adverse events. PRECAUTIONS General • The effectiveness of a single treatment cycle of less than three injec- ttons of Synvisc has not been estalillshed. • The safety and effectiveness of Synvisc In locations other than the knee and tor conditions other than osteoatthhiis have not been established. • Do not inject anesthetics or other medications into the knee joint during Synvisc therapy Such medications may dilute Synvisc and affect its safety and effectiveness. • Use caution when Injecting Synvisc inio pallenis who are allergic to avian proteins, feathers, and egg products. • The safety and effectWeness of Synvisc In severely Inflamed knee joints have not been established. • Strict aseptic admlnlstratlDn technique must be followed. • STERIIl COHrENTS. The syringe Is intended for single use. The contents of the syringe must be used Immediately after ha packaging Is opened. Discard any unused Synvisc. • Do not use Synvisc If package Is opened or damaged. Store in original packaging (protected from light) at room temperature below BB'f (30"C).D0 NOT FREEZE. • Remove synovial fluid or effusion before each Synvisc Injection. • Synvisc should be used with caution when there Is evidence of lymphatic or venous stasis In that leg. Information for Patients • Provide patients whh a copy of the Patient Labeling prior to use. • Transient pain, swelling, and/or efhislon of the Injected joint may occur after inlra-artlcuiar injection of Synvisc. In some cases, the sifuslons may be considerable and cause pronounced pain; cases where swelling Is extensive should be discussed viNh the physician. • As with any Invasive joint procedure, it is recommended that the patient avoW any strenuous activities or prolonged weight-bearing activities such as logging or tennis following the intra-artlcuiar injection. • The salety and effectiveness of repeat freatment cycles of Synvisc have not been established. • The packaging of this product contains dry natural nibber latex. O 2001, Wyeth-Ayerst Pliarmaceutlcals UsainSpecHicPopulatiom • PtBflnancy: The safety and effecthreness of Synvisc have not been established in pregnant women. • Nursing mothere: It Is not knovm if Synvisc Is excreted in human milk. The safety and effectiveness of Synvisc have not been established In lactating women. • The safety and effectiveness of Synvisc have not been established in children. ADVERSE EVElrrS Advene Events InvoMng the Inlectid Joint Clinical Trials A total of 511 patients (559 knees) received 1771 Injections In seven dlnlcal Mais of Synvisc. Tfiere were 39 reports In 37 patients (2.2% of injectlDns, 7.2% of patients) of knee pain and/or swelling after these injections. Ten patients (10 knees) were treated with arthrocentesls and removal of Joint ofhrskin. Two additional patients (two knees) received treahnent with inba-atticuiar steroids. TWo patients (tvra knees) received NSAIDs. One of these patients also received arthrocentesls. One patient was treated with arthroscopy. The remaining patients with adverse events tocalized to the knee received no treatment or only analgesics. Postmari<et Experience The most common adverse events repotted have been pain, swelling and/or effusion InvoMng the Injected knee, in some cases, the effusion was considerable and caussd pronounced pain. In some Instances, patients have presented with knees that were tender, warm and red. it Is Important to rule out Infection or crystalline arthropathies In such cases. Synovial fluid asplratas of varying volumes have revealed a range ol cell counts, from very few to over 50,000 ceils/mm'. Reported treatments have Included symptomallc therapy (e.g., rest, Ice, heat, elevation, simple analgesics and NSAIDs) and/or arihrocenlssls. Intra-artlc- ular cortlcosterohls have been used when infection was excluded. Patients have rarely undergone arthroscopy or other procedures. Reactions generally abate within a few days. Clinical benefit from treatment may still occur otter such reactkms. Intra-artlcular Infections did not occur In any of the clinical trials and have been reported only rarely during dlnlcal use ol Synvisc. Other Adverse Events Clinical Trials In three concunently controlled clinical trials with a total of 112 patients who received Synvisc and 110 patients who received either saline or arthrtjcentesls, there were no statistically signllicant differences in the numbera or types ol adverse events behveen the group of patients that received Synvisc and the group that received control treatments. Systemic adverse events occuned in 10 (2.0%) of the Synvisc-treated padents. There was one case each of rash (thorax and back) and Itching of the skin following Synvisc InjecUons In these studies. These symptoms did not recur when diese patlenis received additional Synvisc Injections. The remaining generalized adverse events reported were calf cramps, hemorrhoid problems, ankle edema, muscle pain, tonsillitis with nausea, tachyanhylhmla, phlebitis with varicosities and low back sprain. Postmari<et Experience Other adverse events reported Include: rash, hives, itching, fever; nausea, headache, dizziness, chills, musde cramps, paresthesia, peripheral edema, malaise, respliatory difficulties, flushing and facial swelling. There have been rare reports of thromhocytopenia coincident whh Synvisc Injection. (Adverse events reported ailyin woridwide postmar­ keting experience, not seen In dlnlcal hials, are considered more rare and are italicized.) DISTRIBUTED BY: Wyeth-Ayerst Phannaceutlcals Philadelphia, Pennsylvania 19101 Telephone: 1-800-99-WETH DEVELOPED AND MANUFACTURED BY: Biomatrix, Inc., 65 Railroad Avenue RIdgefleld, New Jersey 07657 Telephone: (201) 945-9550 fax: (201)345-0363 Synvisc* Is a registered bademari< of Biomatrix, Inc. Synvisc* is covered by U.S. patents. This summary provides the most important Infomiation about Synvisc. If you want to read more, ask your doctor or phamiaclst to let you read the professional labeling. This Brief Summary for DIrect-to-Consuroer advertising Is based on Synvisc Physician Insert, CI 6082-2, Revised September 29,2000. D«ve(op«d and manufactured by I Biomatrix ® Mariistad and dlstributad by WYETH-AYEHST LABORATORIES Philadelphia, PA 19101 74406-02 Synvisc is usually covered by most insurance plans. Many require that your doctor stocl< Synvisc. If your doctor does not stocl< Synvisc and he or she writes a Synvisc prescription for you, sonne insurance plans, including Medicare, may not cover the cost. Therefore, it is recommended that you ask your doctor if his or her office stocks Synvisc. Procedures vary from policy to policy, so please check with your doctor and/or your insurer. If you have additional questions about insurance coverage, please contact the Synvisc Reimbursement Hotline at 1-800-982-8292. This toll-free number can be accessed between 9:00 AM and 6:00 PM . Eastern Time, Monday through Friday. First Person Perspiration and inspiration What does a TV talk show host have in common with two Olympians? Personal tragedy—and physical triumph. BY LISA LING O N MONDAY, I'M GOING to try something that even my trainer friend told me would be impossible: run the Boston Marathon. It's not that she didn't have faith in me. It was the timing of my decision — two months ago. Hardly a lot of prep time for a marathon virgin like me. But she also knew the reason — or, rather, reasons: my beautiful 14-year-old cousin Ali Pierce, who died of liver cancer in November 1996, and her father, my Uncle John. While training for the Boston Marathon the following year — to raise money in All's name for other kids afflicted with cancer —he collapsed and died instantly of a heart attack, just 10 feet from the finish line. We're all convinced he died of a broken heart, because two days before, he had received a perfect bill of health. When what is now known as 'Ali and Dad's army" secured 10 slots to run in the 2001 Boston Marathon, it was like a calling for me. Ever since my cousin died, I'd wanted to do something to help All's mom, my Aunt Anna, the new spokesperson for the "army." Though I've never run a marathon, I was determined to pick up where Uncle John left off. Running has never been an activity I've particularly enjoyed. In fact, 10 USAWEEKEND-April 13-15,2001 Lisa Ling, 27, right — co-host of The View and a USA WEEKEND contributing editor — warms up with trainer Lisa Slmonsen in New York's Central Park. before I began training, the thought of running more than 3 miles was enough to exhaust me. When I decided to go for it, I called Lisa Simonsen, a trainer. She told me I was crazy to think I could run the Boston with only eight weeks to go. But after I explained myself, we immediately scheduled a time to run the 6-mile loop in Central Park so she could test me. It was exhausting. I kept thinking about my sick cousin Ali in her hospital bed. I saw her face so clearly in my mind, and clenched my fists as though holding her small, frail hands. As tough as it was, I finished without having to walk. Six weeks later, I completed more than 16 miles, fists tightly clenched. Several bona fide athletes have linked their achievements to tragedies of some kind. Softball player Lori Harrigan and kayaker Cliff Meidl are two amazing examples. Each faced what seemed at the time like insurmountable obstacles and turned personal devastation into a motivating force. Both became Olympians. Harrigan went to the 2000 Olympics depressed. A week before, her childhood pitching coach, Mando Madrid, had died of a muscle disease he had fought for much of his life. Throughout Harrigan's pitching career, it was "the nod" that Madrid would give Harrigan during games

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