Please see additional important patient information and side effects on the next page.
For more information about Synvisc, see your doctor or call 1-800-281-9106 for a free booklet.
Wyeth-Ayerst Pharmaceuticals
marketer ot Synvisc, is a proud sponsor of
the Arthritis Foundation.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This Summary describes synvisc, a prescriptinon formulation of hylan G-F 20 for knee pain due to osteoarthritis. Please read it carefully. Only your doctor has the training necessary to weigh the benefits and risks of Synvisc thearpy for you. Contact your doctor if you have any questions.
WHAT IS SYNVISC?Synvisc is a viscous and elastic sterile mixture that is made up of hylan A fluid, hylan B gel, and salt water. The two hylans are manufactured from hyaluronan (sodium hyaluronate) that comes from chicken combs. Hyaluronan is a natural chemical found in the body and is present in a particularly high amount in joint tissues and in the flud that fills the joint. The body's own hyalurronan acts like a lubricant and a shock absorber in the joint, and is needed for the joint to operate properly. In osteoarthritis, there may not be enough hyaluronan, and there may be a change in the quality of the haluronan in joint fluid and tissues.
Synvisc has comparable viscous and elastic properties to synovial fluid of 18 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 who do not get adequate relief from siimple painkillers or from exercise and physical therapy. The most pain relief and the greatest amount of treatment success occurred 8 to 12 weeks after synvisc treatment began.
If you have any questions or would like to find out more about Synvisc, you may call Wyeth-Ayerst Pharmaceuticals, at 1 800 999 9384 or fax 610 964 5999.
General
ADVERSE EVENTS
Adverse Events Involving the Injected Joint
Clinical Trials
A total of 511 patients (559 knees) received 1771 injections in seven clinical trials of Synvisc. There were 39 reports in 37 patients (2.2% of injections, 7.2% of pateints) of knee pain/and or swelling after these injections. Ten patients (10 knees) were treated with arthrocentesis and removal of joint effusion. Two additional patients (two knees) received NSAIDs. One of these patients also received arthrocentesis. One patient was treated with arthroscopy. The remaining patients with adverse events localized to the knee received no treatment or only analgesics.
Postmarket Experience
The most common adverse events reported have been pain, swelling and/or effusion involving the injected knee. In some cases, the effusion was considerabel and caused 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 arthropathles in such cases. Synovial fluid aspirates of varying volumes have revealed a range of cell counts, from very few to over 50,000 cells/mm.3 Reported treatments have included symptomatic therapy (e.g., rest, ice, heat, elevation, simple analgesics and NSAIDs) and/or arthrocentesis. Intra-articular corticosteriods have been used when infection was excluded. Rarely, arthroscopy has been performed. The occurrance of post-injection effusions may be associated with patient history of effusion, advanced stage of disease, and/or the number of injections a patient receives. reactions generally abate within a few days. Clinical benefit from the treatment may still occur after such reactions. Intra-articular infections did not occur in any of the clinical trials and have been reported only rarely during clinical use of Synvisc.
Other Adverse Events
Clinical Trials
In three concurrently controlled clinical trials with a total of 112 patients who received Synvisc and 110 patients who received either saline or arthrocentesis there were no statistically significant differences in the numbers or types of adverse events between the group of patients that received Synvisc and the group that received control treatments. Systemic adverse evetrns occurred in 10 (2.0%) of the Synvis-treated patients. There was one case each of rash (thorax and back) and itching of the skin following Synvisc injections in these studies. These symptoms did not recur when these patients received additional Synvisc injections. The remaining generalized adverse events reported were calf cramps, hemorroid problems anide edema, muscle pain, tonsilitis with nausea, tachyarthythmia, phlebitis with varicosities and low back sprain.
Postmarket Experience
Other adverse events reported include: rash, hives, itching, fever, nausea headache, dizziness, chills, muscle cramps, paresthesia, perpheral adema malase, respiratory difficulties, flushing and facial swelling. There have been rare reports of thrombocytopenia colincident with Synvisc injection. These event may or may not be causually related to Synvisc. (Adverse events reported only worldwide postmarketing experience, not seen in clincial trials are considered ore rare and are italicized.)
DISTRIBUTED BY:
Synvisc is a registered trademark of Biomatrix, Inc.
Synvisc is covered by U.S. patents.
This summary provides the most important information about Synvisc. If you want to read more, ask your doctor or pharmacist to let you read the professional labeling.
This Brief Summary for Direct-to-Consumer advertising is based on the current Synvisc Physician Insert, CI 5014-5, Revised May 13, 1999.