TriVisc is a registered trademark of OrthogenRx, Inc.
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Full Prescribing Information for TriVisc.
Important Safety Information
IMPORTANT SAFETY INFORMATION
TriVisc is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of present infections or skin diseases in the area of the injection site to reduce the potential for developing septic arthritis.
The effectiveness of a single treatment cycle of less than 3 injections has not been established.
Safety of TriVisc was established in two clinical studies of an identical chemical formulation of TriVisc. In a clinical trial of 306 patients, the frequency of adverse events was 2.9% which was identical to the frequency in the saline-control group. In the first cycle of injections the most commonly reported adverse events in the TriVisc equivalent group included injection site pain (6), allergic reaction (3), arthralgia (2), and bleeding at the injection site (2). In a clinical study involving 513 complete TriVisc equivalent treatment cycles and 487 complete phosphate buffered saline treatment cycles, the frequency of adverse events between the groups was the same and did not increase over the course of the three re-treatment cycles.