Full Prescribing and
Important Safety Information
- GenVisc® 850 is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics (e.g., acetaminophen).
- GenVisc 850 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.
- In a clinical trial of 297 patients, the frequency of adverse events in the first treatment cycle was 2.9% which was identical to the frequency in the saline-control group.
- The most commonly reported adverse events in the GenVisc 850 group included injection site pain (6), allergic reaction (3), arthralgia (2), and bleeding at the injection site (2).
- In a clinical study 513 complete GenVisc 850 treatment cycles and a total of 487 complete PBS treatment cycles the frequency of adverse events between the groups was the same and did not increase over the course of the three retreatment cycles