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
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.