High Molecular Weight Hyaluronan is indicated in 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. In clinical studies, the most commonly reported adverse events for ORTHOVISC® High Molecular Weight Hyaluronan were arthralgia, back pain, and headache. Other side effects included local injection site adverse events. In clinical studies, the most commonly reported adverse events for MONOVISC® High Molecular Weight Hyaluronan were arthralgia, joint swelling and injection site pain.
ORTHOVISC® and MONOVISC® High Molecular Weight Hyaluronan are contraindicated in patients with known hypersensitivity to hyaluronate formulations or known hypersensitivity (allergy) to gram positive bacterial proteins. ORTHOVISC® and MONOVISC® High Molecular Weight Hyaluronan should not be injected in patients with infections or skin diseases in the area of the injection site or joint. MONOVISC® High Molecular Weight Hyaluronan should not be administered to patients with known bleeding disorders. Intra-articular injection of sodium hyaluronate preparations has occasionally been associated with allergic/anaphylactic reactions and transient hypotension, which have generally resolved spontaneously or after conservative treatment.