ORTHOVISC™ High Molecular Weight Hyaluronan

ORTHOVISC is indicated in the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics; eg, acetaminophen.

Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations, or to gram positive bacterial proteins. Do not inject ORTHOVISC in the knees of patients with infections or skin diseases in the area of the injection site or joint.

Do not concomitantly use disinfectants containing quarternary ammonium salts for skin preparation as hyaluronic acid can precipitate in their presence.
Transient increases in inflammation in the injected knee following ORTHOVISC injection have been reported in patients with inflammatory osteoarthritis.
 
PRECAUTIONS: General

• Strict aseptic injection technique should be used during the application of ORTHOVISC®.
• The safety and effectiveness of the use of ORTHOVISC® in joints other than the knee have not been demonstrated.
• The effectiveness of a single treatment cycle of less than 3 injections has not been established. Pain relief may not be seen until after the third injection.
• The effectiveness of ORTHOVISC® has not been established for more than one course of treatment.
• STERILE CONTENTS. The pre-filled syringe is intended for single use only. The contents of the syringe should be used immediately after opening. Discard any unused ORTHOVISC®. Do not resterilize.
• Do not use ORTHOVISC® if the package has been opened or damaged.
• Store ORTHOVISC® in its original package at room temperature (below 77°F/25°C). DO NOT FREEZE.
• Remove joint effusion, if present, before injecting ORTHOVISC®.
• Only medical professionals trained in accepted injection techniques for delivering agents into the knee joint should inject ORTHOVISC® for the indicated use.

ADVERSE EVENTS: 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. ORTHOVISC® was investigated in 3 randomized, controlled clinical studies conducted in the U.S. An integrated safety analysis was conducted, pooling the ORTHOVISC® groups from the 3 studies and pooling the control groups, which were either intra-articular saline injections or arthrocentesis. In the integrated analysis, there were 562 patients in the groups treated with ORTHOVISC® (434 receiving 3 injections and 128 receiving 4 injections), 296 in the group treated with physiological saline, and 123 in the group treated with arthrocentesis. Adverse events occurring at >5% of the overall integrated population included: arthralgia (12.6% in the ORTHOVISC® group, 17.2% in the saline group, and 0.8% in the arthrocentesis group); back pain (6.9% in the ORTHOVISC® group, 12.2% in the saline group, and 4.9% in the arthrocentesis group); and headache NOS (12.1% in the ORTHOVISC® group, 16.6% in the saline group, and 17.9% in the arthrocentesis group). Injection site adverse events (including erythema, edema, pain and reaction NOS) occurred at rates of 0.4%, 0.9%, 2.5% and 0.2%, respectively, in the ORTHOVISC® group, compared to 0.0%, 0.3%, 2.0%, and 0.7% in the saline group and 0.0%, 0.0%, 0.8% and 0.8% in the arthrocentesis group.