Your doctor has determined that the knee pain you are experiencing is caused by osteoarthritis and that you are a candidate for a non-surgical, non-pharmacological, pain-relieving therapy called SUPARTZ Joint Fluid Therapy. SUPARTZ Joint Fluid Therapy is used for the treatment of pain in osteoarthritis of the knee in patients who have failed to get adequate relief from simple painkillers or from exercise and physical therapy.

What is SUPARTZ Joint Fluid Therapy?

SUPARTZ Joint Fluid Therapy is a solution made up of highly purified sodium hyaluronate (hyaluronan). Hyaluronan is a natural chemical found in the body and is found in particularly high amounts in joint tissues and in the fluid (synovial fluid) that fills the joints. The body’s own hyaluronan acts like a lubricant and shock absorber in synovial fluid of a healthy joint. Osteoarthritis reduces your synovial fluid’s ability to protect and lubricate your joint.

SUPARTZ Joint Fluid Therapy is available in 2.5 mL pre-filled syringes. SUPARTZ Joint Fluid Therapy is given in a shot directly in your knee.

What are the benefits of SUPARTZ Joint Fluid Therapy?

The safety and effectiveness of SUPARTZ Joint Fluid Therapy were studied in five clinical trials. These studies were conducted in Germany (1991); Sweden (1993); France (1995); the UK and Australia (1996). Patients received, in one knee joint, five weekly injections of SUPARTZ Joint Fluid Therapy or salt water. In the French study there were three treatment groups: five SUPARTZ Joint Fluid Therapy injections per patient, three SUPARTZ Joint Fluid Therapy injections followed by two injections of the salt water per patient, or five injections of the salt water per patient. The results of these five studies (619 patients received SUPARTZ Joint Fluid Therapy, 537 received salt water) have shown that five weekly injections of SUPARTZ Joint Fluid Therapy in the knee is both safe and effective for the relief of pain associated with osteoarthritis of the knee that was not relieved by simple painkillers or by exercise and physical therapy.

How is SUPARTZ Joint Fluid Therapy given?

Your doctor will give you an injection of SUPARTZ Joint Fluid Therapy (25 mg/2.5 mL) into your knee once a week for five weeks (a total of five injections). Your doctor may recommend a local anesthetic to reduce the possible discomfort associated with an injection.

What should you expect following your series of injections?

The goal of SUPARTZ Joint Fluid Therapy is the relief of pain. You may experience some pain relief before you receive the full series of five injections. However, studies suggest that most patients experiencing relief do so after the full series of five injections. The actual amount and duration of pain relief varies from patient to patient.

Immediately after you have the injection and for the next 48 hours, you may need to avoid activities such as jogging, tennis, heavy lifting or standing on your feet for a long time. Please note that no treatment, including SUPARTZ Joint Fluid Therapy, helps in every single patient.

What other treatments are available for osteoarthritis?

If you have osteoarthritis, there are several things you can do that do not involve SUPARTZ Joint Fluid Therapy injections. These include the following:

Non-drug treatments

• Avoiding activities that cause excess pain in your joints
• Exercise
• Physical therapy

Drug therapy

• Painkillers such as acetaminophen and narcotics
• Drugs that reduce inflammation, such as aspirin, and other non-steroidal anti-inflammatory agents (NSAIDs), such as ibuprofen and naproxen
• Corticosteroids that are injected directly into the joint

Are there any reasons why you should not utilize SUPARTZ Joint Fluid Therapy?

• You should not use this product if you are allergic to products from birds such as feathers, eggs and poultry.
• You should not have the injection if you have infections or skin diseases in the area the injection will be given.
• You should not take this product if you have had any previous allergic reaction to SUPARTZ Joint Fluid Therapy or similar material, i.e., hyaluronate products.
• The safety and effectiveness of SUPARTZ Joint Fluid Therapy have not been established in pregnant women, in lactating women, and in children.

Possible adverse events:

• In the studies mentioned above, the following were the most common adverse events (occurring in greater than 4 percent of SUPARTZ Joint Fluid Therapy-treated patients): joint pain with no evidence of inflammation, joint pain with evidence of inflammation, back pain, pain (non-specific), injection site reaction, headache and injection site pain. However, these adverse events also occurred at similar rates in the patients treated with salt water.
• In the five studies, five allergic reactions were reported in the SUPARTZ Joint Fluid Therapy group. No severe allergic reactions were observed in any study patients.

Other things you should know about SUPARTZ

Joint Fluid Therapy:

• SUPARTZ joint fluid therapy is only for injection into the knee, performed by a qualified physician.
• Pain and/or swelling of the injected joint may occur after injection of SUPARTZ Joint Fluid Therapy.
• The safety and effectiveness of repeat treatment cycles of SUPARTZ Joint Fluid Therapy have not been established.
• The effectiveness of a single treatment cycle of less than five injections has not been established.
• The safety and effectiveness of the use of SUPARTZ Joint Fluid Therapy in joints other than the knee have not been established.
• The safety and effectiveness of the use of SUPARTZ Joint Fluid Therapy given at the same time as other injectables have not been established.

How can you get more information about SUPARTZ Joint Fluid Therapy?

• Ask your doctor.
• Call Smith & Nephew at 1-800-836-4080.
• Consult the SUPARTZ Joint Fluid Therapy website at www.supartz.com.

Distributed by:

Smith & Nephew, Inc.
1450 Brooks Road
Memphis TN 38116
1-800-821-5700

Manufactured by:

Seikagaku Corporation
6-1, Marunuochi
1-chrome Chiyoda-Ku
Tokyo 100-0005, Japan

February 2001