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Synvisc for Knee Osteoarthritis
 
 
 


 
Synvisc® is a milestone viscosupplementation treatment used to relieve knee pain caused by osteoarthritis. This elastoviscous joint fluid supplement acts as a shock absorber and lubricant for the knee, and is used in patients who do not obtain adequate relief from simple painkillers or from exercise and physical therapy.

What is Synvisc?

Synvisc is a milestone viscosupplementation treatment used to relieve pain due to osteoarthritis of the knee. This elastoviscous supplement, injected directly into the knee joint, acts as a shock absorber and lubricant, and is used for patients who do not obtain adequate relief from simple painkillers or from exercise and physical therapy. Synvisc is a device, not a drug, and is designed to replace the diseased synovial fluid found in osteoarthritic knees.

What is Synvisc made from?

Synvisc is an elastic and viscous fluid that is made up of hylan A and hylan B biological polymers. The two hylans are manufactured from hyaluronan that comes from chicken combs. Hyaluronan is a natural chemical found in the body and is present in all tissues, but there is a particularly high amount in joint tissues and in the fluid that fills the knee joint. The body's own hyaluronan acts like a shock absorber and lubricant in the joint, and is needed for the joint to operate properly. In painful osteoarthritic knees, there is deterioration of the quality (low elasticity and viscosity) of the hyaluronan in joint fluid and tissues, or there may not be enough hyaluronan.

How does Synvisc differ from other hyaluronan preparations?

Synvisc is the only viscosupplementation product that has physical properties comparable to those of the healthy synovial fluid found in 18- to 27-year-old humans. Due to its high molecular weight, Synvisc has superior shock-absorbing and lubricating properties and remains in the joint longer than hyaluronan.

Is Synvisc a drug or a device?

Synvisc is classified as a device because it exerts its effect by a physical action (elastoviscosity), not by a chemical action. Because it is a non-drug, Synvisc should not interfere with any medicine that the patient may take.

What is viscosupplementation?

Viscosupplementation is the therapeutic procedure by which the physical properties (elastoviscosity) of diseased synovial fluid are restored and augmented with an elastoviscous fluid like Synvisc. This will result in a decrease of joint pain, thereby helping the joint to become more mobile.

How is Synvisc eliminated from the body?

Once injected into the joint space, Synvisc passes through the lymph system into the blood and is completely metabolized in the liver, where it is broken down into water and carbon dioxide.

TREATMENT ISSUES

How is Synvisc administered?

Synvisc is injected directly into the knee joint three times (Days 1, 8 and 15) over a 15-day period by a qualified physician.

Why are three injections required?

Clinical investigations with Synvisc have demonstrated that three injections one week apart provide optimal pain relief and restoration of joint mobility. Completion of the full three-injection treatment course is recommended to achieve the greatest therapeutic benefit.

How do I know if Synvisc is right for me?

A physician is the best person to advise you on any course of treatment, including Synvisc. So to find out if you are a good candidate for Synvisc treatment, the first step is to make an appointment with your physician.

Am I too old for Synvisc?

There are no specific precautions or contraindications regarding the use of Synvisc in elderly patients. During clinical trials, the safety profile of Synvisc was well established in elderly patients. This may be attributed to the local, nonpharmacologic action of Synvisc, as well as to its lack of interactions with medications of other concurrent diseases. The mean age of men and women who participated in Synvisc premarketing clinical trials was 61 years (range of 18 to 93), with the majority of patients over 40 years.

At what point in the treatment of osteoarthritis should Synvisc be considered?

Synvisc is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g. acetaminophen. And of course, a physician is the best person to advise you on any course of treatment, including Synvisc.

Can I receive Synvisc in both of my knees?

Yes, if both knees have pain. Synvisc treatment may be given in both knees simultaneously or separately, according to your physician's recommendations.

Can I take other medications while receiving Synvisc treatment?

Yes. Since Synvisc is an elastoviscous fluid device injected directly into the knee joint, it does not interfere with any medicine that your physician recommends, including pain relievers and anti-inflammatory drugs. You should discuss with your physician any medicine taken.

Should I modify my level of physical activity after receiving Synvisc treatment?

You should consult your physician about what level of activity is right for you, but in general, patients are able to maintain their normal daily activities after receiving treatment. However, patients should avoid strenuous activities such as jogging, tennis and heavy lifting for at least 48 hours after receiving an injection.

Is Synvisc treatment effective in knees with advanced osteoarthritis and loss of cartilage?

Synvisc has been shown to be effective in all stages of this disease, although it is most effective in the early stages of joint pathology. However, some patients with advanced osteoarthritis have also responded to Synvisc with variable results. All patients receiving Synvisc should be mobile and have no health conditions that prevent normal use of the knee.

Can Synvisc be used in joints other than the knee?

The U.S. Food and Drug Administration approved patient information which states: "The safety and effectiveness of Synvisc in locations other than the knee and for conditions other than osteoarthritis have not been established."

Is Synvisc a cure for osteoarthritis of the knee?

There is no cure for osteoarthritis. Synvisc is a treatment for the pain of osteoarthritis. In some patients, successful treatment may reduce pain within the first week after treatment begins. In most patients, the most pain relief and the greatest amount of treatment success occurred 8 to 12 weeks after Synvisc treatment began.

BENEFITS

What are the benefits of receiving Synvisc treatment?

Successful treatment with Synvisc should reduce pain in an osteoarthritic knee, resulting in increased mobility. In addition, because it is a non-drug, local treatment, Synvisc should not interfere with any medicine that the patient may take.

How soon after Synvisc treatment should I experience relief?

Each patient's response to Synvisc regarding relief of pain and restoration of joint mobility will vary, depending upon the stage of joint pathology and pre-existing medical conditions. In general, however, some patients experienced significant pain relief within the first week after Synvisc treatment began. In most patients, the most pain relief and the greatest amount of treatment success occurred 8 to 12 weeks after treatment began.

How long can I expect the benefits of Synvisc to last?

Each patient reacts differently to Synvisc treatment. The benefits of Synvisc can last for months, but in most patients, the most pain relief and the greatest amount of treatment success occurred 8 to 12 weeks after treatment began. There are several clinical studies which address the effectiveness of Synvisc treatment.

SAFETY

How safe is Synvisc?

Extensive safety and toxicity tests were performed on Synvisc before the first clinical trials. Preclinical studies showed that Synvisc is nonantigenic, nontoxic, noninflammatory, and does not elicit foreign body reactions. Hyaluronan, from which hylan is derived, has been safely used in ophthalmic and orthopedic applications in millions of patients. In clinical trials, transient local pain, swelling, and/or effusion occurred in 2.2% of intra-articular injections of Synvisc.

What are the side effects of Synvisc?

There have been no general (systemic) side effects attributed to Synvisc. However, because Synvisc is injected directly into the joint, some patients may feel localized discomfort after treatment. Some pain, swelling and effusion may occur in and around the knee. Both usually go away within a short period and do not interfere with the success of the treatment. If you continue to feel discomfort or notice other problems, you should consult your physician.

Are there any allergies that may affect Synvisc treatment?

No cases of anaphylaxis or anaphylactoid reactions have been reported in connection with Synvisc treatment. You should consult your physician if you have a history of hypersensitivities to hyaluronan preparations or are allergic to avian proteins, feathers and egg products.

Do I need a prescription for Synvisc?

Yes, Synvisc is a prescription device. In most cases, it can be prescribed and dispensed simultaneously in a physician's office. In other instances, the physician can write a prescription for the patient to pick up Synvisc at his or her pharmacy and return it to the physician for injection.

Will Synvisc be reimbursed by medical insurance plans?

Most insurance plans will pay for Synvisc. You should call your insurance company to make certain.

How can I find out more about Synvisc?

Talk to your physician for more information about Synvisc.

OSTEOARTHRITIS

What is osteoarthritis of the knee?

Arthritis is a medical condition which can affect joints. The most common form of arthritis is osteoarthritis, affecting nearly 16 million Americans. This degenerative joint disease typically affects people over the age of 50, but can affect anyone above the age of 18. Risk factors include age, obesity, female gender, genetic predisposition and previous trauma to the knee joint. The first and most important symptom of osteoarthritis is pain, which can be accompanied with swelling of the joint and accumulation of fluid in the joint.

The space between the cartilage-covered bones in the knee joint contains synovial fluid which acts as a cushion for the tissues of the joint. But with the onset of osteoarthritis, the synovial fluid becomes thinner and loses its elasticity. The thin synovial fluid simply cannot act as an effective shock absorber. This lack of protection aggravates the condition because the cartilage protecting the bones in the osteoarthritic knee is increasingly exposed to impact and friction. The pain felt when weight is put on the knee is caused by the increased sensitivity of the nerve endings in the soft tissues of the joint. This increased sensitivity to pain is the result of the decrease of the protective capacity of the synovial fluid (low elastoviscosity).

The unprotected cartilage begins to wear away and lose its smoothness. The cartilage continues to break down as the disease progresses; the bones which are normally protected by the cartilage and synovial fluid develop bony spurs. As a result, even simple movements of the knee can become extremely painful. Pain in the knee can seriously limit mobility, making the sufferer feel weak and unstable when performing even the most common activities, like walking or climbing stairs.

What causes osteoarthritis of the knee?

The exact cause of osteoarthritis is not known. However, the most important and debilitating symptom of OA is pain.

How do I know if I have osteoarthritis of the knee?

Only your physician can make such a diagnosis. The cardinal symptom of OA is pain which may be amplified with swelling of the joint. Pain can be experienced at rest or during movement.

What treatments are available for osteoarthritis of the knee?

Traditional treatments for osteoarthritis of the knee vary according to the severity of the disease. In the early stages, weight control, regular exercise, physiotherapy, assistive devices (canes, braces) as well as the use of simple analgesics (acetaminophen) may provide relief. However, not all patients respond adequately to conservative nonpharmacologic therapy and simple analgesics. After conservative therapy, nonsteroidal anti-inflammatory drugs (NSAIDs) are used. Some people experience unpleasant side effects (to the NSAIDs) such as heartburn, dyspepsia, vomiting and ulcers. The longer one takes NSAIDs, the more likely he or she is to suffer from irritation of the gastrointestinal tract. Local cortisone injections or surgery were the last defenses against OA. Now there's another treatment option – viscosupplementation with Synvisc.

Where does Synvisc fit into the sequence of treatments for osteoarthritis of the knee?

Synvisc is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g. acetaminophen, which occurs before NSAID therapy. Synvisc has been shown to be effective in all stages of OA, although it is most effective in the early stages of this disease.


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