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Be sure to read the following important information carefully. This information does not take the place of your doctor's advice. If you do not understand this information or want to know more, ask your doctor.

Glossary of Terms

Hyaluronan (pronounced hy-al-u-ROE-nan): is a natural substance that is present in very high amounts in joints. It acts like a lubricant and a shock absorber in the joint and is needed for the joint to work properly.

Non-steroidal anti-inflammatory drugs: also known as “NSAIDs”; medication used to treat pain or swelling. There are many examples of NSAIDs, including (but not limited to) aspirin and ibuprofen. Some of these are over-the-counter drugs, and some can only be obtained by prescription.

Osteoarthritis (pronounced OS-te-o-arth-RI-tis): (OA) is a type of arthritis that involves the wearing down of cartilage (the protective covering on the ends of your bones) and loss of cushioning fluid in the joint.

Table of Contents

• Glossary of Terms
• Table of Contents
• What is the SYNVISC® (hylan g-f 20) product?
• How is the SYNVISC® (hylan g-f 20) product used? (Indications)
• How is the SYNVISC® (hylan g-f 20) product given?
• Are there any reasons why I should not receive SYNVISC® (hylan g-f 20) injections? (Contraindications)
• What should my doctor warn me about?
• What are the risks of getting SYNVISC® (hylan g-f 20) injections?
• What are the benefits of getting SYNVISC® (hylan g-f 20) injections?
• What do I need to do after I get a SYNVISC® (hylan g-f 20) injection?
• What other treatments are available for OA?
  • Non-drug treatments
  • Drug therapy
• What adverse events were observed in the clinical studies?
• How do I get more information about the SYNVISC® (hylan g-f 20) product? (User Assistance)

What is the SYNVISC® (hylan g-f 20) product?

SYNVISC (hylan g-f 20) is a gel-like mixture that is made up of hylan A fluid, hylan B gel, and salt water. Hylan A and hylan B are made from a substance called hyaluronan (pronounced hy-al-u-ROE-nan), also known as sodium hyaluronate that comes from chicken combs. Hyaluronan is a natural substance found in the body and is present in very high amounts in joints. The body's own hyaluronan acts like a lubricant and a shock absorber in the joint and is needed for the joint to work properly. Osteoarthritis (pronounced os-TE-o-ar-THRI-tis) (OA) is a type of arthritis that involves the wearing down of cartilage (the protective covering on the ends of your bones). In OA, there may not be enough hyaluronan, and there may be a decrease in the quality of the hyaluronan in the joint. SYNVISC (hylan g-f 20) comes in syringes containing 2 mL (half a teaspoon) of product. SYNVISC (hylan g-f 20) is injected directly into your knee.

How is the SYNVISC® (hylan g-f 20) product used? (Indications)

The FDA-approved indication for SYNVISC (hylan g-f 20) is:

SYNVISC (hylan g-f 20) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

How is the SYNVISC® (hylan g-f 20) product given?

Your doctor will inject SYNVISC (hylan g-f 20) into your knee.

Are there any reasons why I should not receive SYNVISC® (hylan g-f 20) injections? (Contraindications)

Your doctor will determine if there is any reason why you are not an appropriate candidate for SYNVISC (hylan g-f 20) . You should be aware that SYNVISC (hylan g-f 20) :

• Should not be used in patients who have had any prior allergic reactions to SYNVISC (hylan g-f 20) , Synvisc (hylan g-f 20) -One® or any hyaluronan-based products. Signs of an allergic reaction may include swelling of your face, tongue, or throat; difficulty breathing or swallowing; shortness of breath; wheezing; chest pain; a tightness in your throat; sleepiness; rash; itching; hives; flushing; and/or fever.
• Should not be used in patients with a knee joint infection, skin disease or infection around the area where the injection will be given, or circulatory problems in the legs.

What should my doctor warn me about?

The following are important treatment considerations for you to discuss with your doctor and understand in order to help avoid unsatisfactory results and complications:

• SYNVISC (hylan g-f 20) is only for injection into the knee, performed by a doctor or other qualified health care professional. SYNVISC (hylan g-f 20) has not been tested to show pain relief in joints other than the knee.
• SYNVISC (hylan g-f 20) has not been tested to show better pain relief when combined with other injected medicines.
• Tell your doctor if you are allergic to products from birds such as feathers, eggs, and poultry.
• Tell your doctor if you have significant swelling or blood clots in the leg.
• SYNVISC (hylan g-f 20) has not been tested in pregnant women, or women who are nursing. You should tell your doctor if you think you are pregnant, or if you are nursing a child.
• SYNVISC (hylan g-f 20) has not been tested in children ( ≤ 21 years of age).

What are the risks of getting SYNVISC® (hylan g-f 20) injections?

The side effects (also called reactions) sometimes seen when SYNVISC (hylan g-f 20) is injected into the knee as a first or repeat set of injections were pain, swelling, heat, redness, and/or fluid build-up around the knee. These reactions were generally mild and did not last long. If you have a reaction where the swelling is extensive and painful you should notify your doctor. The reactions seemed to occur more often when SYNVISC (hylan g-f 20) was injected into the knee as a repeat set of injections than when SYNVISC (hylan g-f 20) was injected as a first set of injections. Reactions are generally treated by resting and applying ice to the injected knee. Sometimes it is necessary to give pain relievers by mouth such as acetaminophen or NSAIDs, or to give injections of steroids, or to remove fluid from the knee joint. Patients rarely undergo arthroscopy (a surgical inspection of the knee joint) or other medical procedures related to these reactions.

Other less common side effects have been: rashes, hives, itching, muscle pain/cramps, flushing and/or swelling of your face, fast heart beat, nausea (or feeling sick to your stomach), dizziness, fever, chills, headache, difficulty breathing, swelling in your arms and/or legs, prickly feeling of your skin, and in rare cases a low number of platelets in the blood (platelets are a type of blood cell that are needed to help clot your blood when you are cut or injured). Before you are given SYNVISC (hylan g-f 20) , tell your doctor if something like this has ever happened to you after receiving an injection of SYNVISC (hylan g-f 20) or other hyaluronan products. If any of the above symptoms or signs appear after you are given SYNVISC (hylan g-f 20) , or if you have any other problems, you should call your doctor. Rare cases of knee joint infection have been reported after SYNVISC (hylan g-f 20) injections.

What are the benefits of getting SYNVISC® (hylan g-f 20) injections?

As shown in medical studies of patients with osteoarthritis (OA) of the knee, where approximately half received a single injection of SYNVISC (hylan g-f 20) and the other half either had fluid removed from the knee and/or received injections of the same volume of salt water (a “Saline Control” injection), the major benefits of SYNVISC (hylan g-f 20) are pain relief and improvement in other symptoms related to OA of the knee.

What do I need to do after I get a SYNVISC® (hylan g-f 20) injection?

It is recommended you avoid strenuous activities (for example, highimpact sports such as soccer, tennis or jogging) or prolonged weightbearing activities for approximately 48 hours following the injection. You should consult your doctor regarding the appropriate time to resume such activities.

What other treatments are available for OA?

If you have OA, there are other things you can do besides getting SYNVISC (hylan g-f 20) . These include:

Non-drug treatments

• Avoiding activities that cause knee pain
• Exercise or physical therapy
• Weight loss
• Removal of excess fluid from your knee

Drug therapy

• Pain relievers such as acetaminophen and narcotics
• Drugs that reduce inflammation (signs of inflammation are swelling, pain or redness), such as aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen and naproxen)
• Steroids that are injected directly into your knee.

What did the clinical studies show?

Two medical studies involving a total of 132 patients were done in Germany. The patients in these studies were at least 40 years old and had knee pain due to OA. The patients were placed in one of two groups. One group was given an injection of SYNVISC (hylan g-f 20) into one or both knees once a week for three weeks. The second group was given an injection of salt water once a week for three weeks. As part of the study, knee joint pain was measured for 26 weeks. Also, patients and doctors were asked to judge the success of the treatment for 26 weeks. Patients with OA knee pain, who did not get pain relief with other medicines, got pain relief with SYNVISC (hylan g-f 20) . The patients given SYNVISC (hylan g-f 20) had more pain relief than the patients given salt water. Some patients started to feel pain relief after the first week of SYNVISC (hylan g-f 20) treatment. The most pain relief and the greatest amount of treatment success was seen 8 to 12 weeks after SYNVISC (hylan g-f 20) treatment started.

A medical study done in the United States involved 90 patients. The patients were at least 40 years old and had knee pain due to OA. Patients were placed into one of two groups. One group was given SYNVISC (hylan g-f 20) once a week for three weeks. The second group had a needle inserted into the knee to have any fluid removed (this procedure is called arthrocentesis [pronounced AR-thro-sen-TEE-sis]) once a week for three weeks.

Patients improved after SYNVISC (hylan g-f 20) treatment, but not more than patients who had arthrocentesis. This study was different from the German studies because the last time the two groups were compared was only two weeks after the last SYNVISC (hylan g-f 20) injection. The study was also different in other ways, including length of time that patients had to stop taking medicines before they could start treatment. The length of time patients had to stop taking medicines was two weeks in the German studies and four weeks in the U.S. study.

What adverse events were observed in the clinical studies?

The side effects (also called reactions) sometimes seen when SYNVISC (hylan g-f 20) is injected into the knee as a first or repeat set of injections were pain, swelling, heat, redness, and/or fluid build-up around the knee. These reactions were generally mild and did not last long.

How do I get more information about the SYNVISC® (hylan g-f 20) product? (User Assistance)

If you have any questions or would like to find out more about SYNVISC (hylan g-f 20) , you may call Genzyme Biosurgery at 1-888-3-SYNVISC (hylan g-f 20) (1-888-379-6847) or visit www.synvisc (hylan g-f 20) .com.

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.