Synvisc One Injection

In the U.S.

• Synvisc
• Synvisc Hylan G-F
• Synvisc One

Available Dosage Forms:

• Injectable
• Solution

Therapeutic Class: Cartilaginous Defect Repair Agent

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hylan polymers A and B injection in children up to 21 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of hylan polymers A and B injection in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to bird products such as poultry, feathers, or eggs or
• Lymphatic or venous stasis (severe swelling or blood clots) in the legs—Use with caution. May make these conditions worse.

• Allergy to products containing hyaluronan or sodium hyaluronate or
• Skin or knee joint infections or other problems at the place where the injection is to be given—Should not be given in patients with these conditions.

• Joint effusion (too much fluid in the knees)—Patients with this condition should be treated first before receiving this medicine.

This section provides information on the proper use of a number of products that contain hylan polymers a and b. It may not be specific to Synvisc One. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into your knee joint. It may take more than one injection for the pain to go away.

Synvisc® is given as a 3-injection regimen. It is usually given once a week and repeated after a week for a total of three injections.

Synvisc-One® is given as a single injection only.

This medicine usually comes with patient information insert. Read the information carefully and make sure you understand it efore receiving this medicine. If you have any questions, ask your doctor.

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Temporary pain or swelling in the knee joint may occur after receiving the injection. Call your doctor if the pain or swelling in the knee persists or becomes worse after receiving this medicine.

Do not strain your knee joint for two days after receiving this medicine. Avoid activities such as jogging, soccer, tennis, heavy lifting, or standing on your feet for a long time.

Do not use this medicine with disinfectants containing quaternary ammonium salts (e.g., benzalkonium chloride). This may prevent hylan polymers A and B injection from working properly.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Difficulty with moving
• fluid build up around the knee
• muscle pain or stiffness
• pain and stiffness in the joints

• Bleeding after defecation
• bluish color
• changes in skin color
• fainting
• fast, pounding, or irregular heartbeat or pulse
• pain or aching in the lower legs
• swelling of the ankles, feet, or legs
• tenderness
• uncomfortable swelling around the anus
• warmth or swelling of the joints

• Redness in the joints
• trouble with walking

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• difficulty with breathing
• feeling of warmth
• general feeling of discomfort or illness
• muscle cramps
• pinpoint red spots on the skin
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• tingling of the hands or feet
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Itching of the skin
• rash
• sprain in the lower back

• Pain at the injection site

• Dizziness
• headache
• nausea
• raised red swellings on the skin, lips, tongue, or in the throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.