Pronunciation:

HYE-lan POL-a-mers A and B

Brand Names:

• Synvisc
• Synvisc Hylan G-F
• Synvisc One

Dosage Forms:

• Injectable
• Solution

Classifications:

Therapeutic

Cartilaginous Defect Repair Agent

Uses of This Medicine:

Hyaluronate sodium derivative is similar to a substance that occurs naturally in joints that helps joints work properly by acting like a lubricant and shock absorber. This medicine is injected into the knee to relieve pain caused by osteoarthritis.

This medicine is to be administered only by or under the immediate supervision of your doctor. It is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children

Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of hyaluronate sodium derivative in children with use in other age groups.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of hyaluronate sodium derivative in the elderly with use in other age groups.

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.

Other 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.

Other interactions

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:

• Skin or knee joint infections or other problems at the place where the injection is to be given This medicine should not be injected there

Proper Use of This Medicine:

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For parenteral dosage form (injection):
  • For knee pain caused by osteoarthritis:
    • Adults By injection into the knee, 16 milligrams (mg) once a week (one week apart) for a total of three injections.
    • Children Use and dose must be determined by your doctor.

Precautions While Using This Medicine:

For the first 48 hours after you receive this medicine, avoid strenuous activities or prolonged (more than 1 hour) activities that put a lot of weight on your legs, such as jogging, heavy lifting, playing tennis, or standing on your feet for a long period of time.

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

Rare

Difficulty breathing

hives

shortness of breath

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:

More common

Knee pain

pain at the injection site

swelling of the knee

Rare

Calf cramps

dizziness

facial flushing with swelling of the lips

headache

infection of the joint

itching of the skin

muscle pain

nausea

pain on one side of the body with anxiety, nausea, and tiredness

rapid heartbeat

skin rash

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.