Pronunciation:

HYE-lan POL-a-mers A and B

Brand Names:

• Synvisc
• Synvisc Hylan G-F
• Synvisc One

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Cartilaginous Defect Repair Agent

Uses of This Medicine:

Hylan polymers A and B injection is used to treat knee pain caused by osteoarthritis (OA) in patients who have already been treated with pain relievers (eg, acetaminophen) and other non-drug treatments that did not work well.

Hylan polymers A and B is similar to a substance that occurs naturally in the joints. It works by acting like a lubricant and shock absorber in the joints and helps the joints to work properly.

This medicine is to be administered only by or under the immediate supervision of your doctor.

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—

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

Older adults—

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.

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:

• Allergy to bird products (eg, 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
• Knee joint infection or
• Skin disease or infection at the injection site—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.

Proper Use of This Medicine:

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 before receiving this medicine. If you have any questions, ask your doctor.

Precautions While Using This Medicine:

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 48 hours 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 (eg, benzalkonium chloride). This may prevent hylan polymers A and B injection from working properly.

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 or nurse immediately if any of the following side effects occur:

More common

Difficulty with moving

fluid build up around the knee

muscle pain or stiffness

pain and stiffness in the joints

Less common

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

Rare

Redness in the joints

Incidence not known

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

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

tingling of the hands or feet

trouble breathing

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:

Less common

Itching of the skin

rash

sprain in the lower back

Rare

Pain at the injection site

Incidence not known

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.