Hylan polymers a and b (Injection, Intra-articular)

Hylan polymers A and B injection is used to treat knee pain from osteoarthritis (OA) in patients who have already tried pain relievers (for example, acetaminophen) and other non-drug treatments that did not provide enough relief.

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, helping them to function properly.

This medicine must be given only by or under the immediate supervision of your doctor.

Your doctor will monitor your progress closely while you are getting this medicine. This will help your doctor determine if the medicine is working well and if you should keep receiving it.

You may experience temporary pain or swelling in the knee joint after the injection. Call your doctor if the pain or swelling in the knee lasts or gets worse after you receive this medicine.

Do not put strain on your knee joint for 48 hours after receiving this medicine. Avoid activities such as jogging, playing soccer, playing tennis, heavy lifting, or standing for a long time.

Do not use this medicine with disinfectants that contain quaternary ammonium salts (for example, benzalkonium chloride). This may stop hylan polymers A and B injection from working properly.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medications. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies to determine how hylan polymers A and B injection affects children 21 years old and younger. Safety and effectiveness have not been proven.

Geriatric

There is no information available on how hylan polymers A and B injection affects older patients.

Breast Feeding

There are no adequate studies in women to assess the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medications.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Allergy to bird products (e.g., poultry, feathers, or eggs) or
• Lymphatic or venous stasis (severe swelling or blood clots) in the legs—Use with caution. This may worsen these conditions.

• 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 to patients with these conditions.

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

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

Check with your doctor or nurse right away if you notice any of the following side effects:

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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen 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.

In the U.S.

• Synvisc
• Synvisc Hylan G-F
• Synvisc One

Available Dosage Forms:

• Solution

Therapeutic Class: Cartilaginous Defect Repair Agent

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.