Hyaluronan

Hyaluronan is similar to the fluid that surrounds the joints in your body. This fluid acts as a lubricant and shock absorber for the joints.

Hyaluronan is used to treat knee pain caused by osteoarthritis.

Hyaluronan is usually given after other arthritis medications have been tried without success.

Hyaluronan may also be used for purposes not listed in this medication guide.

You should not receive hyaluronan if you have a bleeding disorder, or if you have an infection in your knee or in the skin around your knee.

You should not use hyaluronan if you are allergic to it, or if you have:

• a bleeding or blood clotting disorder such as hemophilia; or
• an infection in your knee or in the skin around your knee.

It is not known whether hyaluronan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether hyaluronan passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Hyaluronan is injected directly into your knee joint. A healthcare provider will give you this injection.

Hyaluronan is usually given once every week for 3 to 4 weeks.

Follow your doctor's dosing instructions very carefully.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Call your doctor for instructions if you miss an appointment for your hyaluronan injection.

You should not be treated with hyaluronan if you are allergic to it, or if you have:

• an allergy to gram positive bacteria proteins (ask your doctor if you are not sure);

• a bleeding or blood clotting disorder such as hemophilia; or

• an infection in your knee or in the skin around your knee.

It is not known whether hyaluronan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether hyaluronan passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Hyaluronan is not approved for use by anyone younger than 21 years old.

Since hyaluronan is usually given in a single dose, it does not have a daily dosing schedule.

If you need to receive more than one hyaluronan injection, call your doctor for instructions if you miss your next injection appointment.

For at least 48 hours after your injection: Avoid jogging, strenuous activity, or high-impact sports such as tennis. Also avoid weight-bearing activity or standing for longer than 1 hour at a time.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• bleeding;

• increased knee pain; or

• signs of infection (warmth, swelling, redness) around your knee.

Common side effects may include:

• joint pain, stiffness, or swelling;

• itching, numbness, or tingling;

• headache, dizziness;

• back pain;

• swelling, pain, redness, or mild discomfort where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Data not available

Hyaluronan is contraindicated in patients who are allergic to avian products, feathers, and egg products.

Intraarticular injections are contraindicated in patients with skin diseases and a history of, or existing, infections at the injection site.

Disinfectants containing quaternary ammonium salts will cause precipitation and should not be used for skin preparation.

The effectiveness of a single treatment cycle of less than 3 injections has not been established.

The safety and effectiveness of repeat treatment cycles have not been established.

The safety and effectives of hyaluronan in joints other than the knee, or with concurrent other intraarticular injections has not been established.

Patients should be advised to avoid any strenuous or prolonged (greater than 1 hour) weightbearing activities for 48 hours after the injection.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Data not available