Hyaluronate sodium (Injection)

Hyaluronate is like a substance that is found naturally in joints, helping them function properly by acting as a lubricant and shock absorber. This medicine is injected directly into the knee to relieve pain caused by osteoarthritis.

This medicine should be given only by your doctor or under their close supervision.

For the first 48 hours after you receive this medicine, do not engage in strenuous activities or prolonged activities (more than 1 hour) that put a lot of weight on your legs, such as jogging, heavy lifting, playing tennis, or standing for a long time.

In deciding to use a medicine, it is important to consider the risks of taking it against the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

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

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Skin infection or other problems at the site where the injection will be given—This medicine should not be injected there.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects happen:

Less common

• Blue color or flushing or redness of skin
• cough
• difficulty in swallowing
• dizziness or feeling faint (severe)
• fever
• redness or pain at the injection site
• skin rash, hives, and/or itching
• stuffy nose
• swelling of eyelids, face, or lips
• tightness in chest, troubled breathing, and/or wheezing

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body gets used to the medicine. Also, your health care professional may be able to provide ways to prevent or lessen 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:

More common

• Diarrhea
• headache
• itching of the skin
• large, nonelevated blue or purplish patches in the skin
• loss of appetite
• nausea and/or vomiting
• stomach pain
• swelling of the knee

Other side effects not listed may also occur in some patients. If you notice any other effects, consult 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.

• Euflexxa
• Gel-One
• Hyalgan
• Hyalgan L/L
• Supartz
• Supartz FX

Available Dosage Forms:

• Gel/Jelly
• Solution

Therapeutic Class: Musculoskeletal Agent

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, 20 milligrams (mg) once a week (one week apart) for a total of five injections. Children—Use and dose must be determined by your doctor.