How to use HYALGAN®

HYALGAN® is administered by intra-articular injection. A treatment cycle consists of 5 injections, 1 injection per week for 5 weeks. Some patients may experience benefit with 3 injections. This has been noted in studies of patients who were followed for 60 days after receiving 3 injections, 1 injection per week for 3 weeks.


WARNING


Do not concomitantly use disinfectants containing quaternary ammonium salts* for skin preparation because hyaluronic acid can precipitate in their presence. Inject subcutaneous lidocaine or similar local anesthetic prior to injection of HYALGAN®.

*
The following products may contain quaternary ammonium salts: water repellents, fungicides, emulsifiers, paper softeners, antistatic agents, and corrosion inhibitors. For example, Benzalkonium Chloride.

PRECAUTIONS


  • Do not use HYALGAN® if the package is opened or damaged. Store in the original packaging (protected from light) below 77°F (25°C). DO NOT FREEZE.
  • Strict aseptic administration technique must be followed.
  • Remove joint effusion fluid, if present, before injection of HYALGAN®. Do not use the same syringe for removing joint effusion fluid and for injecting HYALGAN®. Take care to remove the tip cap of the syringe and needle aseptically. Inject HYALGAN® into the joint through a 20-gauge needle.
  • The syringe/vial is intended for single use. The contents of the syringe/vial must be used immediately once the container has been opened. Discard any unused HYALGAN®. Inject the full 2 mL in one knee only. If treatment is bilateral, a separate syringe/vial should be used for each knee.14


Important Safety Information

HYALGAN is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of present infections or skin diseases in the area of the injection site to reduce the potential for developing septic arthritis.

Transient increases in inflammation in the injected knee following HYALGAN injection have been reported in some patients with inflammatory arthritis such as rheumatoid arthritis or gouty arthritis. Physicians should evaluate whether HYALGAN treatment should be initiated when objective signs of inflammation are present.

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

Patients should be advised to avoid any strenuous or prolonged weight-bearing activities within 48 hours following intra-articular injection.

Use caution when injecting HYALGAN into patients who are allergic to avian proteins, feathers and egg products.

Joint effusion, if present, should be removed prior to injection.

The safety and effectiveness of HYALGAN has not been established in children or in pregnant or lactating women. It is unknown whether HYALGAN is excreted in human milk.

In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs placebo was injection-site pain. Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus. However, the incidence of these events was similar in the HYALGAN-treated and placebo groups. In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle.

Indication

HYALGAN is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, eg, acetaminophen.

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