Safety – Hyalgan for Healthcare Professionals

The original HA treatment for osteoarthritis knee pain—a safe and effective 5 injection regimen.

First HA injection treatment

Approved in the US¹

Most published clinical data

Of any HA in the world¹

Over 60M

Injections worldwide¹

Over 12M

Patients treated worldwide¹

No significant adverse events with repeat cycles in a clinical study¹

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.

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 the repeat treatment cycles did not increase over that reported for a single treatment cycle.

Please see package insert for full prescribing information including indications, contraindications, warnings, precautions, and adverse events.

Rx Only.

Please see Full Prescribing Information.

The most trusted HA treatment worldwide

The original HA treatment for osteoarthritis knee pain—a safe and effective 5 injection regimen.

References

STUDY SUMMARY: ALTMAN, 1998

Intra-articular sodium hyaluronate (HYALGAN®) in the treatment of patients with osteoarthritis of the knee: A randomized clinical trial2

Study design

Results

STUDY SUMMARY: SCALI, 1995

Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: A long-term study3

Study design

Results

STUDY SUMMARY: NEUSTADT, 2003

Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN®) in patients with osteoarthritis of the knee4

Study design

Results

Intra-articular sodium hyaluronate (HYALGAN^®) in the treatment of patients with osteoarthritis of the knee: A randomized clinical trial²

Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: A long-term study³

Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN^®) in patients with osteoarthritis of the knee⁴