Skip to the content
Patient Site
  • Prescribing Information
  • Important Safety Information
Hyalgan for Healthcare ProfessionalsHyalgan for Healthcare Professionals
Patient Site
  • Prescribing Information
  • Important Safety Information
  • Clinical Studies
  • Safety
  • Order
  • Reimbursement
  • Home
  • Clinical Studies
  • Safety
  • Order
  • Reimbursement
  • Patient Site
  • Fidia Pharma USA Inc.
An older man kneeing down to work in his garden An older man kneeing down to work in his garden

The most trusted HA treatment worldwide

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

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.

www.HYALGAN.com

  • Prescribing Information
  • Important Safety Information
  • References
  • Legal Disclaimer
  • Privacy Policy
  • Contact Us
  • FidiaPharma.us

HYALGAN is a registered trademark of Fidia Farmaceutici S.p.A., Abano Terme, Italy.
© 2025 Fidia Pharma USA Inc, Florham Park, NJ 07932
This site is intended for use by US residents only. Last Update: January 2021

References

1. HYALGAN®, data on file. Fidia Farmaceutici S.p.A., Italy. 2. Altman RD, Moskowitz R; HYALGAN® Study Group. Intraarticular sodium hyaluronate (HYALGAN®) in the treatment of patients with osteoarthritis of the knee: a randomized clinical trial. J Rheumatol. 1998;25(11):2203-2212. 3. Scali JJ. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: a long term study. Eur J Rheumatol Inflamm. 1995;15(1):57-62. 4. Neustadt DH. Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN®) in patients with osteoarthritis of the knee. Clin Exp Rheumatol. 2003;21(3):307-311. 5. Bruyere O, Cooper C, Pelletier JP, et al. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: A report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum. 2014;44(3):253-263. 6. Miller LE, Block JE. An 8-week multimodal treatment program improves symptoms of knee osteoarthritis: a real-world multicenter experience. Pragmatic and Observational Research. 2013;4:39-44. 7. Miller LE, Block JE. An 8-week knee osteoarthritis treatment program of hyaluronic acid injection, deliberate physical rehabilitation, and patient education is cost effective at 2 years follow-up: The OsteoArthritis Centers of America™ Experience. Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders. 2014;7:49-55.

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

26-week, double-blind, placebo-controlled, multicenter study (N=495) in patients 40 years of age or older with K-L grade 2 or 3 OA of the knee, comparing IA HYALGAN® 20 mg weekly x 5 with IA saline and 500 mg bid naproxen. All patients were allowed up to 4000 mg/d for rescue analgesia (acetaminophen) as needed for pain

Results
  • In the HYALGAN® pivotal trial (N=495), the 5-injection regimen significantly improved pain measures through 26 weeks of follow-up
  • Patients receiving HYALGAN® experienced significantly less pain than those in the placebo group (P<.05) at Weeks 4, 5, 12, 21, and 26
  • 2/3 of patients receiving HYALGAN® reported pain relief each month for 6 months
STUDY SUMMARY: SCALI, 1995
Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: A long-term study3
Study design

30-month, repeat-use, open-label study (N=75) of IA HYALGAN® 20mg weekly x5, repeated every 6 months for 5 treatment cycles. One cycle=5 injections. A total of 5 IA injections were administered

Results
  • Progressive improvement in pain relief with repeat cycles over 30 months
  • Improvements were observed after the first treatment cycle at 6 months and resulted in a 55% reduction in spontaneous pain at the end of the study (P<.001)
  • No significant adverse events with repeat cycles
  • Repeated treatment cycles improved symptoms, particularly in patients with early stage OA of the knee
  • General assessment of overall treatment efficacy rated as “good” or “very good” with significant difference from baseline (P=.05) in 88% of patients
STUDY SUMMARY: NEUSTADT, 2003
Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN®) in patients with osteoarthritis of the knee4
Study design

Prospective cohort study to evaluate the long-term efficacy and safety of 5 weekly intra-articular injection of HYALGAN® in 76 patients (92 knees) with moderate to severe OA of the knee, whose pain was not controlled by conventional measures. Clinical improvement was defined as >50% reduction in a visual analog scale (VAS) for pain at rest, night pain, and pain on walking

Results
  • Ten of 15 (67%) knees improved after a repeat treatment course
  • 72% of patients achieved a greater than 50% improvement in VAS pain scores for 1 year or longer