References

  1. 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.
  2. Hammesfahr JFR, Knopf AB, Stitik T. Safety of intra-articular hyaluronates for pain associated with osteoarthritis of the knee. Am J Orthop. 2003;32(6):277-283.
  3. Kelly MA, Goldberg VM, Healy WL, Pagnano MW, Hamburger MI. Osteoarthritis and beyond: a consensus on the past, present, and future of hyaluronans in orthopedics. Orthopedics. 2003;26(10):1064-1079.
  4. HYALGAN®, data on file. Fidia Pharma USA, Inc.
  5. HYALGAN® (sodium hyaluronate), approval letter. Food and Drug Administration Web site. http://www.accessdata.fda.gov/cdrh_docs/pdf/P950027a.pdf. Accessed August 18, 2011.
  6. Carrabba M, Paresce E, Angelini M, Re KA, Torchiana EEM, Perbellini A. The safety and efficacy of different dose schedules of hyaluronic acid in the treatment of painful osteoarthritis of the knee with joint effusion. Eur J Rheumatol Inflamm. 1995;15(1):25-31.
  7. Bragantini A, Cassini M, De Bastiani G, Perbellini A. Controlled single-blind trial of intra-articularly injected hyaluronic acid (HYALGAN®) in osteo-arthritis of the knee. Clin Trials J. 1987;24(4):333-340.
  8. Grecomoro G, Martorana U, Di Marco C. Intra-articular treatment with sodium hyaluronate in gonarthrosis: a controlled clinical trial versus placebo. Pharmatherapeutica. 1987;5(2):137-141.
  9. 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.
  10. Ghosh P, Guidolin D. Potential mechanism of action of intra-articular hyaluronan therapy in osteoarthritis: are the effects molecular-weight dependent? Semin Arthritis Rheum. 2002;32(1):10-37.
  11. Balazs E. The physical properties of synovial fluid and the specific role of hyaluronic acid. In: Helfet AJ, ed. Disorders of the Knee. 2nd ed. Philadelphia, PA: JB Lippincott; 1982:61-74.
  12. Gotoh S, Miyazaki K, Onaya J, Sakamoto T, Tokuyasu T, Namiki O. Experimental knee pain model in rats and analgesic effect of sodium hyaluronate (SPH) [in Japanese]. Nippon Yakurigaku Zasshi. 1988;92(1):17-27.
  13. Pozo MA, Balazs EA, Belmonte C. Reduction of sensory responses to passive movements of inflamed knee joints by hylan, a hyaluronan derivative. Exp Brain Res. 1997;116:3-9.
  14. HYALGAN® (sodium hyaluronate) [prescribing information]. Bridgewater, NJ: Sanofi-aventis U.S. LLC; January 2009.
  15. 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.

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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