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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 or in cases of present infections or skin diseases in the area of the injection site. Use caution when injecting HYALGAN into patients who are allergic to avian proteins, feathers, and egg products.

The safety and effectiveness of HYALGAN has not been established in children or in pregnant or lactating women, for use in other joints or for concomitant use with other injectables. It is unknown whether HYALGAN® is excreted in human milk. The effectiveness of a single treatment cycle of less than 3 injections has not been established.

Transient increases in inflammation in the injected knee following HYALGAN injection have been reported in some patients with inflammatory arthritis and should not be injected if objective signs of inflammation are present. Transient pain and/or swelling of the injected joint may occur after intra-articular injection of HYALGAN®. Anaphylactoid and allergic reactions have been reported with the use of this product.

In the US clinical trial, adverse events included injection-site pain, gastrointestinal complaints, headache, local ecchymosis (bruising) and rash, local joint pain and swelling, and local pruritus (itching). In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a treatment cycle.

RX Only.

See the package insert section of this website for full prescribing information.

1-866-7-HYALGAN

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.
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.
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.
HYALGAN®, data on file. Fidia Farmaceutici S.p.A., Italy.
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.
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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.
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.
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.
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.
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.
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.
HYALGAN®. [package insert]. Abano Terme, Italy: Fidia Farmaceutici; May 2014
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.
Stitik TP et al. Arch Phys Med Rehabil. 2007;88(2):135-141
Turajane T, Labpiboonpong V, Maungsiri S. Cost analysis of intraarticular sodium hyaluronate treatment in knee osteoarthritis patients who failed conservative treatment. J Med Assoc Thai. 2007;90(9):1839-1844.
Parmet S, Lynm C, Glass RM. Osteoarthritis of the knee. JAMA. 2003;289(8):1068.

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