Using HYALGAN^®

Why Hyalgan

A solid 30-year record of experience worldwide ^4,5

Approximately 50 million injections of HYALGAN^® have been administered worldwide ⁴
Well-established safety profile
Local treatment with no known drug interactions ^2,3

When to use HYALGAN^®

Use early in the disease process ^3,15

Proven results for patients with mild to moderate OA (Kellgren grade 2 or 3) ³
Can be used concurrently with COX-2 inhibitors or NSAIDs ³
May reduce patient use of NSAIDs ¹⁵

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*.

* Some patients may experience benefit with 3 injections given at weekly intervals (one injection per week for three weeks). This has been noted in studies reported in the literature in which patients treated with 3 injections were followed for 60 days.

Warning

Do not concomitantly use disinfectants containing quaternary ammonium salts* for skin preparation because hyaluronic acid can precipitate in their presence.

* 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

References

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.

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.

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.

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.

Using HYALGAN®

A solid 30-year record of experience worldwide 4,5

When to use HYALGAN®

How to use HYALGAN®