References

  1. Ågerup B, Berg P, Åkermark C. Non-animal stabilized hyaluronic acid: a new formulation for the treatment of osteoarthritis. BioDrugs. 2005;19(1):23-30. doi:10.2165/00063030-200519010-00003
  2. Leighton R, Åkermark C, Therrien R, et al. NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014;22(1):17-25. doi:10.1016/j.joca.2013.10.009
  3. Arden NK, Åkermark C, Andersson M, Todman MG, Altman RD. A randomized saline-controlled trial of NASHA hyaluronic acid for knee osteoarthritis. Curr Med Res Opin. 2014;30(2):279-86. doi:10.1185/03007995.2013.855631
  4. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013;2(1):1000108. doi:10.4172/2167-7921.1000108
  5. Krocker D, Matziolis G, Tuischer J, et al. Reduction of arthrosis associated knee pain through a single intra-articular injection of synthetic hyaluronic acid. Z Rheumatol. 2006;65(4):327-31. doi:10.1007/s00393-006-0063-2
  6. Altman RD, Åkermark C, Beaulieu AD, Schnitzer T. Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2004;12(8):642-49. doi:10.1016/j.joca.2004.04.010
  7. Conrozier T, Couris CM, Mathieu P, et al. Safety, efficacy and predictive factors of efficacy of a single intra-articular injection of non-animal-stabilized-hyaluronic-acid in the hip joint: results of a standardized follow-up of patients treated for hip osteoarthritis in daily practice. Arch Orthop Trauma Surg. 2009;129(6):843-8. doi:10.1007/s00402-008-0778-4
  8. Berg P, Olsson U. Intra-articular injection of non-animal stabilised hyaluronic acid (NASHA) for osteoarthritis of the hip: A pilot study. Clin Exp Rheumatol. 2004;22(3):300-6.
  9. Altman R, Lim S, Steen RG, Dasa V. Hyaluronic acid injections are associated with delay of total knee replacement surgery in patients with knee osteoarthritis: evidence from a large U.S. health claims database. PLoS One. 2015;10(12):e0145776. doi:10.1371/journal.pone.0145776.
  10. Romero Jurado M, Enrique Fidalgo A, Rodríguez Villar V, Mar Medina J, Soler López B. Factors related with the time to surgery in waiting-list patients for knee prostheses. Reumatol Clin. 2013;9(3):148-55. doi:10.1016/j.reumae.2012.09.003
  11. Kompel AJ, Roemer FW, Murakami AM, Diaz LE, Crema MD, Guermazi A. Intra-articular corticosteroid injections in the hip and knee: Perhaps not as safe as we thought? Radiology. 2019;293(3):656-63. doi:10.1148/radiol.2019190341
  12. McAlindon TE, LaValley MP, Harvey WF, et al. Effect of intra-articular triamcinolone vs saline on knee cartilage volume and pain in patients with knee osteoarthritis: a randomized clinical trial. JAMA. 2017;317(19):1967-75. doi:10.1001/jama.2017.5283
  13. Bioventus LLC. Quantity of DUROLANE Patients Treated. Data on file, RPT-001056.
  14. Osteoarthritis Research Society International. What is Osteoarthritis? https://www.oarsi.org/what-osteoarthritis. Accessed July 28, 2020.
  15. Arthritis Society. What is Arthritis. https://arthritis.ca/about-arthritis/what-is-arthritis. Accessed July 28, 2020.
  16. Arthritis Society. Osteoarthritis. https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/osteoarthritis. Accessed September 2017.
  17. Arthritis Foundation. Osteoarthritis. https://www.arthritis.org/diseases/osteoarthritis. Accessed July 28, 2020.
  18. Takahashi K, Hashimoto S, Kubo T, Hirasawa Y, Lotz M, Amiel D. Effect of hyaluronan on chondrocyte apoptosis and nitric oxide production in experimentally induced osteoarthritis. J Rheumatol. 2000;27(7):1713-20.
  19. Mayo Clinic. Exercise helps ease arthritis pain and stiffness. https://www.mayoclinic.org/diseases-conditions/arthritis/in-depth/arthritis/art-20047971. Last updated December 1, 2020.
  20. Health Canada. Health Canada Clarifies Position on Platelet Rich Plasma. Accessed July 16, 2020. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70559a-eng.php
  21. Altman RD, Manjoo A, Fierlinger A, Niazi F, Nicholls M. The mechanism of action for hyaluronic acid treatment in the osteoarthritic knee: a systematic review. BMC Musculoskelet Disord. 2015;16:321. doi:10.1186/s12891-015-0775-z
  22. Altman RD, Fredericson M, Bhattacharyya SK, et al. Association between hyaluronic acid injections and time-to-total knee replacement surgery. J Knee Surg. 2016;29(7):564-57. doi:10.1055/s-0035-1568992
  23. Papakonstantinou E, Roth M, Karakiulakis G. Hyaluronic acid: A key molecule in skin aging. Dermatoendocrinol. 2012;4(3):253-58. doi:10.4161/derm.21923
  24. Balazs EA, Denlinger JL. Viscosupplementation: a new concept in the treatment of osteoarthritis. J Rheumatol Suppl. 1993;39:3-9.
  25. Ågerup B, Berg P, Åkermark C. Non-animal stabilized hyaluronic acid: a new formulation for the treatment of osteoarthritis. BioDrugs. 2005;19(1):23-30. doi:10.2165/00063030-200519010-00003
  26. Lindqvist U, Tolmachev V, Kairemo K, Aström G, Jonsson E, Lundqvist H. Elimination of stabilised hyaluronan from the knee joint in healthy men. Clin Pharmacokinet. 2002;41(8):603-13. doi:10.2165/00003088-200241080-00004
  27. Bioventus LLC. DUROLANE 2M Patients Treated. Bioventus data on file, RPT-001056.
  28. Zhang H, Zhang K, Zhang X, et al. Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz. Arthritis Res Ther. 2015;17(1):51. doi:10.1186/s13075-015-0557-x.
  29. Edsman K, Hjelm R, Lärkner H, et al. Intra-articular duration of Durolane™ after single injection into the rabbit knee. Cartilage. 2011;2(4)384-8. doi:10.1177/1947603511400184
  30. Bioventus LLC. Galderma: Molecular Weight of DUROLANE. Data on file, RPT-000834.
  31. Larsen NE, Dursema HD, Pollak CT, Skrabut EM. Clearance kinetics of a hylan-based viscosupplement after intra-articular and intravenous administration in animal models. J Biomed Mater Res B Appl Biomater. 2012;100(2):457–62. doi:10.1002/jbm.b.31971
  32. Brown TJ, Laurent UB, Fraser JR. Turnover of hyaluronan in synovial joints: elimination of labelled hyaluronan from the knee joint of the rabbit. Exp Physiol. 1991;76(1):125–34. doi:10.1113/expphysiol.1991.sp003474
  33. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.
  34. Arthritis Foundation. What is osteoarthritis? Accessed February 9, 2019. www.arthritis.org/about-arthritis/types/osteoarthritis/what-is-osteoarthritis.php
  35. Mackowiak J, Jones J, Dasa V. A comparison of 4-year total medical care costs, adverse outcomes, and opioid/prescription analgesic use for 3 knee osteoarthritis pain treatments: Intra-articular hyaluronic acid, intra-articular corticosteroids, and knee arthroplasty. Semin Arthritis Rheum. 2020;50(6):1525-34. doi:10.1016/j.semarthrit.2020.01.003

Summary of Indications for Use

DUROLANE (3 mL): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been approved in the EU for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, shoulder, elbow, wrist, fingers, and toes.

DUROLANE SJ (1 mL): Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, elbow, wrist, fingers, and toes.

Both DUROLANE and DUROLANE SJ are also indicated for pain following joint arthroscopy in the presence of osteoarthritis within 3 months of the procedure.

There are no known contraindications.

You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children.

Risks can include transient pain, swelling and/or stiffness at the injection site.

Full prescribing information can be found in product labeling (1 mL / 3 mL).