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Safety


The safety profiles of SYNVISC® and Synvisc-One® have been established through clinical studies1-3

In clinical studies, Synvisc-One demonstrated AE profiles similar to placebo2

  • No severe adverse events (AEs) were observed with either initial or repeat treatment2

Synvisc-One Adverse Events2

  • The frequency and type of adverse events (AEs) were similar between the Synvisc-One and saline control groups.
  • There were no serious AEs in the injected knee in either the Synvisc-One or the saline control group. Device-related AEs involving the injected knee were mild or moderate in nature and were treated symptomatically
Patients with device-related AEs in the injected knee1
   
   
MedDRA preferred term
Synvisc-One
n=123, n (%)
Saline Control
N=130, n (%)
   
    Any device-related AE 7 (5.7%) 4 (3.1%)    
    Arthralgia 2 (1.6%) 3 (2.3%)    
    Arthritis 1 (0.8%) 0    
    Arthropathy 1 (0.8%) 0    
    Injection-site pain 1 (0.8%) 1 (0.8%)    
    Joint effusion 2 (1.6%) 0    
    MedDRA=Medical Dictionary for Regulatory Activities.
Note: Patients are counted once for each unique AE, and may have had more than 1 unique AE.
   

Repeat Treatment Safety2

  • 160 patients were treated during this phase of the study, of which 77 patients received a second injection of
    Synvisc-One.
  • Of these 77 patients, 5.2% experienced five device-related AEs in the injected knee. All were mild to moderate and were treated symptomatically.
  • Patients who developed injected knee AEs during the initial phase of the study, and who subsequently received repeat treatment, did not experience injected knee AEs upon repeat exposure to Synvisc-One.

Adverse Events

In clinical trials, the frequency and type of AEs were similar between SYNVISC and control treatments4,5

Most commonly reported device-related AEs with SYNVISC1

  • Pain in the injected knee
  • Swelling in the injected knee
  • Joint effusion

Potential AEs that may occur in association with intra-articular injection, including SYNVISC4:

  • Arthralgia
  • Injection-site pain
  • Joint stiffness
  • Arthritis
  • Joint swelling
  • Arthropathy
  • Joint warmth
  • Gait disturbance

References

  1. Wobig M, Dickhut A, Maier R, Vetter G. Viscosupplementation with hylan G-F 20: a 26-week controlled trial of efficacy and safety in the osteoarthritic knee. Clin Ther. 1998;20(3):410-423.
  2. Chevalier X, Jerosch J, Goupille P, et al. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010;69(1):113-119.
  3. Kemper F, Gebhardt U, Meng T, Murray C. Tolerability and short-term effectiveness of hylan G-F 20 in 4253 patients with osteoarthritis of the knee in clinical practice. Curr Med Res Opin. 2005;21(8):1261-1269.
  4. SYNVISC (hylan G-F 20) [prescribing information]. Cambridge, MA: Genzyme Corporation; 2014.
  5. Wobig M, Dickhut A, Maier R, Vetter G. Viscosupplementation with Hylan G-F 20: a 26-week controlled trial of efficacy and safety in the osteoarthritic knee. Clin Ther. 1998;20(3):410-423.

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