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 |
|
| |
|
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
- 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.
- 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.
- 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.
- SYNVISC (hylan G-F 20) [prescribing information]. Cambridge, MA: Genzyme Corporation; 2014.
- 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.
