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Prescribing Information
Important Safety Information  |   Prescribing Information For U.S. Healthcare Professionals Only

Important Safety Information: SYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and angioedema have been reported for both SYNVISC and Synvisc-One. View More

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Synvisc-One

In a saline-controlled trial, Synvisc-One delivered superior pain relief over 26 weeks.1

Study Design

  • Prospective, randomized, double-blind multicenter trial of 253 patients who had osteoarthritis of the knee confirmed via recent radiograph and were at least 40 years old.
  • The primary end point was the difference between the groups in the change from baseline in patient-assessed pain as measured by the WOMAC A score (average of 5 questions) over 26 weeks.
  • Patients were followed for 26 weeks. Study visits were scheduled for screening, baseline, and weeks 1, 4, 8, 12, 18 and 26.
  • If patients had at least mild pain in the injected knee at the week 26 visit they were offered an injection of Synvisc-One and were followed for 4 weeks for repeat treatment safety.

Efficacy Results1

  • The primary endpoint for the study, the difference between the treatment groups in change from baseline over 26 weeks in the WOMAC A Pain Score was met.
  • Synvisc-One also demonstrated superiority to saline control in multiple pre-defined secondary outcome measures, which included Patient Global Assessment over and at 26 weeks, Clinical Observer Global Assessment over and at 26 weeks, and pain while walking on a flat surface (WOMAC A1) over and at 26 weeks.

Over 70% of patients responded to Synvisc-One1

Walking pain response rates

Walking osteoarthritis knee pain response rates graph

Greater magnitude of pain relief with Synvisc-One vs. saline control1

Walking pain relief

Walking osteoarthritis knee pain relief graph

Adverse Events1

  • 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 Safety1

  • 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.

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Indication

SYNVISC® (hylan G-F 20) and Synvisc-One® (hylan G-F 20) are 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 simple analgesics, e.g., acetaminophen.

Important Safety Information

SYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and angioedema have been reported for both SYNVISC and Synvisc-One.

Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence. Do not inject SYNVISC or Synvisc-One extraarticularly, into the synovial tissues, into the fat pad or joint capsule, or intravascularly.

The safety and efficacy of Synvisc-One in locations other than the knee, or for conditions other than osteoarthritis, or in combination with other intra-articular injectables, or in severely inflamed knee joints have not been established. Use caution when injecting SYNVISC or Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of lymphatic or venous stasis in the leg to be treated; or who have severe inflammation in the knee to be treated. Remove any synovial fluid or effusion before injecting SYNVISC or Synvisc-One. Strict adherence to aseptic technique must be followed to avoid joint infection. The safety and effectiveness of SYNVISC and Synvisc-One have not been established in children (≤21 years old) or in pregnant or lactating women. Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment.

For SYNVISC

In clinical trials, the most commonly reported adverse events were transient pain, swelling, and or joint effusion in the injected knee. The following reported adverse events are among those that may occur in association with intra-articular injections, including Synvisc: arthralgia, joint stiffness, joint effusion, joint swelling, joint warmth, injection site pain, arthritis, arthropathy, and gait disturbance.

Full Prescribing Information for SYNVISC

For Synvisc-One

The most commonly reported adverse events were arthralgia, arthritis, arthropathy, injection site pain, and joint effusion. The following reported adverse events are among those that may occur in association with intra-articular injections, including Synvisc-One: arthralgia, joint stiffness, joint effusion, joint swelling, joint warmth, injection site pain, arthritis, arthropathy, and gait disturbance.

Full Prescribing Information for Synvisc-One

Reference

  1. 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;(1)69:113-119.