SYNVISC® Clinical Efficacy
Long Lasting OA Knee Pain Relief
SYNVISC® provides long-lasting relief for up to 6 months for chronic OA knee pain1
The SYNVISC family delivers maximum duration of relief for chronic OA knee pain among currently approved viscosupplements.1, 3-14, 17
The SYNVISC family has consistently shown significant OA knee pain reduction for up to 6 months compared with baseline in multiple, randomized, controlled studies.1,15-18,a-d
AEs observed with the SYNVISC family of viscosupplements were similar to those for placebo.1,17,18,a,b
At 12 months, patients experienced an average 44.8% reduction in pain from baseline with SYNVISC in a randomized, controlled, clinical trial vs Hyalgan.16,d
- Secondary outcome observed in study where primary outcome variable was intergroup difference in OA knee pain as measured by VAS at 6 months
Synvisc® demonstrated rapid OA knee pain relief as early as week 1 and up to 26 week with significant improvement from baseline1,17,a
In the pivotal clinical trial, significant pain reduction from baseline occurred 1 week after the first injection of SYNVISC and lasted through 26 weeks, as assessed by blinded evaluators.1,17,a
WEIGHT-BEARING PAIN: PATIENT ASSESSMENT17, b
- AEs related to SYNVISC were reported for 2.2% of injections and 7.2% of patients after a single course of treatment17
- Most commonly reported device-related AEs with SYNVISC: pain in injected knee, swelling in injected knee, and joint effusion17
- No severe AEs were observed in the SYNVISC group
Synvisc-One® (hylan G-F 20) showed superiority vs saline in reducing pain at 6 months in a randomized clinical study2,4-5,18,19
SYNVISC-One® demonstrated significantly greater improvement in OA knee pain than saline control in the pivotal clinical trial2,18,b,c
PAIN RELIEF (WOMAC A)
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
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.
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.
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.
- 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.
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- Caborn D, Rush J, Lanzer W, Parenti D, Murray C. A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. J Rheumatol. 2004;31(2):333-343.
- Raman R, Dutta A, Day N, Sharma HK, Shaw CJ, Johnson GV. Efficacy of hylan G-F 20 and sodium hyaluronate in the treatment of osteoarthritis of the knee—a prospective randomized clinical trial. Knee. 2008;15(4):318-324.
- SYNVISC [prescribing information]. Cambridge, MA: Genzyme Corporation; 2014.
- Synvisc-One [prescribing information]. Cambridge, MA: Genzyme Corporation; 2014.
- Gel-One summary of safety and effectiveness data. Silver Spring, MD: US Food and Drug Administration; 2016.