For U.S. Healthcare Professionals Only
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

SYNVISC® provides up to 6 months of OA knee pain relief with 3 injections1,2

Efficacy Results

Patients treated with SYNVISC in the pivotal clinical trial showed a significantly greater improvement in OA knee pain than patients treated with saline over a 26-week period2


  • SYNVISC demonstrated significant reductions in pain 1 week after the first injection2
Weight-bearing pain: evaluator assessment

Click below to view additional SYNVISC studies

SYNVISC demonstrated significant reductions in pain associated with OA of the knee compared with Hyalgan (sodium hyaluronate)3

Efficacy Results

In a head-to-head clinical trial, SYNVISC provided significant improvements in OA knee pain versus Hyalgan at 6 weeks (P=0.001) and 6 months (P=0.02)4

Reduction in osteoarthritis knee pain over 6 months

SYNVISC provides superior OA knee pain relief at 6 months compared with ICS injections4

Efficacy Results

Superior, long-term efficacy and comparable tolerability versus a long-acting corticosteroid were established in the first 26-week, randomized, controlled study comparing triamcinolone hexacetonide (TH) and SYNVISC5

SYNVISC delivered significant, long-term overall clinical improvement in osteoarthritis knee pain

SYNVISC demonstrated significant reduction in OA knee pain at rest compared with NSAIDs in a head-to-head clinical trial5

Efficacy Results

Mean improvement from baseline in pain at rest at 12 weeks

SYNVISC provided significant improvements in OA knee pain versus NSAIDs at 12 weeks (P=0.05)5

  • AEs were reported in the case report forms of 6 patients5
    • — The remaining 3 patients had local and transient AEs in the injected knees

Adverse Events

In clinical trials, the frequency and type of AEs were similar between SYNVISC and control treatments1,2

Device-related adverse events involving the injected knee included injection-site pain, swelling in the injected knee, and joint effusion

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 SYNVISC1:

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

Hyalgan (sodium hyaluronate) is a registered trademark of Fidia Pharma USA Inc.

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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

References

  1. Synvisc Prescribing Information. Cambridge, MA: Genzyme Corporation; 2010.
  2. 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.
  3. 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.
  4. 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.
  5. Adams ME, Atkinson MH, Lussier AJ, et al. The role of viscosupplementation with hylan G-F 20 (Synvisc®) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthr Cartilage. 1995;3(4):213-225.