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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Science

SYNVISC® and Synvisc-One® are specifically designed to mimic healthy, young synovial fluid1,2,3

Crosslinking provides SYNVISC and Synvisc-One with rheological properties similar to healthy, young synovial fluid1,2,3

   
    Healthy, young
synovial fluid1,2,3
SYNVISC and
Synvisc-One1,2
Osteoarthritic
synovial fluid5,6
   
    Average molecular weight*
(million Daltons)
6 6 1.9    
    Elasticity* (Pa at 2.5 Hz) 117 111 1.9    
    Viscosity* (Pa at 2.5 Hz) 45 25 1.4    
   

*The clinical significance of these physical properties is unknown. No comparative conclusions regarding safety or efficacy should be derived from these data points.
As in 21- to 45-year-old adults
As in 18- to 27-year-old adults

SYNVISC and Synvisc‑One have distinct characteristics within the viscosupplement class

Only SYNVISC and Synvisc-One are composed of 2 crosslinked polymers: a fluid (Hylan A) and a gel (Hylan B)1,2*

SYNVISC and Synvisc-One are composed of 2 crosslinked polymers: Hylan A (fluid), and Hylan B (gel)

*The clinical significance of these physical properties is unknown.

SYNVISC and Synvisc-One are specifically designed with unique viscoelastic properties1,2

Physical properties of viscosupplements1-12
   
    Physical properties of viscosupplements    
   
    The clinical significance of these physical properties is unknown. This information is not based on any head-to-head clinical trial. No comparative conclusions regarding safety or efficacy should be derived from these data points.
SYNVISC and Synvisc-One are registered trademarks of Genzyme. All other registered trademarks belong to their respective companies.
   

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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. Synvisc-One Prescribing Information. Cambridge, MA: Genzyme Corporation; 2010.
  3. Balazs EA, Watson D, Duff IF, Roseman S. Hyaluronic acid in synovial fluid, I: molecular parameters of hyaluronic acid in normal and arthritic human fluids. Arthritis Rheum. 1967;10(4):357-376.
  4. Data on file. Genzyme Corp.
  5. Mazzucco D, McKinley G, Scott RD, Spector M. Rheology of joint fluid in total knee arthroplasty patients. J Orthop Res. 2002;20(6):1157-1163.
  6. Watterson JR, Esdaile JM. Viscosupplementation: therapeutic mechanisms and clinical potential in osteoarthritis of the knee. J Am Acad Orthop Surg. 2000;8(5):277-284.
  7. Euflexxa Product Information. Parsippany, NJ: Ferring Pharmaceuticals; 2011.
  8. Gel-One Package Insert. Warsaw, IN: Zimmer USA; 2011. Accessed April 6, 2011.
  9. Hyalgan Prescribing Information. Parsippany, NJ: Fidia Pharma US Inc, 2011.
  10. Orthovisc Prescribing Information. Raynham, MA: DePuy Mitek, Inc; 2005.
  11. Supartz Prescribing Information. Durham, NC: Bioventis LLC; 2012.
  12. Monovisc Prescribing Information. Bedford, MA: Anika Therapeutics, Inc; 2014.