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. Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence. View More

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About Synvisc-One

Synvisc-One® (hylan G-F 20) is a viscosupplement injection made from a natural substance that lubricates and cushions knee joints. Synvisc-One is the #1 prescribed viscosupplement in the United States.1

Only Synvisc-One provides up to 6 months of osteoarthritis knee pain relief with a single injection2-4, 6-9

Synvisc-One offers:

The most commonly reported adverse events were arthralgia, arthritis, arthropathy, injection site pain, and joint effusion.

* This information is not based on any head-to-head clinical data, so the clinical significance of this information is unknown. No comparative conclusions regarding safety or efficacy should be derived from these data points.

SYNVISC® and Synvisc-One® are registered trademarks of Genzyme corportation. All other products and brand names are trademarks and/or registered trademarks of 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.

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 (≤21years 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 (PDF)

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 (PDF)

References

  1. Synvisc Prescribing Information. Cambridge, MA: Genzyme Corp; 2010.
  2. Data on file. Genzyme Corp.
  3. Synvisc-One Prescribing Information. Cambridge, MA: Genzyme Corp; 2010.
  4. Euflexxa Product Information. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2009.
  5. FDA approves longer duration efficacy and safety for Euflexxa® [press release]. Parsippany, NJ: Ferring Pharmaceuticals, Inc; October 21, 2011.
  6. Gel-One Package Insert. http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080020c.pdf. Accessed September 2, 2011.
  7. Hyalgan Prescribing Information. Bridgewater, NJ: sanofi-aventis US LLC; 2009.
  8. Orthovisc Prescribing Information. Raynham, MA: DePuy Mitek, Inc; 2005.
  9. Supartz Prescribing Information. Memphis, TN: Smith & Nephew, Inc; 2007.