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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. 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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SYNVISC Information

SYNVISC (3 Injections) vs. Sodium Hyaluronate

In the treatment of osteoarthritis knee pain, the SYNVISC® (hylan G-F 20) provided superior pain relief compared to Hyalgan® (sodium hyaluronate).1

Because viscosupplements are injected directly into the knee, they have none of the GI or cardiovascular safety issues associated with oral medications. And, SYNVISC was the first viscosupplement that offered up to six months of knee pain relief with only three injections.

Science behind SYNVISC

SYNVISC has a unique composition

Unlike other viscosupplements, SYNVISC is a mixture of two hylan polymers derived from American and Canadian chicken comb hyaluronan. Hylans are produced by chemically cross-linking hyaluronan in two steps.

SYNVISC is hylan G-F 20, meaning it is 80% hylan A fluid plus 20% hylan B gel. This composition yields a molecular weight and viscoelastic properties that closely match healthy synovial fluid.

SYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee.

SYNVISC treatment has been shown to:

  • Increase the elastoviscosity of synovial fluid
  • Reduce OA knee pain

SYNVISC vs. sodium hyaluronate

SYNVISC is made from cross-linked sodium hyaluronate2,3

Compare Synvisc-One knee injection to other viscosupplements

Most viscosupplements have single hyaluronan

All viscosupplements contain hyaluronan (HA), or sodium hyaluronate, a natural complex sugar of the glycosaminoglycan family. HA is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine. The HA is sourced from either chicken combs or bacterial fermentation. Research has shown that the elastic and viscous properties of articular synovial fluid are mainly due to its HA component. Most approved viscosupplements contain single HA chains.

* Precise placement of the injection into the joint space must be achieved in order to optimize efficacy and minimize adverse reactions. The knee joint should be aspirated before the SYNVISC injection.

Find out more about SYNVISC safety in our Clinical Summary.

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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. Raman R, et al. Efficacy of Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee — A prospective randomized clinical trial. Knee. 2008 Aug ;15(4):318-24. Epub 2008 Apr 21.
  2. Adams ME, Lussier AJ, Peyron JG. A risk-benefit assessment of injections of hyaluronan and its derivatives in the treatment of osteoarthritis of the knee. Drug Saf. 2000;23:115-130.
  3. Synvisc Prescribing Information. Cambridge, MA: Genzyme Corp; 2010.