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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. 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 Information

In clinical trials, the frequency and type of adverse events were similar between SYNVISC and control treatments1

SYNVISC Adverse Events Involving the Injected Joint

Single Course

Repeat Course

Percentage of Injections

2.2%

6.3%

Percentage of Patients

7.2%

22.3%

Device-related adverse events involving the injected knee included injection site pain, swelling in the injected knee, and joint effusion.
  • In clinical trials, 2.2% of injections resulted in knee pain and swelling
    • – A total of 157 patients received 553 injections in the 3 clinical trials of repeated courses of SYNVISC treatment

Most commonly reported device-related adverse events with SYNVISC1

  • Pain in the injected knee
  • Swelling in the injected knee
  • Joint effusion

Potential adverse events that may occur in association with
intra-articular injection, including SYNVISC1:

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

SYNVISC Efficacy

SYNVISC provides up to 6 months of pain relief with 3 injections2-3

Patients treated with SYNVISC showed a significantly greater improvement in all outcome measures than patients treated with saline over a 26-week period3

  • SYNVISC demonstrated significant reductions in pain 1 week after the first injection

Trial conducted to assess the efficacy and safety of three 2-mL injections of SYNVISC (hylan G-F 20) given at 1-week intervals in patients with chronic, idiopathic OA of the knee.3

  • Primary end points: Improvement from baseline in pain during weight-bearing movement, pain at rest during the night, reduction of pain during the most painful movement of the knee, and treatment success at weeks 12 and 26
  • Prospective, double-blind, randomized
  • Conducted at 4 centers, N=110; 117 knees
  • Patients were randomized to treatment with SYNVISC (57 knees) or physiologic buffered saline solution (60 knees)
  • Clinical evaluations of efficacy and safety were conducted prior to the second and third injections at weeks 1 and 2, and then at weeks 3, 8, and 12. Follow-up interview was conducted at week 26

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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 (≤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

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 Corp; 2010.
  2. Data on file. Genzyme Corp.
  3. 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.