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,
eg, acetaminophen.
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 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 intraarticular injectables 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
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 local
pain, swelling, and/or effusion in the injected knee. In some cases, these symptoms
have been extensive. Allergic reactions such as rash and hives have been reported
rarely.
View the Complete Prescribing Information for SYNVISC (PDF 404K)
For Synvisc-One
The most commonly reported related local adverse events were transient, mild to
moderate arthralgia, arthritis, arthropathy, injection site pain, and joint effusion.
No serious adverse events have been reported in knees injected with Synvisc-One
in the pivotal trial. Serious local side effects have been reported only rarely
during post-marketing use. Repeat treatment did not affect the safety profile. In
the pivotal clinical trial, there was one related systemic event of syncope. The
most common systemic side effects irrespective of relationship to Synvisc-One were
headache, back pain, nasopharyngitis, and influenza. Systemic adverse event profiles
were similar between patients in the Synvisc-One and Saline Control groups.
View the Complete Prescribing Information for Synvisc-One (PDF 168K)