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Repeat Treatment With Synvisc-One®

Your patients may ask about receiving Synvisc-One again after experiencing up to six months of pain relief. They may also inquire about the safety of another treatment for managing knee pain.

Synvisc-One has a demonstrated safety profile in both initial and repeat treatments.1 Local adverse events for viscosupplements are usually pain and/or swelling in the injected knee.

The repeat treatment phase evaluated the safety profile of a second injection of Synvisc-One. One hundred and sixty patients were treated during this phase of the study, of which 77 patients received a second injection of Synvisc-One. These patients were followed for 4 weeks and out of 77 patients, only 4 (5.2%) experienced device-related AEs in the injected knee. All such events were mild to moderate and were treated symptomatically. Patients who developed injected knee AEs during the initial phase of the study, and who subsequently received repeat treatment, did not experience injected knee AEs upon repeat exposure to Synvisc-One.

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 non pharmacologic 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. Use caution when injecting SYNVISC or Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of venous or lymphatic stasis in the leg to be treated; or who have severe inflammation in the knee to be treated.

Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment. Aspiration of any effusion prior to injection is highly recommended. 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. It is unknown whether SYNVISC or Synvisc-One is excreted in human milk.

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. Other side effects such as rash have been reported rarely.

View the Complete Prescribing Information for SYNVISC (PDF)

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 were reported in clinical trials in knees injected with Synvisc-One. Serious local adverse events have been reported only rarely in 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)

References

1. Synvisc-One Prescribing Information. Cambridge, MA: Genzyme Corp; 2009.