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DOSAGE GUIDELINES: The dosage regimen for hylan G-F 20 is dependent on the joint being treated.
Synvisc: Osteoarthritis of the knee: The recommended treatment regimen is three 2 mL injections in the knee, with an interval of 1 week between each injection. To achieve maximum effect, it is essential to administer all three injections. The maximum recommended dosage is six injections within six months, with a minimum of four weeks between treatment regimens.
Osteoarthritis of the hip/ankle/shoulder: The recommended initial treatment regimen is a single 2 mL injection. If however, adequate symptomatic relief is not achieved after this injection, it is recommended to administer a second 2 mL injection. Clinical data have demonstrated that patients benefit from this second injection when administered between 1 and 3 months after the first injection.
DURATION OF EFFECT: Hylan G-F 20 treatment affects only the injected joint; it does not produce a general systemic effect.
Generally the duration of effect for those patients who respond to treatment has been reported up to 26 weeks, although shorter and longer periods have also been observed. However, prospective clinical data in knee osteoarthritis patients have shown benefit of treatment up to 52 weeks, following a single course of three Synvisc injections.
Synvisc-One: Osteoarthritis of the knee: The recommended treatment regimen is one 6 mL injection in the knee. The injection may be repeated 6 months after the first injection, if justified by the patient's symptoms.
DURATION OF EFFECT: Hylan G-F 20 treatment affects only the injected joint; it does not produce a general systemic effect.
Prospective clinical trial data in knee osteoarthritis patients have shown a reduction in pain for up to 52 weeks following a single Synvisc-One injection as well as related improvements in stiffness and function.
Clinical data from a double-blind, randomized, controlled trial in knee OA patients have shown a statistically significant and clinically meaningful reduction in pain compared to placebo. A total of 253 patients were treated (124 received Synvisc-One and 129 received placebo). Over 26 weeks, patients receiving Synvisc-One demonstrated a mean percent change in pain from baseline of 36% while patients in the placebo group had a mean percent change in pain from baseline of 29%.
Additional prospective clinical data from two multi-center, open-label studies in knee OA patients have shown statistically significant improvements in pain relief compared to baseline for up to 52 weeks following a single administration of Synvisc-One.
In the first study, 394 patients that received Synvisc-One demonstrated a statistically significant change in the WOMAC A1 - pain on walking subscore (-28±19.89 mm on 100 mm VAS) from baseline over Week 26. In addition, statistically significant changes from baseline in WOMAC A1, and WOMAC A, B and C scores were observed over all six observation time periods between week 1 and week 52, demonstrating improvement in pain on walking and pain (WOMAC A1 -32.7±19.95 mm; WOMAC A -29.18±19.158 mm), stiffness (WOMAC B -25.77±22.047 mm), and function (WOMAC C -25.72±19.449 mm) over 52 weeks.
In the second study, 571 patients that received Synvisc-One, demonstrated statistically significant improvement in pain over 26 weeks as measured by Verbal Pain Questionnaire (VPQ). The mean pain assessment improved from 3.20 at Baseline to 2.24 at 26 week visit, with 64.6% of patients achieving pain relief. Secondary endpoints demonstrated statistically significant improvement in VPQ scores at all observation time points from 1 week to 52 weeks, with mean VPQ scores declining from 3.20 at baseline to 2.26 at 52 week visit and 61.5% of patients achieving pain relief.
