Euflexxa Generic Name & Formulations
Store at 2º-25ºC (36º-77ºF).
Protect from light.
Do not freeze.
If refrigerated, remove from refrigeration at least 20-30 minutes before use.
Euflexxa Dosage and Administration
Prior to Treatment Evaluations
Remove joint effusion, if present.
Euflexxa Boxed Warnings
Safety and effectiveness have not been established in pregnant women.
Nursing Mother Considerations
Safety and effectiveness have not been established in lactating women. It is not known if Euflexxa is excreted in human milk.
Safety and effectiveness have not been demonstrated in children.
Euflexxa Adverse Reactions
Euflexxa Clinical Trials
12-Week Clinical Study
Euflexxa was evaluated in a 12-week double-blind, active control study in a total of 321 patients with stage 2-3 osteoarthritis of the knee (according to the Kellgren and Lawrence grading system). Patients were randomly assigned to receive either Euflexxa (n=160) or the active control (Synvisc; n=161) weekly for 3 weeks.The Western Ontario McMaster Universities Osteoarthritis (WOMAC) Index pain subscale was the primary efficacy measure.
Results showed that both treatment groups experienced statistically significant improvements from baseline (P =.0001). Efficacy was found to be comparable between the Euflexxa and Synvisc groups (change from baseline in WOMAC pain score: 29.8mm vs 28.8mm, respectively).
26-Week Clinical Study
Euflexxa was also evaluated in the FLEXX trial, a 26-week, randomized, double-blind study. Patients were randomly assigned to receive 3 weekly injections of either Euflexxa or saline into the target knee. Following the 26-week double-blind period, patients were offered to receive an additional 3 weekly injections of Euflexxa in a 26-week open-label safety extension.
Results showed a statistically and clinically significant decrease in osteoarthritis knee pain with Euflexxa compared with saline as measured by a 50-foot walk test at week 26 (mean change in pain scores: -25.7mm vs -18.5mm, respectively; P =.002).
Findings from the open-label extension demonstrated that repeated injection cycles of Euflexxa were well tolerated up to 52 weeks.
Euflexxa Patient Counseling
Transient pain and/or swelling of the injected joint may occur after intra-articular injection.
Avoid strenuous activities or prolonged (>1 hour) weight-bearing activities within 48 hours following intra-articular injection.
Safety of repeated treatment cycles has been established up to 1 year.