EUFLEXXA Dosage & Rx Info | Uses, Side Effects

Euflexxa Generic Name & Formulations

Legal Class

General Description

Sodium hyaluronate 10mg/mL; soln for intra-articular inj.

Pharmacological Class

Hyaluronan.

How Supplied

Single-use prefilled syringes (2mL)—1

Storage

Store at 2º-25ºC (36º-77ºF).

Protect from light.

Do not freeze.

If refrigerated, remove from refrigeration at least 20-30 minutes before use.

Manufacturer

Ferring Pharmaceuticals, Inc.

Euflexxa Indications

Indications

Osteoarthritis of the knee in patients who have failed nonpharmacologic therapy and analgesics (eg, acetaminophen).

Euflexxa Dosage and Administration

Prior to Treatment Evaluations

Remove joint effusion, if present.

Adult

Prior to treatment: remove joint effusion (use separate syringe), if present. Inject 2mL (full syringe contents) intra-articularly in each affected knee weekly for 3 weeks. Use separate syringes for each knee.

Children

Not recommended.

Euflexxa Contraindications

Contraindications

Knee joint infection or skin disease at inj site.

Euflexxa Boxed Warnings

Not Applicable

Euflexxa Warnings/Precautions

Warnings/Precautions

Repeated treatment cycles: not established. Avoid intravascular injection. Avoid strenuous activity within 48hrs after injection. Pregnancy. Nursing mothers.

Pregnancy Considerations

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.

Pediatric Considerations

Safety and effectiveness have not been demonstrated in children.

Euflexxa Pharmacokinetics

Elimination

Fecal. Half-life: 17 hours–1.5 days.

Euflexxa Interactions

Interactions

Avoid disinfectants with quaternary ammonium salts. Concomitant other intra-articular injectables: not recommended.

Euflexxa Adverse Reactions

Adverse Reactions

Arthralgia, increase blood pressure, inj site pain, local reactions, transient knee inflammation.

Euflexxa Clinical Trials

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 Note