Arthritis/rheumatic disorders:
Indications for: DUROLANE
For the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacological therapy or simple analgesics (eg, acetaminophen).
Clinical Trials:
In clinical trials, treatment with Durolane resulted in greater reduction in Visual Analog Scale pain scores at 3 and 6 months compared with Synvisc One (hylan G-F 20) (P <.001). In addition, Durolane was associated with longer lasting pain relief (primary outcome: Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] pain responder rate) compared with methylprednisolone acetate injection.
Comparative Study of Safety and Efficacy of Two Hyaluronic Acids for Knee OA
A total of 349 patients with mild to moderate OA of the knee were randomly assigned 1:1 to receive Durolane or a commercially available 5-injection regimen of hyaluronic acid product over the course of 5 weeks. The primary endpoint of the study was based on WOMAC 20-point Likert-scale. Patients were followed for 26 weeks and efficacy was assessed at 6, 10, 14, 18, and 26 weeks.
Results showed that Durolane was noninferior to the 5-injection hyaluronic acid product. The least squares mean (LSM) WOMAC pain subscale score change from baseline (CFB) over 18 weeks was -5.97 for Durolane and -5.87 for the 5-injection hyaluronic acid, with a difference of -0.09 (95% CI, -0.58, 0.39). A single injection of Durolane provided a benefit for pain reduction in patients with OA in the knee for up to 26 weeks.
Repeated Injection Data
The safety of repeated use of Durolane was supported by data from an open-label study and an extension phase of the noninferiority trial vs methylprednisolone acetate. Patients were offered a second injection of Durolane 3 months or 26-weeks after the initial injection. Results showed that adverse event rates were comparable between the groups.
Adult Dosage:
Remove joint effusion before inj. Give as a single intra-articular inj. 3mL per knee or hip. Local anesthetic by SC inj or topical freezing agents may be used prior to inj. Use separate syringes for each joint.
Children Dosage:
Not studied.
DUROLANE Contraindications:
Knee joint infections, infections, or skin disease in the area of injection site.
DUROLANE Warnings/Precautions:
Do not inject by intravascular or extra-articular route, or in the synovial tissues or capsule. Avoid infected or severely inflamed synovial joint, active skin disease or infection at or near inj site. Venous or lymphatic stasis in the leg. Pre-existing chondrocalcinosis. Hyaluronic acid sensitivity. Avoid strenuous activity within 48hrs after injection. Pregnancy, nursing mothers: not studied.
DUROLANE Classification:
Hyaluronan.
DUROLANE Interactions:
Concomitant other intra-articular injectables: not established.
Adverse Reactions:
Transient pain, swelling, joint stiffness; infection.
Generic Drug Availability:
NO
How Supplied:
Single-use prefilled syringe (3mL)—1
