DUROLANE Dosage & Rx Info | Uses, Side Effects

Durolane Generic Name & Formulations

Legal Class

General Description

Hyaluronic acid 20mg/mL; viscoelastic gel for intra-articular inj.

Pharmacological Class

Hyaluronan.

How Supplied

Single-use prefilled syringe (3mL)—1

Storage

Stored between 0-30ºC (32-86ºF).

Transient spikes up to 40ºC (104ºF) are permitted as long as they do not exceed 24 hours.

Protect from freezing.

Refrigeration is not needed.

Shelf-life: 36 months; use prior to expiry date.

Manufacturer

Bioventus

Generic Availability

Durolane Indications

Indications

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).

Durolane Dosage and Administration

Adult

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

Not studied.

Durolane Contraindications

Contraindications

Knee joint infections, infections, or skin disease in the area of injection site.

Durolane Boxed Warnings

Not Applicable

Durolane Warnings/Precautions

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.

Pregnancy Considerations

Safety and effectiveness have not been established in pregnant individuals.

Nursing Mother Considerations

Safety and effectiveness in lactating women have not been established. It is not known whether Durolane is excreted in human milk.

Pediatric Considerations

The safety and effectiveness of Durolane have not been established in children (21 years of age or younger).

Durolane Pharmacokinetics

See Literature

Durolane Interactions

Interactions

Concomitant other intra-articular injectables: not established.

Durolane Adverse Reactions

Adverse Reactions

Transient pain, swelling, joint stiffness; infection.

Durolane Clinical Trials

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.

Durolane Note