Monovisc® for healthcare professionals

Monovisc® is indicated in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics, e.g. acetaminophen.1

Make Monovisc® a key part of your OA pain action plan

  • Effective OA pain relief for up to six months, with a proven onset at two weeks*,2,3
  • 99% of Monovisc® patients experienced sustained OA pain reduction as measured by WOMAC pain scales†,‡,4
  • More HA per syringe than any other single injection¶,1,5,6,7
  • A non-avian HA§ with a good safety profile1,3,4

Comparative clinical significance has not been proven

Easy-to-use ergonomic syringe plunger and flange extender

WOMAC pain assessment*

*Study 0702. Prospective, multi-center (31 centers), randomized, double-blind, placebo-controlled clinical study of 6 months to evaluate the safety and efficacy of a single injection of Monovisc® for the treatment of knee pain from OA in 35- to 75-year-old patients (n=369) with symptomatic OA of the knee. Patients had Grade II or III OA with baseline index knee WOMAC pain scores of 200–400 mm (< 150 mm for contralateral knee), and a washout period for all NSAIDs, corticosteroids and analgesics prior to study initiation. All patients received Monovisc® or a saline solution (placebo) as a single 4 mL injection. Efficacy was assessed at Weeks 2, 4, 8, 12, 20 and 26 following injection. The primary endpoint was the proportion of treatment successes in the Monovisc® (n=184) and the placebo (n=185) groups. Patient success was defined as a patient who achieved ≥ 40% improvement in WOMAC pain score and ≥ 15 mm improvement as compared to baseline at Week 12. Secondary outcomes included patient and evaluator global assessments, WOMAC physical function, walking pain and pain – stairs, investigator and patient global assessment, acetaminophen usage and range of motion. A total of 331 patients (Monovisc®: n=162; placebo: n=169) completed the study (Week 26).2,3

WOMAC = Western Ontario and McMaster Universities Arthritis Index.

**The number of patients at each timepoint may vary from 162 to 181.

More HA per syringe than any other single injection ¶,1,5,6,7

Total HA per syringe; single-injection viscosupplements

  • Monovisc® creates a high-viscosity environment to treat the symptoms of osteoarthritis.1,5,6,7
  • Monovisc® is lightly cross-linked. Crossed-linked HA is thought to have improved viscoelastic properties and a longer residence time in the joint.*,‡,1,3,4

*Study 0702. Prospective, multi-center (31 centers), randomized, double-blind, placebo-controlled clinical study of 6 months to evaluate the safety and efficacy of a single injection of Monovisc® for the treatment of knee pain from OA in 35- to 75-year-old patients (n=369) with symptomatic OA of the knee. Patients had Grade II or III OA with baseline index knee WOMAC pain scores of 200–400 mm (< 150 mm for contralateral knee), and a washout period for all NSAIDs, corticosteroids and analgesics prior to study initiation. All patients received Monovisc® or a saline solution (placebo) as a single 4 mL injection. Efficacy was assessed at Weeks 2, 4, 8, 12, 20 and 26 following injection. The primary endpoint was the proportion of treatment successes in the Monovisc® (n=184) and the placebo (n=185) groups. Patient success was defined as a patient who achieved ≥40% improvement in WOMAC pain score and ≥15 mm improvement as compared to baseline at Week 12. Secondary outcomes included patient and evaluator global assessments, WOMAC physical function, walking pain and pain – stairs, investigator and patient global assessment, acetaminophen usage and range of motion. A total of 331 patients (Monovisc®: n=162; placebo: n=169) completed the study (Week 26).2,3

‡Study 0703. 26-week, open-label, uncontrolled, multicenter pilot study evaluating the safety and efficacy of European marketed and approved Monovisc® for symptomatic pain relief in 80 patients (43–77 years old) with Grade I, II or III OA; 7 patients did not meet the inclusion/exclusion criteria, therefore 73 patients took part in the study. Patients had OA symptoms for at least 6 months, were willing to discontinue analgesics (including NSAIDs) and had baseline WOMAC pain scores of 200–400 mm. 40% of patients had pre-injection aspiration before Monovisc® injection. All patients were injected with the entire contents of the syringe (4 mL) and there were no complications associated with any of the procedures. Efficacy was assessed by the degree of structural severity with the Kellgren-Lawrence (K-L) classification. Pain was assessed using the WOMAC pain scale in VAS (Visual Analog Scale) format. Baseline and Post-treatment Patient and Investigator Global assessments were made throughout the study, at day of injection and at 4, 8, 13 and 26 weeks (+/- 7–10 days) after injection. Only descriptive analysis was performed.4

¶Comparative clinical significance has not been proven

A non-avian HA with a good safety profile*,‡,1,3,4

  • A good safety profile with worldwide marketing experience since 2008.3
  • No serious adverse events reported during the clinical trial programs.3,4
  • Naturally sourced HA: Monovisc® is made from ultra pure, high molecular weight sodium hyaluronate produced by bacterial fermentation.1

Your patients rely on you.
You can rely on Monovisc®.

Contraindications:

  • Pre-existing infections of the skin region of the intended injection site
  • Known infection of the index joint
  • Known systemic bleeding disorders

Relevant warnings and precautions:

  • Swelling, discomfort, infections and bleeding
  • Synovial space should not be overfilled and stop injection/withdraw needle if pain increases
  • Not tested in pregnant or lactating women or in children
  • Concomitant use with other intra-articular injectables and effect of repeated injections has not been tested

For more information:

For important information relating to adverse reactions and dosing information which have not been discussed in this piece, call us at

1-888-550-6060

or by email at medinfo@pendopharm.com.