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PROFESSIONALS

EXPANDED INDICATIONS
TO RELIEVE OSTEOARTHRITIS
PAIN IN THE:

Knee

Hip

Shoulder NEW

Ankle

MAKE MONOVISC® A KEY PART OF YOUR OSTEOARTHRITIS (OA) PAIN RELIEF ACTION PLAN

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

logo Monovisc

CHOOSE AN OPTIMAL MOLECULAR WEIGHT, CROSS-LINKED, HYALURONIC ACID (HA) WITH CLINICALLY PROVEN, LONG-LASTING PAIN RELIEF FOR THE KNEES, HIPS, SHOULDERS AND ANKLES

  • Effective OA pain relief for up to six months1–5
  • Excellent safety profile across all indications*,†,‡,§,3–5,7

Comparative clinical significance has not been proven.

Monovisc syringe
Easy-to-use ergonomic syringe plunger and flange extender

Clinically proven OA knee pain relief

MONOVISC® SIGNIFICANTLY REDUCED THE WOMAC PAIN SCORE VS. SALINE FROM WEEK 12 POST-INJECTION UP TO WEEK 26¶,**,6,7

Percent reduction of WOMAC pain score in the knee from baseline with Cingal®, Monovisc®, or saline in the ITT population**,††,‡‡,6,7

Monovisc up to 6 month graph Monovisc up to 6 month graph

Safety measures

Five serious adverse events were reported in four subjects. None were considered related to treatment and all were resolved without sequelae.

The most common adverse events were headache, arthralgia, spinal pain, back pain, and nasopharyngitis. Six were related to study medication: arthralgia with Cingal® (n=2) and Monovisc® (n=2), peripheral edema with Cingal® (n=1), and rash with Monovisc® (n=1).

NEW

CONSISTENT LONG-LASTING PAIN RELIEF ACROSS ALL
INDICATIONS1–5

Responder rate at 6 months¶¶,3–5,7

Monovisc up to 6 month graph

A SIGNIFICANT AMOUNT OF HA DELIVERED PER SYRINGE†††,1,8–10

Total HA per syringe; single-injection viscosupplements

Monovisc comparasion graph
  • Monovisc® creates a high-viscosity environment to treat osteoarthritis pain in the knee, hip, shoulder and ankle.1,8–10
  • Monovisc® is cross-linked. Crossed-linked HA is thought to have improved viscoelastic properties and a longer residence time in the joint‡‡‡,§§§,¶¶¶,1,11,12

EXCELLENT SAFETY
PROFILE ACROSS ALL INDICATIONS*,†,‡,§,3–5,7

  • Excellent safety profile with worldwide marketing experience since 2008.3–5,7
  • No serious adverse events reported during the clinical trial programs.3–5,7
  • Naturally sourced HA: Monovisc® is made from ultra-pure, optimal molecular weight sodium hyaluronate produced by bacterial fermentation.1

YOUR PATIENTS RELY ON YOU. YOU CAN RELY ON MONOVISC®.

Contraindications:

  • Known sensitivity to hyaluronic acid-based products
  • 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:

  • Only medical professionals trained in accepted injection techniques for delivering agents to joint spaces should inject sodium hyaluronate for this application.
  • The synovial space should not be overfilled.
  • If pain increased during the injection procedure, the injection should be stopped and the needle withdrawn.
  • The safety and effectiveness of Monovisc® concomitantly with other intra-articular injectables have not been tested.
  • Monovisc® has not been tested in pregnant or lactating women or in children.
  • The effect of repeated injections of Monovisc® has not been tested.
  • Mild to moderate episodes of transient swelling and discomfort have occasionally been observed following intra-articular injection of sodium hyaluronate preparations.

For more information:

Please consult the Monovisc® Package Insert for important information relating to adverse reactions and directions for use that has not been discussed in this piece, or visit www.monovisc.ca.

The Package Insert is also available upon request by calling 1-888-550-6060 or by emailing [email protected].

HA: hyaluronic acid; ITT: intent to treat; WOMAC: Western Ontario and McMaster Universities Osteoarthritis index; AEs: adverse events; TH: triamcinolone hexacetonide; NSAID: non-steroidal anti-inflammatory
*In a prospective, multicentre, double-blind, placebo-controlled, active-comparator study, subjects with confirmed knee OA were randomized to Cingal®, Monovisc® or saline. Three AEs related to Monovisc® medication (arthralgia and rash) were reported.6
†In an open-label, multicentre study evaluating the safety and efficacy of Monovisc® for hip OA, none of the AEs were listed as related to study medication. No serious AEs were reported.3
‡In an open-label, multicentre study evaluating the safety and efficacy of Monovisc® for shoulder OA, one AE was listed as related to study medication (joint swelling). No serious AEs were reported.4
§In an open-label, multicentre study evaluating the safety and efficacy of Monovisc® for ankle OA, none of the AEs were listed as related to study medication. No serious AEs were reported.5
¶A prospective, multicentre, randomized, double-blind, placebo-controlled, active-comparator clinical trial conducted at 30 sites in Europe and Canada. Eligible subjects with radiologically confirmed knee OA were randomized 2:2:1 to a single injection of Cingal® (4 mL, 88 mg HA plus 18 mg TH), Monovisc® (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The WOMAC pain score was used to assess patient outcomes at 1, 3, 6, 12, 18, and 26 weeks following the injection. A total of 368 subjects were enrolled and randomized to Cingal® (n=149), Monovisc® (n=150), or saline (n=69). The primary efficacy outcome was a change in WOMAC pain score through 12 weeks with Cingal® versus saline.6
**Baseline values ± standard deviation (mm): Cingal® 59.0 ± 12.3; Monovisc® 61.0 ± 11.7; saline 58.8 ± 10.6. Pain reduction (WOMAC score ± standard deviation [mm]): Week 1: Cingal® (−34.6 ± 20.8); Monovisc® (−29.6 ± 21.4); saline (−26.6 ± 18.2). Week 12: Cingal® (−41.1 ± 20.5); Monovisc® (−39.0 ± 21.9); saline (−30.8 ± 23.7). Week 18: Cingal® (−40.5 ± 20.4); Monovisc® (−38.5 ± 23.8); saline (−31.4 ± 24.2). Week 26: Cingal® (−42.4 ± 18.7); Monovisc® (−39.5 ± 22.8); saline (−32.9 ± 23.6).6,7
††Pain and symptom relief were not statistically different between Monovisc® and Cingal® treatments from Week 6 through Week 26. The Cingal® group had significantly lower WOMAC pain scores than the saline group through 26 weeks in the ITT population with the exception of Week 6 (p=0.09).6
‡‡The primary endpoint was the change from WOMAC baseline in knee pain through 12 weeks between Cingal® vs. saline. Secondary endpoints included the change from WOMAC baseline in knee pain at Weeks 1 and 3 between Cingal® and Monovisc®, and the change from WOMAC baseline in knee pain through 26 weeks between Cingal® and saline.6
§§Statistical significance was not tested. The control group showed a 56% improvement relative to baseline.6
¶¶As identified by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society (OMERACT-OARSI) responder index.3–5,7
***Responder rate for treatment of pain in OA of the knee is calculated from Cingal® study where Monovisc® served as an active comparator.7
†††Comparative clinical significance has not been proven.
‡‡‡Study 0702. Prospective, multicentre (31 centres), 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).11
§§§Study 0703. 26-week, open-label, uncontrolled, multicentre 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 visual analog scale (VAS) 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.12
¶¶¶Durolane® and Synvisc-One® are cross-linked.8,9

References:
1. Monovisc® Package Insert. PENDOPHARM. March 2025. 2. Petterson S, Plancher K. Single intra-articular injection of lightly cross-linked hyaluronic acid reduces knee pain in symptomatic knee osteoarthritis: a multicenter, double-blind, randomized, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc 2019;27(6):1992–2002. 3. Data on file. PENDOPHARM. Monovisc® 18-01 Clinical study report. 4. Data on file. PENDOPHARM. Monovisc® 18-02 Clinical study report. 5. Data on file. PENDOPHARM. Monovisc® 18-03 Clinical study report. 6. Hangody L, et al. Intraarticular injection of a cross-linked sodium hyaluronate combined with triamcinolone hexacetonide (Cingal®) to provide symptomatic relief of osteoarthritis of the knee: a randomized, double-blind, placebo-controlled multicenter clinical trial. Cartilage 2018;9(3):276–283. 7. Data on file. Clinical Study Report: Cingal 13-01. 8. Compendium of Pharmaceuticals and Specialties. Synvisc-One® Product Monograph. Genzyme Canada Inc. March 2, 2009. Synvisc-One® is a registered trademark of Genzyme Corporation, U.S.A. 9. Durolane® website. Available from: www.durolane.com. Accessed on: January 13, 2014. Durolane® is a registered trademark of Galderma S.A., Switzerland. 10. Electronic Compendium of Pharmaceuticals and Specialties. NeoVisc® Product Monograph. Tribute Pharmaceuticals Canada Inc. Accessed on: March 5, 2014. NeoVisc® is a registered trademark of Tribute Pharmaceuticals Canada Inc., Canada. 11. Baczkowicz D, et al. Effects of viscosupplementation on quality of knee joint arthrokinematic motion analyzed by vibroarthrography. Cartilage 2021;12(4):438–447. 12. Faivre J, et al. Crosslinking hyaluronic acid soft-tissue fillers: current status and perspectives from an industrial point of view. Expert Rev Med Devices 2021;18(12):1175–1187.

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