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Make Monovisc® a key part of your osteoarthritis (OA) knee pain relief action plan
Monovisc® is indicated in the treatment of pain in 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
Choose a high-molecular-weight, cross-linked, non-avian hyaluronic acid (HA) with clinically proven, long-lasting OA knee pain relief
- 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‡,1,5–7
- 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
Monovisc® significantly reduced the WOMAC pain score vs. saline from Week 12 post-injection up to Week 26§,¶,5,6
WOMAC pain score percent reduction from baseline with Monovisc® or saline in the ITT population6
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).
More HA per syringe than any other single injection‡,1,7–9
Total HA per syringe; single-injection viscosupplements
- Monovisc® creates a high-viscosity environment to treat the symptoms of osteoarthritis of the knee.1,7–9
- Monovisc® is cross-linked. Crossed-linked HA is thought to have improved viscoelastic properties and a longer residence time in the joint.*,†,1,3,4
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 that has not been discussed here, call us at 1-888-550-6060 or by email at [emailprotected].
HA: hyaluronic acid; ITT: intent to treat; WOMAC: Western Ontario and McMaster Universities Osteoarthritis index; ITT: intent to treat; TH: triamcinolone hexacetonide; NSAID: non-steroidal anti-inflammatory
*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).2,3
†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.4
‡Comparative clinical significance has not been proven.
§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 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 change in WOMAC score through 12 weeks with Cingal® versus saline.6
¶Baseline values ± standard deviation (mm): Monovisc® 61.0 ± 11.7; saline 58.8 ± 10.6. Pain reduction (%) (WOMAC score ± standard deviation [mm]): Week 12: Monovisc® 64% (−39.0 ± 21.9); saline 52% (−30.8 ± 23.7). Week 18: Monovisc® 63% (−38.5 ± 23.8); saline 53% (−31.4 ± 24.2). Week 26: Monovisc® 65% (−39.5 ± 22.8); saline 60% (−32.9 ± 23.6).5
**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).5
References:
1. Monovisc® Package Insert. PENDOPHARM. March 2013. 2. Data on file. PENDOPHARM. Study 0702. 3. Monovisc® 0702 pivotal clinical trial. FDA Monovisc® Summary of Safety and Effectiveness Data. 2014. 4. Data on file. PENDOPHARM. Study 0703. 5. Data on file. Clinical study report: Cingal® 13-01. Anika Therapeutics Inc. January 2015. 6. Hangody L. 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. 2017;1–8. 7. 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. 8. Durolane® website. Available from: www.durolane.com. Accessed on: January 13, 2014. Durolane® is a registered trademark of Galderma S.A., Switzerland. 9. 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.
