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
Comparative clinical significance has not been proven.
WOMAC pain score percent reduction from baseline with Monovisc® or saline in the ITT population6
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).
Total HA per syringe; single-injection viscosupplements
A non-avian HA with a good safety profile*,†,1,3,4
Relevant warnings and precautions:
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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.