Monovisc
Monovisc® is a single injection viscosupplement utilized to treat knee joint pain caused by osteoarthritis (OA). It is comprised of highly purified, partially cross-linked sodium hyaluronate (NaHA) in a phosphate-buffered saline solution, and it is both biocompatible and resorbable.
With just one injection, Monovisc may provide pain relief that lasts for up to 6 months.1 It is the only non-animal sourced hyaluronic acid (HA) single-injection treatment approved for use in the United States, and it delivers the maximum dose of HA (88mg) currently available in any single injection treatment.
Reference
1. MONOVISC 0702 Pivotal Clinical Trial. FDA Monovisc Summary of Safety and Effectiveness Data 2014
Anika Therapeutics
Anika Therapeutics
Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. We partner with clinicians to understand what they need most to treat their patients and we develop minimally invasive products that restore active living for people around the world. We are committed to leading in high opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions, sports medicine, and Arthrosurface joint solutions.
- Convenient single injection treatment
- Highly concentrated, non-animal sourced HA
- Long lasting relief through 26 weeks
- Convenience of a single injection as opposed to multiple visits to the physician
- No confirmed pseudoseptic reactions reported
References
1. MONOVISC 0702 Pivotal Clinical Trial. FDA Monovisc Summary of Safety and Effectiveness Data 2014
2. Clinical Efficacy and Safety of MONOVISC. A lightly cross-linked highly concentrated hyaluronan specially formulated for single injection in osteoarthritis. White Paper Study conducted by Michael J. Daley, PhD. 2013
3. Post-Approval Study of MONOVISC, A Symptomatic Treatment of Osteoarthritis, White Paper, 2012
Indicated for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (eg, acetaminophen).
Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations.
Do not administer to patients with known hypersensitivity (allergy) to gram-positive bacterial proteins.
Do not inject Monovisc in the knees of patients with infections or skin diseases in the area of the infection site or joint.
Do not administer to patients with known systemic bleeding disorders.
- Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation as hyaluronan can precipitate in their presence.
- Transient increases in inflammation in the injected knee following Monovisc injection have been reported in some patients with inflammatory osteoarthritis.
General Precautions
- Strict aseptic injection technique should be used during the application of Monovisc.
- The safety and effectiveness of the use of Monovisc in joints other than the knee have not been demonstrated.
- The effectiveness of Monovisc has not been established for more than one course of treatment.
- The pre-filled syringe is intended for single use only. The contents of the syringe should be used immediately after opening. Discard any unused Monovisc. Do not re-sterilize.
- Do not use Monovisc if the package has been opened or damaged.
- Remove joint effusion, if present, before injecting Monovisc.
- Only medical professionals trained in accepted injection techniques for delivering agents into the knee joint should inject Monovisc for the indicated use.
The most common reported adverse events associated with Monovisc are the following:
- Arthralgia
- Joint swelling
- Injection site pain
Store Monovisc in its original package at room temperature (below 77ºF/25ºC). Do not freeze.
