MONOVISC ( high molecular weight hyaluronan ) 4 mL injection

DESCRIPTION

Monovisc™ is a sterile, non-pyrogenic, viscoelastic solution of hyaluronan contained in a single-use syringe. Monovisc™ consists of high molecular weight, ultra-pure, natural hyaluronan, a complex sugar of the glycosaminoglycan family. The hyaluronan in Monovisc™ is derived from bacterial cells and is cross-linked with a proprietary cross-linker.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Detailed Device Description

The Monovisc™ device is a proprietary high molecular weight hyaluronic acid (HA) visco-supplementation intended for the treatment of pain in patients with moderate osteoarthritis (OA) of the knee who have failed conservative non-pharmacological therapy and simple analgesics. The device is administered by a single injection via the para-patellar approach under sterile conditions. The dosage delivered by the single injection is equivalent to three injections of Anika's FDA approved (P030019) Orthovisc HA product.

Sodium hyaluronate is a natural complex sugar of the glycosaminoglycan family. The sodium hyaluronate polymer consists of repeating disaccharide units of sodium glucuronate-N-acetylglucosamine. The molecular weight range of hyaluronic acid in Monovisc™ is between 1 and 2.9 million Daltons. Monovisc™ has a nominal sodium hyaluronate concentration of 22 mg/mL, dissolved in physiologic saline. It is supplied in a 5.0 mL syringe containing 4.0 mL of Monovisc™ The contents of the syringe are sterile, non-pyrogenic and non-inflammatory.

Monovisc™ is prepared by cross-linking hyaluronan (hyaluronic acid, HA) with proprietary cross-linking agent. The HA is derived from bacterial fermentation (Streptococcus equi). The HA used in Monovisc™ is the same grade and specification that is used in Orthovisc® (P030019), and delivers a comparable amount of HA to the 3-injection Orthovisc® regimen.

Each pre-filled syringe with 4 mL of Monovisc™ contains:

Directions For Use

Monovisc™ is injected into the knee joint and is administered as a single intra-articular injection. Standard intra-articular injection site preparation and precautions should be used. Strict aseptic administration technique must be followed.

1. Using an 18 – 20 gauge needle, remove synovial fluid or effusion before injecting Monovisc™. Do not use the same syringe for removing synovial fluid and for injecting Monovisc™; however, the same 18 – 20 gauge needle should be used.
2. Remove the protective rubber cap on the tip of the syringe and securely attach a small gauge needle (18 - 20 gauge) to the tip. Twist the tip cap before pulling it off, as this will minimize product leakage.
3. To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub. Do not over tighten or apply excessive leverage when attaching the needle or removing the needle guard, as this may break the syringe tip.
4. Inject the full 4 mL in one knee only (do not overfill the joint). If treatment is bilateral, a separate syringe should be used for each knee.

HOW SUPPLIED:

Monovisc™ is supplied in a single-use 5 mL syringe containing a 4 mL dose of treatment. Each syringe is labeled Monovisc™ for ready identification. The contents of the syringe are sterile and non-pyrogenic. The syringe components contain no latex.

Monovisc (high molecular weight hyaluronan injection) is a complex sugar used to treat pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). Common side effects of Monovisc include:

• joint pain and swelling,
• injection site reactions,
• rash,
• headache,
• dizziness,
• chills,
• hives,
• itching,
• nausea,
• muscle cramps
• ,
• swelling of legs and feet, and
• a general feeling of being unwell (malaise)

Monovisc is supplied in a single-use 5 mL syringe containing a 4 mL dose of treatment. Monovisc may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Monovisc should only be administered if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Monovisc (high molecular weight hyaluronan injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

SIDE EFFECTS

Potential Adverse Effects Of The Device On Health

Reported Device-Related Adverse Events

The most common reported adverse events associated with Monovisc™ are the following:

• Arthralgia
• Joint swelling
• Injection site pain

Incidences of rash, headache, dizziness, chills, hives, itching, nausea, muscle cramps, peripheral edema, and malaise have also been reported in association with intra-articular injections.

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