Synvisc-One Intra-articular Injection

Synvisc-One is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.

2.25 mL glass syringe containing one 2 mL (16 mg) dose of hylan G-F 20. The contents of the syringe are sterile and nonpyrogenic.

Synvisc-One is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-Ones are derivatives of hyaluronan (sodium hyaluronate). Synvisc-One is unique in that the hyaluronan is chemically crosslinked. Hyaluronan is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine.

Synvisc-One is a gel-like mixture that comes in a syringe containing 6 mL (1 ½ teaspoon) and is injected into your knee. It is made up of hylan A fluid, hylan B gel, and salt water. Synvisc-One A and hylan B are made from a substance called hyaluronan (pronounced hy-al-u-ROE-nan), also known as sodium hyaluronate that comes from chicken combs. Hyaluronan is a natural substance found in the body and is present in very high amounts in joints. The body’s own hyaluronan acts like a lubricant and a shock absorber in the joint and is needed for the joint to work properly.

Joints contain a fluid, called synovial fluid, which acts as a lubricant and shock absorber. Patients with osteoarthritis have synovial fluid that is thinner than normal, and, therefore, it is less effective as a lubricant and shock-absorber. Hylan G-F 20 is an elastic fluid that is made from a substance called hyaluronan, that is found in normal joint fluid. Hyaluronan is the key substance in joint fluid that provides the shock-absorbing quality to the fluid, and it is essential for the proper functioning of joints. When Hylan G-F 20 is injected into the knee of a patient with osteoarthritis, the drug helps to restore the shock-absorbing effect of the fluid within the knee. This can reduce pain, resulting in a more active lifestyle.

Hylan G-F 20 is administered by intra-articular injection once a week (one week apart) for a total of three injections. Strict aseptic administration technique must be followed.

• Using an 18- to 22-gauge needle, remove synovial fluid or effusion before each Hylan G-F 20 injection.
• Do not use the same syringe for removing synovial fluid and for injecting Hylan G-F 20 however the same 18- to 22-gauge needle should be used.
• Twist the tip cap before pulling it off, as this will minimize product leakage.
• To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub.

Pediatrics: The safety and effectiveness of Hylan G-F have not been established in pediatric patients. Pediatric patients are defined as patients ≤ 21 years of age.

Do not administer to patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations. Do not inject Hylan G-F 20 in the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site

The most commonly reported adverse events associated with Synvisc-One are the following: Pain in the injected knee, Swelling in the injected knee, Joint effusion

The safety and effectiveness of Hylan G-F 20 have not been established in pregnant women. It is not known if Hylan G-F 20 is excreted in human milk. The safety and effectiveness of Hylan G-F 20 have not been established in lactating women.

• The effectiveness of a single treatment cycle of less than three injections (2 mL each) of Synvisc-One has not been established.
• The safety and effectiveness of Synvisc-One in locations other than the knee and for conditions other than osteoarthritis have not been established.
• The safety and effectiveness of the use of Synvisc-One concomitantly with other intra-articular injectables have not been established.
• Use caution when injecting Synvisc-One into patients who are allergic to avian proteins, feathers, and egg products.
• The safety and effectiveness of Synvisc-One in severely inflamed knee joints have not been established.
• Strict aseptic administration technique must be followed.
• STERILE CONTENTS. The syringe is intended for single use. The contents of the syringe must be used immediately after its packaging is opened. Discard any unused Synvisc-One.
• Do not use Synvisc-One if package is opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.
• Remove synovial fluid or effusion before each Synvisc-One injection.
• Synvisc-One should be used with caution when there is evidence of lymphatic or venous stasis in the leg to be injected.

Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence. Do not inject Synvisc-One G-F extra-articularly or into the synovial tissues and capsule. Local and systemic adverse events, generally in the area of the injection, have occurred following extra-articular injection of Synvisc-One G-F. Intravascular injections of Synvisc-One G-F may cause systemic adverse events.

Drugs for Osteoarthritis

Do not use Synvisc-One if the package has been opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.