Synvisc

WARNINGS

  • Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.
  • Do not inject SYNVISC (hylan g-f 20) 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 (hylan g-f 20) .
  • Intravascular injections of SYNVISC (hylan g-f 20) may cause systemic adverse events.

PRECAUTIONS

General

  • The effectiveness of a single treatment cycle of less than three injections (2 mL each) of SYNVISC (hylan g-f 20) has not been established.
  • The safety and effectiveness of SYNVISC (hylan g-f 20) 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 (hylan g-f 20) concomitantly with other intra-articular injectables have not been established.
  • Use caution when injecting SYNVISC (hylan g-f 20) into patients who are allergic to avian proteins, feathers, and egg products.
  • The safety and effectiveness of SYNVISC (hylan g-f 20) 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 (hylan g-f 20) .
  • Do not use SYNVISC (hylan g-f 20) 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 (hylan g-f 20) injection.
  • SYNVISC (hylan g-f 20) should be used with caution when there is evidence of lymphatic or venous stasis in the leg to be injected.

Information for Patients

  • Provide patients with a copy of the Patient Labeling prior to use.
  • Transient pain, swelling and/or effusion of the injected joint may occur after intra-articular injection of SYNVISC (hylan g-f 20) . In some cases the effusion may be considerable and can cause pronounced pain; cases where swelling is extensive should be discussed with the physician.
  • As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activities (for example, highimpact sports such as soccer, tennis or jogging) or prolonged weight-bearing activities for approximately 48 hours following the intra-articular injection. The patient should consult his or her physician regarding the appropriate time to resume such activities.

Use in Specific Populations

  • Pregnancy: The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in pregnant women.
  • Nursing mothers:It is not known if SYNVISC (hylan g-f 20) is excreted in human milk. The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in lactating women.
  • Pediatrics: The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in pediatric patients. Pediatric patients are defined as patients” 21 years of age.

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

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