HYLAN G-F 20 INJ
Clinical Criteria Summary
Exclusion Criteria
- Known hypersensitivity or allergy to hyaluronate or hylan preparations
- Knee joint infection
- Skin disease or infection in the area of the injection site
Inclusion Criteria
- Documented symptomatic (pain/stiffness) osteoarthritis (OA) of the knee that interferes with functional activities (e.g., ambulation, prolonged standing) and/or is associated with significant pain
- Inadequate improvement in pain/function following an adequate trial (2 to 3 months) of non-pharmacologic measures (e.g., cane/crutches, bracing/orthotics, weight loss, physical therapy/exercise)
- Inadequate improvement in pain/function following a therapeutic trial of at least 3 analgesics (e.g., acetaminophen, topical capsaicin or topical NSAIDs, oral NSAIDs or duloxetine), OR patient is unable to tolerate or is not a candidate for NSAIDs or other oral therapies
- Patient and/or provider have elected to continue conservative (nonsurgical) treatment for OA
Practice Restrictions & Administration Guidelines
- Use limited to specialists in Orthopedics, Rheumatology, and Physical Medicine and Rehabilitation
- Patients with more advanced stages of OA and near complete loss of joint space may be less likely to benefit
- All hyaluronic acid (HA) or hylan products are for intra-articular (IA) use only
- Avian source products (Gel-One, Hyalgan, Supartz, Synvisc, Synvisc-One): Administer with caution in patients with a known allergy to avian proteins, feathers, or eggs
- Non-avian source products (Durolane, Euflexxa, Gel-Syn 3, GenVisc 850, Hymovis, Monovisc, Orthovisc, Synojoynt, Trivisc): Can be used in patients with an allergy to avian proteins
- Refer to product labeling for specific warnings (e.g., Gel-One should be used with caution in patients with an allergy to cinnamon)
- Safety/efficacy of concomitant administration with other IA agents has not been established
- Pseudosepsis or severe acute inflammatory reactions (SAIR) have been reported with Synvisc, typically occurring with the second or third injection in a course or with subsequent courses
- Repeat courses should not be administered within 6 months of the last injection