Hyaluronate and Derivatives

Refractory interstitial cystitis

Hypersensitivity to hyaluronate or any component of the formulation

Intradermal/Submucosal: Additional contraindications include history of anaphylaxis or presence of multiple severe allergies (Juvederm [all formulations], Perlane, Restylane, Restylane Defyne, Restylane Lyft, Restylane Refyne, Restylane Silk, Restylane-L); bleeding disorders (Perlane, Restylane, Restylane Lyft, Restylane Silk, Restylane-L); history of hypersensitivity to gram-positive bacterial proteins (Juvederm [all formulations], Perlane, Restylane, Restylane Defyne, Restylane Lyft, Restylane Refyne, Restylane Silk, Restylane-L), or local anesthetics of the amide type, such as lidocaine (Juvederm Ultra XC, Juvederm Ultra Plus XC, Juvederm Volbella XC, Juvederm Vollure XC, Restylane Defyne, Restylane Lyft, Restylane Refyne, Restylane Silk); implantation/injection into sites other than the anatomical spaces recommended per labeling (Perlane, Restylane, Restylane Silk, Restylane-L)

Intra-articular: Additional contraindications include knee joint infections or infections or skin diseases at the site of injection (Euflexxa, Gel-One, Gelsyn-3, GenVisc 850, Hyalgan, Hymovis, Monovisc, OrthoVisc, Supartz, Supartz FX, Synvisc, Synvisc-One, Visco-3); hypersensitivity to gram-positive bacterial proteins (Hymovis, Monovisc, Orthovisc); systemic bleeding disorders (Monovisc)

Intraocular: There are no contraindications in the manufacturer's labeling (Amvisc, Amvisc Plus, Provisc).

Subcutaneous/Supraperiosteal: Additional contraindications include history of anaphylaxis or history or presence of multiple severe allergies (Juvederm Voluma XC, Restylane Lyft); patients with a history of allergies to gram-positive bacterial proteins or lidocaine (Juvederm Voluma XC, Restylane Lyft).

Intra-articular: Inject directly into the knee joint; do not inject extra-articularly or into the synovial capsule or tissues. Do not use disinfectants containing quaternary ammonium salts for skin cleansing prior to injection. Remove synovial fluid or effusion, if present, prior to injection. If used for bilateral treatment, use a separate syringe for each knee. Refer to manufacturer's labeling for additional instructions on injection technique.

Intradermal/Submucosal/Subcutaneous/Supraperiosteal: Do not inject into a blood vessel. Following injection, slowly massage area so that it conforms to the contour of the surrounding tissue. May apply ice pack to injection site for a short period immediately after administration if treatment area swollen. Refer to manufacturer's labeling for additional instructions on injection technique. Prior to treatment, the patient should avoid taking aspirin, nonsteroidal anti-inflammatory medications, St John wort, or high doses of vitamin E supplements; these agents may increase bruising and bleeding at the injection site.

Juvederm (all formulations except Voluma XC) is intended for mid-to-deep intradermal injection.

Juvederm Voluma XC is intended for subcutaneous and/or supraperiosteal injection.

Juvederm Ultra XC is also intended for submucosal injection (lip augmentation).

Perlane is intended for injection into the deep dermis to superficial subcutis.

Restylane and Restylane-L are intended for mid-to-deep intradermal injection (facial wrinkles) or submucosal injection (lip augmentation).

Restylane Defyne and Restylane Refyne are intended for mid-to-deep intradermal injection (facial wrinkles).

Restylane Lyft is intended for deep dermis to superficial subcutis (facial wrinkles) or subcutaneous and/or supraperiosteal (cheek augmentation).

Restylane Silk is intended for mid to deep dermis (periorbital rhytids) or submucosal injection (lip augmentation).

Ophthalmic: Allow to reach room temperature prior to use. Drug may become cloudy or form a slight precipitate after administration; clinical significance unknown, but cloudy or precipitated material should be removed by irrigation or aspiration

Topical:

Bionect products: Clean and disinfect wound prior to use (do not use quaternary ammonium salts due to potential for hyaluronic acid precipitation), and debride if necessary; apply a thin layer to wound or ulcer without extensive rubbing. After application, cover the area with a sterile gauze pad and if necessary, an elastic or compressive bandage.

Hylase Wound: Clean ulcer or wound with normal saline, remove excess moisture with dry gauze, then apply gel liberally to wound or ulcer and surrounding areas. After application, cover the area with a sterile nonstick gauze pad and adhesive tape/bandage.

Intraocular pressure (ophthalmic formulations); signs and symptoms of excess local inflammation or infection (intradermal formulations)

Adverse events were not observed in animal reproduction studies. Safety for use in pregnant women has not been established.