Hyaluronic Acid Derivatives

Pronunciation: HYE-a-loo-RON-ik AS-id
Class: Physical adjunct

Trade Names

2nd Skin Quick Heal
- Gel

Amvisc
- Solution, intraocular 12 mg/mL

Amvisc Plus
- Solution, intraocular 16 mg/mL

Bionect
- Topical cream 0.2%
- Topical gel 0.2%

DermaPlex
- Gel

Euflexxa
- Solution for injection sodium hyaluronate 10 mg/mL

Healon
- Solution, intraocular 10 mg/mL

Healon GV
- Solution, intraocular 14 mg/mL

Healon 5
- Solution, intraocular 23 mg/mL

Hyalgan
- Solution for intra-articular injection sodium hyaluronate 10 mg/mL

Hygel
- Topical gel 0.2%

Hylira
- Topical gel 0.2%
- Topical lotion 0.1%

Juvederm Ultra
- Gel, intradermal 24 mg/mL

Juvederm Ultra Plus
- Gel, intradermal 24 mg/mL

Juvederm Ultra Plus XC
- Gel, intradermal 24 mg/mL with 0.3% lidocaine

Orthovisc
- Solution for injection 15 mg/mL

Perlane
- Gel for injection 20 mg/mL

Perlane-L
- Gel for injection 20 mg/mL with 0.3% lidocaine

Provisc
- Solution, intraocular 10 mg/mL

Restylane
- Gel for injection 20 mg/mL

Restylane-L
- Gel for injection 20 mg/mL with 0.3% lidocaine

Shellgel
- Solution, intraocular 12 mg/mL

Supartz
- Solution for injection sodium hyaluronate 10 mg/mL

Synvisc
- Solution for injection hylan polymers 8 mg/mL

Synvisc One
- Solution for injection hylan polymers 8 mg/mL

Pharmacology

Improves elasticity and viscosity of synovial fluid. In ophthalmic surgery, it acts as a space-occupying fluid that is replaced by the body's natural fluids.

Indications and Usage

Bionect , Hygel , Hylira Gel, 2nd Skin Quick Heal , DermaPlex

Dressing and management of partial- to full-thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds, including cuts, abrasions, donor sites, and postoperative incisions, irritations of the skin, and first- and second-degree burns. The dressing is intended to cover a wound or burn on a patient's skin and protect against abrasion, friction, and desiccation.

Euflexxa , Hyalgan , Orthovisc , Supartz , Synvisc , Synvisc One

Treatment of pain of osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics (eg, acetaminophen).

Juvederm Ultra , Juvederm Ultra Plus , Juvederm Ultra XC , Perlane , Perlane-L , Restylane , Restylane-L

Mid to deep injection for correction of moderate to severe facial wrinkles and folds (eg, nasolabial folds).

Hylira Lotion

Treatment of symptoms associated with dry, scaly skin.

Intraocular

For use as a surgical aid to protect corneal endothelium during cataract (extracapsular) procedures, intraocular lens implantation, and anterior segment surgery.

Unlabeled Uses

Treatment of an osteoarthritis of the hand, hip, and temporomandibular joint; treatment of nonradicular pain in the lumbar spine (intra-articular injection only).

Contraindications

Infections or skin diseases in the area of the injection site; concomitant skin disinfectants containing quaternary ammonium salts; hypersensitivity to any component of the product; severe allergies manifested by a history of anaphylaxis or history or presence of multiple allergies ( Juvederm products, Perlane , Restylane ); history of allergies to gram-positive bacterial proteins ( Juvederm products, Perlane , Restylane ); use in breast augmentation and for implantation into bone, tendon, ligament, or muscle ( Restylane ); implantation into blood or dermal vessels; known allergies to avian or avian-derived products, including eggs, feathers, or poultry (intra-articular products except Euflexxa ); bleeding disorders ( Perlane-L and Restylane-L ); implantation in anatomical spaces other than dermis or superficial layers of the subcutis ( Perlane-L and Restylane-L ); history of allergies to lidocaine ( Juvederm Ultra Plus XC , Perlane-L , Restylane-L ).

Dosage and Administration

2nd Skin Quick Heal , Bionect , DermaPlex , Hygel , Hylira Gel
Adults

Topical Apply a thin layer without extensive rubbing onto wound surface 2 or 3 times daily. Cover the lesion area with a sterile gauze pad and, if necessary, with an elastic or compressive bandage. Clean and disinfect wound or ulcer prior to treatment. With long-standing ulcers, consider cleaning and/or debriding the wound by surgical or enzymatic means prior to treatment.

Euflexxa
Adults

Intra-articular Give a total of 3 injections (2 mL) 1 wk apart.

Intraocular use
Adults

Intraocular Slowly infuse through a needle or cannula into the anterior chamber of the eye.

Hyalgan , Supartz
Adults

Intra-articular Give a total of 5 injections/treatment cycle (2 mL for Hyalgan and 2.5 mL for Supartz ) at weekly intervals.

Hylira Lotion
Adults

Topical Apply a liberal amount to affected area(s) 2 or 3 times daily or as directed and rub in thoroughly.

Orthovisc
Adults

Intra-articular Inject 2 mL into knee joint in a series of injections 1 wk apart for 3 or 4 injections. Inject full contents into knee. If treatment is bilateral, use a separate syringe for each knee.

Perlane products, Restylane products
Adults

Dermal Implantation Limit to 1.5 mL per treatment site ( Juvederm products). 6 mL per treatment site ( Perlane and Restylane products)

Synvisc
Adults

Intra-articular Give a total of 3 injections/treatment cycle (2 mL) at weekly intervals.

Synvisc One
Adults

Intra-articular Inject 6 mL into 1 knee only.

General Advice

  • Topical and injectable anesthetics may be used to manage pain during and after injection.
  • Wash the treatment area with soap and water before swabbing with alcohol or other antiseptic.
  • Administer using a thin gauge needle (for correction only).
  • If immediate blanching occurs, stop injection and massage the area until normal color returns (for correction only).
  • When injection is complete, gently massage treated site so that it conforms to the contour of the surrounding tissues (for correction only).
  • One to two weeks after the initial treatment, an additional treatment may be necessary to achieve the desired level of correction (for correction only).
  • Do not inject into a blood vessel.
Hyaluronic acid
  • Some products are for mid to deep dermal implantation only. Not for intradermal, subcutaneous, IM, or IV administration; breast augmentation; or administration into bone, tendon, ligament, or muscle.
  • Carefully follow manufacturer's recommendations for assembly of needle to syringe and treatment procedure.
  • The syringe is intended for single use only. Use immediately once package is opened. Discard any unused solution. Do not save unused solution for later administration.
  • Do not use if contents of syringe show signs of separation and/or appear cloudy.
  • Do not mix with other products prior to injection.
Hyaluronic acid derivatives
  • Some products are for intra-articular administration into knee joint only. Not for intradermal, subcutaneous, IM, or IV administration, nor administration into any joint other than the knee.
  • Inject subcutaneous lidocaine or similar local anesthetic prior to intra-articular injection of the hyaluronic acid derivative.
  • Do not coadminister other intra-articular drugs.
Intraocular use
  • A single-use disposable cannula should be used to administer these products. Do not reuse cannula. If reuse becomes necessary on the same patient during surgical procedures, rinse the cannula thoroughly with distilled water to remove all traces of residual material.
  • Injection can be performed either before or after delivery of the lens. Can also be used to coat surgical instruments and the intraocular lens prior to insertion.
  • Mixing of quaternary ammonium salts, such as benzalkonium chloride, with sodium hyaluronate results in the formation of a precipitate. The eye should not be irrigated with any solution containing benzalkonium chloride when using sodium hyaluronate.

Storage/Stability

Hyalgan , Juvederm products, Orthovisc , Perlane , Restylane , and Supartz

Store at 77°F. Do not freeze. Protect from light.

Synvisc

Store at controlled room temperature (below 86°F). Store in original package. Protect from light and freezing.

Euflexxa

Store at 36° to 77°F. Protect from light. Do not freeze.

Hylira , Bionect , Hygel , 2nd Skin Quick Heal , DermaPlex

Store between 59° and 86°F.

Intraocular products

Store between 36° and 46°F. Protect from freezing. Refrigerated product should be allowed to reach room temperature, for approximately 20 to 40 min, prior to use.

Drug Interactions

Aspirin, NSAIDs, warfarin

Increased bruising or bleeding at injection sites.

Immunosuppressives

Use with caution.

Adverse Reactions

Cardiovascular

Euflexxa

Increased blood pressure (4%).

Synvisc

Phlebitis with varicosities; tachyarrhythmia.

CNS

Euflexxa

Fatigue, headache, paresthesia (1%).

Juvederm products

Headache (postmarketing).

Hyalgan

Headache (18%).

Orthovisc

Headache (at least 5%).

Restylane

Aggravated depression; depression; headache; migraine.

Supartz

Headache (4%); dizziness (1% to 4%).

Synvisc

Chills, dizziness, headache, malaise, paresthesia (postmarketing).

Dermatologic

Euflexxa

Rash (3%).

Juvederm products

Blister, rash (postmarketing).

Restylane

Swelling (87%); redness (85%); bruising (52%); itching (30%); acne, contact dermatitis.

Synvisc

Pruritus, rash on thorax and back (2%); hives, itching, rash (postmarketing).

EENT

Euflexxa

Rhinitis, swollen eyelids (3%).

Intraocular use

Increased IOP (7%); superficial and conjunctival punctate keratitis (4%); cystoid macular edema, posterior capsule opacity (3%); conjunctivitis, corneal edema, corneal erosion, Seidel phenomenon, sphincter damage, uveitis (1%).

Restylane

Sinusitis.

Supartz

Rhinitis, sinusitis (1% to 4%).

GI

Euflexxa

Peptic ulcer (3%); nausea (2%).

Hyalgan

GI complaints (29%, severe in 2%).

Restylane

Tooth pain.

Supartz

Abdominal pain, diarrhea, dyspepsia, nausea (1% to 4%).

Synvisc

Nausea (postmarketing).

Genitourinary

Restylane

Urinary incontinence.

Supartz

UTI (1% to 4%).

Hematologic

Restylane

Hypercholesterolemia.

Synvisc

Thrombocytopenia (postmarketing).

Local

Hyalgan

Injection-site pain (23%); skin reaction (including ecchymosis and rash) (14%); joint pain, swelling (13%, severe in 1%); pruritus (7%); positive bacterial cultures of aspirated effusion for the treated knee (1%).

Juvederm products

Firmness (94%); redness (93%); pain/tenderness (90%); swelling (86%); lumps/bumps (84%); bruising, discoloration (78%); itching (36%); abscess, bleeding, infection, inflammation, and necrosis at injection site (postmarketing).

Orthovisc

Injection-site pain (3%).

Perlane

Tenderness (92%); swelling (91%); bruising (87%); redness (84%); pain (81%); itching (32%).

Supartz

Injection-site reaction (including application/injection-site inflammation and purpura) (6%); injection-site pain (4%).

Synvisc

Knee pain or swelling (2%).

Musculoskeletal

Euflexxa

Knee pain (53%); arthralgia (9%); back pain (6%); knee swelling, skeletal pain, total knee replacement (3%); joint swelling, tendonitis (2%); arthrosis, joint disorder, joint effusion, limb pain (1%).

Orthovisc

Arthralgia, back pain (at least 5%).

Restylane

Arthralgia, back pain.

Supartz

Arthralgia (18%); arthropathy/arthrosis/arthritis (11%).

Synvisc

Calf cramps, muscle pain; muscle cramps (postmarketing).

Respiratory

Euflexxa

Upper respiratory tract infection (12%); bronchitis (1%).

Restylane

Bronchitis; pneumonia; upper respiratory tract infection.

Supartz

Bronchitis, upper respiratory tract infection (1% to 4%).

Synvisc

Respiratory difficulties (postmarketing).

Miscellaneous

Euflexxa

Asthenia, herpes zoster/herpes simplex (3%); infections (1%).

Hyalgan

Fever, shock (postmarketing).

Juvederm products

Allergic reaction (postmarketing).

Orthovisc

Pain (3%); bursitis (1%).

Restylane

Tenderness (78%); pain (57%); allergic reactions; herpes simplex; inflicted injury; osteoporosis.

Supartz

Back pain, nonspecific pain (6%); fall, flu-like symptoms, inflicted injury, leg pain and discomfort (1% to 4%).

Synvisc

Ankle edema; hemorrhoid problems; low back pain; face edema, fever, flushing, intra-articular infections, peripheral edema (postmarketing).

Postmarketing

Allergic adverse reactions, bacterial infections, inflammatory adverse reactions, necrosis ( Perlane , Restylane ).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hypersensitivity

Anaphylactoid reactions may occur.

Special Risk Patients

Do not use in patients with known susceptibility to keloid formation or hypertrophic scarring. Use with caution in patients receiving immunosuppressive therapy and in patients taking aspirin or NSAIDs because of an increased risk for bruising and bleeding. Use with caution when there is evidence of lymphatic or venous stasis in the leg ( Synvisc ). Use with caution in patients allergic to avian products, feathers, and egg protein ( Hyalgan , Supartz , Synvisc ).

Herpes

May cause reactivation in patients with a history of herpes ( Perlane ).

Infection/Inflammatory process

Defer treatment until inflammatory process or infection has been controlled; implantation carries risk of infection ( Juvederm products, Perlane , Restylane ).

Inflammatory arthritis

Transient increases in inflammation may occur in the injected knee.

Inflammatory reaction

Risk of inflammatory reaction may be increased if laser treatment, chemical peeling, or active dermal response is considered after procedure.

Intraocular pressure

Preexisting glaucoma or compromised outflow and operative procedures may increase postoperative IOP. Therefore, do not overfill the eye chamber. Thoroughly remove intraocular solution from the anterior chamber after surgery to prevent or minimize postoperative increases in IOP.

Latex allergy

Parts of Euflexxa syringe contain natural rubber latex. Provisc contains dry natural rubber.

Necrosis

Localized superficial necrosis may occur after injection in glabellar area ( Perlane , Restylane ).

Ocular particulates

If particulate matter is observed after ophthalmic injection, remove by irrigation and/or aspiration.

Prolonged use

Prolonged use of topical products may give rise to sensitization phenomena.

Patient Information

  • Advise patient that medication will be prepared and administered in a health care setting by health care provider.
  • Advise patient to review patient information leaflet before starting therapy.
  • Remind patient that office visits will be required to monitor therapy and that they should keep appointments.
  • Instruct patients to contact health care provider immediately if their condition worsens.
  • Hyaluronic Acid
  • Advise patient that if treated area is swollen directly after the injection that an ice pack can be applied on the swollen site for a short period of time.
  • Advise patient that mild to moderate injection-site reactions are common and should resolve in a few days but to notify health care provider if injection-site reaction does not resolve or worsens.
  • Caution patient to avoid exposing treated area to excessive sun and UV lamp or extreme cold weather until any initial swelling and redness have resolved.
  • Hyaluronic Acid Derivatives
  • Explain importance of completing entire treatment cycle in order to obtain max benefit.
  • Advise patient that transient pain and/or swelling of the injected joint may occur and to notify health care provider if this occurs and becomes intolerable or if the injection site becomes red and/or warm.
  • Caution patient to avoid strenuous or prolonged (eg, more than 1 h) weight-bearing activities (eg, jogging, tennis) for 48 h after treatment.
  • Instruct patient to continue taking other arthritis medications prescribed by health care provider.

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