A-Z Drug Facts > Hyaluronic Acid Derivatives

Hyaluronic Acid Derivatives

Pronunciation: (HYE-al-ure-ON-ik)
Class: Physical adjunct

Trade Names:
Bionect
- Topical cream 0.2%
- Topical gel 0.2%
- Topical spray 0.2%

Trade Names:
Euflexxa
- Solution for injection sodium hyaluronate 10 mg per mL

Trade Names:
Hyalgan
- Solution sodium hyaluronate 10 mg per mL

Trade Names:
Hygel
- Topical gel 0.2%

Trade Names:
Hylira
- Gel 0.2%

Trade Names:
Juvederm 24 HV
- Gel for injection 24 mg/mL

Trade Names:
Juvederm 30
- Gel for injection 24 mg/mL

Trade Names:
Juvederm 30 HV
- Gel for injection 24 mg/mL

Trade Names:
Orthovisc
- Solution for injection 15 mg per mL

Trade Names:
Perlane
- Gel for injection 20 mg/mL

Trade Names:
Restylane
- Gel for injection 20 mg/mL

Trade Names:
Shellgel
- Ophthalmic injection 12 mg/mL

Trade Names:
Sodium hyaluronate
- Topical lotion 0.1%

Trade Names:
Supartz
- Solution for injection sodium hyaluronate 10 mg per mL

Trade Names:
Synvisc
- Solution for injection hylan polymers 8 mg (hylan G-F 20) per mL

Pharmacology

Improves elasticity and viscosity of synovial fluid.

Indications and Usage

Bionect

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.

Juvederm 24 HV , Juvederm 30 , Juvederm 30 HV , Perlane , Restylane

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

Hylira

Treatment of symptoms associated with dry, scaly skin.

Shellgel

Use during surgery in the anterior and posterior segments of the human eye, including cataract extraction, corneal transplantation surgery, surgical procedures to reattach the retina, intraocular lens implantation, and glaucoma filtering surgery.

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).

Unlabeled Uses

Treatment of an osteoarthritis of the hand, hip, and temporomandibular joint; treatment of nonradicular pain in the lumbar spine.

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 ( Orthovisc ); bleeding disorders ( Perlane ); implantation in anatomical spaces other than dermis or superficial layers of the subcutis ( Perlane ).

Dosage and Administration

Adults Juvederm 24 HV , Juvederm 30 , Juvederm 30 HV

Transcutaneous Inject 1.6 mL/treatment site. Max, 20 mL/60 kg/yr.

Perlane , Restylane

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

Bionect
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.

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
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 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.

Synvisc
Adults

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

Shellgel
Adults Cataract Surgery or Intraocular Lens Implantation

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

Corneal Transplant Surgery

Intraocular Remove corneal button and fill anterior chamber with Shellgel until it is level with the surface of the cornea. Then place the donor graft on top of the Shellgel and suture into place.

Glaucoma Filtration Surgery

Intraocular Inject Shellgel through a corneal paracentesis to restore and maintain anterior chamber volume during the performance of the trabeculectomy.

Retinal Reattachment

Intraocular After release of subretinal fluid and development of buckling by trying to mattress sutures, air is injected into the vitreous cavity and then exchanged with Shellgel injected through a 22-to 30-gauge needle passed via the pars plana epithelium. The volume of Shellgel injected (2 to 4 mL) will vary with the volume of the subretinal fluid released and the space occupied by the buckle.

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 if 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).

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.

Shellgel

• A single-use disposable cannula, such as the one provided in the package, should be used to administer Shellgel . Do not reuse cannula.

Storage/Stability

Store Bionect , Hyalgan , Juvederm products, Perlane Orthovisc , Restylane , and Supartz at controlled room temperature (below 77°F). Do not freeze. Protect from light. Store Synvisc 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

Store at 59° to 86°F.

Shellgel

Store at 36° to 46°F. Protect from freezing. Refrigerated product should be allowed to reach room temperature, approximately 20 to 45 min, prior to use.

Drug Interactions

None well documented.

Adverse Reactions

Cardiovascular

Euflexxa

Increased blood pressure (4%).

Synvisc

Phlebitis with varicosities; tachyrhythmia.

CNS

Euflexxa

Fatigue, headache, paresthesia (1%).

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%).

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%).

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

Redness (93%); firmness (91%); pain/tenderness (90%); swelling (89%); lumps/bumps (83%); bruising (61%); itching (36%); discoloration (34%).

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 cramps; muscle pain (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).

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 ( Hylira ). Safety and efficacy not established.

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; in patients taking aspirin or NSAIDs may be at increased risk for bruising and bleeding; and 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 ).

External use

Avoid contact with eyes, lips, and mucous membranes ( Hylira ).

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 Restylane .

Latex allergy

Parts of Euflexxa syringe contain natural rubber latex.

Necrosis

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

Ocular particulates

If particulate matter is observed after ophthalmic injection, they should be removed by irrigation or aspiration ( Shellgel ).

Ophthalmic use

Thoroughly remove Shellgel from the anterior chamber after surgery to prevent or minimize postoperative increases in IOP.

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 to keep appointments.

• Bionect
• Instruct patients to contact health care provider immediately if their condition worsens.

• Hylaform
• Instruct patients to promptly report any evidence of problems possibly associated with use of the product to health care provider.

• 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 and 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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