Hyaluronic Acid Derivatives

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Hyaluronic Acid Derivatives

Pronouncation: (high-uhl-yur-AHN-ick acid derivatives)
Class: Physical adjunct

Trade Names:
Hyalgan
- Solution 20 mg sodium hyaluronate per 2 mL

Trade Names:
Orthovisc
- Solution for injection 30 mg per 2 mL

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

Trade Names:
Supartz
- Solution 25 mg sodium hyaluronate per 2.5 mL

Trade Names:
Synvisc
- Solution 16 mg hylan polymers (hylan G-F 20) per 2 mL

Mechanism of Action

Pharmacology

Improves elasticity and viscosity of synovial fluid.

Indications and Usage

Treatment of pain of osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (eg, acetaminophen); mid to deep dermal implantation for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds ( Restylane ).

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 ( Restylane ); history of allergies to gram-positive bacterial proteins ( Restylane ); use in breast augmentation and for implantation into bone, tendon, ligament, or muscle ( Restylane ); implantation into blood or dermal vessels ( Restylane ); known allergies to avian or avian-derived products, including eggs, feathers, or poultry ( Orthovisc ).

Dosage and Administration

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.

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.

Restylane
Correction of Severe Facial Wrinkles and Dermal Folds Adults

Dermal Implantation Limit to 1.5 mL per treatment site.

Synvisc
Adults

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

General Advice

Hyaluronic acid
  • For mid to deep dermal implantation only. Not for intradermal, subcutaneous, IM, or IV administration, breast augmentation, nor 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
  • 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 administer other intra-articular drugs concomitantly.
  • The vial/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.

Storage/Stability

Store Hyalgan , Orthovisc , Supartz , and Restylane at controlled room temperature (less than 77°F). Store Synvisc at controlled room temperature (less than 86°F). Store in original package. Protect from light and freezing.

Drug Interactions

None well documented.

Adverse Reactions

Cardiovascular

Synvisc

Tachyrhythmia; phlebitis with varicosities.

CNS

Hyalgan

Headache (18%).

Orthovisc

Headache (at least 5%).

Restylane

Depression; aggravated depression; headache.

Supartz

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

Synvisc

Headache, dizziness, chills, paresthesia, malaise (postmarketing).

Dermatologic

Restylane

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

Synvisc

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

EENT

Restylane

Sinusitis.

Supartz

Sinusitis, rhinitis (1% to 4%).

GI

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%).

Orthovisc

Injection site pain (3%).

Supartz

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

Synvisc

Knee pain or swelling (2%).

Musculoskeletal

Orthovisc

Arthralgia, back pain (at least 5%).

Restylane

Arthralgia.

Supartz

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

Synvisc

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

Respiratory

Restylane

Upper respiratory tract infection; bronchitis; pneumonia.

Supartz

Upper respiratory tract infection, bronchitis (1% to 4%).

Synvisc

Respiratory difficulties (postmarketing).

Miscellaneous

Hyalgan

Fever, shock (postmarketing).

Orthovisc

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

Restylane

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

Supartz

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

Synvisc

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

Precautions

Pregnancy

Safety and efficacy not established.

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hypersensitivity

Anaphylactoid reactions may occur.

Special Risk Patients

Use with caution in patients receiving immunosuppressive therapy; patients taking aspirin or NSAIDs may be at increased risk for bruising and bleeding ( Restylane ); when there is evidence of lymphatic or venous stasis in the leg ( Synvisc ).

Infection/inflammatory process

Defer treatment until inflammatory process or infection has been controlled; implantation carries risk of infection ( 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 .

Necrosis

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

Quaternary ammonium salts

Because precipitation of drug may occur, avoid concomitant use of disinfectants or skin preparations containing quaternary ammonium salts.

Safety and efficacy

Long-term safety and efficacy (beyond 1 yr) has not been established ( Restylane ).

Patient Information

  • Explain name, dosing regimen, action, potential side effects, and expected response to treatment.
  • Advise patient that medication will be prepared and administered in a health care setting by a health care provider.
  • Advise patient to review Patient Information sheet before starting therapy.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Instruct patient not to take any prescription or OTC medications, dietary supplements, or herbal preparations unless advised by health care provider.
  • Remind patient that office visits will be required to monitor therapy and to keep appointments.
  • 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 hr) weight-bearing activities (eg, jogging, tennis) for 48 hr after treatment.
  • Instruct patient to continue taking other arthritis medications prescribed by 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.




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