sodium hyaluronate (Amvisc, Hyalgan, Amvisc Plus, Euflexxa, Healon, Healon GV, Healon5, AMO Vitrax, Nuflexxa, Supartz)

Dosing and uses of Amvisc, Hyalgan (sodium hyaluronate)

• Adult
• Pediatric

 

Adult dosage forms and strengths

intra-articular injection

• 10mg/mL
• 15mg/mL

cream topicaL

• 0.2%

gel topicaL

• 0.2%
• 2.5%

transdermal gel injection

• 20mg/mL

intraocular injection solution

• 12mg/mL
• 16mg/mL
• 10mg/mL

 

Osteoarthritis of Knee

Indicated for treatment of pain in osteoarthritis of the knee

Administer by intra-articular injection into the affected knee(s)

Euflexxa: Inject 20 mg (2 mL) qWeek for 3 weeks

Hyalgan: Inject 20 mg (2 mL) qWeek for 3-5 weeks

Supartz: Inject 25 mg (2.5 mL) qWeek for 5 weeks

Other information

• Concomitant use of disinfectants containing quaternary ammonium salts (eg, benzalkonium chloride) for skin preparation can precipitate in presence of hyaluronic acid
• Use strict aseptic injection technique
• Inject the full contents of single syringe into 1 knee only; if treatment is bilateral, a separate syringe should be used for each knee

 

Ophthalmic Viscoelastic Devices (OVDs)

Surgical aid to protect corneal endothelium during anterior segment and vitreous procedures (eg, cataract extraction, intraocular lens implantation, corneal transplant, glaucoma filtration, retinal attachment surgery)

AMO Vitrax, Amvisc, Amvisc Plus, Healon, Healon GV, Healon5: Inject sufficient amount slowly (using cannula or needle) into anterior chamber or vitreous cavity of eye; some procedures/products require removal of the sodium hyaluronate following surgical completion

 

Skin Ulcers and Wounds

Cream: Apply a thin layer to wound or ulcer that have been cleaned and desinfected

Gel: Apply liberally once daily to ulcer cavity or wound and surrounding areas

 

Lip Augmentation

<21 years: Safety and efficacy not established

>21 years: 1.5 mL per lip (upper or lower) per treatment session

 

Pediatric dosage forms and strengths

Safety & efficacy not established

 

Amvisc, Hyalgan (sodium hyaluronate) adverse (side) effects

>10%

Intradermal Injection

• Erythema (75-93%)
• Swelling (91-03%)
• Tenderness (61-92%)
• Lumps/bumps (56-83$)
• Discoloration (33-78%)
• Pruritus (25-36%)

 

1-10%

Increased blood pressure (4%)

Fatigue (1%)

Pain at injection site (intra-articular) (3%)

Nausea (<2%)

Infection (1%)

Tendonitis (6%)

Limb pain (2%)

Parasthesia (1%)

 

Frequency not defined

Intra-articular injection

• Arthralgia
• Headache
• Injection site pain
• Anaphylactoid reaction

Intraocular administration

• Increased IOP
• Keratitis
• Cystoid macular edema
• Conjunctival hemorrhage

 

Warnings

Contraindications

Intra-articular use

• Hypersensitivity to hyaluronate preparations, avian-derived products (eg, eggs, feathers, poultry), gram-positive bacterial proteins
• Do not inject in knees with infection or skin diseases in area of injection site or joint

Ophthalmic use

• No known contraindications

 

Cautions

Intra-articular use

• Transient increased inflammation in injected knee may occur
• Avoid strenuous activity or prolonged (>1 hr) weight-bearing activities (eg, running, tennis) within 48 hr following injection
• Pain relief may not be evident until after 3rd injection
• Remove joint effusion, if present, before injection

Ophthalmic use

• Use only if solution is clear
• Monitor intraocular pressure

 

Pregnancy and lactation

Pregnancy category: N/A

Lactation: Not known if excreted in breast milk; not recommended

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Amvisc, Hyalgan (sodium hyaluronate)

Mechanism of action

Sodium hyaluronate and its derivatives form a viscoelastic solution in water suitable for aqueous and vitreous humor in ophthalmic surgery; works as a lubricant, which plays an important role in managing interactions between adjacent tissues

Protects sking against friction and abrassion in the management of wounds and ulcers

 

Pharmacokinetics

Distribution: Slow (intravitreous injection)

Excretion: Canal of Schlemm (ophthalmic)