hyaluronic acid and derivatives (Orthovisc, Synvisc, Synvisc-One, Monovisc, hyaluronan, hylan G-F 20)

Dosing and uses of Orthovisc, Synvisc (hyaluronic-acid-and-derivatives)

• Adult
• Pediatric

 

Adult dosage forms and strengths

intra-articular injection (prefilled syringe)

• 16mg/2mL (Synvisc)
• 30mg/2mL (Orthovisc)
• 48mg/6mL (Synvisc-One)
• 88mg/4mL (Monovisc)

 

Osteoarthritis of the Knee

Indicated for treatment of pain in osteoarthritis of the knee

Synvisc: Inject intra-articularly 16 mg (2 mL) to affected knee qWeek for 3 weeks

Synvisc-One: Inject intra-articularly 48 mg (6 mL) to affected knee once as a single injection

Orthovisc: Inject intr-articularly 30 mg (2 mL) to affected knee qWeek for 3 weeks

Monovisc: Inject intra-articularly 88 mg (4 mL) to affected knee once as a single injection

 

Administration

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 intra-articularly into 1 knee only; if treatment is bilateral, a separate syringe should be used for each knee

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Orthovisc, Synvisc (hyaluronic-acid-and-derivatives) adverse (side) effects

>10%

Arthralgia (25%)

Tenderness (61-92%)

Swelling (81-91%)

Firmness (88-89%)

Bruising (52-87%)

Pruritus (25-36%)

Skin discoloration (33-78%)

Firmness (86-89%)

Lumps/bumps (56-83%)

 

1-10%

Increased blood pressure (4%)

Fatigue (1%)

Nausea (<2%)

Injection site pain (3%)

Paresthesia (1%)

Tendonitis (2%)

Limb pain (1%)

Tendonitis (2%)

Joint effusion (2%)

 

<1%

Angioedema

Arthritis

Herpetic eruptions

Thrombocytopenia

Peripheral edema

Vasovagal reaction

Hives

Gait disturbances

 

Warnings

Contraindications

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

 

Cautions

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

Not for injection intra-articular into synovium

 

Pregnancy and lactation

Pregnancy category: Not tested in pregnant women

Lactation: Unknown whether distributed in breast milk, caution advised

 

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 Orthovisc, Synvisc (hyaluronic-acid-and-derivatives)

Mechanism of action

When injected intra-arterially, supplements joint cushioning to temporarily provide pain relief caused by osteoarthritis

High molecular weight polysaccharide composed of repeating disaccharide units of sodium glucuronate and N-acetylglucosamine; derived from bacterial cells