Dosing & Uses
Dosage Forms & Strengths
intra-articular injection (prefilled syringe)
- 16mg/2mL (Synvisc)
- 30mg/2mL (Orthovisc)
- 48mg/6mL (Synvisc-One)
- 88mg/4mL (Monovisc)
- 24mg/3mL (Hymovis)
- 25mg/2.5mL (GenVisc 850)
- 25mg/2.5mL (Supartz FX)
- 25mg/2.5mL (Visco-3)
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
Supartz FX, GenVisc 850: Inject 25 mg (2.5 mL) once weekly for 5 weeks; 5 injections total; some patients may benefit from a total of 3 injections
Hymovis: Inject 24 mg (3 mL) once weekly for 2 weeks (2 injections total)
Visco-3: Inject 25 mg (2.5 mL) once weekly for 3 weeks (3 injections total)
Emphysema (Orphan)
Orphan designation for emphysema due to alpha1-antitrypsin deficiency
Sponsor
- Gerard M. Turino, MD; Division of Pulmonary, Critical Care & Sleep Medicine; Mt. Sinai Roosevelt Hospital Center; New York, New York 10019
Safety and efficacy not established
Adverse 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 and components
Knee joint infections or infections or skin diseases at the site of the injection
Hypersensitivity to gram-positive bacterial proteins (Hymovis, Monovisc); systemic bleeding (Monovisc)
Cautions
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
Disinfectants containing quaternary ammonium salts should not be used for skin preparation (may cause precipitation of hyaluronate)
Not to be administered intravascularly, extra-articularly, or for injecting into the synovium
Remove synovial fluid or effusion, if present before injection
Not for use in cases of severe intra-articular effusion
If venous or lymphatic stasis present in the leg, use with caution
Patients with inflammatory arthritis may experience transient increases in reddening or inflammation, pain, sensation of heat after injection into the knee
Some products produced from avian sources; use caution in patients with hypersensitivity to avian proteins, egg products, or feathers
To be administered by experienced healthcare provider with appropriate experience, training, knowledge of anatomy at injection site, and aseptic technique
Pregnancy & 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
Mechanism of Action
When injected intra-articularly, 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
Administration
Intra-Articular 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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Synvisc-One intra-articular - | 48 mg/6 mL solution |  | |
| Synvisc intra-articular - | 16 mg/2 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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