hyaluronic acid and derivatives (Rx)

Brand and Other Names:Orthovisc, Synvisc, more...Synvisc-One, Monovisc, hyaluronan, hylan G-F 20, Hymovis, GenVisc 850, Supartz FX, Visco-3

Dosing & Uses

AdultPediatric

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

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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

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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

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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.

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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

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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

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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.

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.