Varithena (polidocanol)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Polidocanol, a nonionic detergent, is used as a sclerosing agent.
Polidocanol is a nonionic detergent consisting of 2 components, a polar hydrophilic (dodecyl alcohol) chain and an apolar hydrophobic (polyethylene oxide) chain, and is used as a sclerosing agent. The drug is commercially available in the US as a sterile, nonpyrogenic 0.5 or 1% solution that is colorless to faintly greenish-yellow. Each mL contains 5 mg (0.5%) or 10 mg (1%) of polidocanol in water for injection with 5% (v/v) ethanol at pH 6.5-8.0; disodium hydrogen phosphate dihydrate and potassium dihydrogen phosphate are added for pH adjustment.
Polidocanol has a concentration- and volume-dependent damaging effect on blood vessel endothelium. Following IV injection, polidocanol induces local endothelial damage in the target vein. Platelets then aggregate at the site of damage and attach to the venous wall; eventually, a dense network of platelets, cellular debris, and fibrin occludes the vessel.
Finally, the occluded vein is replaced with connective fibrous tissue. The onset and offset of the local sclerosing effect is rapid; the effect on the vein is permanent.
Following IV injection of polidocanol solution (4.5-18 mg) for the treatment of spider and reticular veins in 4 adults, low systemic plasma concentrations of polidocanol were observed in all 4 patients. Peak plasma concentrations occurred 5 minutes after IV injection. The mean apparent terminal half-life of polidocanol in these patients was 1.5 hours.
Generic name: polidocanol
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Varithena
Indications
The following indications are listed for Varithena:
- Varicose Veins
Dosing
No dosing information is available for this tab.
Polidocanol is administered only by IV injection. Extravasation should be avoided. (See Administration Precautions under Cautions: Warnings/Precautions.)
Polidocanol is commercially available as a 0.5 or 1% solution in single-use ampuls (containing a total of 10 or 20 mg of polidocanol, respectively, in each 2-mL ampul). Although polidocanol has been administered as an endovenous foam or microfoam, these preparations are not commercially available in the US and extemporaneous preparation of polidocanol foam is not approved by the US Food and Drug Administration (FDA).
Unopened ampuls of polidocanol solution should be stored at 15-30degreesC; the solution does not contain a preservative and should be used immediately after opening.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Polidocanol injection should not be used if particulate matter is observed or if the contents of the vial are discolored or the vial is damaged in any way.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Drug interaction studies have not been performed using polidocanol.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Known allergy (anaphylaxis) to polidocanol. (See Sensitivity Reactions under Cautions: Warnings/Precautions.)
Acute thromboembolic diseases.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in 6% or more of adults treated with polidocanol and reported more frequently than with placebo are injection site reactions, including hematoma (42%), irritation (41%), discoloration (38%), pain (24%), pruritus (19%), warmth (16%), neovascularization (8%), and thrombosis (6%).
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of polidocanol have not been established in pediatric patients.
Category C. (See Users Guide.)
There are no adequate and well-controlled studies using polidocanol in pregnant women; the drug should not be used during pregnancy.
It is not known whether polidocanol is distributed into human milk. Because many drugs are distributed into milk and because of the potential for serious adverse reactions in nursing infants, use of the drug should be avoided in nursing women.
Clinical studies of polidocanol did not include a sufficient number of geriatric patients 65 years of age and older to determine whether they respond differently than younger adults.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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