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Clinical pharmacology

Initial U.S. Approval:  2013

Mechanism of Action: Varithena™ is a drug/device combination product that generates injectable foam. The injectable foam is composed of a liquid and gas phase, both of which are necessary to have its therapeutic effect. Varithena™ is intended to act as follows: (1) the foam displaces blood from the vein to be treated, and (2) the polidocanol then scleroses the endothelium.

The active pharmaceutical ingredient of Varithena™ is polidocanol, a non-ionic surfactant sclerosing agent. The hydrophobic pole of the polidocanol molecule attaches to the lipid cell membrane of the venous endothelium, resulting in disruption of the osmotic barrier, destruction of the venous endothelium, and vasospasm. Following exposure to polidocanol, the interior surface of the vein becomes thrombogenic, which leads to thrombus formation and venous occlusion. The occluded vein is eventually replaced by fibrous connective tissue. Polidocanol is deactivated upon contact with blood, thus limiting the sclerosant action to the endothelium near the site of injection.

Indications and usage 

Varithena™ (polidocanol injectable foam) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena™ improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

Dosage and administration 

[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

For intravenous use under ultrasound guidance only.
Use up to 5 mL per injection and 15 mL per treatment session.
Separate treatment sessions by a minimum of 5 days

How supplied

Supplied as polidocanol solution (10 mg/mL) in 18 mL; must be activated before use.
Once activated, Varithena™ is a white, injectable foam delivering a 1% polidocanol solution.
Each mL of Varithena™ injectable foam contains 1.3 mg of polidocanol.

Reference

Package insert data - Drug information

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Varithena™ (polidocanol injectable foam)