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Varithena™ (polidocanol injectable foam), for intravenous use

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back     ]     [Sclerosing agents]
CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION HOW SUPPLIED

CLINICAL PHARMACOLOGY: top of page

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  top of page

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  top of page


[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 top of page

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
Medical Calculators - A thru Z
Lab Values - A thru Z