Physicians now have a new tool at their disposal to vanish unsightly veins. The United States Food & Drug Administration has approved BTG’s Varithena (polidocanol injectable foam) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system.
Varithena (formerly known as Varisolve PEM) is a pharmaceutical-grade, low-nitrogen, polidocanol foam, indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee. The approval was based on two pivotal, placebo-controlled Phase III trials, in which Varithena achieved a clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible varicosities, and addressed the underlying venous incompetence in the majority of patients treated.
Treatment with Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Physicians are advised to observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.