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Varithena™ (polidocanol injectable foam) is 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.
Varithena™ injectable foam contains the sclerosant, polidocanol. It is intended for intravenous use only.
Chemically, polidocanol is polyoxyl lauryl ether. The structural formula is represented below:
Polidocanol has the molecular formula CH3(CH2)11(OCH2CH)nOH and a molecular weight of 582.9 when the average ethylene glycol moieties is nine (n=9). Polidocanol is a white to almost white, waxy, hygroscopic solid that is soluble in water and alcohol and melts at temperatures above 20°C.
Varithena™ is a sterile, injectable foam of an aqueous polidocanol solution (1%) containing the following inactive ingredients: ethanol (4.2% w/w), disodium hydrogen phosphate dihydrate (0.24% w/w), and potassium dihydrogen phosphate (0.085% w/w) with pH adjustment using 0.1 M sodium hydroxide solution and 0.1 M hydrochloric acid solution to achieve a pH of 6.0-7.5.
Activate the Varithena™ canister to enable foam generation from the polidocanol solution (180 mg/18 mL (10 mg/mL)). 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. An activated canister of Varithena™ generates 90 mL of injectable foam, which following purging instructions contained in the IFU, is sufficient to yield 45 mL of usable injectable foam for intravenous injection. The polidocanol solution is stored under a carbon dioxide atmosphere in an aluminum canister prior to use.
The injectable foam is generated after activation of the polidocanol canister with oxygen from a second aluminum canister, resulting in a final gas mixture of oxygen:carbon dioxide in a ratio of 65:35 with low (<0.8%) nitrogen content. At the time of use, Varithena™ is generated as an injectable foam of controlled density and bubble size. The foam is then transferred to a syringe through the Varithena™ transfer unit. The injectable foam has a liquid to gas ratio of approximately 1:7 by volume. The median bubble diameter is less than 100 µm and no bubbles are greater than 500 µm.