INDICATIONS

Varithena^® (polidocanol injectable foam) is a prescription medicine used to treat varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg's GSV system. Varithena^® improves symptoms related to or caused by varicose veins, and the appearance of varicose veins.

IMPORTANT SAFETY INFORMATION

You should not be treated with Varithena^® if you are allergic to polidocanol or have clots in your blood vessels.

Severe allergic reactions have been reported in people treated with liquid forms of polidocanol and some patients have died from these reactions. Varithena^® is a foam made from polidocanol. A healthcare professional will observe you for signs of allergic reactions for at least 10 minutes after you are treated with Varithena^®.

Tell your doctor about all of your medical conditions, including if you

• have arterial disease (a disease of the blood vessels)
• have reduced mobility
• have a history of blood clots in the veins or lungs
• have had major surgery in the past 3 months
• have recently had a long hospital stay
• are pregnant or have recently been pregnant

The most common side effects seen with Varithena^® are leg pain or discomfort, injection site bruising or pain, and potentially serious blood clots in the leg veins. These are not all of the possible side effects of Varithena^®. Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088. Varithena^® is administered by your doctor. Doctors using Varithena® must be experienced in vein procedures and trained in using Varithena^®.

See Full Prescribing Information for Varithena^®.