Sotradecol is a sclerosing (skler-OH-sing) agent. It works by increasing the formation of blood clots and scar tissue inside certain types of veins. This helps decrease dilation of enlarged veins.

Sotradecol is used to treat small uncomplicated varicose veins in the legs.

Sotradecol is not a cure for varicose veins and the effects of this medication may not be permanent.

Sotradecol may also be used for purposes not listed in this medication guide.

You should not receive Sotradecol if you are bedridden due to serious illness, or if you have a blood clot, a bleeding disorder, allergies, cancer, severe blood infection, or any untreated or uncontrolled disease.

Sotradecol is injected into a vein through an IV. A healthcare provider will give you this injection.

You will be watched closely for several hours after your injection, to make sure this medication is not causing harmful effects.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

You may need to wear compression stockings for several days or weeks after your treatment. Carefully follow your doctor's instructions about caring for yourself after receiving this medication.

You should not receive Sotradecol if you are allergic to it, or if you have:

• a blood clot disorder such as deep vein thrombosis (DVT) or thrombophlebitis (swelling of a vein caused by a blood clot);

• Buerger's disease (a blood clotting disorder affecting the arms and legs);

• allergies;

• cancer;

• a severe infection of your blood (sepsis);

• any untreated or uncontrolled disease such as diabetes, overactive thyroid, tuberculosis, asthma, blood cell disorder, or skin disease; or

• if you are bed-ridden due to severe illness.

Sotradecol should not be used to treat varicose veins that are caused by a tumor in your stomach or pelvis area, unless the tumor has been surgically removed.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether sodium tetradecyl sulfate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Because you will receive Sotradecol in a clinical setting, you are not likely to miss a dose.

Since Sotradecol is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; sneezing, runny nose, difficult breathing; swelling of your face, lips, tongue, or throat.

Sotradecol may cause serious side effects. Call your doctor at once if you have:

• pain or swelling in one or both legs;

• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or

• pain, itching, peeling, skin sores, or skin changes where the medicine was injected.

Common side effects of Sotradecol may include:

• mild headache;

• nausea, vomiting; or

• discolored skin along the treated vein (may be permanent).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.