Sotradecol (sodium tetradecyl sulfate injection)

Expand Your Practice

Using Sotradecol® (Sodium Tetradecyl Sulfate Injection) can help expand your varicose veins practice. By using Sotradecol injection for the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves, you can expand the treatment options you offer your patients. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.

• The only FDA approved, commercially available sodium tetradecyl sulfate injection in the US market
• Manufactured to meet the FDA’s quality standards, including sterility, purity, pH and concentration requirements
• Available in two convenient concentrations: 1% or 3%
• Sold by AngioDynamics in 2 ml vials, 5 units/box

Important Safety Information
Sotradecol is contraindicated in patients with previous hypersensitivity to the drug; inflammation or incompetence of superficial or deep veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; diabetes; toxic hyperthyroidism; tuberculosis; asthma; neoplasm; sepsis; blood dyscrasias; and acute respiratory or skin diseases.

Due to the risk of deep vein thrombosis, patients should be evaluated for valvular competency and deep venous patency before treatment and slow injections of a small volume (< 2 mL) should be injected. Patients should be monitored post-treatment for deep vein thrombosis and pulmonary embolism. Extreme caution must be exercised in the presence of underlying arterial disease.

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and use the smallest effective volume at each injection site.

Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution, it is recommended that 0.5 mL of Sotradecol be injected, followed by observation for several hours before administration of a second or larger dose. Emergency resuscitation equipment should be immediately available, and the physician prepared to treat an anaphylactic reaction.

At least 6 deaths have been reported. Four of the deaths were cases of anaphylaxis; one in a patient with a history of asthma, a contraindication to Sotradecol use.

Another death was in a patient who was taking an antiovulatory agent. One death (pulmonary embolism) occurred in a patient not taking an antiovulatory agent, treated with sodium tetradecyl acetate. Other adverse reactions reported include pulmonary embolism; local injection site reactions (pain, urticaria, ulceration); permanent discoloration of sclerosed vein segment; sloughing and necrosis of tissue following extravasation of the drug; allergic reactions (hives, asthma, hayfever); headache; nausea; and vomiting.

Please see full Prescribing Information for more information here.