Treatment Procedure with Sotradecol Injection

(sodium tetradecyl sulfate injection)

Sotradecol® injection is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.

Sotradecol injection is injected via a needle directly into the vein, which causes irritation and damage to the lining of the vein. This results in partial or complete blocking or destruction of the vein that may or may not be permanent. Several treatments may be needed to reduce the size and visibility of the veins.

Your doctor will evaluate your veins to determine if they are appropriate for treatment with Sotradecol injection.  This may include ultrasound or other tests.

Here is an overview of what to expect when you undergo a treatment with Sotradecol injection:

• Your doctor will evaluate your veins and your medical history, including medications you are taking.
• The day of the procedure, wear shorts and comfortable clothing.
• You’ll be brought into a procedure room where you will lie down on a table.
• Local anesthetic will be applied to the areas of vein treatment so that discomfort is minimized.
• Sotradecol injection will be injected through a syringe to the areas of treatment.
• If this is your first treatment, your doctor may observe your response to a small dose prior to additional doses.  This observation may take up to several hours. Subsequent appointments should take less time.
• After your leg vein treatment, you’ll be given instructions to keep some form of pressure wrapping on your leg, and will be asked to return for a follow up appointments.

Important Safety Information for Sotradecol® Injection
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.