Sotradecol® for Sclerotherapy*
Sodium Tetradecyl Sulfate Injection
Sotradecol is the only FDA-approved, commercially available sodium tetradecyl sulfate injection in the United States. Features:
- Meets FDA purity, sterility, pH and concentration specifications
- 1% or 3% solution available in 2ml vials, 5 vials/box
Prescribing Information
FOR INTRAVENOUS USE ONLY
Rx Only
DESCRIPTION
Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy solid. The structural formula is as follows:C14H29NaSO4 7-Ethyl-2-methyl-4-hendecanol sulfate sodium salt MW 316.44
Sotradecol® (sodium tetradecyl sulfate injection) is a sterile nonpyrogenic solution for intravenous use as a sclerosing agent.
1% (10 mg/mL): Each mL contains sodium tetradecyl sulfate 10 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 4.0 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.
3% (30 mg/mL): Each mL contains sodium tetradecyl sulfate 30 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 9.0 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.
CLINICAL PHARMACOLOGY
Sotradecol (sodium tetradecyl sulfate injection) is a sclerosing agent. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. Subsequent formation of fibrous tissue results in partial or complete vein obliteration that may or may not be permanent.
INDICATIONS AND USAGE
Sotradecol (sodium tetradecyl sulfate 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.
CONTRAINDICATIONS
Sotradecol (sodium tetradecyl sulfate injection) is contraindicated in previous hypersensitivity reactions to the drug; in acute superficial thrombophlebitis; valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.
WARNINGS
Sotradecol (sodium tetradecyl sulfate injection) should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injection technique. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important.
Emergency resuscitation equipment should be immediately available. Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, it is recommended that 0.5 mL of Sotradecol be injected into a varicosity, followed by observation of the patient for several hours before administration of a second or larger dose. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately.
Because of the danger of thrombosis extension into the deep venous system, thorough preinjection evaluation for valvular competency should be carried out and slow injections with a small amount (not over 2 mL) of the preparation should be injected into the varicosity. Deep venous patency must be determined by noninvasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show significant valvular or deep venous incompetence.
The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.
PRECAUTIONS GENERAL
Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease).
DRUG INTERACTIONS
No well-controlled studies have been performed on patients taking antiovulatory agents. The physician must use judgment and evaluate any patient taking antiovulatory drugs prior to initiating treatment with Sotradecol (sodium tetradecyl sulfate injection). (See ADVERSE REACTIONS section).
Heparin should not be included in the same syringe as Sotradecol (sodium tetradecyl sulfate injection), since the two are incompatible.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
When tested in the L5178YTK +/- mouse lymphoma assay, sodium tetradecyl sulfate did not induce a dose-related increase in the frequency of thymidine kinase-deficient mutants and, therefore, was judged to be nonmutagenic in this system. However, no long-term animal carcinogenicity studies with sodium tetradecyl sulfate have been performed.
PREGNANCY
Teratogenic Effects – Pregnancy Category C. Animal reproduction studies have not been conducted with Sotradecol. It is also not known whether Sotradecol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sotradecol should be given to a pregnant woman only if clearly needed and the benefits outweigh the risks.
NURSING MOTHERS
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sotradecol is administered to a nursing woman.
PEDIATRIC USE
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS
Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug. (See WARNINGS section).
Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS section). At least six deaths have been reported with the use of Sotradecol (sodium tetradecyl sulfate injection). Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol (sodium tetradecyl sulfate injection). One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol (sodium tetradecyl sulfate injection). (See WARNINGS section).
One death has been reported in a patient who received Sotradecol and who had been receiving an antiovulatory agent. Another death (fatal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored.
Sotradecol (sodium tetradecyl sulfate injection) is for intravenous use only. The strength of solution required depends on the size and degree of varicosity. In general, the 1% solution will be found most useful with the 3% solution preferred for larger varicosities. The dosage should be kept small, using 0.5 to 2 mL(preferably 1 mL maximum) for each injection, and the maximumsingle treatment should not exceed 10 mL.
HOW SUPPLIED
Sotradecol (sodium tetradecyl sulfate injection) 1% (10 mg/mL) – 2 mL vials; in packages of 5, NDC65974-162-02 3% (30 mg/mL) – 2 mL vials; in packages of 5, NDC65974-163-02
STORAGE
Store at 20°C to 25°C (68°F to 77°F) (See USP Controlled Room Temperature).
ANIMAL TOXICOLOGY
The intravenous LD50 of sodium tetradecyl sulfate in mice was reported to be 90 +/- 5 mg/kg.
In the rat, the acute intravenous LD50 of sodium tetradecyl sulfate was estimated to be between 72 mg/kg and 108 mg/kg.
Purified sodium tetradecyl sulfate was found to have an LD50 of 2 g/kg when administered orally by stomach tube as a 25% aqueous solution to rats. In rats given 0.15 g/kg in drinking water for 30 days, no appreciable toxicity was seen, although some growth inhibition was discernible.
Manufactured for:
AngioDynamics, Inc.
Queensbury, NY 12804
1-800-772-6446
Manufactured by:
Bioniche Teo
Inverin, Co. Galway, Ireland
Version 0588102
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January 8, 2010
Recently, the Food and Drug Administration's (FDA) Division of Drug, Marketing, Advertising, and Communications (DDMAC) issued a Warning Letter to Bioniche Pharma USA objecting to several web pages that promoted Sotradecol® (sodium tetradecyl sulfate injection). Specifically, these web pages failed to convey any information regarding the risks associated with Sotradecol®, claims on the web pages broadened the approved indications beyond the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves, and the web page overstated the efficacy of Sotradecol®.
Bioniche Pharma USA would like to take the opportunity to provide important corrective information about the safe and appropriate use of Sotradecol®.
Indication and Efficacy:
The web pages misleadingly suggested that Sotradecol® is effective in all sclerotherapy patients and procedures. However, Sotradecol® 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.
Bioniche Pharma's past use of photographs and general claims regarding Sotradecol's® use in the sclerotherapy market should not be interpreted as claims that Sotradecol® may be used in any sclerotherapy patient or that patients may achieve varicose-free legs as a result of treatment with Sotradecol®.
Risk Information:
The web pages did not disclose any important risk information about Sotradecol®. The information is presented below:
Contraindications:
Sotradecol® is contraindicated in:
• patients with previous hypersensitivity reactions to the drug;
• acute superficial thrombophlebitis;
• valvular or deep vein incompetence;
• huge superficial veins with wide open communications to deeper veins;
• phlebitis migrans;
• acute cellulites;
• allergic conditions;
• acute infections;
• varicosities caused by abdominal and pelvic tumors unless the tumor has been removed;
• bedridden patients;
• such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.
Warnings and Precautions:
Sotradecol® should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injections technique. To avoid severe adverse local effects, including tissue necrosis, following extravasation, physicians must use extreme care in intravenous needle placement and use the minimal effective volume at each injection site.
Emergency resuscitation equipment should be immediately available. Allergic reactions including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, 0.5 mL of Sotradecol® should be injected into a varicosity, followed by several hours of observation before administration of a second or larger dose. The physician should be prepared to treat anaphylaxis appropriately.
At least six deaths have been reported with the use of Sotradecol®. Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol®. One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol®.
One death has been reported in a patient who received Sotradecol® and who had been receiving an antiovulatory agent. Another death (fatal pulmonary embolism) has been reported in 36-year-old female treated with sodium tetradecyl acetate which was not taking oral contraceptives.
Venous sclerotherapy should not be undertaken if tests (Trendelenberg or Perthers), and angiography show significant valvular or deep venous incompetence because of the danger of thrombosis extension into the deep venous system. Physicians should conduct preinjection evaluation for valvular competency and deep venous potency must be determined by angiography or noninvasive testing such as duplex ultrasound. Physicians should administer slow injections with a small amount (not over 2 mL) of the preparation into the varicosity.
Deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of Sotradecol®. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.
Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriocsclerosis or thromboangiitis obliterans (Buerger's Disease).
Adverse Reactions with Sotradecol®
The following adverse reactions have been reported with the use of Sotradecol®
• Local reactions (pain, urticaria or ulceration) may occur at the site of injections.
• A permanent discoloration may remain along the path of the sclerosed vein segment.
• Sloughing and necrosis of tissue may occur following extravasation of the drug.
• Allergic reactions (hives, asthma, hayfever and anaphylactic shock).
• Mild systemic reactions including headache, nausea and vomiting.
For further information please refer to full prescribing information at the following link here. If you have any questions about this letter or about the use of Sotradecol® please contact Rhonda Noll, Sr. Director of Regulatory Affairs at 1-877-769-6200.