Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
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.
(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.
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.
Like all medications, Sotradecol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: