The manufacturers of certain testosterone products (., AndroGel and Striant) state that their products are contraindicated in patients with soybean, soy, or soya lecithin hypersensitivity because they are derived partially from soy plants. There is a risk of serious hypersensitivity reactions or anaphylaxis with the use of testosterone undecanoate (Aveed) oil for injection. These allergic reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose. Observe patients in the healthcare setting for 30 minutes after an Aveed injection in order to provide appropriate medical treatment in the event of serious hypersensitivity reactions or anaphylaxis. The Aveed injection contains benzyl benzoate, the ester of benzyl alcohol and benzoic acid, and refined castor oil. Therefore, testosterone undecanoate use is contraindicated in patients with polyoxyethylated castor oil hypersensitivity, benzoic acid hypersensitivity, or benzyl alcohol hypersensitivity. Patients with suspected hypersensitivity reactions should not be re-treated with testosterone undecanoate injection.
Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In a few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user's shirts and/or other fabric, such as towels and sheets [see WARNINGS AND PRECAUTIONS ].
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