The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) medication guide for Testosterone. For Testosterone Undecanoate, REMS includes elements to assure safe use and implementation system . For additional information: /REMS
US BOXED WARNINGS :
Pulmonary Oil Microembolism (POME) Reactions And Anaphylaxis :
-Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
-Following each injection of testosterone undecanoate observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
Secondary Exposure To Topical Testosterone :
-Virilization has been reported in children who were secondarily exposed to topical testosterone products.
-Children should avoid contact with unwashed or unclothed application sites in men using testosterone topical.
-Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
Safety and efficacy have not been established in patients younger than 18 years.
Testosterone Enanthate and Testosterone Implant are indicated for delayed puberty in adolescent patients.
Testosterone Cypionate: Safety and efficacy have not been established in patients younger than 12 years.
Consult WARNINGS section for additional precautions.
Primary hypogonadism (congenital or acquired): Testicular failure due to diseases and conditions in the body such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals; these men usually have low serum testosterone levels and gonadotropins (FSH, LH) above normal range Hypogonadotropic hypogonadism (congenital or acquired): Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation; these men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
Testosterone, like many anabolic steroids, was classified as a controlled substance in 1991. Testosterone is administered parenterally in normal and delayed-release (depot) forms. In September 1995, the FDA approved testosterone transdermal patches (Androderm), and many transdermal forms and brands are now available including implants, gels, and topical solutions. A testosterone buccal system, Striant, was FDA-approved in July 2003; Striant is a mucoadhesive product that adheres to the buccal mucosa and provides a controlled and sustained release of testosterone. In May 2014, the FDA approved an intranasal gel formulation of testosterone (Natesto). A transdermal patch (Intrinsa) for hormone replacement in women is under investigation; the daily dosages used in women are much lower than for products used in males. The FDA refused approval for Intrinsa in 2004 stating that more data regarding safety, especially in relation to cardiovascular and breast health, were required.