Testosterone has been subject to abuse, typically at doses higher than recommended for approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions; if testosterone abuse suspected, check serum testosterone concentrations to ensure they are within therapeutic range; consider possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events
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.
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