Testosterone 300 mg

Testim® was evaluated in a randomized multicenter, multi-dose, active and placebo controlled 90-day study in 406 adult males with morning testosterone concentrations ≤ 300 ng/dL. The study was double-blind for the doses of Testim and placebo, but open label for the non-scrotal testosterone transdermal system. During the first 60 days, patients were evenly randomized to Testim 50 mg, Testim 100 mg, placebo gel, or testosterone transdermal system. At Day 60, patients receiving Testim were maintained at the same dose, or were titrated up or down within their treatment group, based on 24-hour averaged serum testosterone concentration obtained on Day 30.

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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Bicalutamide monotherapy has been associated with abnormal liver function tests such as elevated liver enzymes in % of men relative to % for standard care. [21] [96] Hepatic changes such as marked increases in liver enzymes or hepatitis that necessitated discontinuation of bicalutamide have occurred in approximately to 1% of men in clinical trials. [20] [27] Monitoring of liver function during treatment is recommended, particularly in the first few months. [21] [84] In men of advanced age with prostate cancer, bicalutamide monotherapy has been associated with an increase in non-prostate cancer mortality , in part due to an increase in the rate of heart failure. [97] [21] These mortality-related effects are thought to be a consequence of androgen deprivation, rather than a specific drug-related toxicity of bicalutamide. [98]

Testosterone 300 mg

testosterone 300 mg

Bicalutamide monotherapy has been associated with abnormal liver function tests such as elevated liver enzymes in % of men relative to % for standard care. [21] [96] Hepatic changes such as marked increases in liver enzymes or hepatitis that necessitated discontinuation of bicalutamide have occurred in approximately to 1% of men in clinical trials. [20] [27] Monitoring of liver function during treatment is recommended, particularly in the first few months. [21] [84] In men of advanced age with prostate cancer, bicalutamide monotherapy has been associated with an increase in non-prostate cancer mortality , in part due to an increase in the rate of heart failure. [97] [21] These mortality-related effects are thought to be a consequence of androgen deprivation, rather than a specific drug-related toxicity of bicalutamide. [98]

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