Testosterone — Important Safety Information (ISI)

Read this information carefully before starting testosterone replacement therapy. Discuss any questions with your provider.

What Is Testosterone Replacement Therapy?

Testosterone replacement therapy (TRT) involves the administration of exogenous testosterone to treat testosterone deficiency (hypogonadism) in men. Formulations prescribed at Tactus Health include testosterone cypionate (injectable), testosterone enanthate (injectable), and topical testosterone gels/creams. All formulations are prescription-only and require lab-confirmed diagnosis of low testosterone before initiation.

Boxed Warning

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients of the potential serious adverse reactions in children. Testosterone products are for male use only and are not indicated for use in women.

Contraindications

• Known or suspected prostate or breast carcinoma
• Women (especially pregnant or potentially pregnant women)
• Serious cardiac, hepatic, or renal disease
• Hypersensitivity to testosterone or any product component

Warnings and Precautions

• Polycythemia (Erythrocytosis): TRT increases red blood cell production. Monitor hematocrit. Dose reduction or temporary discontinuation may be necessary if hematocrit rises above 54%.
• Venous Thromboembolism (VTE): Cases of deep vein thrombosis and pulmonary embolism reported. Evaluate immediately if VTE is suspected. Use with caution in patients with risk factors for thrombosis.
• Cardiovascular Risk: Long-term cardiovascular effects remain an area of ongoing study. Monitor blood pressure and cardiovascular risk factors. Use with caution in patients with pre-existing cardiovascular disease.
• Sleep Apnea: May exacerbate sleep apnea, particularly in patients who are obese or have chronic lung disease. Monitor for symptoms.
• Lipids: TRT may decrease HDL cholesterol. Monitor lipid levels periodically.
• Infertility: Exogenous testosterone suppresses endogenous testosterone production and spermatogenesis. Not recommended for men who wish to maintain fertility. Fertility typically returns after discontinuation.
• Edema: May cause fluid retention. Use with caution in patients with cardiac, renal, or hepatic disease.
• Hepatic Effects: Peliosis hepatis and hepatocellular carcinoma have been associated with prolonged high-dose androgen use. Risk is primarily with oral 17-alpha alkylated androgens. Injectable and transdermal formulations carry lower hepatic risk.
• Abuse and Dependence: Testosterone is a Schedule III controlled substance with potential for abuse and dependence.
• PSA and Prostate: Monitor PSA at baseline and at 3 to 6 months, then annually. Testosterone is contraindicated in patients with known or suspected prostate carcinoma.

Monitoring Requirements

Our providers monitor the following at baseline and at follow-up intervals during TRT:

• Total and free testosterone levels
• Estradiol (E2)
• Hematocrit / complete blood count
• PSA (men 40 and older)
• Lipid panel
• Liver function (as indicated)
• Blood pressure

Most Common Adverse Reactions

• Acne and oily skin
• Injection site reactions (pain, swelling , injectable formulations)
• Increased hematocrit
• Mood changes (typically positive; occasionally irritability)
• Testicular atrophy (from suppression of endogenous production)
• Elevated estradiol (managed with aromatase inhibition if needed)
• Application site reactions (topical formulations)

Drug Interactions

• Anticoagulants: Androgens may potentiate the action of anticoagulants (warfarin). Monitor INR closely.
• Insulin/Oral Hypoglycemics: Androgens may decrease blood glucose and may require adjustment of antidiabetic medication.
• Corticosteroids: Concurrent use may enhance edema formation.