Testosterone Replacement Therapy

Important Safety Information — Testosterone Replacement Therapy

What is it approved for?

Testosterone cypionate injection and testosterone gel are FDA-approved as replacement therapy in men with conditions associated with a deficiency or absence of the body's own testosterone: primary hypogonadism (for example, after injury to or removal of the testicles, or undescended testicles) and hypogonadotropic hypogonadism (a pituitary or hypothalamic cause). The labels state that safety and effectiveness in men with “age-related hypogonadism” (low testosterone with aging alone) have not been established, that testosterone is not indicated for women, and that it has not been shown to be safe or effective for athletic use.

Do not use if

• are a man with breast cancer, or with known or suspected prostate cancer;
• are pregnant (testosterone can cause fetal harm), or are a woman or a child (testosterone is not indicated for women or for males under 18);
• have serious heart, liver or kidney disease (a contraindication on the testosterone cypionate label);
• are allergic to testosterone or any ingredient in the product.

Before starting, tell your provider if

• have high blood pressure (testosterone is not recommended if it is not controlled), heart disease, or have had a heart attack, stroke, or a blood clot in a leg or lung;
• have sleep apnea or risk factors for it;
• have an enlarged prostate (BPH), urinary symptoms, a raised PSA, or a history of prostate problems;
• have a high red blood cell count (polycythemia), or liver or kidney problems;
• have ever had depression, anxiety, other mood changes, or thoughts of suicide;
• have a history of misusing anabolic steroids or other substances;
• plan to have children, or have had fertility problems;
• take blood thinners (anticoagulants), or any other prescription or over-the-counter medicines, vitamins or supplements;
• are immobilized, or have cancer that can raise calcium levels.

Serious side effects — get medical help right away

• Blood pressure increases and heart risk. Testosterone can raise blood pressure, which can increase the risk of major adverse cardiovascular events over time; it is not recommended for men with uncontrolled high blood pressure. Long-term trials to assess the cardiovascular outcomes of testosterone cypionate have not been conducted; in the TRAVERSE trial of a testosterone gel, rates of major cardiovascular events were similar to placebo. Heart attack and stroke are among the reported adverse reactions. Get emergency help for chest pain or signs of a stroke.
• Blood clots. Blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with testosterone products. Get emergency help for leg pain or swelling, chest pain or sudden shortness of breath.
• Too many red blood cells (polycythemia). Testosterone can raise hematocrit and hemoglobin. Your provider checks these before and during treatment and may lower the dose or stop treatment if they rise too far.
• Prostate effects. Men with an enlarged prostate may have worsening urinary symptoms, including sudden blockage of urine flow. PSA commonly rises on treatment, and prostate cancer is a contraindication, so your provider evaluates prostate health before and during treatment.
• Sleep apnea. Testosterone treatment may worsen sleep apnea, especially in men with risk factors for it.
• Fluid retention. Androgens can cause the body to hold salt and water (edema), which can be serious in men with heart, kidney or liver disease.
• Reduced fertility. Testosterone from outside the body may suppress sperm production, and a reduced sperm count may occur after prolonged use. Tell your provider if you may want children in the future.
• Mood changes, misuse and dependence. Anxiety, depression and mood swings have been reported. Misuse of testosterone, usually at higher doses and together with other anabolic steroids, has caused cardiac arrest, heart attack, stroke, liver toxicity and serious psychiatric effects including major depression, mania, paranoia and psychosis; stopping very high doses abruptly can cause withdrawal symptoms, including depressed mood, that last weeks or months. Tell your provider about any mood change. If you have thoughts of harming yourself, call or text 988, or call 911 in an emergency.
• Liver effects. Prolonged use of high doses of androgens has been associated with liver tumors and peliosis hepatis (blood-filled cysts in the liver), and jaundice has been reported. Your provider may check liver tests.

Common side effects

Common side effects: with the injection, pain and inflammation at the injection site, acne, oily skin, more body hair, male-pattern hair loss, breast enlargement, more frequent or prolonged erections, changes in sex drive, headache, nausea and fluid retention; with the gel, a rise in PSA, mood swings, higher blood pressure, increased hematocrit or hemoglobin, and skin irritation where it is applied. These are not all the possible side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

Testosterone is contraindicated in pregnancy: it can cause fetal harm, including virilization of a female baby. It is not recommended for nursing mothers and is not indicated for women. Women and children should avoid contact with a man's gel application sites.

Testosterone is a Schedule III controlled substance. Federal and state rules for controlled substances apply, a licensed provider may require blood tests and, where the law requires it, an in-person evaluation, and an online visit alone does not result in a prescription.

Testosterone has not been shown to be safe or effective for athletic or bodybuilding use. Misuse at high doses, especially with other anabolic steroids, has caused serious heart, liver and psychiatric harm.

Testosterone gel is flammable until it dries; keep away from fire and flames and do not smoke until the gel has dried.

Prescription only. Testosterone Replacement is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.