Testosterone Cypionate

Indication

Testosterone Cypionate Injection, USP is indicated as testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). Limitations of use include not for use in men with age-related hypogonadism whose testosterone levels are low solely due to aging.

Important safety information

Testosterone may cause serious side effects, including:

• Increased risk of major adverse cardiovascular events (non-fatal heart attack, non-fatal stroke, and cardiovascular death). Discuss your cardiovascular risk with your provider before and during therapy.
• Increase in red blood cell count (polycythemia), which may require dose reduction or treatment interruption.
• Worsening of benign prostatic hyperplasia (BPH) and possible increased risk of prostate cancer. Routine prostate monitoring is recommended.
• Sleep apnea, particularly in people with risk factors such as obesity or chronic lung disease.
• Lower fertility and possible suppression of natural sperm production.
• Mood changes, including depression, irritability, or aggression.
• Liver problems, including elevated liver enzymes (rare with injectable testosterone).
• Edema (fluid retention), with or without congestive heart failure.
• Gynecomastia (breast enlargement).
• Venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
• Possible misuse and abuse — testosterone is a Schedule III controlled substance.

Secondary exposure to testosterone

Although Testosterone Cypionate is administered by injection (not topical), patients should still take care to avoid skin-to-skin contact at the injection site until any oil residue is fully absorbed. Children and women should avoid contact with unwashed or unclothed application sites of any testosterone product. Signs of accidental exposure in children include enlargement of the penis or clitoris, premature pubic hair, increased erections, and aggressive behavior.

Do not use testosterone cypionate if you

• Have or have had cancer of the prostate or breast.
• Are pregnant or may become pregnant — testosterone can cause serious harm to an unborn baby.
• Have had a serious allergic reaction to testosterone or any of the ingredients in this product.

Most common side effects

• Acne, oily skin
• Injection site pain, redness, or bruising
• Increased red blood cell count
• Headache, mood changes
• Hair loss or increased body hair
• Decreased sperm count

Reporting side effects

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to the manufacturer or to your NowYou care team.

Important

This summary does not include all information about this medication. It is not a substitute for the full Prescribing Information or for talking with your healthcare provider. Please read the full Prescribing Information and Medication Guide before starting treatment, and discuss any questions with your provider.