INDICATION

TESTOPEL^® (testosterone pellets) is approved for testosterone replacement therapy in adult males for certain conditions associated with low or absent testosterone in the body.

It is not known if TESTOPEL is safe or effective to treat men who have low testosterone due to aging.

IMPORTANT SAFETY INFORMATION ABOUT TESTOPEL

• Men with breast cancer should not use TESTOPEL. In patients with breast cancer, TESTOPEL may cause elevated calcium levels in the blood. Men who have or might have prostate cancer or have had an adverse reaction should not use TESTOPEL. Men treated with TESTOPEL may be at an increased risk for developing an enlarged prostate and prostatic cancer. TESTOPEL is not approved for use in women. If a woman is pregnant or may become pregnant, that woman should not use TESTOPEL because it may harm the unborn baby
• TESTOPEL can cause blood clots in the legs or lungs. Tell your doctor if you have signs and symptoms of a blood clot in your leg including leg pain, swelling, warmth, or redness, or of a blood clot in your lungs including difficulty breathing or chest pain
• Use of TESTOPEL can possibly increase the risk of heart attack, stroke, or death
• TESTOPEL, like other testosterone products, can increase the risk of cardiovascular risk over time. Your blood pressure should be monitored while on TESTOPEL, especially if you’ve been previously diagnosed with high blood pressure. If your blood pressure is unable to be controlled, TESTOPEL may need to be stopped
• Serious side effects relating to the heart and blood vessels and mental status are associated with abuse of testosterone and anabolic androgenic steroids
• Swelling of your ankles, feet, or body with or without heart failure may be a serious problem in patients treated with TESTOPEL who have heart, kidney, or liver disease. In addition to your doctor stopping treatment with TESTOPEL, your doctor may need you to take a medicine known as a diuretic
• Gynecomastia (enlarged breasts in men) frequently develops and occasionally persists in patients being treated for hypogonadism
• TESTOPEL should be used cautiously in healthy males with delayed puberty. Adolescent males taking TESTOPEL for delayed puberty should have bone development checked every 6 months. In children, TESTOPEL may speed up bone maturity without having a similar gain in linear growth (height). This may result in a decreased adult height
• TESTOPEL has been associated with infections at the implant site. In addition, there are times when the TESTOPEL pellets may come out of the skin. Both could occur at any time and each may require further treatment. Tell your doctor if you experience thickening or hardening of the skin at the implant site, inflammation, bleeding, bruising, wound drainage, pain, itching, or pellets coming out of the skin
• TESTOPEL has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk for serious adverse health effects, TESTOPEL should not be used for such purpose
• Because TESTOPEL pellets are placed under the skin, it is more difficult for your doctor to change the dosage compared to medicines taken by mouth or medicines injected into the muscle (intramuscular injection). Surgical removal may be required if treatment with TESTOPEL needs to be stopped
• While taking TESTOPEL, your doctor may periodically do tests to check for liver damage. Your doctor may also check for increased red blood cells if you are receiving high doses of TESTOPEL
• Side effects of TESTOPEL include more erections than normal or erections that last a long time, nausea, vomiting, changes in skin color, ankle swelling, changes in body hair, male pattern baldness, acne, suppression of certain clotting factors, bleeding in patients on blood thinners, increase or decrease in sex drive, headache, anxiety, depression, inflammation and pain at the implantation site and, rarely, anaphylactoid reaction (a sudden onset of allergic reaction)
• Drug abuse is intentional use of a drug, even once, for its rewarding psychological and physiological effects
• Physical dependence can result in withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking very high doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism
• Serious side effects associated with abuse of testosterone and anabolic androgenic steroids include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression
• Side effects associated with abuse or misuse by men include mini-stroke, convulsions, mild mania (elation and hyperactivity), irritability, abnormal blood lipids, decrease in size or function of testicles, decreased or absence of fertility
• Side effects associated with abuse or misuse by women include unwanted hair growth, development of male characteristics, voice deepening, clitoris enlargement, decrease in size or function of breasts, male pattern baldness, menstrual irregularities
• Side effects associated with abuse or misuse by male and female adolescents include halting of growth and early puberty

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.