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Testorus® (testosterone gel) are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions. It is not known if Testorus® is safe or effective to treat men who have low testosterone due to aging.
It is not known if Testorus® is safe or effective in children younger than 18 years old.
Testorus Gel is a controlled substance (CIII) because it contains testosterone that can be a target for
people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to
anyone else. Selling or giving away this medicine may harm others and is against the law.
Testorus Gel is not meant for use in women.
IMPORTANT SAFETY INFORMATION1,2
o Testorus Gel can transfer from your body to others, including children and women. This can
happen if other people come into contact with the area where the Testorus Gel was applied.
Children and women should avoid contact with the unwashed or not covered (unclothed) areas
where Testorus Gel Rus Bio has been applied to your skin.
o Early signs and symptoms of puberty have occurred in young children who have come in direct
contact with testosterone by touching areas where men have used Testorus Gel Rus Bio.
o Signs and symptoms of early puberty in a child who has come in direct contact with Testorus Gel
Rus Bio may include:
o Abnormal sexual changes:
o Enlarged penis or clitoris.
o Early growth of hair near the vagina or around the penis (pubic hair).
o Erections or acting out sexual urges (sex drive).
o Behavior problems, including acting aggressively or behaving in an angry or violent way.
o Signs and symptoms in a woman who has come in direct contact with Testorus Gel may include:
o Changes in body hair.
o An abnormal increase in pimples (acne).
o To lower the risk of transfer of Testorus Gel Rus Bio. from your body to others, you should
follow these important instructions:
o Apply Testorus Gel Rus Bio. only to your shoulders and upper arms that will be covered by a
short-sleeve t-shirt.
o Apply Testorus Gel Rus Bio only to areas of your shoulders, upper arms, or stomach area
(abdomen) that will be covered by a short-sleeve t-shirt.
o Wash your hands right away with soap and water after applying Testorus Gel Rus Bio.
o After the gel has dried, cover the application area with clothing. Keep the area covered until you
have washed the application area well or have showered.
o If you expect to have skin-to-skin contact with another person, first wash the application area
well with soap and water.
o If a child or woman touches the area where you have applied Testorus Gel Rus Bio, that area on
the child or woman should be washed well with soap and water right away.
o Stop using Testorus Gel Rus Bio and call your healthcare provider right away if you see any
signs and symptoms of puberty in a child, or changes in body hair or increased acne in a
woman, that may have happened through accidental touching of the area where you have
applied Testorus Gel Rus Bio
o Do not use Testorus Gel Rus Bio if you:
o Have breast cancer or have or might have prostate cancer.
o Are pregnant. Testorus Gel Rus Bio may harm your unborn baby. Women who are pregnant
should avoid contact with the area of skin where Testorus Gel Rus Bio has been applied.
o Before using Testorus Gel Rus Bio, tell your healthcare provider about all of your medical
conditions, including if you have breast cancer; prostate cancer; urinary problems due to enlarged
prostate; heart, kidney, or liver problems; or problems breathing while you sleep (sleep apnea).
o Tell your healthcare provider about all the medicines you take, including prescription and over-
the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider
if you take insulin, medicines that decrease blood clotting (blood thinners), or corticosteroids.
o Testorus Gel Rus Bio can cause serious side effects, including:
o If you already have an enlargement of your prostate gland, your signs and symptoms can
get worse while using Testorus Gel Rus Bio (including changes in urination).
o Possible increased risk of prostate cancer.
o Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include
leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include
difficulty breathing or chest pain.
o Possible increased risk of heart attack or stroke.
o In large doses, Testorus Gel Rus Bio may lower your sperm count.
o Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious
problems for people who have heart, kidney, or liver disease.
o Enlarged or painful breasts.
o Having problems breathing while you sleep (sleep apnea).
o The most common side effects of Testorus Gel Rus Bio include increased prostate specific
antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red
blood cell count, and skin irritation where the gel is applied.
o The most common side effects of Testorus Gel Rus Bio include acne, skin irritation
where Testorus Gel Rus Bio is applied, lab test changes, and increased prostate specific antigen.
o This is the most important information to know aboutTestorus Gel Rus Bio. For further
information, talk with your healthcare provider.
Please see the full Prescribing Information, including BOXED WARNING, and Medication
Guide for Testorus Gel Rus Bio and please see the full Prescribing Information, including BOXED
WARNING, and Medication Guide for Testorus Gel Rus Bio
