IMPORTANT SAFETY INFORMATION
What is FORTESTA® (testosterone) Gel?
FORTESTA Gel is a prescription medication that contains testosterone. It is used to treat adult males who have low or no testosterone. Your healthcare provider will test your blood before you start taking and while you are taking FORTESTA Gel.
It is not known if FORTESTA Gel is safe or effective in children younger than 18 years old. Improper use of FORTESTA Gel may affect bone growth in children.
FORTESTA Gel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your FORTESTA Gel in a safe place to protect it. Never give FORTESTA Gel to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.
FORTESTA Gel is not meant for use in women.
What is the most important information I should know about FORTESTA Gel?
- FORTESTA Gel can transfer from your body to others. This can happen if other people come into contact with the area where the FORTESTA Gel was applied.
- Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like
- Women and children should avoid contact with the unwashed or unclothed areas where
FORTESTA Gel has been applied. If a woman or child makes contact with the FORTESTA Gel application area, that area on the woman or child should be washed well with soap and water right away.
- To lower the risk of transfer of FORTESTA Gel from your body to others, you should: Apply FORTESTA Gel only to the front and inside area of your thighs that will be covered by clothing and wash your hands right away with soap and water after applying FORTESTA Gel. After the gel has dried, cover the application area with clothing and keep the area covered until you have washed the application area well or have showered.
- If you expect another person to have skin-to-skin contact with your thighs, first wash the application area well with soap and water.
- Stop using FORTESTA Gel and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to FORTESTA Gel.
- Do not use FORTESTA Gel if you have breast cancer, have or might have prostate cancer, are pregnant, may become pregnant, or are breastfeeding.
- FORTESTA Gel may harm your unborn or breastfeeding baby. Women who are, or who may become pregnant should avoid contact with the area of skin where FORTESTA Gel has been applied.
- Your doctor may check your testosterone, prostate specific antigen (PSA), blood count, liver function, cholesterol and blood calcium levels while taking FORTESTA Gel.
Other possible serious side effects include:
- If you already have enlargement of your prostate gland your signs and symptoms can get worse while using FORTESTA Gel
- Possible increased risk of prostate cancer
- In large doses FORTESTA Gel may lower your sperm count
- 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
- Enlarged or painful breasts
- Have problems breathing while you sleep (sleep apnea)
- Increased red blood cell count
- Blood clots in the legs. This can include pain, swelling or redness of your legs
- FORTESTA Gel may cause an increase in blood calcium levels in some patients with cancer
- FORTESTA Gel is flammable until dry. Let FORTESTA Gel dry before smoking or going near an open flame
- Call your healthcare provider right away if you have any of the serious side effects listed above
Tell your HCP about all of your medications, especially insulin, medicines that decrease blood clotting, and corticosteroids.
The most common side effects of FORTESTA Gel include skin redness or irritation where FORTESTA Gel is applied, increased prostate specific antigen (PSA) (a test used to screen for prostate cancer), and abnormal dreams.
Please see the full Prescribing Information, including the Boxed Warning and Medication Guide for patients.