Risk of virilization in children and women following secondary exposure to testosterone in topically administered testosterone gel. Advise children and women to avoid contact with application sites of men using testosterone gel. (See Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.)
Advise men using testosterone gel to strictly adhere to recommended instructions for use. (See Administration under Dosage and Administration.)
REMS:
FDA approved a REMS for testosterone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of testosterone and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
TESTOSTERONE (tes TOS ter one) is the main male hormone. It supports normal male traits such as muscle growth, facial hair, and deep voice. This medicine is used in males to treat low testosterone levels.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual or allergic reaction to testosterone, other medicines, foods, dyes, or preservatives
this drug is not for use in females
How should I use this medicine?
This medicine will be inserted under your skin by your doctor or health care professional.
Contact your pediatrician or health care professional regarding the use of this medicine in children. While this medicine may be prescribed for children for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
Try not to miss a dose. Your doctor or health care professional will tell you when your next dose is due. Notify the office if you are unable to keep an appointment.
What may interact with this medicine?
medicines for diabetes
medicines that treat or prevent blood clots like warfarin
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. They will need to check the level of testosterone in your blood.
This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.
Call your doctor or health care professional if you notice a change in the way this medicine is working. It is possible that the pellets may accidentally fall out.
This drug is banned from use in athletes by most athletic organizations.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
breast enlargement
breathing problems
changes in mood, especially anger, depression, or rage
dark urine
general ill feeling or flu-like symptoms
light-colored stools
loss of appetite, nausea
nausea, vomiting
right upper belly pain
stomach pain
swelling of ankles
too frequent or persistent erections
trouble passing urine or change in the amount of urine
unusually weak or tired
yellowing of eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug will be inserted under your skin by your doctor. It will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
