Features of 2% FORTESTA® Gel and its Authorized Generic

Why ask your healthcare professional about 2% FORTESTA® Gel and its Authorized Generic?

2% FORTESTA® Gel and its Authorized Generic are topical gels with a 2% concentration of testosterone (T) that are applied to the front and inner thighs with just one finger. A small amount of gel applied each day may be all that's needed to help raise your T.

Results from a clinical study showed that 2% FORTESTA® Gel was effective for a majority of men who were treated for low testosterone (Low T).

  • The most common side effects of FORTESTA® Gel and Testosterone Gel include skin redness or irritation where FORTESTA® Gel or Testosterone Gel is applied, increased prostate specific antigen (PSA) (a test used to screen for prostate cancer), and abnormal dreams

Treatment with 2% FORTESTA® Gel or its Authorized Generic is:

Applied with just one finger
Colorless and odorless, applied with just one finger
  • Direct, discreet application onto front and inner thighs
  • The most common adverse reaction is skin redness or irritation where FORTESTA® Gel or Testosterone Gel is applied
Quick to dry
Quick to dry—dried quickly (in less than 2.5 minutes) after application in a study of men with Low T
  • Your drying time may vary
  • Avoid swimming, showering, or bathing for at least 2 hours after you apply FORTESTA® Gel or Testosterone Gel
  • FORTESTA® Gel and Testosterone Gel are flammable until dry. Let FORTESTA® Gel or Testosterone Gel dry before smoking or going near an open flame
Low volume of gel
Low volume of gel—a small amount may be all you need
  • Two pumps of 2% FORTESTA® Gel or its Authorized Generic, which contains 20 mg of testosterone total, are no bigger than a quarter
  • Your healthcare professional will decide the dose that is right for you. Please follow the dosing instructions as provided by your healthcare professional
Available in a small, travel-sized canister
When it is time to throw away the canister, safely throw away used FORTESTA® Gel or its Authorized Generic in household trash. Be careful to prevent accidental exposure of children or pets.
Approximate size
20 mg of gel is no bigger than a quarter

If you're just starting a Low T treatment, or looking to return to one, ask your healthcare professional if 2% FORTESTA® Gel or its Authorized Generic is right for you.


INDICATION

What are FORTESTA® (testosterone) Gel and Testosterone Gel?

FORTESTA® Gel and Testosterone Gel are prescription medications that contain testosterone. They are used to treat adult males who have low or no testosterone due to certain medical conditions. Your healthcare provider will test your blood before you start taking and while you are taking FORTESTA® Gel or Testosterone Gel.

It is not known if FORTESTA® Gel and Testosterone Gel are safe or effective to treat men who have low testosterone due to aging.

It is not known if FORTESTA® Gel and Testosterone Gel are safe or effective in children younger than 18 years old. Improper use of FORTESTA® Gel and Testosterone Gel may affect bone growth in children.

FORTESTA® Gel and Testosterone Gel are controlled substances (CIII) because they contain testosterone that can be a target for people who abuse prescription medicines. Keep your FORTESTA® Gel or Testosterone Gel in a safe place to protect it. Never give FORTESTA® Gel or Testosterone 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 and Testosterone Gel are not meant for use in women.

IMPORTANT SAFETY INFORMATION about FORTESTA® Gel and Testosterone Gel

What is the most important information I should know about FORTESTA® Gel and Testosterone Gel?

  • FORTESTA® Gel and Testosterone Gel can transfer from your body to others. This can happen if other people come into contact with the area where the FORTESTA® Gel or Testosterone 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 FORTESTA® Gel and Testosterone Gel
    • Women and children should avoid contact with the unwashed or unclothed areas where FORTESTA® Gel or Testosterone Gel have been applied. If a woman or child makes contact with the FORTESTA® Gel or Testosterone 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 or Testosterone Gel from your body to others, you should: Apply FORTESTA® Gel or Testosterone 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 or Testosterone 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 or Testosterone 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 or Testosterone Gel
  • Do not use FORTESTA® Gel or Testosterone Gel if you have breast cancer, have or might have prostate cancer, are pregnant, may become pregnant, or are breastfeeding
    • FORTESTA® Gel and Testosterone 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 or Testosterone Gel have 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 or Testosterone 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 or Testosterone Gel
  • Possible increased risk of prostate cancer
  • Blood clots in the legs or lungs. This can include pain, swelling or redness of your legs, difficulty breathing, or chest pain
  • Possible increased risk of heart attack, death or stroke
  • In large doses FORTESTA® Gel and Testosterone 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
  • Problems breathing while you sleep (sleep apnea)
  • Increased red blood cell count
  • FORTESTA® Gel and Testosterone Gel may cause an increase in blood calcium levels in some patients with cancer
  • FORTESTA® Gel and Testosterone Gel are flammable until dry. Let FORTESTA® Gel and Testosterone 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 healthcare provider about all of your medications, especially insulin, medicines that decrease blood clotting, and corticosteroids.

The most common side effects of FORTESTA® Gel and Testosterone Gel include skin redness or irritation where FORTESTA® Gel or Testosterone Gel is applied, increased prostate specific antigen (PSA) (a test used to screen for prostate cancer), and abnormal dreams.

Other side effects include more erections than are normal for you or erections that last for a long time.

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.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FORTESTA® Gel and Testosterone Gel. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information, including the Medication Guide for patients for FORTESTA® Gel.

Please see the full Prescribing Information, including the Medication Guide for patients for Testosterone Gel.

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.

MORE SAFETY INFO
INDICATION

What are FORTESTA® (testosterone) Gel and Testosterone Gel?

FORTESTA® Gel and Testosterone Gel are prescription medications that contain testosterone. They are used to treat adult males who have low or no testosterone due to certain medical conditions. Your healthcare provider will test your blood before you start taking and while you are taking FORTESTA® Gel or Testosterone Gel.

It is not known if FORTESTA® Gel and Testosterone Gel are safe or effective to treat men who have low testosterone due to aging.

It is not known if FORTESTA® Gel and Testosterone Gel are safe or effective in children younger than 18 years old. Improper use of FORTESTA® Gel and Testosterone Gel may affect bone growth in children.

FORTESTA® Gel and Testosterone Gel are controlled substances (CIII) because they contain testosterone that can be a target for people who abuse prescription medicines. Keep your FORTESTA® Gel or Testosterone Gel in a safe place to protect it. Never give FORTESTA® Gel or Testosterone 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 and Testosterone Gel are not meant for use in women.

IMPORTANT SAFETY INFORMATION about FORTESTA® Gel and Testosterone Gel

What is the most important information I should know about FORTESTA® Gel and Testosterone Gel?

  • FORTESTA® Gel and Testosterone Gel can transfer from your body to others. This can happen if other people come into contact with the area where the FORTESTA® Gel or Testosterone 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 FORTESTA® Gel and Testosterone Gel
    • Women and children should avoid contact with the unwashed or unclothed areas where FORTESTA® Gel or Testosterone Gel have been applied. If a woman or child makes contact with the FORTESTA® Gel or Testosterone 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 or Testosterone Gel from your body to others, you should: Apply FORTESTA® Gel or Testosterone 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 or Testosterone 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 or Testosterone 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 or Testosterone Gel
  • Do not use FORTESTA® Gel or Testosterone Gel if you have breast cancer, have or might have prostate cancer, are pregnant, may become pregnant, or are breastfeeding
    • FORTESTA® Gel and Testosterone 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 or Testosterone Gel have 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 or Testosterone 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 or Testosterone Gel
  • Possible increased risk of prostate cancer
  • Blood clots in the legs or lungs. This can include pain, swelling or redness of your legs, difficulty breathing, or chest pain
  • Possible increased risk of heart attack, death or stroke
  • In large doses FORTESTA® Gel and Testosterone 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
  • Problems breathing while you sleep (sleep apnea)
  • Increased red blood cell count
  • FORTESTA® Gel and Testosterone Gel may cause an increase in blood calcium levels in some patients with cancer
  • FORTESTA® Gel and Testosterone Gel are flammable until dry. Let FORTESTA® Gel and Testosterone 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 healthcare provider about all of your medications, especially insulin, medicines that decrease blood clotting, and corticosteroids.

The most common side effects of FORTESTA® Gel and Testosterone Gel include skin redness or irritation where FORTESTA® Gel or Testosterone Gel is applied, increased prostate specific antigen (PSA) (a test used to screen for prostate cancer), and abnormal dreams.

Other side effects include more erections than are normal for you or erections that last for a long time.

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.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FORTESTA® Gel and Testosterone Gel. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information, including the Medication Guide for patients for FORTESTA® Gel.

Please see the full Prescribing Information, including the Medication Guide for patients for Testosterone Gel.

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.


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FORTESTA® is a registered trademark of Endo International plc or one of its affiliates.

© 2016 Endo Pharmaceuticals Inc. All rights reserved. Malvern, PA 19355

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IMPORTANT SAFETY INFORMATION about FORTESTA® Gel and Testosterone Gel

What is the most important information I should know about FORTESTA® Gel and Testosterone Gel?