Fortesta

FORTESTA is a clear, colorless, odorless, gel containing testosterone. FORTESTA is available in a metered-dose pump. Each pump actuation provides 10 mg of testosterone and each container is capable of dispensing 120 pump actuations. One pump actuation dispenses 0.5 g of gel.

The active pharmacologic ingredient in FORTESTA is testosterone. Testosterone USP is a white to almost white powder described chemically as 17-beta hydroxyandrost-4-en-3-one.

Pharmacologically inactive ingredients in FORTESTA are: propylene glycol, purified water, ethanol, 2-propanol, oleic acid, carbomer 1382, triethanolamine and butylated hydroxytoluene.

• Endo Pharmaceuticals, Inc.

• Low Testosterone (Low T)

You should not use this medicine if you have prostate cancer or male breast cancer.

Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with this medicine, or with a man's skin where the medicine has been applied.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Misuse of testosterone can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.

Follow all directions on your prescription label. Never use testosterone topical in larger amounts, or for longer than prescribed.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

Different brands of testosterone topical have different instructions for use. Not every brand of this medicine is used on the same skin areas. Some brands are applied to the shoulder, upper arm, or stomach. Other brands are applied to the thighs or to the underarms. Carefully follow the patient instructions provided with your medicine.

Do not apply testosterone topical to your penis or scrotum. Some brands of this medicine should also not be applied to the back, chest, or stomach areas. Apply this medicine only to the skin areas recommended for your specific brand of testosterone topical.

Apply testosterone gel to dry skin after showering or bathing. Allow the medicine to dry for at least 5 minutes before you dress.

Wash your hands with soap and water after applying the gel.

Cover treated skin areas with clothing to keep from getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.

Apply the transdermal skin patch to a flat, clean, dry, and undamaged area of skin on your back, stomach, upper arm, or thigh. Wear the patch for 24 hours and then replace it with a new patch. Choose a different skin area each time you put on a new patch. Do not use the same skin area twice in a 7-day period.

While using testosterone topical, you may need frequent blood tests.

Use testosterone topical regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

Keep each skin patch in the foil pouch until you are ready to use it. Do not use a skin patch that has been cut or damaged After removing a skin patch, fold it closed with the sticky side in, and throw it away in a place where pets and children cannot reach it.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using testosterone topical and call your doctor at once if you have:

• increased urination (many times per day), loss of bladder control;

• painful or difficult urination;

• breast pain or swelling;

• painful or bothersome erections;

• swelling, rapid weight gain, shortness of breath during sleep;

• chest pain or pressure, pain spreading to your jaw or shoulder;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.

Common side effects may include:

• redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;

• headache, mood changes;

• increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);

• vomiting, diarrhea;

• strange dreams;

• frequent or prolonged erections; or

• high blood pressure--severe headache, blurred vision, pounding in your neck or ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• If you have an allergy to testosterone or any other part of Fortesta (testosterone gel).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are male and have breast or prostate cancer.
• If you have any of these health problems: Heart disease, kidney disease, or liver disease.
• If you are a woman. This medicine is not approved for use in women. If you are a woman using this medicine, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.
• If the patient is a child. Do not give Fortesta to a child.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Fortesta with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, hard stools (constipation), or bone pain.
• For males, erections (hard penis) that happen often or that last a long time.
• Passing urine more often.
• Trouble passing urine.
• Passing urine in a weak stream or drips.
• Not able to control passing urine.
• Mood changes.
• Low mood (depression).
• Change in how you act.
• Enlarged breasts.
• Breast pain.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Upset stomach or throwing up.
• Trouble breathing when sleeping.
• Feeling sleepy during the day.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Change in color of skin.
• Change in size or shape of testicles.
• Very bad irritation where Fortesta is used.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Fortesta is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Fortesta or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Fortesta. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Fortesta gel should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with Fortesta gel, or with a man's skin areas where the gel has been applied. If contact does occur, wash with soap and water right away.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with Fortesta. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Misuse of Fortesta can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.