What is AndroGel?

AndroGel contains testosterone, a naturally occurring male hormone necessary for many processes in the body. It works by replacing or supplementing the testosterone that is naturally made in the body.

AndroGel is used to treat conditions in men that result from a lack of natural testosterone.

AndroGel will not enhance athletic performance and should not be used for this purpose.

Warnings

You should not use AndroGel if you have prostate cancer, male breast cancer, are pregnant, or are breastfeeding.

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

Before taking this medicine

You should not use AndroGel if you are allergic to testosterone patches or gels, or if you have;

• prostate cancer; or
• male breast cancer.

To make sure AndroGel is safe for you, tell your doctor if you have ever had:

• cancer;
• enlarged prostate, urination problems;
• sleep apnea (breathing stops during sleep);
• high blood pressure, heart disease, heart attack, or stroke;
• a blood clot;
• diabetes; or
• liver disease or kidney disease.

Older men who use AndroGel may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk.

AndroGel 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 testosterone 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.

Do not use AndroGel on anyone younger than 18 years old.

How should I use AndroGel?

Use AndroGel exactly as it was prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than prescribed.

Misuse of AndroGel 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.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply AndroGel only to your shoulders, upper arms, and/or abdomen that will be covered by a short sleeve t-shirt. Wash your hands with soap and water before and after applying the gel. Keep the area covered until you have washed the application area well or have showered. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.

Do not apply AndroGel to your penis or scrotum.

Apply AndroGel to dry skin after showering or bathing. Allow the medicine to dry for at least 5 minutes before you dress. Avoid showering, swimming or bathing for at least 2 hours after you application.

AndroGel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

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.

While using AndroGel, you may need frequent blood tests.

Use AndroGel 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.

What happens if I miss a dose?

Apply the gel as soon as you remember. Skip the missed dose if it is almost time to apply your next dose. Do not use extra gel to make up the missed dose.

What should I avoid while using AndroGel?

Do not apply this medicine to your penis or your scrotum.

Avoid swimming, bathing, or showering for at least 5 hours after applying AndroFel.

AndroGel side effects

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

Stop using AndroGel 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 AndroGel side effects may include:

• redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;
• increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);
• increased prostate-specific antigen;
• increased blood pressure;
• headache;
• mood changes, strange dreams;
• frequent or prolonged erections;
• nausea, vomiting; or
• swelling in your lower legs.

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 .

What other drugs will affect AndroGel?

Tell your doctor about all your current medicines and any you start or stop using during your treatment with AndroGel, especially:

• insulin;
• a blood thinner; (warfarin, Coumadin, Jantoven); or
• a steroid medicine; methylprednisolone (Medrol), prednisone (Sterapred), and others.

This list is not complete. Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is Jatenzo?

Jatenzo (testosterone) is a liquid filled capsule used to treat symptoms of low testosterone in men who have hypogonadism (a condition in which the body does not produce enough natural testosterone).

Jatenzo is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland, (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism.

Your doctor will order certain lab tests to check your testosterone levels to see if they are low before you begin to take this medicine.

Jatenzo should not be used treat the symptoms of low testosterone in men who have low testosterone due to aging (‘age-related hypogonadism’).

Jatenzo is not intended for use by women.

Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Jatenzo works by replacing testosterone that is normally produced by the body.

It is not known if testosterone is safe or effective in children younger than 18 years old. Improper use may affect bone growth in children.

Jatenzo is a controlled substance because it contains testosterone that can be a target for people who abuse prescription medicines. Keep this medicine in a safe place to protect it. Never give your Jatenzo 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.

Warnings

You should not be treated with Jatenzo if you have prostate cancer, male breast cancer, or low testosterone levels due to getting older.

Testosterone can increase your blood pressure, which can increase your risk of heart attack, stroke, or death. You may need to stop using Jatenzo or start taking blood pressure medication.

Jatenzo should not be used to enhance athletic performance.

Before taking this medicine

You should not take Jatenzo if you are allergic to testosterone, or if you have:

• low testosterone levels due to getting older;
• known or suspected prostate cancer; or
• male breast cancer.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart problems;
• high blood pressure;
• diabetes;
• chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• urination problems due to an enlarged prostate;
• depression, anxiety, a mood disorder, suicidal thoughts or actions;
• cancer;
• high red blood cell count (hematocrit) or high hemoglobin levels on a blood test; or
• liver or kidney disease.

Jatenzo is not approved for use in women.

It may be harder for you to get a woman pregnant while you are using this medicine.

Using Jatenzo may increase your risk of developing prostate cancer. Ask your doctor about your individual risk.

How should I take Jatenzo?

Take Jatenzo as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform tests to make sure this medicine is the right treatment for you.

The recommended starting dose of Jatenzo is 237 mg taken orally twice daily, once in the morning and once in the evening. Take with food.

You will need frequent blood tests and your blood pressure will need to be checked often. Your next dose may be delayed based on the results.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program.

Testosterone may be habit-forming. Misuse can cause addiction or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Jatenzo?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Jatenzo side effects

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

Testosterone can increase your blood pressure, which can increase your risk of heart attack, stroke, or death. You may need to stop using this medicine or start taking blood pressure medication.

Jatenzo may cause serious side effects. Call your doctor at once if you have:

• pain or swelling in your breasts;
• sleep apnea (breathing stops during sleep);
• unusual changes in mood or behavior, new or worsening depression, suicidal thoughts or actions;
• heart problems – swelling, rapid weight gain, feeling short of breath;
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of a blood clot in the lung – chest pain, sudden cough or shortness of breath, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot deep in the body – pain, swelling or warmth in your leg; or
• signs of an enlarged prostate – increased urination, a weak stream of urine, an urgent need to urinate, or loss of bladder control.

Common Jatenzo side effects may include:

• increased red blood cell counts;
• an enlarged prostate;
• erections that are more frequent or that last longer than usual;
• increased blood pressure;
• nausea, heartburn, burping;
• diarrhea;
• headache;
• swelling in your lower legs;
• joint, muscle or back pain;
• cold symptoms;
• breast swelling; or
• weight gain.