FIRST-Testosterone

FIRST-Testosterone (for the skin) is used as hormone replacement therapy in adult men who have specific medical conditions that result in low or no testosterone levels.

Testosterone will not improve athletic performance and should not be used for that reason.

Testosterone is not approved for use in women or in men with low testosterone levels due to aging.

Testosterone may also be used for reasons not mentioned in this medication guide.

You should not receive treatment with testosterone if you have prostate cancer or male breast cancer.

FIRST-Testosterone can transfer from your skin to others. Avoid allowing treated skin areas to touch other people, especially children and women.

This medicine is not approved for use in women. Testosterone may harm an unborn baby.

You should not use FIRST-Testosterone if you are allergic to it, or if you have:

• known or suspected prostate cancer; or
• male breast cancer.

Tell your doctor if you have or have ever had:

• heart problems;
• cancer;
• diabetes;
• urination problems due to an enlarged prostate;
• a heart attack, stroke, or blood clot;
• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorders;
• any other medical condition; or
• liver or kidney disease.

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

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

This medicine is not approved for use in women. Testosterone may harm an unborn baby. Testosterone can be absorbed through skin contact with another person who is being treated with this medication.

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

Testosterone can increase your risk of blood clots, stroke, or heart attack. Get emergency medical help if you have: chest pain, pain, swelling or warmth in your leg, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath, or trouble breathing.

Testosterone may cause serious side effects. Stop using testosterone and call your doctor right away 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;
• signs of heart problems or fluid retention--swelling, rapid weight gain, feeling short of breath;
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• signs of an enlarged prostate--increased or urgent need to urinate, little or no urination, loss of bladder control, or other problems urinating.

Topical testosterone is absorbed through the skin and can cause side effects in anyone who comes into contact with FIRST-Testosterone. You may need to stop using testosterone and call your doctor if a person who has close contact with you develops unexpected sexual changes or male features, aggressive behavior, changes in body hair, increase in acne, or unexpected bone growth.

Common side effects of FIRST-Testosterone may include:

• redness or irritation in the area of the skin where the medicine was applied;
• acne, skin color changes;
• abnormal labs such as increased prostate-specific antigen and increased red blood cell counts;
• increased blood pressure;
• headache;
• mood changes such as depression, strange dreams;
• erections that are more frequent or that last longer than usual;
• nausea, vomiting, or diarrhea; 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 at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Never use testosterone in larger amounts, or for longer than prescribed.

Do not take by mouth. Topical medicine is for use only on the skin.

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

Wash your hands before and after applying this medicine. Use a mild soap to clean the skin area to be treated.

Your dose needs and application site may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Read and carefully follow any Instructions for Use provided for preparing and applying testosterone for the first time and subsequent doses. Each brand form of testosterone has different instructions for use.

Apply this medicine only to the skin areas recommended for your specific formulation of testosterone. Ask your doctor or pharmacist if you do not understand these instructions.

Certain brand forms of testosterone contain alcohol and are flammable until dry. Do not use near high heat or open flame.

You will need frequent blood tests and your blood pressure will need to be checked often.

Do not keep leftover medicine. Just one dose can cause serious side effects in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program, or how to safely dispose of unused or used testosterone.

Testosterone may be habit-forming. Misuse can cause addiction, overdose, 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, heat, and light. Follow all storage instructions provided with testosterone.

Apply the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not apply two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Do not apply FIRST-Testosterone to your penis or scrotum. Certain brand forms should also not be applied to the stomach, shoulders, upper arms, knees, or areas that receive the most pressure while sleeping or sitting.

Avoid swimming, strenuous activity, or washing the area where the medicine was applied for at least 2 to 5 hours after applying it to ensure absorption.

Do not get this medicine in your eyes. If contact does occur, rinse with water.

Avoid contact with unwashed or uncovered application areas. Cover treated skin areas with clothing to avoid contact with other people (especially children and women).

Avoid using other medications or skin products on the treated skin areas, unless your doctor tells you to.

Tell your doctor about all your other medicines, especially:

• insulin;
• corticotropin (ACTH);
• a blood thinner--warfarin, Coumadin, Jantoven, apixaban, rivaroxaban, dabigatran; or
• oral or topical steroid medicine--prednisone, dexamethasone, and others.

This list is not complete. Other drugs may affect testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.