Kyzatrex (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).

Kyzatrex 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 Kyzatrex.

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

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. Kyzatrex works by replacing testosterone that is normally produced by the body.

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

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

Kyzatrex 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.

Kyzatrex should not be used to enhance athletic performance.

Before taking this medicine

You should not take Kyzatrex 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 Kyzatrex 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.

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

Take Kyzatrex 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.

Kyzatrex capsules are available in three strengths of 100 mg, 150 mg, and 200 mg.

Take Kyzatrex by mouth twice daily. Take one time in the morning and take one time in the evening. If your dose is 100 mg daily, just take one time in the morning.

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.

You should not take Kyzatrex 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 Kyzatrex 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.

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

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Kyzatrex 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.

Kyzatrex 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 Kyzatrex 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.

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.

Tell your doctor about all your other medicines, especially:

• insulin;

• medicine to treat pain, cough, or cold symptoms;

• a blood thinner - warfarin, Coumadin, Jantoven, apixaban, rivaroxaban, dabigatran; or

• steroid medicine - prednisone, dexamethasone, 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 drug interactions are listed here.