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Brand Name(s):

  • Jatenzo®

Other Name(s):

  • testosterone undecanoate

IMPORTANT WARNING

Testosterone may cause an increase in blood pressure which can increase your risk of having a heart attack or stroke that may be life-threatening. Tell your doctor if you have or have ever had high blood pressure, heart disease, a heart attack, or a stroke. Tell your doctor and pharmacist if you are taking medications for blood pressure, pain, or cold symptoms. If you experience any of the following symptoms, call your doctor immediately: chest pain; shortness of breath; pain in the arms, back, neck, or jaw; slow or difficult speech; dizziness or faintness; or weakness or numbness of an arm or leg.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to testosterone. Your blood pressure should be checked before starting treatment and regularly while you are taking testosterone.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with testosterone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Testosterone is used to treat symptoms of low testosterone in men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone 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 testosterone. Testosterone 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. Testosterone works by replacing testosterone that is normally produced by the body.

HOW should this medicine be used?

Testosterone comes as a capsule to take by mouth. It is usually taken with food twice a day (in the morning and in the evening). Take testosterone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take testosterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Testosterone may control your symptoms but will not cure your condition. Your doctor may adjust your dose of testosterone depending on the amount of testosterone in your blood during your treatment and your reaction to the medication.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking testosterone,

  • tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in testosterone capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), insulin (Apridra, Humalog, Humulin, others), medications for diabetes, oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor will probably tell you that you should not take testosterone.
  • tell your doctor if you have or have ever had high cholesterol; sleep apnea (breathing stops for short periods of time during sleep); benign prostate hyperplasia (BPH; an enlarged prostate); high blood levels of calcium; cancer; diabetes; depression or other mental illness; or kidney, liver, or lung disease.
  • you should know that testosterone is only for use in adult men. Children, teenagers, and women should not use this medication. Testosterone may stop bone growth and cause precocious puberty (early puberty) in children and teenagers. Testosterone may cause deepening of voice, hair growth in unusual places, genital enlargement, decrease in breast size, male-pattern hair loss, and unusual menstrual cycles in women. If testosterone is used by women who are pregnant, may become pregnant, or are breastfeeding, it may harm the baby.
  • you should know that there have been reports of serious side effects in people who take testosterone at higher doses, along with other male sex hormone products, or in ways other than directed by a doctor. These side effects may include a heart attack, heart failure, or other heart problems; stroke and mini-stroke; liver disease; seizures; or mental health changes such as depression, mania (frenzied, abnormally excited mood), aggressive or unfriendly behavior, hallucinations (seeing things or hearing voices that do not exist), or delusions (having strange thoughts or beliefs that have no basis in reality). People who use higher doses of testosterone than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, craving, irritability, restlessness, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop using testosterone. Be sure to take testosterone exactly as directed by your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Testosterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • heartburn
  • diarrhea
  • gas
  • headache
  • breast pain or enlargement

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • lower leg pain, swelling, warmth, or redness
  • difficulty breathing, especially at night
  • swelling of the hands, feet, and ankles
  • sudden unexplained weight gain
  • erections that happen too often or that last too long
  • difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
  • vomiting
  • nausea
  • extreme tiredness
  • yellowing of the skin or eyes
  • dark urine
  • pain in the upper right part of the stomach
  • mood changes including depression, anxiety, or becoming suicidal (thinking about harming or killing oneself or planning or trying to do so)

Testosterone may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children.

Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of receiving this medication.

Testosterone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking testosterone.

Do not let anyone else use your medication. Testosterone is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2019.