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Testosterone undecanoate

Pronunciation

Generic Name: testosterone undecanoate (tes-TOS-ter-one)
Brand Name: Aveed

A severe lung problem called a pulmonary oil microembolism reaction has happened with testosterone undecanoate. Allergic reactions have also happened with testosterone undecanoate. Sometimes, allergic reactions have been life-threatening. These reactions have happened while testosterone undecanoate was given and right after. These reactions can happen with any dose of testosterone undecanoate.

You will be watched closely in a health care setting for 30 minutes after a dose of testosterone undecanoate. Call your doctor right away if you have symptoms of a pulmonary oil microembolism reaction (eg, chest pain, cough or the need to cough, dizziness, fainting, shortness of breath, sweating, throat tightness).

Testosterone undecanoate is only available through a special program called the Aveed Risk Evaluation and Mitigation Strategy (REMS) Program. Talk to your doctor to be sure you are enrolled in this program and that you meet all of its requirements.


Testosterone undecanoate is used for:

Treating symptoms of low testosterone in men when the body does not make any testosterone or not enough testosterone (hypogonadism). It may also be used for other conditions as determined by your doctor.

Testosterone undecanoate is a male sex hormone. It works by replacing or supplementing the testosterone that is naturally made in the body.

Do NOT use testosterone undecanoate if:

  • you are allergic to any ingredient in testosterone undecanoate
  • you are pregnant, planning to become pregnant, or are breast-feeding
  • you have breast cancer or known or suspected prostate cancer

Contact your doctor or health care provider right away if any of these apply to you.

Before using testosterone undecanoate:

Some medical conditions may interact with testosterone undecanoate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart problems (eg, heart failure), kidney or liver problems, an enlarged prostate gland, high cholesterol levels, swelling (edema) or problems retaining fluid, lung problems, cancer, high blood calcium levels, diabetes, or sleep apnea (long pauses in breathing while you sleep)
  • if you are very overweight
  • if you have a history of blood clots

Some MEDICINES MAY INTERACT with testosterone undecanoate. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), insulin, or oral hypoglycemics (eg, glyburide) because the risk of their side effects may be increased by testosterone undecanoate

This may not be a complete list of all interactions that may occur. Ask your health care provider if testosterone undecanoate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use testosterone undecanoate:

Use testosterone undecanoate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Testosterone undecanoate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get testosterone undecanoate refilled.
  • Testosterone undecanoate is given as an injection into a muscle at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • Do not use testosterone undecanoate if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of testosterone undecanoate, call your doctor to find out what to do.

Ask your health care provider any questions you may have about how to use testosterone undecanoate.

Important safety information:

  • Tell your doctor or dentist that you take testosterone undecanoate before you receive any medical or dental care, emergency care, or surgery.
  • Testosterone undecanoate is not approved for treating low testosterone levels caused by aging. Discuss any questions or concerns with your doctor.
  • Blood clots have happened in patients using testosterone products such as testosterone undecanoate. Tell your doctor if you have ever had a blood clot. Call your doctor right away if you have symptoms of a blood clot (eg, swelling, warmth, numbness, change of color, or pain in a leg or arm; chest pain; shortness of breath; coughing up blood).
  • Testosterone undecanoate may increase the risk of heart attack or stroke. Call your doctor right away if you have chest pain or pressure, confusion, one-sided weakness, or speech or vision problems.
  • If you already have an enlarged prostate gland, your symptoms can get worse while you get testosterone undecanoate. Call your doctor if your symptoms get worse while using testosterone undecanoate.
  • People treated with medicines like this one may have a raised risk for prostate cancer. Discuss any questions or concerns with your doctor.
  • Testosterone undecanoate may affect sperm in men. This may affect being able to father a child. Discuss any questions or concerns with your doctor.
  • Diabetes patients - Testosterone undecanoate may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Testosterone undecanoate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using testosterone undecanoate.
  • Lab tests may be performed while you use testosterone undecanoate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use testosterone undecanoate with caution in the ELDERLY; they may be more sensitive to its effects, especially heart disease, an enlarged prostate, or prostate cancer.
  • PREGNANCY and BREAST-FEEDING: Using testosterone undecanoate while pregnant may cause harm to the fetus. It is not known if this medicine is found in breast milk. Testosterone undecanoate is not approved for use in women.

Possible side effects of testosterone undecanoate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; change in sex drive; emotional ups and downs; pain at the injection site; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the size or shape of the testicles; changes in skin color; decreased sex ability; enlarged or painful breasts; erections that happen often or that last a long time; long pauses in breathing while you sleep; mood changes; swelling of the hands, ankles, or feet; symptoms of blood clots (eg, calf or leg pain, swelling, redness, or tenderness; chest pain; coughing up blood; shortness of breath); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; right-sided stomach pain; unusual nausea, vomiting, or tiredness; yellowing of the skin or eyes); urination problems (eg, feeling the need to pass urine right away, having a urine accident, passing urine more at night, passing urine often during the day, trouble starting the urine stream, weak urine stream); weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of testosterone undecanoate:

Testosterone undecanoate is usually handled and stored by a health care provider. If you are storing testosterone undecanoate at home, store testosterone undecanoate as directed by your pharmacist or health care provider. Keep testosterone undecanoate out of the reach of children and away from pets.

General information:

  • If you have any questions about testosterone undecanoate, please talk with your doctor, pharmacist, or other health care provider.
  • Testosterone undecanoate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take testosterone undecanoate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 testosterone undecanoate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to testosterone undecanoate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using testosterone undecanoate.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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