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Testosterone undecanoate injection (Aveed®) may cause serious breathing problems and allergic reactions, during or immediately after the injection. The injection should be given by a doctor or nurse in a healthcare setting where these problems or reactions can be treated. You will need to remain in the healthcare setting for at least 30 minutes after you receive your injection. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after your injection: tightening of your throat, difficulty breathing, difficulty swallowing, shortness of breath, cough or urge to cough, chest pain, dizziness, fainting, sweating, rash, hives, or itching.
Because of the risks of serious breathing problems and allergic reactions, testosterone undecanoate injection (Aveed®) is only available through a special program. This program is called the Aveed® REMS. Your doctor must be enrolled in this program before you can receive this medication. Ask your doctor for more information about this program and how you will receive your medication.
You will be given the Medication Guide when you begin treatment with testosterone injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.
WHY is this medicine prescribed?
Testosterone injection is used to treat low or no testosterone levels, stimulate puberty in males with delayed puberty, and certain types of breast cancer. Testosterone is in a class of medications called androgenic hormones. Testosterone is a male sex hormone responsible for development and functioning of male sexual organs and typical male characteristics. Testosterone injection works by replacing the testosterone that is normally produced naturally in the body. When used to treat breast cancer, testosterone works by stopping the release of estrogen.
HOW should this medicine be used?
Testosterone injection comes as a solution (liquid) to be injected into a muscle by a doctor or nurse in an office setting or clinic. It also comes as a solution (liquid) to be injected subcutaneously (under the skin) once a week by yourself or a caregiver. Testosterone also comes as pellets to be implanted under the skin by a doctor or nurse in an office setting or clinic.
Use subcutaneous testosterone injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Your first dose of subcutaneous testosterone injection will be given in your doctor's office. After that, you may be allowed to inject the medicine yourself or a caregiver may give it to you. Your healthcare provider will show you or your caregiver how to inject testosterone. Read the written instructions that come with it before injecting your first dose. Be sure that you understand these instructions, and ask your healthcare provider if you have any questions.
Always look at testosterone solution before you inject it. It should be clear to light yellow in color and free of visible particles. Do not use it if it is cloudy, contains visible particles, or if the expiration date on the package has passed.
You can inject testosterone in the left or right side of your stomach except your navel (belly button) and the area 2 inches around it. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars, tattoos, or stretch marks.
Testosterone injection 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.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving testosterone injection,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
Testosterone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:
Testosterone injection 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 injection may cause the bones to mature more quickly than normal in children who receive the medication. This means that the children may stop growing sooner than expected and may have a shorter than expected adult height. Testosterone may also cause precocious puberty (early puberty) in children and teenagers.
Testosterone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
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 http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What should I know about STORAGE and DISPOSAL of this medication?
Keep testosterone enanthate injection (Xyosted®) in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Do not refrigerate or freeze.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reachhttp://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your testosterone levels to see if they are low before you begin to receive testosterone injection. Your doctor may order certain tests to check your body's response to testosterone injection.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving testosterone injection.
Do not let anyone else use your testosterone enanthate injection. Testosterone is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies
¶ This branded product is no longer on the market. Generic alternatives may be available.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: May 15, 2025.