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 https://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.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
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.
What special precautions should I follow?
Before receiving testosterone injection,
- tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving testosterone injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are male, tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor may tell you that you should not receive testosterone injection.
- tell your doctor if you have or have ever had sleep apnea (breathing stops for short periods of time during sleep); urinary problems; benign prostate hyperplasia (BPH; an enlarged prostate); high blood levels of calcium; cancer; diabetes; depression or other mental illness; high blood pressure, heart disease, a heart attack, or a stroke; blood clots; higher than normal red blood cell counts; or liver, kidney, or lung disease.
- women who can become pregnant should not use this medication. 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 testosterone may cause serious side effects if used at higher doses 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 use testosterone injection exactly as directed by your doctor.
- you should know that testosterone may cause an increase in blood pressure. This may increase your risk of having a heart attack or stroke that may be life-threatening. 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. Your doctor may check your blood pressure before starting treatment and regularly while you are receiving testosterone injection.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
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 https://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 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:
- acne
- pain, redness, bruising, bleeding, or hardness at injection site
- tiredness
- difficulty falling asleep or staying asleep
- mood swings
- weight gain
- headache
- joint pain
- back pain
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:
- lower leg pain, swelling, warmth, or redness
- swelling of the hands, feet, ankles, or lower legs
- difficulty breathing, especially during sleep
- erections that happen too often or that last too long
- difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away, blood in the urine
- nausea or vomiting, yellowing of the skin or eyes, dark urine, or 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)
- enlarged or painful breasts
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 ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).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 reach https://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 https://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