Aveed (Testosterone Undecanoate)

(tes tos' ter one)

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. A program has been set up to limit the use of testosterone undecanoate injection (Aveed) and to inform people about the increased risk of breathing problems and allergic reactions while receiving this medication. The program also makes sure that everyone who received this medication understands the risks and benefits from this medication and receives the medication in a setting where they can be monitored for serious reactions.

Testosterone cypionate (Depo-Testosterone), testosterone enanthate (Delatestryl), testosterone undecanoate (Aveed), and testosterone pellet (Testopel) are forms of testosterone injection 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 use testosterone injection. Testosterone enanthate (Delatestryl) and testosterone pellet (Testopel) are also used to stimulate puberty in males with delayed puberty. Testosterone enanthate (Delatestryl) injection may be used in certain women with a type of breast cancer called mammary cancer that has spread to other parts of the body. Testosterone should not be used to treat the symptoms of low testosterone in men who have low testosterone due to aging ('age related hypogonadism'). Testosterone is in a class of medications called androgenic hormones. 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 injection works by supplying synthetic testosterone to replace the testosterone that is normally produced naturally in the body. When used to treat breast cancer, testosterone works by stopping the release of estrogen.

Testosterone cypionate, testosterone enanthate, and testosterone undecanoate injection come as a solution (liquid) to be injected into a muscle by a doctor or nurse in a hospital or clinic. Testosterone injection is also comes as a pellet to be injected under the skin. 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.

Before receiving testosterone injection,
• tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in testosterone injection products. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what 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; and 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.
• if you are male, tell your doctor if you have breast cancer or have or may have prostate cancer. Also tell your doctor if you have heart, liver, or kidney disease. 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), benign prostate hyperplasia (BPH; an enlarged prostate), high blood levels of calcium, diabetes, or lung disease.
• women should not receive this medication if they are or may become pregnant or are breast-feeding. Testosterone may harm the baby.
• you should know that there have been reports of serious side effects in people who use 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 use testosterone injection exactly as directed by your doctor.

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

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

• acne
• breast enlargement or pain
• hoarseness
• deepening of voice
• pain or redness at injection site
• tiredness
• difficulty falling asleep or staying asleep
• mood swings
• weight gain

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
• shortness of breath
• nausea or vomiting
• swelling of the hands, feet, ankles, or lower legs
• slow or difficult speech
• dizziness or faintness
• weakness or numbness of an arm or leg
• chest pain
• 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
• yellowing of the skin or eyes

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 come into contact with the medication. This means that the children may stop growing sooner than expected and may have a shorter than expected adult height. Testosterone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

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.

Keep all appointments with your doctor and the laboratory. 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. 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.