GENERIC NAME(S): Testosterone Undecanoate
OTHER NAME(S): Aveed Solution
FDA WARNING: The FDA is asking that all testosterone drugs carry a warning that they may increase the risk of heart attacks and strokes. Read More
This medication can rarely cause a certain serious lung problem (pulmonary oil microembolism-POME), caused by tiny droplets of oil that have traveled to the lungs. Symptoms may include cough/urge to cough, difficulty breathing, sweating, tightening of the throat, chest pain, dizziness, or fainting. Most of the time, symptoms last only a few minutes and improve with medical help. However, symptoms have sometimes lasted up to several hours, or worsened and required treatment in a hospital. Serious (rarely fatal) allergic reactions may also occur. These side effects may happen during or right after each injection. To be sure that you do not have a serious reaction, you will need to stay in a health care setting for 30 minutes after each injection so your doctor can carefully monitor you and provide medical help if needed.
This medication is available only through a restricted program called the Aveed REMS Program. Only doctors enrolled in the program may prescribe or give this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.Show More
This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.
Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty.
This product should not be used in women.
How to use Aveed Vial
This medication is given by injection into the buttock muscle as directed by your doctor. After the first dose, it is usually given 4 weeks later, then every 10 weeks. The dosage is based on your medical condition, testosterone blood levels, and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, use a calendar to mark the days you will receive an injection.
Misuse or abuse of testosterone can cause serious side effects such as heart disease (including heart attack), stroke, liver disease, mental/mood problems, abnormal drug-seeking behavior, or improper bone growth (in adolescents). Do not increase your dose or use this drug more often or for longer than prescribed. When testosterone is misused or abused, you may have withdrawal symptoms (such as depression, irritability, tiredness) when you suddenly stop using the drug. These symptoms may last from weeks to months.
Tell your doctor if your condition does not improve or if it worsens.
See also Warning section.
Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. Pain or redness at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects when it is used at normal doses.
Tell your doctor right away if you have any serious side effects, including: breast swelling/tenderness, mental/mood changes (such as depression, agitation, hostility), unusual snoring or difficulty breathing during sleep, swelling hands/ankles/feet, symptoms of liver problems (such as loss of appetite, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine), trouble urinating, increased urination (especially at night), too frequent/prolonged erections, fast/irregular heartbeat.
Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, get medical help right away, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl benzoate, refined castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer (especially prostate or breast cancer), prostate problems (such as enlarged prostate), heart problems (such as heart failure, previous heart attack), stroke, kidney problems, liver problems, high cholesterol, difficulty breathing during sleep (sleep apnea), blood clots (such as in the leg, lungs).
If you have diabetes, this product may lower your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar, such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
Children may be more sensitive to the side effects of this drug. In children, it may affect bone growth. Check your child's height periodically.
Some men, particularly older adults, are at a higher risk for developing enlarged prostate or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Laboratory and/or medical tests (such as testosterone levels, blood cell counts, liver function, cholesterol levels, PSA) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor right away to establish a new dosing schedule.
Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.Information last revised October 2016. Copyright(c) 2016 First Databank, Inc.
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