AVEED® is an injection that is always given at the doctor's office. AVEED® is only available through your doctor's office, clinic, or hospital, and it is not a medicine you will give yourself at home.
Your physician may either buy AVEED® and bill your health plan or order through a Specialty Pharmacy. The Specialty Pharmacy will contact you to collect your payment, bill your health plan, if applicable, and deliver the medication to your doctor's office prior to your appointment.
If your physician orders through a Specialty Pharmacy, you should expect to receive a phone call from your Specialty Pharmacy prior to each injection.
Your doctor will test your blood before you receive and while you are receiving AVEED®.
AVEED® can cause serious side effects including lung problems and allergic reactions. Serious side effects relating to the heart and blood vessels and mental status are associated with abuse of testosterone and anabolic androgenic steroids.
Why a 30-Minute Wait?
Patients must remain at the doctor's office for 30 minutes following each injection with AVEED®, because AVEED® may cause serious side effects. These side effects may occur during or right after an injection.
AVEED® can cause a temporary but potentially serious condition called a pulmonary oil microembolism (POME). POME is NOT a blood clot. AVEED® contains castor oil and POME is believed to be caused by tiny droplets of castor oil that have traveled to the lungs. Castor oil is one of the ingredients that enables AVEED® to be injected every 10 weeks after the first month of therapy.
AVEED® may also cause a severe allergic reaction called anaphylaxis.
Because of these serious potential risks, it's important that you talk to your doctor about whether the benefits of receiving AVEED® outweigh these potential risks. Ask your doctor or nurse if you are unsure about the risks of AVEED®.
Among 3,556 patients in worldwide clinical trials*:
*Patients treated with intramuscular testosterone undecanoate.
Be Sure to Keep up with Your AVEED® Treatments as Prescribed
5 SHOTS A YEAR AFTER THE FIRST MONTH OF THERAPY
To keep your testosterone levels in the normal range, it's important to stay with the recommended dosing schedule and get your treatments every 10 weeks after the first month of therapy.
Download a complete overview of important drug information, possible side effects, and more.
Talking with your doctor about treatment options may be a little easier with the Doctor Discussion Guide.
AVEED® (testosterone undecanoate) injection is a prescription medicine that contains testosterone, a controlled substance (CIII). AVEED® is used to treat adult males who have low or no testosterone due to certain medical conditions.
AVEED® is only for adult males who need testosterone replacement therapy and when the benefit of receiving AVEED® is more than the risk of pulmonary oil microembolism (POME) and anaphylaxis.
It is not known if AVEED® is safe or effective to treat men who have low testosterone due to aging.
It is not known if AVEED® is safe and effective for use in children younger than 18 years old. Improper use of AVEED® may affect bone growth in children.
Do not receive AVEED® if you:
have breast cancer, have or might have prostate cancer, are allergic to AVEED® or to any of the ingredients in AVEED® (testosterone undecanoate, castor oil, benzyl benzoate).
are a woman, or are pregnant. AVEED® may harm your unborn baby.
AVEED® may cause serious side effects, including:
A serious lung problem. AVEED® can cause a serious lung problem called POME. POME is caused by tiny droplets of oil that have traveled to the lungs. Symptoms of a POME reaction may include:
Serious allergic reactions (anaphylaxis). AVEED® can cause a serious allergic reaction right after receiving the injection. Some of these allergic reactions may be life threatening. These reactions can happen after you receive your first dose of AVEED® or may happen after receiving more than 1 dose.
You may need emergency treatment in a hospital, especially if these symptoms get worse over the 24 hours after your AVEED® injection.
These side effects may happen during or right after each injection. To be sure that you are not having one of these reactions:
Before receiving AVEED®, tell your doctor if you have breast cancer, have or might have prostate cancer, have urinary problems due to an enlarged prostate, have heart problems, have liver or kidney problems, have problems breathing while you sleep (sleep apnea), or have any other medical conditions.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Receiving AVEED® with certain other medicines can affect each other. Especially tell your doctor if you take insulin, medicines that decrease blood clotting, or corticosteroids. Ask your doctor or pharmacist for a list of these medicines, if you are unsure.
AVEED® can cause serious side effects, including:
Call your doctor right away if you have any of the serious side effects listed above.
The most common side effects of AVEED® include acne, pain at the injection site, increased prostate specific antigen (a test used to screen for prostate cancer), increased estradiol level, low testosterone level, feeling tired, irritability, increased red blood cell count, difficulty sleeping, or mood swings.
Other side effects include more erections than are normal for you or erections that last for a long time.
Drug abuse is the intentional use of a drug for its rewarding mental and physical effects. Physical dependence is characterized by withdrawal symptoms after abruptly stopping the drug or significantly reducing the dose. Serious side effects relating to the heart and blood vessels, for instance, heart attack and congestive heart failure, and mental status, including major depression, paranoia, delusions, hallucinations, hostility, and aggression, are associated with abuse of testosterone and anabolic androgenic steroids.
Side effects associated with abuse or misuse by men include mini-stroke, convulsions, mild mania (elation and hyperactivity), irritability, abnormal blood lipids, decrease in size or function of testicles, decreased or absence of fertility; by women include unwanted hair growth, development of male characteristics, voice deepening, clitoris enlargement, decrease in size or function of breasts, male pattern baldness, menstrual irregularities; by male and female adolescents include halting of growth and early puberty.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects with AVEED®. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.
Geriatric Patients: There have not been sufficient numbers of geriatric patients in controlled clinical studies with AVEED® to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There are insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer