Aveed
Aveed (testosterone undecanoate) is an injectable testosterone that’s used to treat low testosterone in adult males. It's an FDA-approved testosterone replacement therapy that must be injected by a healthcare professional due to possible allergic reactions and a serious warning called pulmonary oil microembolism (POME), which causes symptoms such as coughing, chest pain, and trouble breathing. Initially, you'll receive the first two injections a month apart, then an injection every 10 weeks after that. Common side effects include acne, pain at the injection site, and fatigue.
What is Aveed (testosterone undecanoate)?
What is Aveed (testosterone undecanoate) used for?
- Low testosterone (also called hypogonadism)
How Aveed (testosterone undecanoate) works
Aveed (testosterone undecanoate) is a testosterone replacement therapy that acts like the natural sex hormone, testosterone. Testosterone is responsible for the development and maintenance of many male features and functions, such as muscle and bone strength and growth and regulating sex drive and sperm production. Aveed (testosterone undecanoate) works by raising testosterone to normal and healthy levels in males with low testosterone.
Drug facts
Risks and warnings for Aveed (testosterone undecanoate)
Aveed (testosterone undecanoate) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Pulmonary oil microembolism (POME) and severe allergic reactions
- Risk factors: Using higher than recommended doses of Aveed (testosterone undecanoate)
During or immediately after injection, Aveed (testosterone undecanoate) can cause a serious lung problem called pulmonary oil microembolism (POME). Symptoms of POME include coughing, trouble breathing, sweating, throat tightening, chest pain, dizziness, and fainting. This can occur because small droplets of oil from the injection can travel to the lung. The reaction can last for a few minutes or up to several hours, but it can also require emergency treatment and hospitalization. This reaction might occur more commonly in people who have received higher than recommended doses of Aveed (testosterone undecanoate).
Also immediately after injection, Aveed (testosterone undecanoate) can cause a life-threatening allergic reaction (anaphylaxis). Symptoms include skin rash, hives, swelling of the lips and tongue, trouble breathing, nausea, diarrhea, and vomiting.
Because of these risks, the FDA has required this medication to be under a Risk Evaluation and Mitigation Strategy (REMS) program. Only specific prescribers that have enrolled in the Aveed REMS program are trained to administer the injection. Both of these reactions can happen after any injection during treatment, including the first injection. You'll need to stay at your prescriber's office for at least 30 minutes after each injection in case you need emergency treatment.
Prostate problems
- Risk factors: History of enlarged prostate
Taking Aveed (testosterone undecanoate) can worsen certain symptoms in people with an enlarged prostate, or benign prostatic hyperplasia (BPH). Let your prescriber know if you experience any changes in your urinary routine, such as more urination at night, feeling like you need to urinate more often or immediately, trouble urinating, accidentally urinating, or urinating slowly.
Aveed (testosterone undecanoate) can also raise your risk of prostate cancer. Your prescriber might have you perform occasional blood tests and physical check-ups before and during treatment with this medication.
Risk of blood clots, including heart attack or stroke
- Risk factors: History of heart conditions
Taking testosterone replacement therapy, like Aveed (testosterone undecanoate), can raise your risk of blood clots. This can lead to problems such as strokes and heart attacks. Your healthcare team will have you perform regular blood tests, called the complete blood count (CBC), to check that your blood cell counts are in the safe range. Get emergency help right away if you have chest pain, cold sweats, left arm pain, difficulty breathing, trouble walking, trouble speaking, or weakness on one side of the body, since you might have to stop taking the medication.
Potential for misuse, dependency, and addiction
- Risk factors: Taking more Aveed (testosterone undecanoate) than prescribed | Taking Aveed (testosterone undecanoate) with other testosterones
Aveed (testosterone undecanoate) is a controlled substance because it has a risk of misuse and dependency, especially if you use higher doses than prescribed or use it with other testosterones.
Continued misuse of Aveed (testosterone undecanoate) can lead to addiction. The FDA has only approved this medication for the treatment of low testosterone in males. Taking Aveed (testosterone undecanoate) for other reasons can lead to serious side effects, such as heart attack, heart failure, stroke, depression, hallucinations, and delusions. Only take this medication as prescribed by your healthcare professional.
Liver problems
Using certain forms of testosterone, such as methyltestosterone and testosterone enanthate intramuscular injection, for long periods of time can cause life-threatening liver problems. This isn't a known risk of Aveed (testosterone undecanoate), but it's important to look out for signs and symptoms of liver damage. Let your prescriber know if you're experiencing stomach pain, light-colored stools, dark urine, or if your skin or the whites of your eyes turn yellow, because you might need to stop the medication.
Swelling in the legs or arms (edema)
- Risk factors: History of heart, liver, or kidney conditions | Taking other medications that cause swelling like corticosteroids
Aveed (testosterone undecanoate) can cause your body to hold onto more salt and water, which can lead to swelling in your legs or arms and sudden weight gain. This is more likely to happen if you're taking other medications that cause swelling, such as corticosteroids (e.g., prednisone, methylprednisolone (Medrol)). It can be more serious in people with heart, liver, or kidney conditions. Talk to your prescriber if you have any of these symptoms, because you might need to stop the medication.
Sleep apnea
- Risk factors: History of sleep apnea | Obesity | History of lung disease
Aveed (testosterone undecanoate) can cause sleep apnea, a condition in which you stop breathing for short periods of time while sleeping. This is more likely to happen to people who also identify as obese or have lung problems. If you experience more daytime sleepiness or if your partner notices that you stop breathing in your sleep more often, talk to your prescriber.
High calcium in the blood
- Risk factors: History of cancer | Taking other medications that cause high calcium in the blood
Aveed (testosterone undecanoate) can cause high calcium in the blood (hypercalcemia), especially in people with cancer. For people with cancer, high calcium levels might be a sign that the cancer has spread to the bones. During treatment with Aveed (testosterone undecanoate), your prescriber might have you perform regular blood tests to make sure your calcium levels are within a safe range.
Side effects of Aveed (testosterone undecanoate)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Acne (5%)
- Injection site pain (5%)
- Rise in prostate-specific antigen (PSA, 5%)
- Rise in estrogen levels (3%)
- Tiredness (2%)
- Irritability (2%)
- Trouble sleeping (insomnia, 2%)
- Mood swings (2%)
Less Common Side Effects
- Injection site redness
- Problems with ejaculation
- Hardening or swelling of the prostate
- Blood in the urine
- Kidney stones
- Problems urinating
- Common cold
- Asthma
- Headache
- Stomach, back, or joint pain
- Weight gain
- Diarrhea
- Excessive sweating
- Hearing loss
- Anxiety
- Depression
- Nervousness
- Aggression
Aveed (testosterone undecanoate) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Pulmonary oil microembolism (POME): cough, sweating, trouble breathing, throat tightening, chest pain, dizziness, fainting
- Severe allergic reaction (anaphylaxis): skin rash, hives, swelling of the lips and tongue, trouble breathing, wheezing, coughing, nausea, diarrhea, vomiting, stomach pain, dizziness, fainting
- Heart attack: chest pain, cold sweats, left arm pain, difficulty breathing
- Stroke: face drooping, trouble seeing, walking, or speaking, weakness on one side of the body
- Blood clot in the legs: pain, swelling, warm to touch, redness
- Blood clot in the lungs: trouble breathing, chest pain, cough
- Liver damage: stomach pain, nausea, vomiting, yellowing of the skin, yellowing of the whites of the eyes, light-colored stools, dark urine, weight loss
- Withdrawal: depression, fatigue, craving, restlessness, irritability, lack of appetite, trouble sleeping (insomnia), lowered sex drive, low testosterone
The following Aveed (testosterone undecanoate) side effects have also been reported
Discuss these possible effects with your doctor:
Tumors of the liver, liver cancer, or peliosis hepatis (a form of liver disease) have occurred during long-term, high-dose therapy with androgens. Although these effects are rare, they can be very serious and may cause death.
Androgens can stimulate existing prostate cancer in men who already have it but have not yet been diagnosed. Also, the prostate (a male gland) may become enlarged. Enlargement of the prostate does not mean that cancer will develop. If enlargement occurs and you have difficulty in urinating, it is a good idea to be checked by your doctor.
When androgens are used in women, especially in high doses, male-like changes may occur, such as hoarseness or deepening of the voice, unnatural hair growth, or unusual hair loss. Most of these changes will go away if the medicine is stopped as soon as the changes are noticed. However, some changes, such as voice changes or enlarged clitoris, may not go away.
When androgens are used in high doses in males, they interfere with the production of sperm. This effect is usually temporary and only happens during the time you are taking the medicine. However, discuss this possible effect with your doctor if you are planning on having children.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
For females only
Acne or oily skin
decreased breast size
irregular menstrual cycles
hoarseness or deepening of voice
increase in size of female genitals
increase in unnatural hair growth or male pattern baldness
These symptoms may occur in females whose male sexual partner uses a scrotal patch.
For males only
Blistering of skin under patch (especially when the nonscrotal patch is applied to bony areas of the skin)
breast soreness or enlargement
frequent or continuing erection of penis lasting up to 4 hours or painful penile erections lasting longer than 4 hours
frequent urge to urinate
itching or redness of skin under patch (less likely with nonscrotal patch) or at site of implants, mild to severe
For prepubertal boys only
early growth of pubic hair
enlargement of penis
frequent or continuing erections
Less common
For males or females
Dizziness
frequent or continuing headache
lack or loss of strength
overall body flushing, redness, or itching of skin
rapidly changing moods, such as depersonalization, dysphoria, euphoria, depression, paranoia, and quick to react or overreact emotionally
swelling of feet or lower legs
unusual bleeding
unusual tiredness
yellow skin or eyes (occurring with fluoxymesterone or methyltestosterone more often than with testosterone)
For females with breast cancer or bedridden males or females—in addition to the side effects listed above
Confusion or mental depression
increased thirst
increased urge to urinate or increased amount of urine
For males only
Black, tarry stools
burning sensation or hardening or thickening of skin under patch
chills
continuing pain at site of implants
difficulty in urinating
itching, skin redness, or rash under patch, severe (less likely with nonscrotal patch)
pain in scrotum or groin
vomiting of blood or material that looks like coffee grounds
Rare
For males or females—more likely with oral androgens or long-term or high doses of androgens
Abdominal or stomach pain, continuing
bad breath odor, continuing
black, tarry or light-colored stools or dark urine
loss of appetite, continuing
mood or mental changes
purple or red spots on body or inside the mouth or nose
swelling, pain, or tenderness of abdomen
vomiting of blood
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
For males and females
Acne, mild
decrease or increase in sexual desire or drive
hair loss or thinning of hair
increase in pubic hair growth
infection, pain, redness, or other irritation at site of injection
nervousness
stomach pain
trouble in sleeping
For males only
Decrease in testicle size
infection, pain, redness, swelling, sores, or other skin irritation underneath patch
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Aveed (testosterone undecanoate)
Pros
- Works well to replace testosterone in your body
- Can be given every 10 weeks (after the first 2 injections)
- No accidental testosterone exposure to another person through skin-to-skin contact like testosterone gels
Cons
- Only available through a REMS program because of life-threatening side effects
- Must be injected by your prescriber, so it can't be given at home
- Only available as a brand-name medication
Pharmacist tips for Aveed (testosterone undecanoate)
- Aveed (testosterone undecanoate) can cause a serious lung problem and a severe allergic reaction immediately after injection. Symptoms include cough, trouble breathing, throat tightening, chest pain, dizziness, and fainting. You'll need to stay at your prescriber's office for at least 30 minutes after each injection in case you need emergency treatment.
- Aveed (testosterone undecanoate) is injected into the upper, outer part of your buttock muscle by your prescriber. They will alternate between the left and right buttock for each injection.
- Aveed (testosterone undecanoate) can often cause the breast area in males to become bigger, painful, or tender. This might continue throughout treatment with this medication. Let your prescriber know if this becomes bothersome.
- Taking Aveed (testosterone undecanoate) together with blood thinners like warfarin (Coumadin) might cause you to bleed more easily, so you might need to get your blood clotting time (INR) checked more often. Let your prescriber know if you experience bleeding that takes longer to stop, bruising, blood in your urine, or dark stools, as your dose might need to be adjusted.
- Aveed (testosterone undecanoate) can lower your blood sugar. If you have diabetes, you might need to check your blood sugar levels more frequently. Know how to manage low blood sugar.
Common questions about Aveed (testosterone undecanoate)
Aveed (testosterone undecanoate) should start to raise your testosterone level after the first injection. While your testosterone level might reach its highest point in about 1 week after a dose, it can take 3 to 4 months before your testosterone levels are stable.
The typical dose is 750 mg of Aveed (testosterone undecanoate) injected on the first day, a second injection 4 weeks later, then every 10 weeks after that. You'll receive injections in the upper, outer part of your buttock muscle by your prescriber at their office or in a clinic.
After your second dose, one injection of Aveed (testosterone undecanoate) should last about 2.5 months, or 10 weeks. Your prescriber will have you do regular blood tests to check your testosterone levels while you are taking this medication. Talk to your prescriber if you have questions on how often you should receive a dose.
In a clinical trial, 94% of people taking Aveed (testosterone undecanoate) had normal testosterone levels after the first three injections, or within 14 weeks. Discuss with your prescriber if you have questions about how well this medication might work for you.
Risk Evaluation and Mitigation Strategy (REMS) is a safety program that the FDA requires for medications with serious safety risks Aveed (testosterone undecanoate) has a REMS because it has a high risk of causing a serious lung problem and allergic reaction. Healthcare facilities and prescribers can only administer Aveed (testosterone undecanoate) if they're enrolled in the Aveed REMS Program, have the necessary supplies and medications on site to address these reactions, and have received training on how to treat these issues if they occur. Your prescriber will talk to you about the risk of these serious side effects. You'll also need to wait in their office for at least 30 minutes after each injection in case emergency treatment is needed.
Aveed (testosterone undecanoate) can lower the amount of sperm you make, which can make it more difficult for you to have a baby. This is more likely to happen when using higher doses of Aveed (testosterone undecanoate). Because this might become permanent, talk to your prescriber if you're trying to have a baby.
Aveed (testosterone undecanoate) and Jatenzo (testosterone undecanoate) are both testosterone medications that are used to treat low testosterone in males, but have differences in how they're taken. Aveed (testosterone undecanoate) is an injection that's given in the buttock muscle at your prescriber's office every 10 weeks after the second dose. Jatenzo (testosterone undecanoate) is a capsule that's taken by mouth twice a day.
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Aveed (testosterone undecanoate) dosage
Typical dosage for Aveed (testosterone undecanoate)
Aveed (testosterone undecanoate) is injected into your buttock muscle by a healthcare professional.
The typical dose is 1 injection (750 mg) on the first day of treatment, then another injection 4 weeks later. After your second dose, you’ll receive an injection every 10 weeks.
Interactions between Aveed (testosterone undecanoate) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acenocoumarol
- Anisindione
- Atorvastatin
- Bupropion
- Dicumarol
- Fluvastatin
- Lovastatin
- Paclitaxel
- Paclitaxel Protein-Bound
- Pexidartinib
- Phenindione
- Phenprocoumon
- Warfarin
Aveed (testosterone undecanoate) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Aveed (testosterone undecanoate) will not be safe for you to take.
- Males with breast cancer or prostate cancer
- Currently pregnant
What are alternatives to Aveed (testosterone undecanoate)?
