Xyosted (testosterone enanthate) is a testosterone replacement therapy (TRT). It's used in adult males to treat low testosterone levels. It comes as an autoinjector for home use, allowing you to self-inject under the skin (subcutaneously) in the stomach once a week. Side effects can include headache and bruising at the injection site. Currently, it's only available as a brand-name medication since no generic version is available.
Xyosted (testosterone enanthate) 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, regulating sex drive, and sperm production. Xyosted (testosterone enanthate) works by raising testosterone to normal and healthy levels in males with low testosterone.
Xyosted (testosterone enanthate) 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.
Risk factors: History of heart problems
Xyosted (testosterone enanthate) can cause high blood pressure that can raise the risk of serious problems, such as heart attack, stroke, and sudden heart-related death. This is more likely to occur in people who already have heart problems. If you develop high blood pressure, you might need to start a new medication to lower it, or adjust your current blood pressure medication. If it continues to remain high, stopping Xyosted (testosterone enanthate) might be necessary. Your prescriber will regularly monitor your blood pressure before and during your treatment with this medication.
Risk factors: History of heart conditions
Taking testosterone replacement therapy, like Xyosted (testosterone enanthate), 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.
Risk factors: History of enlarged prostate
Taking Xyosted (testosterone enanthate) 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.
Xyosted (testosterone enanthate) 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 factors: Taking more Xyosted (testosterone enanthate) than prescribed | Taking Xyosted (testosterone enanthate) with other testosterones
Xyosted (testosterone enanthate) 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 Xyosted (testosterone enanthate) can lead to addiction. The FDA has only approved this medication for the treatment of low testosterone in males. Taking Xyosted (testosterone enanthate) 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.
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 Xyosted (testosterone enanthate), 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.
Risk factors: History of heart, liver, or kidney conditions | Taking other medications that cause swelling like corticosteroids
Xyosted (testosterone enanthate) 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.
Risk factors: History of sleep apnea | Obesity | History of lung disease
Xyosted (testosterone enanthate) 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.
Risk factors: History of cancer | Taking other medications that cause high calcium in the blood
Xyosted (testosterone enanthate) 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 Xyosted (testosterone enanthate), your prescriber might have you perform regular blood tests to make sure your calcium levels are within a safe range.
Risk factors: History of depression | History of other mental health conditions
Xyosted (testosterone enanthate) can cause new or worsening depression, suicidal thoughts and behavior, anxiety, or other mental health changes that can be dangerous. Symptoms can include feeling sad or hopeless, losing interest in activities that once made you happy, changes in appetite, tiredness, trouble sleeping, and feeling worthless. If you or anyone around you notice any changes in your thoughts or behavior, let your prescriber know right away. You might need to stop taking the medication.
Source:Â DailyMed
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.
Available as a ready-to-use autoinjector, so you don't need to draw up the medication
Available in many different strengths
Only needs to be given once a week
Can be injected at home
Can cause high blood pressure, which can lead to serious heart conditions
Requires regular blood tests to monitor testosterone
Contains sesame oil, so not a good option if you have an allergy to sesame
Only available as a brand medication
You might want to check your blood pressure at home while taking Xyosted (testosterone enanthate). That's because the medication can raise your blood pressure, potentially leading to serious side effects such as heart attack and stroke.
Xyosted (testosterone enanthate) 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.
Xyosted (testosterone enanthate) 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.
Xyosted (testosterone enanthate) can lower sperm count. This might affect your ability to have a baby and raise the risk for infertility. Let your healthcare team know if you're thinking of having a baby before you start this medication so they can talk with you about family planning options.
After injecting Xyosted (testosterone enanthate), remember to place the used injector in a sharps container to avoid injury. Check with your local waste removal company or health department to find out where to dispose of the sharps container safely.
Store Xyosted (testosterone enanthate) at room temperature. Don't refrigerate or freeze the medication. Keep the medication in the box until you are ready to use it so that it's protected from light.
How to use Xyosted (testosterone enanthate)
Carefully read and follow the instructions for use before your first injection. Ask your prescriber or pharmacist if you have questions on how to inject the medication correctly.
When you're ready to inject, use your fingers to gently pinch an area of your stomach, and keep pinching until you finish injecting. With your other hand, press the injector firmly against the pinched area until you hear a click. Hold it there for 10 seconds.
After you inject the medication, make sure the viewing window on the injector has turned orange.
The typical starting dose is 75 mg injected once a week under the skin in the stomach. Your prescriber might change the dose based on your testosterone levels in the blood.
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.
Males with breast cancer or prostate cancer
Females who are pregnant
Males with low testosterone due to other reasons
Low testosterone (hypogonadism) in males
Delayed puberty in males
Metastatic breast cancer that have spread to the bones in females who've started menopause in the past 1 to 5 years
Low testosterone (hypogonadism)
Breast cancer that has spread to other parts of the body
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Antares Pharma, Inc. (2018). Instructions for use.
Antares Pharma, Inc. (2024). Xyosted- testosterone enanthate injection [package insert]. DailyMed.Â
Kaminetsky, J. C., et al. (2019). A 52-week study of dose adjusted subcutaneous testosterone enanthate in oil self-administered via disposable auto-injector. The Journal of Urology.
Sizar, O., et al. (2024). Male hypogonadism.
U.S. Food and Drug Administration. (2021). Sharps disposal containers.
Yamaguchi, A. V., et al. (2019). Testosterone replacement therapy and the risk of hypoglycemia. Case Reports in Endocrinology.
You and Your Hormones. (2020). Testosterone.
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