Xyosted (Testosterone) - Subcutaneous

What Is Xyosted?

Xyosted (testosterone) is a prescription medication used to treat low testosterone levels in males (sex assigned at birth) 18 years and older. It belongs to a drug class called androgens.

Your body naturally makes certain hormones like testosterone and dihydrotestosterone (DHT). These hormones help develop male sex organs and maintain secondary sex characteristics. Xyosted works like these hormones in males to increase testosterone levels.

Xyosted is a controlled substance (Schedule III) because it has the potential for abuse and dependency. It is a weekly injection only given under the skin (subcutaneously). It is preservative-free and contains sesame oil. Other forms of testosterone injection are available for intramuscular (shot into the muscle) use, but Xyosted should only be administered subcutaneously.

What Is Xyosted Used For?

The Food and Drug Administration (FDA) approved Xyosted for use alone or with other medicines to treat the symptoms of conditions associated with a deficiency or absence of endogenous testosterone.

Generically available testosterone can also be used in children with delayed puberty and in certain women with an inoperable type of breast cancer.

Xyosted contains a boxed warning, the FDA's strictest safety warning, for the risk of blood pressure increases. Before starting Xyosted, your healthcare provider may check your baseline cardiovascular risk and blood pressure levels. During treatment, routine monitoring of blood pressure and cardiovascular risk factors or heart disease may be necessary.

How to Use Xyosted

Inject Xyosted under the skin in the abdominal (stomach) area only. Avoid injecting into your muscle or veins. Use once weekly or as told by your healthcare provider.

To use Xyosted:

• Wash your hand before and after use.
• Using an alcohol pad, clean the injection site.
• Inspect the solution. Xyosted solution is colorless to pale yellow. Do not use if cloudy, discolored, or has particles. Do not use if the drug seal is broken.
• Inject medicine under your skin (stomach area only)

Do not inject Xyosted into the muscle or swap it out with other forms of testosterone enanthate shot into the muscle.

The improper use of this drug may affect bone growth in children.

Once you're finished with your injection, immediately dispose of the auto-injector and cap in an FDA-cleared sharps disposal container.

If you do not have an FDA-cleared sharps disposal container, you can use any container that is:

• Made of heavy-duty plastic
• Can be closed with a tight-fitting, puncture-resistant lid
• Upright and stable
• Leak-resistant
• Properly labeled to warn of hazardous waste

Do not dispose of the auto-injector in your household trash.

Storage

For storing, leave Xyosted in its original box until use. Store it at room temperature away from light, children, and pets. While traveling, you may store this drug between cool and mildly hot temperatures (59 to 86 degrees F). However, do not refrigerate or freeze it.

Discard any expired or unused drugs. Do not toss them down the drain, sink, or toilet. Ask your pharmacist about the best ways to throw out your medication. Look into drug take back programs that may be available near you.

Off-Label Uses

Healthcare providers may prescribe Xyosted for off-label uses, meaning for conditions not specifically indicated by the FDA. Xyosted can be used off-label as hormone therapy for people transitioning from female to male.

What Are the Side Effects of Xyosted?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Some people may have little or no side effects with Xyosted. Contact your healthcare provider if you experience side effects that do not go away or become troublesome. Some common side effects of Xyosted are:

• Heartburn
• Emotional imbalance
• Acne
• Application site irritation
• Change in taste or bad taste
• Burping
• Trouble sleeping
• Loss of strength and energy
• Sore throat
• Back pain
• Diarrhea

Severe Side Effects

Call your healthcare provider promptly if you have serious side effects. Call 911 if you have a medical emergency or if your symptoms feel life-threatening. Serious side effects may include symptoms of infections, liver problems, or the following:

• Vomiting
• Bone pain
• Blood clot
• Dark urine
• Light-colored stools
• Weakness on one side of the body
• Trouble speaking or thinking
• Change in balance
• Drooping on one side of the face
• Blurred vision
• Chest pain
• Sweating a lot
• Severe headache
• Dizziness
• Erection that lasts more than four hours
• Depression
• Mood and behavior changes
• Thoughts of suicide
• Enlarged breasts
• Breast pain
• Big weight gain
• Trouble breathing during sleep
• Skin discoloration
• Testicle irregularities
• Nosebleed
• Nasal dryness
• Gum changes

Virilization (the development of male physical features) may happen. This can cause facial hair, deep voice, or menstrual changes.

Long-Term Side Effects

Long-term use of Xyosted may lead to:

• High blood pressure (new onset or worsening blood pressure)
• Production of too many red blood cells (increasing the risk of blood clots)
• Abuse and drug dependence
• Worsening of benign prostatic hyperplasia and increased risk of prostate cancer
• Low sperm count
• Liver problems

Dosage: How Much of Xyosted Should I Take?

Missed Dose

Inject the missed dose once you think of it. Skip the missed dose if it is too close to your next dose. Go back to your regular dosing frequency. Do not inject extra or double the amount.

Overdose: What Happens If I Use Too Much Xyosted?

Overdose symptoms of Xyosted may include: 

• Chest pain
• Vomiting
• Trouble speaking
• Blurred vision
• Confusion

Precautions

What Are Reasons I Shouldn't Take Xyosted?

Avoid the use of Xyosted if you are:

• Pregnant (it can cause serious harm to the fetus)
• A male (sex assigned at birth) with known or suspected breast or prostate cancer
• A male who is allergic to testosterone or sesame oil
• A male with low testosterone due to age
• A male with low testosterone without specific medical conditions

Xyosted should also be avoided in adult males with age-related hypogonadism due to the risk of increased blood pressure and adverse cardiovascular events.

What Other Medications Interact With Xyosted?

Avoid another hormone called dehydroepiandrosterone (DHEA) while you are taking Xyosted. It may increase the side effects of testosterone if taken together.

What Medications Are Similar?

Other preparations of testosterone products like Xyosted include:

• Natesto (intranasal testosterone gel)
• Jatenzo (oral testosterone softgel capsule)
• Testopel (testosterone pellet implant under the skin)
• AndroGel (topical testosterone gel)
• Fortesta (topical testosterone gel)
• Androderm (topical testosterone patch)

This list is a list of drugs also prescribed to treat low testosterone levels in males. It is NOT a list of medicines recommended to take with Xyosted. In fact, you should not take these drugs together unless your healthcare provider tells you to. Ask your pharmacist or a healthcare provider if you have questions.

How Can I Stay Healthy While Taking Xyosted?

In addition to administering your shot weekly, you should also pay attention to your body while using Xyosted. This medication can increase the risk of having a heart attack or stroke. Therefore, you should monitor your blood pressure daily regardless of when you began treatment.

Check your blood pressure at your neighborhood pharmacy if you do not have a blood pressure monitor at home. You can also call your health insurance provider to see if you can get one at no cost. Remember to notify your healthcare provider any time you notice that your blood pressure is high.