Patient information: uses, side effects, how to take - Xyosted

What is XYOSTED?

XYOSTED is a prescription medicine that contains testosterone. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions.

It is not known if XYOSTED is safe and effective in children younger than 18 years old. Improper use of XYOSTED may affect bone growth in children.

It is not known if XYOSTED is safe or effective to treat men who have low testosterone due to aging.

XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your XYOSTED in a safe place to protect it. Never give your XYOSTED to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.

XYOSTED is not meant for use by women.

Do not take XYOSTED if you:

are a man who has breast cancer.
have or might have prostate cancer.
are a woman who is pregnant. XYOSTED may harm your unborn baby.
are allergic to XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil.

Before you use XYOSTED, tell your healthcare provider about all your medical conditions, including, if you:

have high blood pressure or are being treated for high blood pressure.
have heart problems.
have high red blood cell count (hematocrit) or high hemoglobin laboratory value.
have urinary problems due to an enlarged prostate.
have kidney or liver problems.
have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder.
have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using XYOSTED with other medicines can affect each other. Especially, tell your healthcare provider if you take:

insulin
medicines that decrease blood clotting (blood thinners)
corticosteroids
medicines for pain and cold.

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of all your medicines if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use XYOSTED?

See the detailed Instructions for Use for information about how to use XYOSTED.
Use XYOSTED exactly as your healthcare provider tells you to take it.
Your healthcare provider will show you or your caregiver how to inject XYOSTED. You should not inject XYOSTED until you have been trained on the proper way to use it.

What are the possible side effects of XYOSTED?

XYOSTED can cause serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin.
- XYOSTED increases red blood cell counts in some patients. High red blood cell counts increase the risk of clots, strokes, and heart attacks.
- You may need to stop XYOSTED if your red blood cell count increases.
- Your healthcare provider should check your red blood cell count and hemoglobin while you use XYOSTED.

If you already have an enlarged prostate, your signs and symptoms may get worse while using XYOSTED. This can include:
- increased urination at night
- trouble starting your urine stream
- having to pass urine many times during the day
- having an urge that you have to go to the bathroom right away
- having a urine accident
- being unable to pass urine or weak urine flow

Increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use XYOSTED.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Increase in blood pressure. XYOSTED can increase your blood pressure. Increases in blood pressure can increase the risk of heart attack or stroke over time. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on XYOSTED, blood pressure medicines may need to be started. If you are taking blood pressure medicines, new blood pressure medicines may need to be added or your current blood pressure medicines may need to be adjusted to control your blood pressure. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. Your healthcare provider will monitor your blood pressure while you are being treated with XYOSTED.
Abuse. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. Your healthcare provider should check you for signs of abuse before and during treatment with XYOSTED.
In large doses XYOSTED may lower your sperm count.
Liver problems. Symptoms of liver problems may include:
- nausea or vomiting
- yellowing of your skin or whites of your eyes
- dark urine
- pain on the right side of your stomach area (abdominal pain)

Swelling of your ankles, feet, or body, with or without heart failure.
Enlarged or painful breasts.
Problems breathing while you sleep (sleep apnea).
Change in mood. Talk to your healthcare provide if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of XYOSTED include:

red blood cell count increase
prostatic specific antigen (PSA) increase (a test used to screen for prostate cancer)
high blood pressure
injection site reactions including:
- bruising
- bleeding
- redness
- hardness

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of XYOSTED. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store XYOSTED?

Do not refrigerate or freeze. Use at room temperature.

Store at controlled room temperature, 68°F to 77°F (20°C to 25°C). Protect from light (keep in carton until time of use). Discard unused portion.

Keep XYOSTED and all medicines out of the reach of children.

General information about the safe and effective use of XYOSTED.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XYOSTED for a condition for which it was not prescribed. Do not give XYOSTED to other people, even they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XYOSTED that is written for health professionals.

What are the ingredients in XYOSTED?

Active ingredient: testosterone enanthate

Inactive ingredients: sesame oil

Manufactured For:

For more information, go to www.XYOSTED.com or call 1-844-XYOSTED (1-844-996-7833).

Instructions for Use

XYOSTED^®

Testosterone Enanthate Injection USP CIII

Single-dose auto-injector.

For a single subcutaneous administration.

Administer one device weekly.

Read this Instructions for Use before you start using XYOSTED (ZYE-oh-sted) and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important Information about XYOSTED:

Use XYOSTED exactly as your healthcare provider tells you to take it.
Inject XYOSTED only 1 time each week. Do not use XYOSTED every day.
Your healthcare provider will show you or your caregiver how to inject XYOSTED. You should not inject XYOSTED until you have been trained on the proper way to use it.
Check XYOSTED before you inject it. XYOSTED should be clear to light yellow in color and should be free of visible particles.
Do not use if the liquid is cloudy or if visible particles are present. You may see air bubble(s), this is normal.
Do not use XYOSTED if the safety seal is broken or if the Auto-Injector appears broken, damaged or changed in any way.
XYOSTED should be injected in the stomach (abdomen) area after cleaning the skin.
Do not inject XYOSTED within 2 inches of the belly button (navel).
Do not inject XYOSTED in any other areas of the body.
Do not inject XYOSTED in areas where the skin is tender, bruised, red, scaly, hard, or has scars or stretch marks.
Discard unused portion.

If you are not sure if XYOSTED was injected, or if you have a hard time giving the injection, do not inject another dose. Call your pharmacist or healthcare provider right away.

If you need help or instructions, call:

1-844-996-7833

Carefully read all steps before beginning injection.
Injection process must be completed without interruption.

Supplies You Will Need

1 XYOSTED Auto-Injector
1 alcohol swab
1 cotton ball or gauze

Storage Conditions

Do not refrigerate or freeze.
Protect from light.
Use at room temperature.
Store at 68° - 77° F (20° - 25° C).
Keep XYOSTED and all medicines away from children.

Inspect Auto-Injector

Do not remove Cap until ready to inject.
Inspect Auto-Injector for any visible damage. Do not use if it appears damaged or broken.
Check the expiration date. Do not use if the expiration date has passed.
Inspect the medicine through the Viewing Window; it should be clear to light yellow and free of visible particles (see Figure 2).

Do not use if the medicine is cloudy or if visible particles are present. You may notice an air bubble, this is normal.

Select & Prep Injection Site

Wash your hands with soap and water.

Wipe the abdomen injection site with an alcohol swab.

Allow the site to dry on its own.

Do not fan or blow on the injection site.

Do not touch the site again before injecting.

Only use the left or right side of the abdomen (belly) for injection sites.

Do not use the area within 2 inches around your navel (belly button).

See Figure 3.

Do not use in areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars, tattoos, or stretch marks.

Administering Injection

1. Remove Cap

Twist the Cap to remove (this will also break the red safety seal). See Figure 4.

After the Cap is removed, a few drops of liquid may appear, this is normal.

The Auto-Injector should be used or discarded after the Cap is removed.

Do not re-Cap for later use.

Do not touch the Needle End of the Auto-Injector with your hand or fingers after the Cap is removed, doing so can cause injection and injury to your hands.

2. Position Auto-Injector

Gently squeeze the abdomen injection site to create a raised area and hold that area firmly until after the injection is complete (see Figure 5).

Place the Needle End of the Auto-Injector on the abdomen injection site.

Keep the Auto-Injector straight at a 90 degree angle to the abdomen injection site. (see Figure 6).

3. Inject & Hold Down

Firmly push the Auto-Injector down on the abdomen site and continue to hold down after you hear the “CLICK” (see Figure 7).

While holding the XYOSTED Auto-Injector down, slowly count from 1 to 10 to allow all of the medicine to be delivered (see Figure 8).

Keep holding the XYOSTED Auto-Injector down for a total of 10 seconds even if your injection is complete and the viewing window turns orange sooner.

It is normal if there is slight bleeding from the site after injection. If this occurs, hold a cotton ball or gauze on the area for a few seconds. Do not rub the area.

4. Inspect Viewing Window

After injecting, inspect the Viewing Window. It should be orange, confirming the dose was administered (see Figure 9).

If the Viewing Window is not orange:

Do not use another Auto-Injector.
Do not attempt another injection.
Call your healthcare provider or 1-844-996-7833 for assistance.

Disposal After Injection

After completing your injection, dispose of the XYOSTED Auto-Injector and Cap in an FDA-cleared sharps disposal container immediately after use.

Do not dispose of the XYOSTED Auto-Injector in your household trash.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
upright and stable during use
leak-resistant
properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the proper way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

This Instructions for Use has been approved by the U.S. Food and Drug Administration

LB-0118 V09

Manufactured for:

Antares Pharma, Inc.

Ewing, NJ 08628

07/2025