XYOSTED testosterone enanthate 100 mg/.5mL Injection, 4 syringes — NDC 54436-200-04 (Billing 54436-0200-04)

1 INDICATIONS AND USAGE XYOSTED (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of Use: Safety and efficacy of XYOSTED in men with “age-related hypogonadism” has not been established.

Safety and efficacy of XYOSTED in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . XYOSTED (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use: Safety and efficacy of XYOSTED in men with “age-related hypogonadism” has not been established ( 1 ).

Safety and efficacy of XYOSTED in males less than 18 years old have not been established ( 1 , 8.4 ).

2 DOSAGE AND ADMINISTRATION Prior to initiating XYOSTED : confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2.1 ). Starting dose: 75 mg subcutaneously in the abdominal region once weekly. Avoid intramuscular and intravascular administration ( 2.2 , 2.3 ).

Dose Adjustment: Based upon total testosterone trough concentrations (measured 7 days after most recent dose) obtained following 6 weeks of dosing and periodically thereafter ( 2.2 ). Discard unused portion ( 2.3 )

2.1Confirmation of Hypogonadism Before Initiation of XYOSTED Prior to initiating XYOSTED, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

2.2Starting Dose and Dose Adjustment The starting dose of XYOSTED is 75 mg, administered subcutaneously in the abdominal region once a week. Dose adjustment Measure total testosterone trough concentrations (measured 7 days after the most recent dose) following 6 weeks of dosing, following 6 weeks after dose adjustment, and periodically while on treatment with XYOSTED. A trough concentration between 350 ng/dL and 650 ng/dL generally provides testosterone exposures in the normal range during the entire dosing interval.

Decrease the dose by 25 mg if the total testosterone trough concentration (C trough ) is ≥650 ng/dL. Increase the dose by 25 mg if the total testosterone C trough is <350 ng/dL. Maintain the same dose if the total testosterone C trough is ≥350 ng/dL and <650 ng/dL.

2.3Important Administration Instructions XYOSTED is for subcutaneous injection in the abdominal region only. Avoid intramuscular or intravascular injection. Instruct patients on the proper use of XYOSTED and direct them to use the proper injection site.

Refer to the Instructions for Use for proper use of XYOSTED. Visually inspect XYOSTED for particulate matter and discoloration prior to administration. Do not use if the liquid is cloudy or if visible particles are present.

Do not use XYOSTED if the seal is broken. Discard unused portion.

3 DOSAGE FORMS AND STRENGTHS XYOSTED injection is available as 0.5 mL of a sterile, preservative-free and nonpyrogenic, clear, colorless to yellow solution containing testosterone enanthate. It is supplied in a single-dose syringe assembled in an autoinjector for subcutaneous administration. XYOSTED is available in three dosage strengths: 50 mg/0.5 mL 75 mg/0.5 mL 100 mg/0.5 mL XYOSTED (testosterone enanthate) Injection is supplied as 0.5 mL of sterile solution in a single-dose autoinjector for subcutaneous administration in three strengths ( 3 ): 50 mg/0.5 mL 75 mg/0.5 mL 100 mg/0.5 mL

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Venous Thromboembolism Inform patients that XYOSTED can cause venous thromboembolism. Advise patients of the signs and symptoms of venous thromboembolism, which may include the following: lower limb pain, edema, or erythema; and dyspnea or chest pain.

Advise patients to promptly report the signs and symptoms of venous thromboembolism, discontinue use of XYOSTED, and seek urgent medical care. Increased Blood Pressure and Risk for Major Adverse Cardiovascular Events (MACE) Inform patients that XYOSTED can increase BP which can increase cardiovascular risk over time. Instruct patients about the importance of monitoring BP periodically while on XYOSTED.

If BP increases while on XYOSTED, antihypertensive medications may need to be started, added, or adjusted to control BP, or XYOSTED may need to be discontinued. Other Adverse Reactions Inform patients that treatment with androgens may lead to adverse reactions which include: Changes in urinary habits related to effects on prostate size, such as increased urination at night, hesitancy, urinary frequency, urinary urgency, having a urine accident, or being unable to pass urine or weak urine flow. Breathing disturbances that may reflect obstructive sleep apnea, including those associated with sleep or excessive daytime sleepiness.

Too frequent or persistent erections of the penis. Ankle swelling that may reflect peripheral edema. Red blood cell count increase, PSA increase, injection site bruising, injection site bleeding.

Instruct patients to report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood, including new onset or worsening of depression, or suicidal ideation. Keep XYOSTED out of the reach of children For more information call: 1-844-XYOSTED (1-844-996-7833) or visit www.XYOSTED.com Manufactured For: Antares Pharma, Inc. Ewing, NJ 08628 XYOSTED and the XYOSTED logo are trademarks of Antares Pharma, Inc.

All rights reserved. ©2025 Antares Pharma, Inc. All rights reserved

This Medication Guide has been approved by the U.S. Food and Drug Administration. For controlled substances, Antares Pharma, Inc. will provide a one-time replacement medication to the patient if the original product is damaged or is unusable due to unforeseen circumstances.

Issued: 07/2025 MEDICATION GUIDE XYOSTED ® (ZYE-oh-sted) (testosterone enanthate) injection, for subcutaneous use CIII 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.

Si… [Excerpted — this section continues on DailyMed.]

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… [Excerpted — this section continues on DailyMed.]