XYOSTED testosterone enanthate 75 mg/.5mL Injection, 1 syringe

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.

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