Brand Name
Xyosted
Generic Name
Enanthate
View Brand Information FDA approval date: September 18, 2012
Classification: Androgen
Form: Injection
What is Xyosted (Enanthate)?
XYOSTED 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 : 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 , luteinizing hormone ) above the normal range. Hypogonadotropic hypogonadism : gonadotropin or luteinizing hormone-releasing hormone 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 males less than 18 years old have not been established [see Use in Specific Populations.
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Brand Information
1INDICATIONS 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
2DOSAGE 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
3CONTRAINDICATIONS
XYOSTED is contraindicated in:
- Men with carcinoma of the breast or known or suspected carcinoma of the prostate
- Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman
- Men with known hypersensitivity to XYOSTED or any of its ingredients (testosterone enanthate and sesame oil).
4OVERDOSAGE
There have been no reports of overdosage in the XYOSTED clinical trials. There is a single report of acute overdosage with use of an approved injectable testosterone product. This subject had serum testosterone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident.
Treatment of overdosage consists of discontinuation of XYOSTED together with appropriate symptomatic and supportive care.
5DESCRIPTION
XYOSTED (testosterone enanthate) injection contains testosterone enanthate, an ester derivative of an endogenous androgen, testosterone. Testosterone enanthate is a white to creamy white crystalline powder described by the chemical name (17β)-17-[(1-Oxoheptyl) oxy]-androst-4-en-3-one. Testosterone enanthate has the molecular formula C
XYOSTED (testosterone enanthate) injection is a sterile, preservative-free, and nonpyrogenic colorless to pale yellow solution supplied in a single-dose syringe assembled in a pressure-assisted autoinjector for subcutaneous administration. Each XYOSTED autoinjector contains 50 mg, 75 mg, or 100 mg of testosterone in sesame oil to form 0.5 mL solution providing three product strengths of 50 mg/0.5 mL, 75 mg/0.5 mL, and 100 mg/0.5 mL.
6CLINICAL STUDIES
XYOSTED was evaluated in a 52-week, open-label study (NCT02159469) to evaluate its efficacy and safety when administered subcutaneously once weekly to 150 adult males with hypogonadism. The study included a Screening Phase, a Treatment Titration Phase, and an Extended Treatment Phase.
Patients were trained on proper use of XYOSTED to self-administer the initial dose of 75 mg once weekly on the same day of the week and at approximately the same time (7:00 am ± 2 hours). The dose was increased by 25 mg at Week 7 if the Week 6 serum total testosterone concentration at the end of the dosing interval (C
The primary endpoint was the percentage of patients with a time-averaged serum total testosterone concentration (C
Secondary endpoints were the percentage of patients with a maximum total testosterone concentration (Cmax) above three predetermined limits: greater than 1500 ng/dL, between 1800 and 2500 ng/dL, and greater than 2500 ng/dL.
One hundred and thirty five (90%) of the 150 hypogonadal men who received XYOSTED had a serum total testosterone concentration C
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
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:
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.
Keep XYOSTED out of the reach of children
For more information call: 1-844-XYOSTED (1-844-996-7833) or visit
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
8Instructions for Use
XYOSTED
Testosterone Enanthate Injection USP CIII
Testosterone Enanthate Injection USP CIII
Single-dose auto-injector.
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.
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.
- Check the expiration date.
- Inspect the medicine through the Viewing Window; it should be clear to light yellow and free of visible particles (
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.
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).
After the Cap is removed, a few drops of liquid may appear, this is normal.
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 (
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. (
3. Inject & Hold Down
Firmly push the Auto-Injector down on the abdomen site and continue to hold down after you hear the “CLICK” (
While holding the XYOSTED Auto-Injector down, slowly count from 1 to 10 to allow all of the medicine to be delivered (
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.
4. Inspect Viewing Window
After injecting, inspect the Viewing Window. It should be orange, confirming the dose was administered (
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
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:
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 V08
Manufactured for:
9PRINCIPAL DISPLAY PANEL - 50 mg/0.5 mL Autoinjector
XYOSTED(testosterone enathate injection, USP) CIII
50 mg/0.5 mL
NDC 54436-250-02
For subcutaneous injections only.
10PRINCIPAL DISPLAY PANEL - 75 mg/0.5 mL Autoinjector
XYOSTED(testosterone enathate injection, USP) CIII
75 mg/0.5 mL
NDC 54436-275-02
For subcutaneous injections only.
11PRINCIPAL DISPLAY PANEL - 100 mg/0.5 mL Autoinjector
XYOSTED (testosterone enathate injection, USP) CIII
100 mg/0.5 mL
NDC 54436-200-02
For subcutaneous injections only.
12PRINCIPAL DISPLAY PANEL - 50 mg/0.5 mL Carton of 4
XYOSTED (testosterone enathate injection, USP)
NDC 54436-250-04
50 mg/0.5 mL
CIII
For subcutaneous injections only
Four Single-dose autoinjectors
Discard after use. DO NOT reuse.
Dispense the enclosed Medication Guide to each patient.
Rx ONLY
13PRINCIPAL DISPLAY PANEL - 75 mg/0.5 mL Carton of 4
XYOSTED (testosterone enathate injection, USP)
NDC 54436-275-04
75 mg/0.5 mL
CIII
For subcutaneous injections only
Four Single-dose autoinjectors
Discard after use. DO NOT reuse.
Dispense the enclosed Medication Guide to each patient.
Rx ONLY
14PRINCIPAL DISPLAY PANEL - 100 mg/0.5 mL Carton of 4
XYOSTED (testosterone enathate injection, USP)
NDC 54436-200-04
100 mg/0.5 mL
CIII
For subcutaneous injections only
Four Single-dose autoinjectors
Discard after use. DO NOT reuse.
Dispense the enclosed Medication Guide to each patient.
Rx ONLY
