XYOSTED Frequently Asked Questions

XYOSTED is a prescription medicine 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 for use in children younger than 18 years old or for the treatment of men who have low testosterone due to aging. Improper use of XYOSTED may affect bone growth in children.

Your doctor will diagnose hypogonadism based on a combination of your symptoms and laboratory testing. A diagnosis of low testosterone is typically confirmed by at least two separate early morning blood tests showing total testosterone levels below 300 ng/dL.

In a clinical study of 150 patients on XYOSTED*, 90% had testosterone levels in the normal range† by week 12. Individual results may vary.

* Studied for 52 weeks when taken every week as directed. Achieving desired blood levels may require dose adjustments at Week 7 based upon Week 6 blood levels. 
Some patients fell below minimum level of 300ng/dL despite dose adjustments.

† “Normal Range” is defined as 300-1,100 ng/dL.

XYOSTED is a once-weekly auto-injector used to deliver testosterone subcutaneously. It is designed to be virtually painless.1*† Your healthcare provider will train you on how to use it properly. For additional resources please see ‘Instructions for Use’ and the ‘How To Take XYOSTED’ video.

* 150 patients entered the one-year trial; 99.4% of injections were reported to be pain free.

† Injection site reactions, including bruising, bleeding, redness, and hardness, were reported in 12.7% of patients who received XYOSTED for up to 1 year in the trial. 
No patients discontinued XYOSTED because of injection site reactions.

1 Data on file. XYO-0008. Antares Pharma, Inc.

The most common side effects are increased hematocrit, hypertension, increased PSA, injection site bruising, headaches, back pain, increased blood creatine phosphokinase, and injection site hemorrhage, each of which occurred in fewer than 15% of participants in two clinical studies in a total of 283 men who received XYOSTED once a week for up to one year. 


Please refer to the Important Safety Information for full Warnings and Precautions.

In a one-year clinical trial of 150 men receiving 1,519 injections, 99.4% of injections were reported as painless.1 Injection site reactions can occur, including: bruising, bleeding, redness, and hardness.

The needle in the XYOSTED auto-injector is not visible before or during injection. The device is designed to be user-friendly and discreet, with a collar-activated mechanism that hides the needle.

Store XYOSTED at room temperature (68°F to 77°F or 20°C to 25°C). Do not refrigerate or freeze. Keep it in the original packaging to protect it from light and out of reach of children.

Yes, you can travel with XYOSTED.* Be sure to pack it in your carry-on luggage if you’re flying. You may also want to bring a copy of your prescription and a letter from your doctor to help with airport security.

* Store XYOSTED at room temperature (68°F to 77°F or 20°C to 25°C). Do not refrigerate or freeze. Keep it in the original packaging to protect it from light and out of reach of children.

Yes. Most eligible* commercially insured patients will pay as little as $25 out of pocket for their XYOSTED each time a prescription is filled. This offer is valid for 13 prescription fills per year. Certain eligibility restrictions apply. You can sign up at www.XYOSTED.com/copay

* Eligibility restrictions: Offer not valid for prescriptions reimbursed under any federal or state healthcare program, including Medicare, Medicaid, or any state medical assistance programs. Offer void where prohibited by law, taxed, or restricted. Offer only valid in the USA. Maximum benefit up to $125 for each prescription filled. Halozyme reserves the right to rescind, revoke, or amend this offer at any time without notice. By using this co-pay card, you demonstrate that you understand and agree to comply with the terms and conditions of this offer as put forth on this co-pay assistance card.

You will need to contact your insurance provider to find out if you are covered.

If your insurance does not cover XYOSTED, you may still be able to access XYOSTED through the XYOSTED4YOU Cash Program. This program is designed to help eligible* patients - whether uninsured or denied coverage - to purchase XYOSTED for $199 per month with a valid prescription.

* Eligibility restrictions: Must be 18 years or over with a valid prescription for XYOSTED® (testosterone enanthate). Must be a U.S. resident with a valid U.S. shipping address. Additional shipping charges may apply. Offer not valid for prescriptions reimbursed under any private insurance or any federal or state healthcare program, including, but not limited to, Medicare, Medicaid, Tricare, or any state medical assistance programs. Purchases made under this program cannot be claimed in any Part D True Out of Pocket Cost (TrOOP) Submission. Patients are responsible for reporting use of this program to any private insurer, health plan or third-party payer. The XYOSTED4YOU Cash Program is not health insurance. Cannot be combined with other offers or programs. Offer void where prohibited by law, taxed, or restricted. Halozyme reserves the right to rescind, revoke, or amend this offer at any time without notice. By enrolling in this program, you demonstrate that you understand and agree to comply with the terms and conditions set forth herein and any additional Terms and Conditions set for by Sterling Pharmacy regarding purchases made under this program.

To participate, you must:

  • Be 18 years or older
  • Have a valid prescription for XYOSTED
  • Be a U.S. resident with a valid U.S. shipping address

Please note: This program is not insurance and cannot be used in combination with any federal or state healthcare programs (like Medicare or Medicaid). 
Additional terms and conditions apply.

You can obtain XYOSTED through one of the program’s partnered specialty pharmacies:

National Specialty Pharmacy 

Sterling Specialty Pharmacy.
Call 1-888-618-4126

Local Specialty Pharmacies 

ahma Rx:
Elmsford, NY
Call 1‑914‑840‑5027
ahma Rx:
New York, NY
Call 1‑212‑749‑6626
ahma Rx:
Garfield, NJ
Call 1‑862‑225‑9422
Allied Pharmacy:
Sugar Land, TX
Call 1‑832-365-3420
Choice Specialty Pharmacy:
Sugarland, TX
Call 1‑832‑944‑6112
Choice Specialty Pharmacy:
Shenandoah, TX
Call 1-346-309-4800
Goldsmith Medicenter Pharmacy:
Des Peres, MO
Call 1-314-432-5020
Pharmacy at Blue Back:
West Hartford, CT
Call 1-860-656-6229

Yes. XYOSTED is available for home delivery through our trusted specialty pharmacy partners. To get started, simply ask your doctor to send your prescription to any one of the specialty pharmacy partners listed below.

National Specialty Pharmacy

Sterling Specialty Pharmacy:
Call 1-888-618-4126

Regional Specialty Pharmacies

Alabama
Village Discount Drug: Cullman, Alabama 
Call 1-256-775-7455
––––––––
California
986 Pharmacy: Santa Monica, CA
Call 1-310-496-7555

ABC Pharmacy: Laguna Hills, CA
Call 1-949-916-9990

Delta Drugs: Glendale, CA
Call 1-818-309-2884

Link Pharmacy: Lake Forest, CA
Call 1-949-215-5899
––––––––
Connecticut
Pharmacy at Blue Back: West Hartford, CT
Call 1-860-656-6229
––––––––
Georgia
Anchor Pharmacy: Decatur, GA
Call 1-404-600-8172
––––––––
Missouri
Goldsmith Medicenter Pharmacy: Des Peres, MO
Call 1-314-432-5020
––––––––
New Jersey
ahma Rx: Garfield, NJ 
Call 1‑862‑225‑9422

––––––––

New York
ahma Rx: Elmsford, NY 
Call 1‑914‑840‑5027

ahma Rx: New York, NY 
Call 1‑212‑749‑6626

Chemist Shoppe: Long Island City, NY
Call 1-718-472-0900, ext 2

Silver Rod: Brooklyn, NY 

Call 1-718-236-5705
––––––––
Rhode Island
Atwood Pharmacy: Johnstown, RI
Call 1-401-864-0460
––––––––
Texas
Choice Specialty Pharmacy: Sugarland, TX 
Call 1‑832‑944‑6112

Choice Specialty Pharmacy: Shenandoah, TX 
Call 1-346-309-4800

Alamo Pharmacy: San Antonio, TX
Call 1-210-314-6782

Allied Pharmacy: Sugar Land, TX
Call 1-832-365-3420


XYOSTED® (testosterone enanthate) injection, for subcutaneous use CIII

XYOSTED 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)
  • Hypogonadotropic hypogonadism (congenital or acquired)

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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

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).

WARNINGS AND PRECAUTIONS

Polycythemia—Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of XYOSTED. Check that hematocrit is not elevated prior to initiating XYOSTED. Evaluate hematocrit approximately every 3 months while the patient is on XYOSTED. If hematocrit becomes elevated, stop XYOSTED until the hematocrit decreases to an acceptable level. If XYOSTED is restarted and again causes hematocrit to become elevated, stop XYOSTED permanently. An increase in red blood cell mass may increase the risk of thromboembolic events.

Venous Thromboembolism (VTE)—There have been post-marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as XYOSTED.

In the Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men (TRAVERSE) Study, a randomized, double-blind, placebo-controlled, cardiovascular (CV) outcomes study, compared to placebo, topical testosterone gel was associated with a higher risk of VTE (1.7% vs 1.2%) which included DVT (0.6% vs 0.5%) and PE (0.9% vs 0.5%).

Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with XYOSTED and initiate appropriate workup and management.

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer—Patients with BPH treated with androgens are at an increased risk of worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at an increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens.

Blood Pressure Increase—XYOSTED can increase blood pressure.  Ambulatory blood pressure monitoring (ABPM) demonstrated XYOSTED increased systolic/diastolic BP by an average of 3.9/1.5 mmHg from baseline after 12 weeks of treatment in clinical trials.  In patients with hypertension on antihypertensive therapy, XYOSTED increased the mean systolic/diastolic BP by 3.9/1.3  mm Hg from baseline.  

The  CV risk associated with topical testosterone gel was evaluated in TRAVERSE, a randomized, double-blind, placebo-controlled, CV outcomes study in men with a history of CV disease or multiple CV risk factors.  In TRAVERSE, topical testosterone gel increased mean systolic blood pressure by 1.8 mmHg from baseline.  However, the incidences of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction [MI] and non-fatal stroke, were similar between treatment groups (7% for topical testosterone gel vs 7.3% for placebo).

Monitor blood pressure periodically in men using XYOSTED, especially men with hypertension.  XYOSTED is not recommended for use in patients with uncontrolled hypertension.

Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations—Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions.

If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

Not for Use in Women—Due to lack of controlled studies in women and potential virilizing effects, XYOSTED is not indicated for use in women.

Potential for Adverse Effects on Spermatogenesis—With large doses of exogenous androgens, including XYOSTED, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count. Patients should be informed of this possible risk when deciding whether to use or to continue to use XYOSTED.

Hepatic Adverse Effects—Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. XYOSTED is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue XYOSTED while the cause is evaluated.

Edema—Androgens, including XYOSTED, may promote retention of sodium and water. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

Gynecomastia—Gynecomastia may develop and may persist in patients being treated for hypogonadism.

Sleep Apnea—Treatment with testosterone products, including XYOSTED, may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease.

Lipid Changes—Changes in the serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy.

Hypercalcemia—Androgens, including XYOSTED, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations regularly during treatment with XYOSTED in these patients.

Decreased Thyroxine-binding Globulin—Androgens, including XYOSTED, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Risk of Depression and Suicide—Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with XYOSTED. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes.

ADVERSE REACTIONS

The safety of XYOSTED was evaluated in 2 clinical studies in a total of 283 men who received weekly subcutaneous doses for up to 1 year. All patients were started on 75 mg weekly, then the dose was titrated to 50 mg or 100 mg weekly, as needed, to achieve pre-dose total testosterone concentrations of ≥350 ng/dL and <650 ng/dL.

The most commonly reported adverse reactions (>5%) were: hematocrit increased, hypertension, PSA increased, injection site bruising, and headache.

DRUG INTERACTIONS

Insulin—Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.

Oral Anticoagulants—Changes in anticoagulant activity may be seen with androgens, therefore, more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.

Corticosteroids—The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease.

Medications that May Also Increase Blood Pressure—Some prescription medications and nonprescription analgesic and cold medications contain drugs known to increase blood pressure. Concomitant administration of these medications with XYOSTED may lead to additional increases in blood pressure.

USE IN SPECIFIC POPULATIONS

Pregnancy—XYOSTED is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies.

Lactation—XYOSTED is not indicated for use in females.

Females and Males of Reproductive Potential - During treatment with large doses of exogenous androgens, including XYOSTED, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis. Reduced fertility is observed in some men taking testosterone replacement therapy. The impact on fertility may be irreversible.

Pediatric Use—Safety and effectiveness of XYOSTED in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

Geriatric Use—There have not been sufficient numbers of geriatric patients in controlled clinical studies with XYOSTED to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 283 patients enrolled in the 6-month and 1-year efficacy and safety clinical study utilizing XYOSTED, 49 (17%) were over 65 years of age. Additionally, there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH.

DRUG ABUSE AND DEPENDENCE

XYOSTED contains testosterone enanthate, a Schedule III controlled substance in the Controlled Substances Act.

Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders.

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression.

The following adverse reactions have been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemia, testicular atrophy, subfertility, and infertility.

The following adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male pattern baldness, and menstrual irregularities.

The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.

Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses for approved indications have not been documented. 

For more information, call
1-844-XYOSTED (1-844-996-7833).

Please see full Prescribing Information and Medication Guide.
April 2025 Update.