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XYOSTED® (testosterone enanthate) CIII
Important Safety Information
Consumer

IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about XYOSTED?

Blood Pressure Increases – XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. 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 you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. Your healthcare provider should monitor your blood pressure while you are being treated with 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 for use in children younger than 18 years old. Improper use of XYOSTED may affect bone growth in children.

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. 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 use 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.
  • Have low testosterone without certain medical conditions. For example, do not take XYOSTED if you have low testosterone due to age.


What should I tell my healthcare provider before using XYOSTED?

Before you use XYOSTED, tell your healthcare provider about all of your medical conditions, including, if you have any of the following: high blood pressure or heart problems, high red blood cell count, urinary problems due to an enlarged prostate, kidney or liver problems, a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder, or 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 or medicines for pain and cold. Know the medicines you take. Ask your pharmacist for a list of all your medicines if you are not sure. Show your list 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:

  • See “What is the most important information I should know about XYOSTED?” above.
  • Increase in blood pressure. XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to heart attack or stroke. 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.
  • Increase in red blood cell count, hematocrit or hemoglobin. 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, hematocrit and hemoglobin while you use XYOSTED.
  • Cardiovascular Risk. Possible increased risk of heart attack, death, or stroke.
  • If you already have an enlarged prostate, your signs and symptoms may get worse while using XYOSTED. This can include: increased nighttime urination, trouble starting urination, more frequent urination, feeling an urge to urinate, having a urine accident, and 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.
  • 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.
  • 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 or pain on the right side of your stomach area (abdominal pain).
  • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease.
  • Enlarged or painful breasts.
  • Problems breathing while you sleep (sleep apnea).
  • Change in mood. Talk to your healthcare provider 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 increase, prostatic specific antigen (PSA) increase (a blood test for prostate cancer), increased blood pressure, and injection site reactions including bruising, bleeding, redness and headache.

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

To report side effects to the FDA, visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information, including Boxed Warning, and Medication Guide.


XYOSTED® (testosterone enanthate) CIII
Important Safety Information and Indications
Healthcare provider

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 males less than 18 years old have not been established


IMPORTANT SAFETY INFORMATION

WARNING: BLOOD PRESSURE INCREASES

  • XYOSTED can cause blood pressure increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.
  • Before initiating XYOSTED, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
  • Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension in patients on XYOSTED.
  • Re-evaluate whether the benefits of XYOSTED outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
  • Due to this risk, use XYOSTED only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.


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).
  • Men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies. The efficacy of XYOSTED has not been established for these conditions, and XYOSTED can increase blood pressure (BP) that can increase the risk of MACE.


WARNINGS AND PRECAUTIONS

Blood Pressure Increases—In clinical trials, XYOSTED increased systolic BP in the first 12 weeks of treatment by an average of 4 mmHg based on ambulatory blood pressure monitoring (ABPM) and by an average of 4 mmHg from baseline following 1 year of treatment based on blood pressure cuff measurements. In the 1-year trial, 10% of XYOSTED treated patients were started on antihypertensive medications or required changes to their antihypertensive medication regimen.

BP increases can increase the risk of MACE, with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

In some patients, the increase in BP with XYOSTED may be too small to detect, but can still increase the risk for MACE.

Before initiating XYOSTED, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Check BP approximately 6 weeks after initiating XYOSTED and periodically thereafter. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Re-evaluate whether the benefits of continued treatment with XYOSTED outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease.

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.

Cardiovascular Risk—Long-term clinical safety trials have not been completed to assess the cardiovascular outcomes of testosterone replacement therapy in adult males. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of MACE, such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in adult males. XYOSTED can cause BP increases that can increase the risk of MACE. Patients should be informed of this possible risk when deciding whether to use or to continue to use XYOSTED.

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.

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. 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.

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.

Lipids—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, including Boxed Warning and Medication Guide.