Xyosted

Xyosted^® is a prescription medication used for testosterone replacement therapy (TRT) in adult men with hypogonadism, a condition that causes lower-than-normal testosterone levels. Xyosted is designed to restore normal testosterone levels in men experiencing symptoms of low testosterone, such as fatigue, reduced libido, depressed mood, and decreased muscle mass.

Each Xyosted injection comes in a pre-filled syringe containing a fixed dose of testosterone enanthate—either 50 milligrams (mg), 75 mg, or 100 mg—and is administered under the skin, typically in the abdomen. It provides a more convenient and less painful alternative to intramuscular testosterone injections.

Common side effects of Xyosted include injection-site reactions such as redness, swelling, or pain, as well as increased blood pressure, headache, acne, and elevated red blood cell count. More serious risks include worsening of benign prostatic hyperplasia (BPH), potential cardiovascular events, and suppression of natural testosterone and sperm production. 

This medication should be taken while under the care of a healthcare provider, who will regularly monitor testosterone levels and adjust dosing as needed.

Xyosted (testosterone enanthate) injection is indicated for:

• Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

Androgen

The most commonly reported adverse reactions (>5%) were:

• Hematocrit increased

• High blood pressure

• PSA increased

• Injection site bruising

• Headache

The price of Xyosted may vary depending on the dosage, quantity, where you buy it, and your insurance plan. The average retail price of Xyosted is about $785 for four 75-mg doses, but coupons and discount cards may be available to bring down the price as low as about $473. Health insurance may cover all or some of the cost of this medication.

The Xyosted Co-pay Card allows eligible people with private health insurance to get medication for as little as a $15 co-pay per prescription filled. And the Xyosted4You cash program offers access to the drug for $175 per month for eligible people who are either uninsured or have health insurance that does not cover Xyosted.

There is currently no lower-cost generic version of Xyosted available

Xyosted is only available by prescription from a healthcare provider. If you’re interested in taking this medication, make an appointment with your provider so they can assess your testosterone levels and discuss whether testosterone therapy is the right treatment for you based on factors like your health status, medical history, and symptoms.

• Men with carcinoma of the breast or known or suspected carcinoma of the prostate

• Women who are pregnant. Testosterone may cause fetal harm

• Known hypersensitivity to Xyosted or its ingredients

• Men with hypogonadal conditions not associated with structural or genetic etiologies

• Drug interactions: Androgens may decrease blood glucose, changes in anticoagulant activity may be seen with androgens, use of testosterone with corticosteroids may result in increased fluid retention, concomitant administration of medications that are known to increase blood pressure with Xyosted may lead to additional increases in blood pressure

• Monitor hematocrit approximately every 3 months to detect increased red blood cell mass and polycythemia

• Monitor patients with benign prostatic hyperplasia (BPH) for worsening signs and symptoms of BPH

• Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products

• Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids

• Exogenous administration of androgens may lead to azoospermia

• Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease

• Sleep apnea may occur in those with risk factors

• Monitor prostatic specific antigen (PSA) and lipid concentrations periodically

• Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with Xyosted

WARNING: BLOOD PRESSURE INCREASES

Xyosted can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.

Before initiating Xyosted, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.

Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of Xyosted outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.

Due to this risk, use Xyosted only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

There are other treatments available for low testosterone. Some treatments may be better suited to you than others. If you’re interested in an alternative to Xyosted, consider connecting with a healthcare provider who can help you evaluate your options.

Other types of testosterone replacement therapy (sometimes called androgen replacement) include:

• Other injectable testosterone medications, such as Aveed^®, Azmiro^®, or Depo^®-Testosterone

• Implantable testosterone pellets, such as Testopel^®

• Oral testosterone therapy medications, such as Jatenzo^® and Tlando^®

• Topical testosterone, such as Testim^® (testosterone gel)

Alternatives to TRT that may help manage low testosterone in men include the following treatments, which can signal the body to have or make more testosterone:

• Aromatase inhibitors, like Arimidex^® (anastrozole)

• Human chorionic gonadotropin (hCG) or Ovidrel^®, a lab-made version of hCG

• Selective estrogen receptor modulators, like Clomid (clomiphene)

Your healthcare provider may also prescribe non-medication alternatives that can support healthy testosterone levels, including:

• Exercise

• Stress management

• Dietary improvements

• Getting enough sleep

• Weight loss

*This information is from the label for brand name Xyosted^®. See the Full Prescribing Information for more complete information. Testosterone enanthate, the active ingredient in Xyosted, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient testosterone enanthate.