Xyosted

Indications

Xyosted is prescribed for testosterone replacement therapy in adult males who have a deficiency or absence of endogenous testosterone. This condition is known as hypogonadism.

The medication is used to treat two main types of testosterone deficiency:

• Primary hypogonadism: This occurs when the testicles are unable to produce enough testosterone. This may be caused by genetic conditions (such as Klinefelter syndrome), physical injury, or medical treatments like chemotherapy or radiation.
• Hypogonadotropic hypogonadism: This occurs when the pituitary gland or hypothalamus (parts of the brain that signal the testicles to make testosterone) is not functioning correctly. This can be caused by tumors, trauma, or congenital deficiencies.

Limitations of Use

Xyosted is specifically indicated for men with medical conditions that cause low testosterone. It has not been established as safe or effective for treating low testosterone levels caused by the natural process of aging. It is also not intended for use in women or children.

Mechanism of Action

Xyosted is a form of testosterone replacement therapy. It contains testosterone enanthate, which is an androgen, or male sex hormone. This medication is designed to supplement or replace the testosterone that the body is not producing on its own due to certain medical conditions.

Testosterone is a hormone naturally produced by the body that is responsible for the development and maintenance of many male physical characteristics. It plays a key role in several functions, including:

• The growth and health of male reproductive organs.
• The development of secondary sex characteristics, such as a deeper voice and body hair.
• The maintenance of muscle mass and bone density.
• The regulation of sexual desire and energy levels.

Xyosted is administered as an injection into the fatty tissue just under the skin. After the injection, the medication is slowly absorbed into the bloodstream over time. Once in the blood, it acts like natural testosterone by binding to specific receptors throughout the body, helping to restore hormone levels to a healthy range.

Common Side Effects

Many people using Xyosted experience mild side effects. These often include:

• Redness, bruising, or pain where the medicine was injected
• Increased red blood cell count (hematocrit)
• High blood pressure
• Acne
• Headache
• Back pain
• Increased prostate-specific antigen (PSA) levels

Serious Side Effects

Some side effects can be severe and require medical attention. Seek help immediately if you experience:

• Heart and blood pressure issues: Xyosted can cause blood pressure to rise, which may increase the risk of a heart attack or stroke.
• Blood clots: Symptoms include swelling, pain, or redness in the legs, or sudden chest pain and difficulty breathing.
• Liver problems: Signs may include yellowing of the eyes or skin, dark urine, or pain in the upper right stomach area.
• Fluid retention: Swelling in the ankles, feet, or legs, especially in those with heart, kidney, or liver disease.
• Breathing changes: New or worsening sleep apnea, characterized by breathing that stops and starts during sleep.
• Mood changes: New or worsening depression, anxiety, or irritability.
• Prostate changes: Difficulty urinating or changes in urinary frequency, which may indicate an enlarged prostate.

Boxed Warning: Increased Blood Pressure

Xyosted can cause an increase in blood pressure, which may raise the risk of major cardiovascular events, including heart attack, stroke, and cardiovascular death. Blood pressure should be measured before starting this medication and monitored regularly during treatment. The risk of these events may be higher in individuals who already have high blood pressure or established heart disease.

Cardiovascular and Blood Clot Risks

Testosterone replacement therapy may increase the risk of blood clots in the legs (deep vein thrombosis) or the lungs (pulmonary embolism). Signs of a blood clot may include pain, swelling, or redness in the legs, or sudden shortness of breath and chest pain. Long-term use of testosterone has also been associated with an increased risk of heart attack and stroke.

Prostate and Cancer Concerns

Xyosted is contraindicated in men with known or suspected prostate cancer or breast cancer. In men with benign prostatic hyperplasia (BPH), testosterone treatment may worsen urinary symptoms, such as difficulty urinating or increased frequency. Regular prostate examinations and screenings are typically recommended for those using testosterone therapy.

Blood Count Changes

Treatment with Xyosted can cause an increase in red blood cell count, a condition known as polycythemia. An excessive increase in red blood cells can increase the risk of blood clots, heart attack, and stroke. Healthcare providers usually monitor hemoglobin and hematocrit levels periodically to manage this risk.

Other Precautions

• Fluid Retention: Testosterone may cause the body to retain salt and water, leading to edema (swelling). This can be particularly serious for individuals with pre-existing heart, kidney, or liver disease.
• Sleep Apnea: Testosterone therapy may worsen sleep apnea in some individuals, especially those with risk factors such as obesity or chronic lung disease.
• Lipid Changes: Changes in serum lipid profiles, including a decrease in HDL (good cholesterol), may occur during treatment.
• Abuse and Misuse: Testosterone is a controlled substance. Using it in higher doses than prescribed, or in combination with other anabolic steroids, can lead to serious health consequences, including heart failure, liver toxicity, and psychiatric issues.

Pregnancy

Xyosted is contraindicated for use in pregnant women. Testosterone is known to be teratogenic and can cause fetal harm. Exposure to testosterone during pregnancy may result in the development of male physical characteristics in a female fetus (virilization). If a woman becomes pregnant while exposed to this medication, she should contact a healthcare provider immediately.

Breastfeeding

It is not known whether testosterone is excreted in human breast milk. Because of the potential for serious adverse reactions in a nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug. Individuals should discuss the risks and benefits with a healthcare professional.

General Considerations

Xyosted is only FDA-approved for use in adult males with specific medical conditions. Women who are pregnant or who may become pregnant should avoid contact with this medication. There is no established safety or efficacy for the use of Xyosted in females.

Available Forms

Xyosted is supplied as a liquid solution for injection. It comes in a pre-filled, disposable autoinjector designed for subcutaneous use, which involves injecting the medication into the fatty tissue of the abdominal area.

• Subcutaneous Injection: A disposable, pre-filled autoinjector.

The autoinjector is designed for self-administration after proper training. Each device is intended for a single dose and must be disposed of in a puncture-resistant container after use.

FDA Approval and Indications

Xyosted (testosterone enanthate) was approved by the U.S. Food and Drug Administration (FDA) in September 2018. It is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, such as primary hypogonadism and hypogonadotropic hypogonadism.

The FDA has specified that Xyosted is not indicated for the treatment of age-related hypogonadism, as the safety and efficacy for this use have not been established.

Boxed Warning

Xyosted contains a boxed warning, the FDA's most serious warning, regarding blood pressure increases. Clinical trials showed that Xyosted can increase blood pressure, which may raise the risk of major adverse cardiovascular events, including:

• Non-fatal heart attack (myocardial infarction)
• Non-fatal stroke
• Cardiovascular death

Because of this risk, Xyosted should only be used for the treatment of men with hypogonadism associated with confirmed structural or genetic causes. Healthcare providers are advised to monitor blood pressure periodically during treatment.

Regulatory Classification

As a testosterone product, Xyosted is classified by the Drug Enforcement Administration (DEA) as a Schedule III controlled substance due to the potential for misuse and abuse.

Insurance and Pharmacy Pricing

The price of Xyosted is influenced by your specific health insurance plan and the pharmacy you choose. Many insurance providers require prior authorization, which means your doctor must provide additional information to the insurance company before they will cover the medication.

Brand-Name vs. Generic

Xyosted is a brand-name medication. While generic versions of testosterone enanthate are available for intramuscular injection, the specific autoinjector system used by Xyosted may not have a direct generic equivalent, which can contribute to a higher cost compared to traditional injection methods.

Savings and Assistance

Patients may be able to lower their out-of-pocket expenses through various options:

• Copay Cards: The manufacturer may offer savings cards for patients with commercial insurance to reduce monthly copayments.
• Patient Assistance: Some programs are available to help individuals who are uninsured or underinsured access the medication at a reduced cost.

To find the most accurate price, contact your insurance company for a coverage summary or ask your pharmacist for the current retail price and any available discounts.