What is Hypogonadism?
Testosterone is a vital male sex hormone that plays a crucial role in maintaining sexual function, muscle mass, bone density, and mood. Hypogonadism is a condition where the body does not produce enough natural testosterone. This deficiency can lead to various symptoms, including decreased libido, erectile dysfunction, reduced muscle mass and strength, fatigue, and depressed mood.
There are two main types of hypogonadism that Xyosted is approved to treat:
- Primary Hypogonadism: Occurs when there is an issue with the testicles themselves, preventing them from producing enough testosterone. This can be due to congenital conditions, injury, or treatments like chemotherapy.
- Hypogonadotropic Hypogonadism (Secondary Hypogonadism): Caused by a problem with the pituitary gland or hypothalamus in the brain, which normally signals the testicles to produce testosterone. Issues like brain tumors, trauma, or radiation can lead to this condition.
The Mechanism of Action: How Xyosted Works
Xyosted contains the active ingredient testosterone enanthate, a synthetic version of the natural hormone. The medication is designed to replace the testosterone that the body is not producing naturally. Once injected, the testosterone enanthate is absorbed into the bloodstream and works to restore testosterone levels to a normal, healthy range. For patients with confirmed hypogonadism, this therapeutic effect helps to alleviate the symptoms associated with the deficiency.
Administration and Dosage of Xyosted
Xyosted is administered as a weekly, self-injected dose using a prefilled autoinjector pen, which delivers the medication subcutaneously (under the skin). A healthcare professional will provide training on the proper injection technique, which involves injecting into the abdomen while rotating injection sites to minimize irritation.
The typical starting dose is 75 mg once per week. After about six weeks, a doctor will check the patient's testosterone levels and adjust the dosage if necessary, aiming for a trough concentration (the level right before the next dose) of 350 ng/dL to 650 ng/dL. Dose adjustments are made in increments of 25 mg, with available strengths being 50 mg, 75 mg, and 100 mg.
Potential Side Effects and Safety Information
Like all medications, Xyosted carries potential risks and side effects. Due to a serious risk of blood pressure increases that can lead to major adverse cardiovascular events (MACE) such as heart attack and stroke, Xyosted has an FDA boxed warning. Patients with pre-existing heart conditions or risk factors for cardiovascular disease may face a higher risk. Regular blood pressure monitoring is necessary during treatment.
Common Side Effects (reported in >5% of clinical trial participants):
- Increased hematocrit (high red blood cell count)
- High blood pressure (hypertension)
- Increased Prostate-Specific Antigen (PSA)
- Headache
- Injection site bruising
Serious Side Effects and Safety Concerns:
- Blood Clots: Increased hematocrit can thicken the blood, raising the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE).
- Prostate Issues: May worsen benign prostatic hyperplasia (BPH) and potentially increase the risk of prostate cancer. Regular prostate monitoring is essential.
- Mood Changes: Can cause or worsen depression, anxiety, or suicidal thoughts.
- Fluid Retention (Edema): Can lead to swelling in the ankles and feet, particularly in patients with cardiac, renal, or hepatic disease.
- Sleep Apnea: Can cause or exacerbate sleep apnea, especially in individuals who are obese.
- Misuse and Dependence: As a controlled substance, Xyosted has potential for misuse and dependence. Abrupt discontinuation can cause withdrawal symptoms.
Xyosted vs. Other Testosterone Replacement Therapies
Xyosted offers a convenient once-weekly subcutaneous injection via an autoinjector. This contrasts with other common TRT options, which vary significantly in administration, frequency, and availability. The following table provides a comparison of Xyosted and another popular injectable option, Depo-Testosterone (testosterone cypionate).
| Feature | Xyosted (testosterone enanthate) | Depo-Testosterone (testosterone cypionate) |
|---|---|---|
| Administration Route | Subcutaneous (under the skin) injection | Intramuscular (into the muscle) injection |
| Injection Frequency | Once per week | Every 2 to 4 weeks |
| Autoinjector | Yes, prefilled autoinjector for self-administration | No, requires standard syringe and needle, typically administered by a healthcare professional |
| Generic Version | No, currently only available as brand-name | Yes, lower-cost generic option available |
| Key Side Effects | Higher risk of blood pressure and hematocrit increases | Can cause gynecomastia and acne |
Conclusion
What is Xyosted used for? Primarily, it is prescribed for adult men with confirmed low testosterone levels caused by specific medical conditions, known as hypogonadism. The weekly subcutaneous injection via an easy-to-use autoinjector offers a convenient and effective way to manage the condition. However, due to its potential for serious side effects, including increased blood pressure and cardiovascular risks, it is essential for patients to be properly screened and monitored by a healthcare provider throughout treatment. Patients should be aware of the serious FDA boxed warning and discuss all health conditions with their doctor before starting Xyosted to ensure it is the right and safest choice for their individual needs. It is not approved for cosmetic or performance-enhancing purposes.
Disclaimer: This article is for informational purposes only and is not medical advice. Consult with a qualified healthcare professional before making any decisions about your health or treatment. Healthline
