What is Kyzatrex?

Kyzatrex is a prescription medicine manufactured by Marius Pharmaceuticals that contains testosterone undecanoate. It is classed as an androgen and is designed to treat adult men who have low or no testosterone due to certain medical conditions. This oral capsule is specifically used for testosterone replacement therapy (TRT) in males with hypogonadism.

Male hypogonadism is characterised by the body’s inability to produce sufficient amounts of natural testosterone, which is a prevalent condition affecting an estimated 40% of men over the age of 45 globally. This hormonal imbalance can lead to a range of concerning symptoms, including fatigue, muscle loss, weight gain, diminished libido, cognitive decline, and mood disorders such as depression and anxiety.

Active ingredient: Testosterone undecanoate

The active ingredient in Kyzatrex is testosterone undecanoate. This active ingredient works by replacing the testosterone to a normal range in the body. It has an impact on the growth, development, and functioning of male sexual organs and typical male characteristics.

What makes Kyzatrex unique is its formulation. It’s a liquid-filled capsule that contains testosterone undecanoate dissolved in a mix of lipids and other solubilisers. This special formulation helps the highly lipophilic molecules of testosterone undecanoate to be absorbed rapidly in the blood along with food.

FDA approval status

The FDA approved Kyzatrex on July 27, 2022, causing a revolution in testosterone replacement therapy. It’s available in three dosage strengths: 100 mg, 150 mg, and 200 mg. This approval was based on clinical studies that showed Kyzatrex’s effectiveness in restoring normal testosterone levels in a high percentage of patients.

How Kyzatrex works

Mechanism of action

Testosterone undecanoate is a prodrug of testosterone. This means that once in the body, it’s converted to testosterone, the primary male sex hormone. This hormone has an impact on various bodily functions, including muscle mass, bone density, fat distribution, and sexual characteristics.

Testosterone undecanoate has a unique structure that allows it to be absorbed through the lymphatic system, bypassing the liver’s first-pass metabolism. This is important because it helps to maintain steady testosterone levels in the blood over time.

Absorption

The absorption of Kyzatrex is closely tied to food intake and patients are advised to take it with meals, as this enhances its absorption. The fatty acid chain of testosterone undecanoate makes it highly lipophilic, allowing it to be absorbed along with dietary fats.

Once absorbed, testosterone undecanoate travels through the lymphatic system and enters the bloodstream. In the circulation, the molecule is split releasing free testosterone. This process helps to maintain stable testosterone levels throughout the day.

It’s important to note that Kyzatrex’s metabolism differs from other forms of testosterone replacement therapy. Unlike gels or patches, it doesn’t carry the risk of transferring testosterone to others through skin contact. And unlike injections, it doesn’t require painful procedures or cause application site reactions.

Does Kyzatrex work?

Kyzatrex has a significant impact on testosterone levels in men with hypogonadism. In a six-month clinical trial involving 139 men with low testosterone, up to 96% of patients achieved normal testosterone levels by day 90 of treatment.

Kyzatrex doesn’t just increase total testosterone. It also has an impact on free testosterone and sex hormone-binding globulin (SHBG) levels. The study showed a twofold increase in mean free testosterone levels and a 30% decrease in mean SHBG levels.

These changes in hormone levels can lead to improvements in various symptoms associated with low testosterone. However, it’s crucial to remember that testosterone treatment should only be used under the guidance of a healthcare provider and for FDA-approved indications. Regular monitoring of blood pressure and other potential side effects is essential during treatment.

Advantages of Kyzatrex over traditional TRT

One of the key advantages of Kyzatrex is its oral delivery method. Unlike testosterone undecanoate injections, it eliminates the need for painful injections, messy gels, or cumbersome patches, providing a more convenient and discreet option for patients. Oral testosterone also avoids the potential for application site reactions, which can be a common issue with other TRT formulations.

Side effects of Kyzatrex

As with any medication, Kyzatrex may be associated with certain side effects. Some of the common side effects include blood pressure increases, elevated red blood cell count (hematocrit) or hemoglobin, increased risk of prostate cancer, liver problems, edema in the ankles and feet, enlarged and painful breasts, and sleep apnea. Patients are advised to closely monitor their health and report any concerning symptoms and serious side effects to their healthcare provider.

Contraindications

Kyzatrex is not recommended for individuals with certain medical conditions, such as breast cancer, prostate cancer, or pregnancy. Patients with low testosterone levels due to reasons other than a medical condition should also avoid using Kyzatrex. Healthcare providers will carefully evaluate each patient’s medical history and current health status to determine the appropriateness of Kyzatrex treatment.

Dosage and administration

Recommended dosage

The recommended starting dose for Kyzatrex is two 100mg soft gels twice daily, once in the morning and once in the evening, for a total of 400mg per day. This dosage is designed to restore testosterone to normal levels and maintain them there. However, it’s important to note that dosing may be adjusted depending on how a patient responds to the treatment.

The minimum recommended dose is 100mg once daily in the morning, while the maximum recommended dose is 400mg twice daily. For total daily doses greater than 100mg, the same dose should be administered in the morning and evening. A healthcare provider will determine the appropriate dosage based on individual needs and testosterone levels.

How to take Kyzatrex

Kyzatrex should always be taken with food to ensure proper absorption and effectiveness. It’s important to follow the prescribed dosage and take it at the same times each day to maintain consistent testosterone levels. The medication comes in three strengths: 100mg, 150mg, and 200mg capsules.

Patients should not increase their dose or use Kyzatrex more often or for longer than prescribed. It’s essential to follow all directions on the prescription label and read all medication guides or instruction sheets provided.

Importance of following prescribed dosage

Adhering to the prescribed dosage is crucial for several reasons. First, it helps to maintain stable testosterone levels, which is essential for managing symptoms of low testosterone. Second, it minimises the risk of adverse effects associated with testosterone undecanoate.

Healthcare providers should check serum testosterone concentrations at least 7 days after starting treatment or after dosage adjustment, 3 to 5 hours after the morning dose. Regular monitoring of serum testosterone concentration and blood pressure should continue throughout the treatment.

Conclusion

Kyzatrex is a controlled substance that has a significant impact on men dealing with low testosterone levels. It offers a unique oral delivery method that bypasses many of the drawbacks associated with other forms of testosterone replacement therapy. The FDA approval of Kyzatrex in 2022 has caused a revolution in how we approach testosterone replacement, giving healthcare providers a new tool to help patients with hypogonadism.

Remember that testosterone replacement therapy should only be used under a doctor’s guidance and for approved reasons. Regular check-ups and blood tests are essential to make sure the treatment is working well and to keep an eye on any potential side effects.

Sources

• DailyMed – KYZATREX- testosterone undecanoate capsule, liquid filled
• Medication Guide for KYZATREX®
• These highlights do not include all the information needed to use KYZATREX