What is the appropriate dosing for Testosterone (T) replacement therapy?

From the Guidelines

Testosterone replacement therapy should be initiated with 50-100mg of testosterone cypionate or enanthate injected intramuscularly every 1-2 weeks, or 50-100mg of testosterone gel applied daily to the skin, with dosing individualized based on symptoms and serum testosterone levels. When considering the various formulations, long-acting injections such as testosterone enanthate and cypionate offer relatively inexpensive and flexible dosing options, although they require intramuscular injection and may result in fluctuating serum testosterone levels 1. Topical options like AndroGel and Testim provide easy application and good skin tolerability, but carry the risk of transfer to partners or children through skin-to-skin contact 1.

Some key points to consider when selecting a testosterone replacement formulation include:

• The advantages and disadvantages of each formulation, such as the risk of transference, skin irritation, and injection-associated complications 1
• The typical dose range for each formulation, which can vary from 50-100mg daily for topical gels to 100-200mg every 2 weeks for intramuscular injections 1
• The application site for each formulation, which can impact the risk of transference and skin irritation 1
• The potential for fluctuating serum testosterone levels with certain formulations, which can impact the efficacy and safety of therapy 1

Dosing should be tailored to individual patient needs, with target serum testosterone levels between 400-700 ng/dL for most men 1. Regular blood tests, conducted 2-3 days after injection for injectable forms or in the morning for topical applications, are essential for monitoring treatment efficacy and potential side effects 1. Follow-up testing should be performed at 3-6 months after starting therapy and annually thereafter, with dose adjustments made as necessary based on clinical response and laboratory values 1.

It is also important to monitor patients for potential side effects, including:

• Polycythemia, which can increase the risk of thrombotic events 1
• Sleep apnea, which can impact cardiovascular health and quality of life 1
• Prostate changes, which can increase the risk of prostate cancer and other prostate-related complications 1
• Cardiovascular effects, which can increase the risk of myocardial infarction and stroke 1

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Testosterone Undecanoate Capsules is not substitutable with other oral testosterone undecanoate products (2. 1). Prior to initiating Testosterone Undecanoate Capsules, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2.2). Take Testosterone Undecanoate Capsules with food (2. 3). Starting dosage: 200 mg orally once in the morning and once in the evening (2.3). Adjust the dosage to a minimum of 100 mg once in the morning and a maximum of 400 mg twice daily based on serum testosterone drawn 3 to 5 hours after the morning dose at least 7 days after starting treatment or following dose adjustment and periodically thereafter (2.3).

The recommended starting dosage for testosterone replacement therapy with testosterone undecanoate capsules is 200 mg orally twice daily. The dosage can be adjusted based on serum testosterone levels, with a minimum dosage of 100 mg once daily and a maximum dosage of 400 mg twice daily.

• The dosage should be adjusted to achieve a serum testosterone concentration within the normal range.
• Serum testosterone levels should be drawn 3 to 5 hours after the morning dose, at least 7 days after starting treatment or following dose adjustment, and periodically thereafter.
• The patient's dosage may need to be titrated to achieve the desired serum testosterone concentration 2.

From the Research

Testosterone Replacement Dosing

• The goal of testosterone replacement therapy is to replace testosterone at levels as close to physiological concentrations as possible 3
• Parenteral testosterone esters, such as enanthate and cypionate, are commonly used, but can result in fluctuating plasma testosterone levels 3
• Alternative options, such as parenteral testosterone undecanoate, subcutaneous testosterone implants, and transdermal testosterone preparations, can provide more stable plasma testosterone levels 3
• Transdermal testosterone gel is a popular option, offering flexible dosing and attractive pharmacokinetic serum testosterone profiles 3
• The choice of testosterone preparation should involve patient input, as compliance is crucial for long-term treatment 3

Routes of Delivery

• Approved routes of delivery for testosterone replacement therapy include buccal, nasal, subdermal, transdermal, and intramuscular (IM) 4
• Each route has its own advantages and disadvantages, and the choice of route should be individualized based on patient characteristics and needs 4

Monitoring and Safety

• Testosterone replacement therapy is associated with multiple benefits, but also carries potential risks, such as deterioration of heart failure in older men with a history of heart failure 4
• Clinicians should consider the unique characteristics of each patient and make necessary adjustments in the management of late-onset hypogonadism (LOH) to provide the safest and most beneficial results 4
• Monitoring of testosterone replacement therapy is crucial to minimize risks, and guidelines recommend regular follow-up and assessment of treatment response 4