From the Guidelines
Exemestane is not recommended for daily use by adult males outside of specific medical conditions under physician supervision due to its potential to cause significant hormonal disruptions and increase the risk of osteoporosis, fractures, and other health issues. Daily use of exemestane by men can cause a rapid decline in circulating estrogen levels, leading to bone loss and increased fracture risk, as seen in studies such as the Intergroup Exemestane Study (IES) 1. Potential effects of exemestane use in men include:
- Decreased estrogen levels, which are necessary for bone health, cognitive function, and cardiovascular protection
- Joint pain
- Decreased bone mineral density leading to osteoporosis
- Increased risk of fractures
- Mood changes
- Decreased libido
- Erectile dysfunction
- Potential cardiovascular issues, including altered lipid profiles
The medication is primarily indicated for breast cancer treatment in postmenopausal women, and its use in men is limited to specific conditions like gynecomastia or certain hormone-sensitive cancers 1. The typical dose for medical purposes is 25mg daily, but men should never self-prescribe this medication. Any use should occur only under medical supervision with regular monitoring of hormone levels, bone density, and cardiovascular health. The body requires a balance of hormones for optimal function, and disrupting this balance without medical necessity can lead to serious health consequences.
It is essential to consider the risks and benefits of exemestane use, as discussed in the American Society of Clinical Oncology clinical practice guideline 1, and to prioritize the patient's overall health and well-being. In the context of real-life clinical medicine, it is crucial to exercise caution when considering the use of exemestane in adult males, given the potential for significant hormonal disruptions and increased risk of health issues.
From the FDA Drug Label
Exemestane significantly lowers circulating estrogen concentrations in postmenopausal women, but has no detectable effect on adrenal biosynthesis of corticosteroids or aldosterone. Daily doses of exemestane up to 25 mg had no significant effect on circulating levels of androstenedione, dehydroepiandrosterone sulfate, or 17-hydroxyprogesterone, and were associated with small decreases in circulating levels of testosterone. A dose-dependent decrease in sex hormone binding globulin (SHBG) has been observed with daily exemestane doses of 2.5 mg or higher. The most common adverse reactions included hot flushes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8% vs. 10%), increased sweating (4% vs. 8%), and increased appetite (3% vs 6%) for EXEMESTANE and megestrol acetate, respectively.
The potential effects of an adult male taking exemestane (Aromasin) daily may include:
- Decreased estrogen levels: Exemestane lowers circulating estrogen concentrations.
- Decreased testosterone levels: Daily doses of exemestane up to 25 mg are associated with small decreases in circulating levels of testosterone.
- Adverse reactions: Common adverse reactions include hot flushes, nausea, fatigue, increased sweating, and increased appetite.
- Hormonal changes: Exemestane may cause a dose-dependent decrease in sex hormone binding globulin (SHBG) and slight, nondose-dependent increases in serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels. It is essential to note that exemestane is not approved for use in adult males, and its effects in this population are not well studied. Therefore, any use of exemestane in adult males should be approached with caution and under the guidance of a healthcare professional 2 2.
From the Research
Potential Effects of Exemestane on Adult Males
The provided studies primarily focus on the effects of exemestane in postmenopausal women with breast cancer. However, we can still discuss the potential effects of exemestane on adult males based on its mechanism of action and available data.
- Hormonal Changes: Exemestane is an aromatase inhibitor, which means it blocks the conversion of androgens to estrogens in the body 3, 4. In adult males, this could lead to a decrease in estrogen levels and potentially disrupt the balance of sex hormones.
- Side Effects: Common side effects of exemestane in women include hot flashes, nausea, fatigue, and increased sweating 3, 4. It is possible that adult males may experience similar side effects, although the frequency and severity may vary.
- Androgenic Effects: High doses of exemestane (200 mg/day) have been associated with androgenic events in a small number of patients 3. However, it is unclear whether this would occur in adult males taking lower doses.
- Bone Health: Aromatase inhibitors like exemestane can lead to bone loss in women 4. Adult males taking exemestane may also be at risk for bone loss, although this has not been extensively studied.
Dosage and Administration
The optimal dosage and administration schedule for exemestane in adult males is not established. Studies have investigated various dosing regimens in women, including daily, 3-times-weekly, and once-weekly schedules 5. However, it is unclear whether these regimens would be effective and safe for adult males.
- Efficacy: Exemestane has been shown to be effective in reducing estrogen levels and improving outcomes in postmenopausal women with breast cancer 3, 4. Its efficacy in adult males is unknown and would require further study.
- Safety: The safety profile of exemestane in adult males is not well established. While it is generally well-tolerated in women, the potential for side effects and long-term consequences in males requires further investigation 6, 7.