Fertinatal

Approved Indications:

• DHEA is approved in some countries as a prescription medication for adrenal insufficiency (e.g., Addison’s disease), where endogenous production of adrenal steroids is deficient.
• Used to treat adrenal androgen deficiency in adult patients.

Clinically Accepted Off-label Uses:

• Age-related decline in DHEA levels (for anti-aging, fatigue, or mood disorders, though evidence is limited).
• Treatment of systemic lupus erythematosus (SLE) as an immunomodulatory agent.
• Management of depression or mild cognitive impairment in elderly adults.
• Sexual dysfunction in women, including hypoactive sexual desire disorder (HSDD).
• Osteoporosis prevention or treatment in postmenopausal women.
• Infertility adjunct in women with diminished ovarian reserve or poor ovarian response.
• Possible adjunct in HIV-associated wasting syndrome.

Note: Many uses remain off-label and require clinical judgment.

• Adults (Adrenal insufficiency or androgen deficiency):
• Typical oral doses range from 25 mg to 50 mg daily, often divided into one or two doses.
• In Women for Sexual Dysfunction or SLE:
• Oral doses of 10 to 50 mg daily are commonly used.
• Elderly or Anti-Aging:
• Doses generally range from 10 to 50 mg daily, with monitoring.
• Pediatrics:
• Not commonly recommended except in specific adrenal insufficiency cases; doses adjusted per specialist guidance.
• Special Populations:
• Renal impairment: No formal dose adjustment; use cautiously.
• Hepatic impairment: Use with caution; no established dose changes.
• Elderly: Lower doses may be preferred initially.
• Administration Route:
• Oral tablets or capsules are standard.
• Also available as topical creams or gels in some formulations.
• Duration:
• Depends on indication; long-term use requires monitoring of hormone levels and side effects.

DHEA is an endogenous steroid hormone produced primarily by the adrenal glands and serves as a metabolic precursor to androgens and estrogens. After administration, DHEA is converted enzymatically in peripheral tissues into active androgens (like testosterone) and estrogens (like estradiol), thereby exerting androgenic and estrogenic effects. These effects influence numerous physiological systems including immune modulation, bone metabolism, mood regulation, and sexual function. DHEA also interacts with several nuclear hormone receptors, influencing gene transcription and cellular functions indirectly.

• Absorption:
• Well absorbed orally with bioavailability approximately 30-70%.
• Distribution:
• Widely distributed, largely bound to albumin and sex hormone-binding globulin (SHBG).
• Metabolism:
• Extensively metabolized in the liver and peripheral tissues via sulfonation to DHEA sulfate (DHEAS) and conversion to androstenedione, testosterone, and estrogens.
• Half-life:
• Plasma half-life is approximately 15 to 38 hours depending on the formulation.
• Elimination:
• Metabolites excreted primarily in urine.

• Pregnancy:
• Classified as FDA Pregnancy Category C; animal studies suggest possible adverse effects, but adequate human data are lacking. Use only if clearly needed and after risk-benefit evaluation.
• Lactation:
• Limited data available; caution advised due to potential androgenic effects on the infant.

• Primary Class: Adrenal androgen / androgen precursor
• Subclass: Endogenous steroid hormone supplement

• Known hypersensitivity to DHEA or formulation excipients.
• Hormone-sensitive cancers (e.g., breast, prostate, uterine cancers).
• Pregnancy and breastfeeding unless benefits outweigh risks.
• Severe hepatic impairment.
• Uncontrolled hormone-sensitive conditions (e.g., endometriosis, uterine fibroids).

• Use cautiously in patients with hormone-sensitive tumors or disorders.
• Monitor for signs of androgen excess (acne, hirsutism, voice changes).
• Potential for alterations in lipid profiles; monitor cardiovascular risk factors.
• Possible mood changes, including irritability or aggression.
• Long-term safety data limited; periodic hormone level monitoring recommended.
• Avoid use in children unless under specialist care.

Common:

• Acne, oily skin
• Hirsutism (in females)
• Hair thinning or male-pattern baldness
• Changes in menstrual cycle
• Mood changes (e.g., irritability, anxiety)
• Headache

Less common/Serious:

• Virilization symptoms (deepening voice, clitoromegaly)
• Liver enzyme elevations
• Edema or fluid retention
• Elevated blood pressure
• Rare allergic reactions

Side effects may be dose-dependent and usually develop within weeks to months of therapy.

• May interact with estrogen or androgen therapies (additive or antagonistic effects).
• Potential interaction with anticoagulants (e.g., warfarin) altering coagulation.
• May influence corticosteroid metabolism or effects.
• No significant CYP450 enzyme induction or inhibition noted, but caution with concomitant hormone-modulating drugs.
• Alcohol may exacerbate hepatic side effects.

• Recent endocrine society guidelines emphasize cautious use of DHEA in adrenal insufficiency to improve quality of life but recommend monitoring for adverse effects.
• Updated lupus management guidelines recognize DHEA as a possible adjunct to reduce corticosteroid dosage in mild to moderate SLE.
• Anti-aging use remains controversial; no formal endorsement due to limited robust evidence.
• Ongoing clinical trials are investigating efficacy in cognitive decline and mood disorders.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from excessive heat, moisture, and direct light.
• Keep in tightly closed container.
• Do not freeze.
• Keep out of reach of children.