1 Hormone compounded hormone cream

This preparation is applied transdermally to the skin. Common application sites include the inner forearm, inner thigh, or lower abdomen — areas with relatively thin, well-perfused skin that support consistent transdermal absorption.

• Apply to clean, dry, intact skin only.
• Rotate sites within the same region to minimize local irritation and support consistent systemic exposure.
• Allow approximately 2 minutes for the cream to absorb before covering with clothing.
• Wash hands thoroughly after application to prevent inadvertent transfer to others.
• Apply at the same time each day to maintain consistent hormone levels.

Dosing is individualized and entirely prescriber-determined based on the patient's clinical presentation, hormonal laboratory values, symptoms, and therapeutic goals. Key principles include:

• Start at the lowest effective dose and titrate based on symptom response and follow-up laboratory monitoring.
• Hormone levels (e.g., serum estradiol, total/free testosterone, progesterone) should be assessed 4–6 weeks after initiation or dose change.
• Dose adjustments should be made incrementally, guided by both subjective symptom improvement and objective lab values.
• Final dosing, frequency, and duration are determined solely by the prescribing clinician.

Mechanism of action depends on the specific hormone compounded. In general, transdermal hormone delivery bypasses first-pass hepatic metabolism, delivering the active hormone directly into the systemic circulation through the skin's dermal vasculature.

• Estradiol: Binds estrogen receptors (ERα and ERβ) in target tissues, modulating gene transcription involved in vasomotor stability, bone metabolism, and urogenital health.
• Progesterone: Binds intracellular progesterone receptors, opposing estrogenic stimulation of the endometrium and modulating central and peripheral progesterone-sensitive tissues.
• Testosterone: Binds androgen receptors and, via aromatization, also contributes to estradiol levels; supports libido, muscle maintenance, and energy.
• Estriol: Weak estrogen with preferential binding to ERβ; used primarily for urogenital atrophy.

Single-hormone compounded transdermal cream is used in prescriber-directed hormone replacement therapy (HRT) contexts including:

• Menopause: Vasomotor symptoms (hot flushes, night sweats), urogenital atrophy, bone loss prevention.
• Hypogonadism: Androgen deficiency in men or women requiring testosterone supplementation.
• Progesterone supplementation: Luteal phase support or uterine protection in patients receiving estrogen therapy.

Monitoring recommendations:

• Baseline and follow-up serum hormone levels (estradiol, testosterone, progesterone as applicable) at 4–6 weeks post-initiation, then every 3–6 months once stable.
• Endometrial monitoring (ultrasound or endometrial biopsy) where unopposed estrogen is considered.
• Annual clinical review of continued need, symptom burden, and risk-benefit balance.
• Per ACOG 2023 guidance, compounded hormone therapy should not be prescribed routinely when FDA-approved formulations exist; documentation of clinical rationale is recommended.

Contraindications:

• Known or suspected estrogen-dependent malignancy (breast, endometrial, ovarian cancer) — for estrogen-containing preparations.
• Undiagnosed abnormal uterine bleeding.
• Active or prior history of venous thromboembolism (DVT, PE) — for estrogen.
• Active liver disease or hepatic impairment.
• Hypersensitivity to any component of the preparation.
• Known or suspected androgen-sensitive malignancy (prostate cancer) — for testosterone-containing preparations.

Warnings & Precautions:

• Inadvertent hormone transfer to children or partners via skin contact is a recognized risk; advise patients on site-covering and handwashing.
• Monitor for signs of hormone excess (virilization with testosterone; endometrial hyperplasia with unopposed estrogen).
• Cardiovascular risk: estrogen therapy may increase risk of VTE; individualize risk-benefit assessment.
• Compounded preparations lack the standardized pharmacokinetic data of FDA-approved products; intra- and inter-batch variability is possible.

Drug Interactions:

• CYP3A4 inducers (rifampin, carbamazepine, St. John's Wort) may reduce plasma hormone levels.
• CYP3A4 inhibitors (ketoconazole, erythromycin) may increase hormone exposure.

Common Side Effects: Application site reactions (erythema, pruritus); breast tenderness (estrogen); acne, hirsutism, or virilization (testosterone at supratherapeutic levels); mood changes.

Store at controlled room temperature (15–25°C / 59–77°F). Keep tightly closed. Protect from heat, moisture, and direct light. Do not refrigerate unless specifically directed. Keep out of reach of children and pets to prevent accidental exposure. Use by the beyond-use date (BUD) labeled on the container, which is determined per USP <795> compounding standards. Do not use if the cream has changed color, consistency, or odor.

Is this cream FDA-approved?

No. This is a patient-specific, prescriber-directed compounded preparation prepared by Genesis Compounding under 503A regulations. It is not FDA-approved as a finished drug product. Compounded preparations are not subject to the same pre-market safety and efficacy review as FDA-approved medications.

How should I apply the cream?

Apply a thin layer to clean, dry, intact skin (inner forearm, inner thigh, or lower abdomen) at the same time each day. Rotate application sites, allow 2 minutes to absorb, and wash hands immediately after to prevent transfer.

What laboratory monitoring is needed?

Your prescriber will order baseline and follow-up hormone levels (estradiol, testosterone, or progesterone, as applicable) typically at 4–6 weeks after starting or changing dose, then every 3–6 months once stable.

Can this hormone transfer to my partner or children?

Yes. Skin-to-skin transfer is a recognized risk. Cover the application site with clothing after absorption and wash hands thoroughly. Children and pregnant women should avoid contact with treated skin.

How long will it take to notice effects?

Symptomatic improvement may begin within 2–4 weeks, but full therapeutic response typically requires 6–12 weeks of consistent use. Laboratory levels should be reassessed before assuming the dose requires adjustment.