CC#6: Compounded Bioidentical Menopausal Hormone Therapy Flashcards
What are bioidentical hormones?
Plant-derived hormones that are chemically similar or structurally identical to those produced by the body
FDA-approved bioidentical products (3)
Micronized progesterone, estradiol, DHEA
Compounded preparations not regulated by the FDA (7)
Estrone, estradiol cypionate, estriol, pregnenolone, testosterone, testosterone cypionate, testosterone propionate
What is “bioidentical hormone” primarily used as by compounding pharmacies?
A marketing term
Available routes of administration of compounded bioidenticals (6)
PO, sublingual, percutaneous, implants, injectable, suppositories
Situations in which bioidential compounding is considered appropriate (2)
For pts when the exact products needed are not commercially available, when different ingredients/ preservatives/routes of admin are required 2/2 pt intolerance/allergy or needs (ie inability to swallow a PO pill)
What federal act do compounding pharmacies fall under that allows them to bypass FDA review for safety/effectiveness/quality?
Section 503A of the Federal Food Drug and Cosmetic Act
Safety issues w/ custom-compounded hormone therapy (4)
Significant variability in mixtures of hormones included, high variability in amount of active med within a specific dose (2/2 lack of regulation), no requirements for adverse event reporting, potential for bacterial contamination
FDA-approved testosterone formulation for cisgender female pts
None currently
Pts in whom short-term transdermal testosterone can be considered as a tx option
Postmenopausal pts w/ sexual interest/arousal disorders (who have been appropriately counseled about risks and unknown long-term effects)
Most commonly reported adverse events seen w/ testosterone therapy in cisgender female pts (3)
Hirsutism, acne, virilization (which may be irreversible)
Advantages of testosterone pellet therapy over IM injections or patches (2)
Better bioavailability, more predictable absorption
Disadvantages of testosterone pellet therapy over PO/topical products (2)
Pellet cannot be removed but rather dissolves over time, potentially exposes user to testosterone over longer period of time
General situations in which individualized testing is useful (3)?
When there is a narrow therapeutic window for a drug/class of drugs, when serum hormone levels can be reliably assessed, if results would change management
Kinds of drugs that warrant individualized testing (4)
Meds w/ nonlinear pharmacokinetics, meds that are eliminated by kidney as active drug, meds that are not metabolized by liver through first-pass metabolism, meds that have clearly defined therapeutic/toxic windows based on data from large population pharmacokinetic studies
Percentage of steroid hormones circulating in free form (not bound to albumin)
<5%
General levels of estrogen seen in saliva
Extremely low
Are there any FDA-approved salivary/urinary tests for steroid hormone measurement?
Not currently
Target estradiol level (to provide reasonable relief from sxs) for pts already having started compounded bioidentical menopausal HRT, in order to titrate dosing
40-100pg/mL
Next step in surveillance in pts who are already currently using pellet therapy
Testing to r/o supraphysiologic testosterone levels
Recommended range of testosterone in pts on menopausal testosterone therapy
20-80mg/dL (physiologic premenopausal range)
Characteristics that may be variable in bioidentical hormones (4)
Absorption, potency, purity, quality
Advantages of FDA-approved patches over PO hormones (3)
More consistent delivery, relatively steady level of estradiol, lower risk of VTE
Sxs for which FDA-approved DHEA is available?
Vaginal sxs
Poss routes of estradiol that are FDA-approved (4)
PO tabs, transdermal patches, transdermal gels/ emulsions/sprays, vaginal ring
FDA-approved doses of PO estradiol tabs (3)
0.5mg, 1.0mg, 2.0mg
FDA-approved doses of transdermal patches (6)
14mcg, 25mcg, 37.5mcg, 50mcg, 75mcg, 100mcg
For how many days does the vaginal ring provide systemic levels of estradiol?
90 days
Poss routes of progesterone that are FDA-approved (3)
PO, vaginal gel (not FDA-approved for tx of menopausal sxs), vaginal insert (not FDA-approved for tx of menopausal sxs)
FDA-approved doses of PO micronized progesterone (2)
100mg, 200mg
Available concentrations of vaginal progesterone gel (2)
4%, 8%
Available dose of vaginal progesterone insert
100mg
Dosing of FDA-approved combination estradiol-progesterone therapy
PO estradiol 1mg + micronized progesterone 100mg
Route of testosterone delivery most recommended
Gel
Med, and route of delivery, of FDA-approved DHEA
Prasterone, vaginal insert
Should OBGYNs sell/promote agents/devices as being therapeutic?
No, not w/o adequate evidence of medical benefit
