Eflornithine
Brand name: Vaniqa
Drug class: Skin and Mucous Membrane Agents, Miscellaneous
VA class: DE900
Chemical name: 2-(Difluoromethyl)-dl-ornithine monohydrochloride monohydrate
Molecular formula: C6H12F2N2O2•HCl•H2O
CAS number: 67037-37-0
Introduction
Hair growth retardant.
Uses for Eflornithine
Reduction of Unwanted Facial Hair
Reduction of unwanted facial hair in women.
Eflornithine Dosage and Administration
General
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Marked improvement may occur after 8 weeks of therapy. Hair growth usually returns to baseline levels 8 weeks after discontinuing therapy.
Administration
Topical Administration
Apply to skin as a 13.9% cream.
Apply only to affected areas of the face and adjacent involved areas under the chin; not intended for oral, ophthalmic, or intravaginal use.
Apply a thin film and rub in thoroughly.
Do not wash treated areas for at least 4 hours after application.
Continue hair removal techniques (e.g., plucking, tweezing, cutting, shaving), as needed, throughout treatment. Do not apply cream for at least 5 minutes after hair removal.
May apply cosmetic products and sunscreens after cream has dried.
Dosage
Available as eflornithine hydrochloride; dosage expressed in terms of the salt.
Adults
Reduction of Unwanted Facial Hair
Topical
Apply a thin film twice daily at least 8 hours apart (or as directed by clinician).
If skin irritation or intolerance develops, reduce application frequency to once daily. If irritation continues, discontinue therapy.
Cautions for Eflornithine
Contraindications
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Known hypersensitivity to eflornithine or any ingredient in the formulation.
Warnings/Precautions
Sensitivity Reactions
Hypersensitivity Reactions
Discontinue therapy if hypersensitivity reactions occur.
General Precautions
Dermatologic Effects
Possible transient stinging or burning if applied to abraded or broken skin.
Skin irritation may occur in susceptible patients or in those using higher than recommended dosages.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether eflornithine is distributed into milk. Caution if used in nursing women.
Pediatric Use
Safety and efficacy not established in children <12 years of age.
Geriatric Use
No substantial differences in safety relative to younger adults.
Common Adverse Effects
Burning, stinging, and/or tingling skin; erythema; rash.
Interactions for Eflornithine
Not known whether topical eflornithine interacts with other topically applied drugs.
Eflornithine Pharmacokinetics
Absorption
Following topical application, percutaneous absorption is <1%.
Distribution
Extent
Not known whether eflornithine crosses the placenta or is distributed into milk.
Elimination
Metabolism
No evidence that eflornithine is metabolized.
Elimination Route
Any absorbed eflornithine is excreted in urine as unchanged drug.
Half-life
Approximately 8 hours at steady state.
Stability
Storage
Topical
25°C (may be exposed to 15–30°C); do not freeze.
Actions
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Retards the rate of hair growth. Reduces unwanted hair growth and may cause hair to become finer and lighter.
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Precise mechanism of action is unknown. May inhibit ornithine decarboxylase, which catalyzes biosynthesis of intracellular polyamines required for cell division and differentiation; inhibition of cell division and differentiation may reduce rate of hair growth.
Advice to Patients
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Importance of providing patient a copy of manufacturer’s patient information.
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Eflornithine retards hair growth; it is not a depilatory agent. Continue hair removal techniques (e.g., plucking, tweezing, cutting, shaving) as needed.
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Improvement may be seen within 4–8 weeks of initiating therapy; however, condition may return to pretreatment levels 8 weeks after discontinuing therapy.
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Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
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Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
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Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Topical |
Cream |
13.9% |
Vaniqa |
Skinmedica |
AHFS DI Essentials™. © Copyright 2023, Selected Revisions July 1, 2005. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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