Eflornithine Monograph for Professionals - Drugs.com

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# 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

Medically reviewed by Drugs.com on Jun 21, 2022. Written by ASHP.

## Introduction

Hair growth retardant.

## Uses for Eflornithine

### Reduction of Unwanted Facial Hair

Reduction of unwanted facial hair in women.

## Eflornithine Dosage and Administration

### General

- 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.

Detailed Eflornithine topical dosage information

## Related/similar drugs

spironolactone, Aldactone, flutamide, Vaniqa

## Cautions for Eflornithine

### Contraindications

- 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

- Retards the rate of hair growth. Reduces unwanted hair growth and may cause hair to become finer and lighter.

- 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

- Importance of providing patient a copy of manufacturer’s patient information.

- Eflornithine retards hair growth; it is not a depilatory agent. Continue hair removal techniques (e.g., plucking, tweezing, cutting, shaving) as needed.

- Improvement may be seen within 4–8 weeks of initiating therapy; however, condition may return to pretreatment levels 8 weeks after discontinuing therapy.

- Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

- Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

- 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.

Eflornithine Hydrochloride
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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## More about eflornithine topical

- Reviews (114)
- Side effects
- Dosage information
- During pregnancy
- Drug class: miscellaneous topical agents
- Breastfeeding
- En español

### Patient resources

- Drug Information

### Professional resources

#### Other brands

Vaniqa, Florexa

### Related treatment guides

- Hirsutism

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