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Eflornithine

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
Brands: Vaniqa

Introduction

Hair growth retardant.1

Uses for Eflornithine

Reduction of Unwanted Facial Hair

Reduction of unwanted facial hair in women.1 2

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Eflornithine Dosage and Administration

General

  • Marked improvement may occur after 8 weeks of therapy.1 2 Hair growth usually returns to baseline levels 8 weeks after discontinuing therapy.1 2 8

Administration

Topical Administration

Apply to skin as a 13.9% cream.1 2

Apply only to affected areas of the face and adjacent involved areas under the chin; not intended for oral, ophthalmic, or intravaginal use.1

Apply a thin film and rub in thoroughly.1

Do not wash treated areas for at least 4 hours after application.1 2

Continue hair removal techniques (e.g., plucking, tweezing, cutting, shaving), as needed, throughout treatment.1 Do not apply cream for at least 5 minutes after hair removal.1

May apply cosmetic products and sunscreens after cream has dried.1 2

Dosage

Available as eflornithine hydrochloride; dosage expressed in terms of the salt.1

Adults

Reduction of Unwanted Facial Hair
Topical

Apply a thin film twice daily at least 8 hours apart (or as directed by clinician).1 2

If skin irritation or intolerance develops, reduce application frequency to once daily.1 8 If irritation continues, discontinue therapy.1 8

Cautions for Eflornithine

Contraindications

  • Known hypersensitivity to eflornithine or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Discontinue therapy if hypersensitivity reactions occur.1

General Precautions

Dermatologic Effects

Possible transient stinging or burning if applied to abraded or broken skin.1 2

Skin irritation may occur in susceptible patients or in those using higher than recommended dosages.1 6 8

Specific Populations

Pregnancy

Category C.1

Lactation

Not known whether eflornithine is distributed into milk.1 Caution if used in nursing women.1

Pediatric Use

Safety and efficacy not established in children <12 years of age.1

Geriatric Use

No substantial differences in safety relative to younger adults.1

Common Adverse Effects

Burning, stinging, and/or tingling skin; erythema; rash.1 2 6

Interactions for Eflornithine

Not known whether topical eflornithine interacts with other topically applied drugs.1

Eflornithine Pharmacokinetics

Absorption

Following topical application, percutaneous absorption is <1%.1

Distribution

Extent

Not known whether eflornithine crosses the placenta or is distributed into milk.1

Elimination

Metabolism

No evidence that eflornithine is metabolized.1 b

Elimination Route

Any absorbed eflornithine is excreted in urine as unchanged drug.1 b

Half-life

Approximately 8 hours at steady state.1 b

Stability

Storage

Topical

25°C (may be exposed to 15–30°C); do not freeze.1

Actions

  • Retards the rate of hair growth.1 Reduces unwanted hair growth 1 2 8 and may cause hair to become finer and lighter.2

  • Precise mechanism of action is unknown.1 2 8 May inhibit ornithine decarboxylase, which catalyzes biosynthesis of intracellular polyamines required for cell division and differentiation;1 2 3 4 7 inhibition of cell division and differentiation may reduce rate of hair growth.1 5

Advice to Patients

  • Importance of providing patient a copy of manufacturer’s patient information.1 8

  • Eflornithine retards hair growth; it is not a depilatory agent.1 8 Continue hair removal techniques (e.g., plucking, tweezing, cutting, shaving) as needed.1

  • Improvement may be seen within 4–8 weeks of initiating therapy; however, condition may return to pretreatment levels 8 weeks after discontinuing therapy.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 8

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • 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.

Eflornithine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

13.9%

Vaniqa

Skinmedica

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Vaniqa 13.9% Cream (SKINMEDICA): 30/$94.99 or 60/$189.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bristol-Myers Squibb. Vaniqa (eflornithine hydrochloride 13.9% cream) prescribing information and patient information. Plainsboro, NJ; 2000 Jul 27.

2. Anon. Eflornithine cream for facial hair reduction. Med Lett Drugs Ther. 2000; 42:96. [PubMed 11015161]

3. Paulson YJ, Gilman TM, Heseltine PNR et al. Eflornithine treatment of refractory Pneumocystis carinii pneumonia in patients with acquired immunodeficiency syndrome. Chest. 1992; 101:67-74. [IDIS 290171] [PubMed 1729113]

4. Marion Merrell Dow. Ornidyl (eflornithine hydrochloride for injection concentrate). Kansas City, MO; 1990 Nov.

5. Hynd PI, Nancarrow MJ. Inhibition of polyamine synthesis alters hair follicle function and fiber composition. J Invest Dermatol. 1996; 106:249-53. [PubMed 8601724]

6. Hickman JG, Huber F, Palmisano M. Human dermal safety studies with eflornithine HCl 13.9% cream (Vaniqa), a novel treatment for excessive facial hair. Curr Med Res Opin. 2001; 16:235-44. [PubMed 11268707]

7. Milord F, Pépin J, Loko L et al. Efficacy and toxicity of eflornithine for treatment of Trypanosoma brucei gambiense sleeping sickness. Lancet. 1992; 340:652-55. [IDIS 302125] [PubMed 1355219]

8. Bristol-Myers Squibb, Plainsboro, NJ; personal communication.

a. Women First HealthCare. Vaniqa (eflornithine hydrochloride) cream 13.9%, prescribing information and patient information. San Diego, CA; 2002 Sep.

b. Malhotra B, Noveck R, Behr D et al. Percutaneous absorption and pharmacokinetics of eflornithine HCL 13.9% cream in women with unwanted facial hair. J Clin Pharmacol. 2001; 41:972-8. [PubMed 11549102]

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