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
Hair growth retardant.1
Uses for Eflornithine
Reduction of Unwanted Facial Hair
Eflornithine Dosage and Administration
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
Available as eflornithine hydrochloride; dosage expressed in terms of the salt.1
Reduction of Unwanted Facial Hair
Cautions for Eflornithine
Known hypersensitivity to eflornithine or any ingredient in the formulation.1
Discontinue therapy if hypersensitivity reactions occur.1
Safety and efficacy not established in children <12 years of age.1
No substantial differences in safety relative to younger adults.1
Common Adverse Effects
Interactions for Eflornithine
Not known whether topical eflornithine interacts with other topically applied drugs.1
Following topical application, percutaneous absorption is <1%.1
Not known whether eflornithine crosses the placenta or is distributed into milk.1
25°C (may be exposed to 15–30°C); do not freeze.1
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
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 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.)
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.
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions July 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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]