What it's for (Indications)
- Eflornithine (e.
- g.
- , Depilus 13.
- 9%) is primarily indicated for the reduction of unwanted facial hair in women.
- This medication is specifically formulated to treat facial hirsutism, a condition characterized by excessive or unwanted hair growth on the face, which can be distressing for affected individuals.
- It is not a depilatory agent and does not permanently remove hair; rather, it works to slow down the rate of hair growth, leading to an improvement in the appearance of facial hirsutism over time.
- Clinical studies have demonstrated its efficacy in reducing the overall rate of hair growth, improving the appearance of the affected skin, and decreasing the need for other hair removal methods like shaving or plucking.
- Treatment is typically continued as long as the reduction in hair growth is desired, as discontinuation often results in hair growth returning to pretreatment levels within several months.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Eflornithine cream, 13.9%, should be applied to the affected areas of the face and adjacent under-chin areas twice daily, at least 8 hours apart. A thin layer of the cream should be rubbed thoroughly into the skin. Patients should wash their hands immediately after application. Cosmetics or sunscreens can be applied over the treated areas at least 5 minutes after the application of eflornithine cream. Consistent daily use is crucial for optimal results. Clinical improvement is usually observed within 4 to 8 weeks of treatment. If no improvement is seen after 4 to 6 months of continuous use, treatment should be re-evaluated by a healthcare professional, and discontinuation may be considered. The amount of cream applied should be limited to the minimum necessary to cover the affected areas, and usage should not exceed the recommended twice-daily regimen. |
Safety & Warnings
Common Side Effects
- Common side effects associated with eflornithine cream are primarily dermatological and localized to the application site.
- These include mild to moderate skin irritation, such as transient stinging, burning, redness (erythema), itching (pruritus), and dryness.
- Some patients may experience acne, folliculitis (inflammation of hair follicles), or rash.
- Less frequently reported side effects include pseudofolliculitis barbae, hair loss, headaches, and dizziness.
- Systemic absorption of eflornithine through the skin is minimal, so systemic side effects are rare.
- Most local reactions are temporary and resolve with continued use or by adjusting the frequency of application.
- If severe irritation or hypersensitivity reactions occur, discontinuation of the product and consultation with a healthcare provider are recommended.
- Patients should be advised to report any persistent or bothersome side effects to their physician.
Serious Warnings
- Black Box Warning: Eflornithine cream is intended for topical dermatological use only and should not be used orally, ophthalmically, or intravaginally. While systemic absorption is generally minimal, patients should be advised to apply the cream sparingly to affected areas as directed, avoiding excessive use or application to broken or irritated skin, which could potentially increase systemic exposure. Patients should discontinue use and consult a healthcare professional if severe irritation, redness, burning, stinging, or other adverse skin reactions occur or persist. The safety and efficacy of eflornithine cream have not been established in pediatric patients under 12 years of age or in pregnant or breastfeeding women. It is essential to exclude underlying medical conditions contributing to hirsutism before initiating treatment, as eflornithine cream primarily addresses the cosmetic symptom and does not treat hormonal imbalances or other systemic diseases, requiring a thorough medical evaluation prior to prescription.
- Eflornithine cream is contraindicated in individuals with a known hypersensitivity to eflornithine or any component of the formulation.
- It is intended for external use only and should be kept out of the reach of children.
- Contact with eyes or mucous membranes should be avoided; if accidental contact occurs, rinse thoroughly with water.
- The safety and efficacy of eflornithine cream have not been established in pediatric patients under 12 years of age.
- Pregnancy Category C: Eflornithine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Caution should be exercised when administered to a nursing woman, as it is unknown whether eflornithine is excreted in human milk.
- Patients should be advised that this medication does not permanently remove hair or cure hirsutism; improvement occurs as long as the treatment is continued, and hair growth will return to pretreatment levels within approximately 8 weeks of discontinuation.
- If signs of local intolerance persist, such as severe stinging, burning, itching, or redness, treatment should be interrupted or discontinued.
How it Works (Mechanism of Action)
Eflornithine is an irreversible inhibitor of ornithine decarboxylase (ODC). ODC is a crucial enzyme in the biosynthesis of polyamines (putrescine, spermidine, and spermine), which are essential for cell division, differentiation, and growth, including that of hair follicles. By irreversibly binding to and inhibiting ODC, eflornithine reduces the rate of polyamine synthesis within the hair follicle. This reduction in polyamine levels slows down cell division and metabolic activity in the hair follicles, thereby decreasing the rate of hair growth. This mechanism specifically targets the growth phase (anagen) of the hair cycle, leading to a reduction in the length and thickness of facial hair. The effect is localized to the treated area due to minimal systemic absorption, resulting in a reduction in unwanted facial hair without causing significant systemic adverse effects. The inhibition is reversible upon cessation of treatment, allowing hair growth to return to previous rates.
Commercial Brands (Alternatives)
No other brands found for this formula.