Eflornithine

What is Eflornithine?

• Eflornithine (Vaniqa),is a hydrochloride form of eflornithine, a difluoromethylated ornithine compound with antineoplastic activity.

Eflornithine

Ornithine and Eflornithine Comparison Structures

What are the uses of this medicine?

• Eflornithine (Vaniqa), is a prescription medication applied to the skin for the reduction of unwanted facial hair in women.

How does this medicine work?

• The hydrochloride form of eflornithine, a difluoromethylated ornithine compound with antineoplastic activity. Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme required for polyamine biosynthesis, thereby inhibiting the formation and proliferation of tumor cells.
• Polyamines are involved in nucleosome oligomerization and DNA conformation, creating a chromatin environment that stimulates neoplastic transformation of cells.
• This agent has been shown to induce apoptosis in leiomyoma cells.

• Vaniqa interferes with an enzyme found in the hair follicle of the skin needed for hair growth.
• This results in slower hair growth and improved appearance where Vaniqa is applied.
• Vaniqa does not permanently remove hair or "cure" unwanted facial hair.
• It is not a depilatory. Your treatment program should include continuation of any hair removal technique you are currently using.
• Vaniqa will help you manage your condition and improve your appearance.
• Improvement in the condition occurs gradually. Don't be discouraged if you see no immediate improvement. Be patient. Improvement may be seen as early as 4 to 8 weeks of treatment. Improvement may take longer in some individuals. If no improvement is seen after 6 months of use, discontinue use. Clinical studies show that in about 8 weeks after stopping treatment with Vaniqa, the hair will return to the same condition as before beginning treatment.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to any of the ingredients in the cream.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• using any facial or skin creams

Is this medicine FDA approved?

• Eflornithine was developed in the 1970s and came into medical use in 1990.

How should this medicine be used?

Recommended dosage:

• Use twice daily at least 8 hours apart or as directed by a physician.
• The patient should continue to use hair removal techniques as needed in conjunction with Vaniqa. (Vaniqa should be applied at least 5 minutes after hair removal.)

Administration:

• Follow the instructions for application of Vaniqa carefully.
• Apply a thin layer of Vaniqa to the affected areas of the face and adjacent involved areas under the chin and rub in thoroughly.
• You should not wash the treatment areas for at least 4 hours after application of Vaniqa.
• Vaniqa® may cause temporary redness, rash, burning, stinging or tingling, especially when the skin is damaged.
• If irritation continues, stop use of Vaniqa and contact your doctor.
• Avoid getting the medication in your eyes or inside your nose or mouth.
• If the product gets in your eyes, rinse thoroughly with water and contact your doctor.
• If you forget or miss a dose of Vaniqa, do not try to “make it up”. Return to your normal application schedule as soon as you can.
• You may use your normal cosmetics or sunscreen after applying Vaniqa, but you should wait a few minutes to allow the treatment to be absorbed before applying them.
• If your condition gets worse with treatment, stop use of Vaniqa and contact your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a cream containing 13.9% (139 mg/g) of anhydrous eflornithine hydrochloride as eflornithine hydrochloride monohydrate (150 mg/g).

This medicine is available in fallowing brand namesː

• Vaniqa

What side effects can this medication cause?

The most common side effects of this medicine include:

• temporary redness, stinging, burning, tingling or rash on areas of the skin where it is applied.
• Folliculitis may also occur.

Less common,but serious side effects may include:

• bleeding skin, cheililis, contact dermatitis, swelling of lips, herpes simplex, numbness and rosacea.

What special precautions should I follow?

• Vaniqa is only for external use only. Transient stinging or burning may occur when applied to abraded or broken skin.
• This medication is not a depilatory, but rather appears to retard hair growth to improve the condition and the patient's appearance. Patients will likely need to continue using a hair removal method (e.g., shaving, plucking, etc.) in conjunction with Vaniqa (eflornithine hydrochloride) Cream, 13.9%.
• Onset of improvement was seen after as little as 4-8 weeks of treatment in the 24-week clinical trials. The condition may return to pretreatment levels 8 weeks after discontinuing treatment.
• If skin irritation or intolerance develops, direct the patient to temporarily reduce the frequency of application (e.g., once a day). If irritation continues, the patient should discontinue use of the product.
• It is not known whether or not eflornithine hydrochloride is excreted in human milk. Caution should be exercised when Vaniqa is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Overdosage information with Vaniqa is unavailable. Given the low percutaneous penetration of this drug, overdosage via the topical route is not expected
• Use of an intravenous formulation of eflornithine hydrochloride at high doses (400 mg/kg/day or approximately 24 g/day) for the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness) has been associated with adverse events and laboratory abnormalities.
• Adverse events may include hair loss, facial swelling, seizures, hearing impairment, stomach upset, loss of appetite, headache, weakness and dizziness.
• A variety of hematological toxicities, including anemia, thrombocytopenia and leukopenia have also been observed, but these were usually reversible upon discontinuation of treatment.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• The patient should be monitored, and appropriate supportive measures administered as necessary.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• If you are pregnant or plan to become pregnant, discuss with your doctor whether you should use Vaniqa during pregnancy. No clinical studies have been performed in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of this product have not been established in pediatric patients less than 12 years of age.

What are the active and inactive ingredients in this medicine?

• The active ingredient in Vaniqa is eflornithine hydrochloride. Vaniqa also contains ceteareth-20, cetearyl alcohol, dimethicone, glyceryl stearate, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, stearyl alcohol and water.

Who manufactures and distributes this medicine?

Distributed By:

• SkinMedica, Inc.
• Carlsbad, CA

What should I know about storage and disposal of this medication?

• Vaniqa should be stored at 15°C-30° C (59° F-86° F).
• Do not freeze.
• Keep this and all medicines out of the reach of children.

• Dailymed label info on Eflornithine
• FDA Eflornithine

Eflornithine Resources
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