Vaniqa

Apply the missed dose as soon as you remember it, if at least 8 hours has passed since your previous application. However, if it is almost time for the next application, skip the missed dose and continue your regular application schedule. Do not apply extra cream to make up for a missed dose.

There have been no studies of eflornithine therapy in pregnant women.

It is not known if eflornithine is secreted into breast milk.

VANIQA® (eflornithine hydrochloride) cream, 13.9% is indicated for the reduction of unwanted facial hair in women.

VANIQA® has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.

VANIQA® (eflornithine hydrochloride) cream, 13.9% is available as: 45 gram tube NDC 0023-4857-45 Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Do not freeze. See tube crimp and carton end for expiration date and lot number.

Distributed by: Allergan, Inc., Irvine, CA 92612. Revised: Sep 2013

Eflornithine topical is for external use only.

Continue to use eflornithine topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with eflornithine topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with eflornithine topical.

Serious side effects have been reported with Vaniqa.  See "Vaniqa Precautions" section.

Common side effects of Vaniqa include:

• acne
• folliculitis (hair bumps)
• stinging or burning of the skin
• headache
• dry skin
• itching or tingling of the skin
• redness or irritation of the skin
• indigestion
• rash
• hair loss
• dizziness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vaniqa. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA­-1088.

Use Vaniqa only for the condition for which it was prescribed by your doctor.

This medication comes in cream form and is to be used twice daily, at least eight hours apart, or as directed by your doctor. 

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.
• Do not wash the treatment areas for at least 4 hours after application of Vaniqa.
• Wash your hands after each application. 
• 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.

Vaniqa does not permanently remove hair or "cure" unwanted facial hair. You will need to continue your normal procedures for hair removal. 

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. 

If your condition gets worse with treatment, stop use of Vaniqa and contact your doctor.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dosage regimen of Vaniqa (eflornithine) is application twice a day, at least 8 hours apart. 

If the medicine gets in your eyes, rinse thoroughly with water and contact your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Vaniqa by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use.
• Use at least 5 minutes after you get rid of hair.
• Put a thin layer on the affected skin and rub in gently.
• Do not wash affected part for at least 4 hours.
• Makeup may be used after the skin has dried.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.