In the U.S.—

• Enzyme inhibitor

Eflornithine ( ee–FLOOR–nith–een) is used to slow down bodily substances called enzymes that help hair grow. The effect is slower facial hair growth.

VANIQA is available only with your doctor's prescription, in the following dosage form:

Topical
• Cream (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For eflornithine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to eflornithine. Also tell your health care professional if you are allergic to any other substances or topical medications.

Pregnancy—Studies with eflornithine have not been done in pregnant women. In animal studies, when taken by mouth, eflornithine has been shown to cause birth defects or other problems. If you are pregnant or plan to become pregnant, discuss with your doctor whether you should use VANIQA during pregnancy.

Breast-feeding—It is not known whether eflornithine passes into breast milk. Mothers who are taking VANIQA and wish to breast–feed should discuss this with their doctor.

Children—There is no specific information comparing use of eflornithine in children under the age of 12 years with use in other age groups. However, VANIQA is not expected to cause different side effects or problems in older children than it does in adults.

Older adults—VANIQA has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.

VANIQA comes with a patient instruction sheet. Read this sheet carefully and follow the directions. If you have any questions on how to use VANIQA, be sure to ask your health care professional.

VANIQA is usually used on the face and nearby involved areas under the chin only. Do not get the medicine in your eyes, nose, or mouth. Rinse thoroughly with water and contact your doctor if the medicine gets in the eyes

You need to continue your normal hair removal procedures while using VANIQA, and the medicine should be applied at least five minutes after the unwanted hair has been removed. You should wait until the medicine dries before applying cosmetics or sunscreen.

Do not wash the treated areas for at least 4 hours after applying the medicine.

Dosing—

The dose of eflornithine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average dose of eflornithine. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical dosage form (cream):
  • For reduced rate of facial hair growth in women.
    • Adults and children 12 years of age or older—Coat the problem areas on the face and nearby areas under the chin with the medicine two times a day with the second treatment coming at least eight hours after the first.
    • Children under 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you forget or miss a dose of VANIQA, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store VANIQA:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Store at 15°C–30°C (59°F–86°F) .
• Keep the medicine from freezing..
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.