Eflornithine (Topical)

Eflornithine is used to slow down enzymes in the body that help hair grow. This leads to slower facial hair growth.

This medicine is available only with your doctor's prescription.

If you have skin irritation, use the medicine less often. If the irritation does not go away, stop using the medicine and talk to your doctor.

If you do not see any improvement after six months of treatment, stop using the medicine and contact your doctor.

If your condition gets worse while using the medicine, stop using it and contact your doctor.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of eflornithine in children under 12 years old with its use in other age groups. However, this medicine is not expected to cause different side effects or problems in older children than in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older adults than in younger adults.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction may happen. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around meal times or with specific types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Some side effects may happen that usually do not require medical help. These side effects might improve during treatment as your body gets used to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects persist, are annoying, or if you have any questions about them:

More common

• Acne
• stinging skin

Less common

• Burning or bleeding skin
• chapped, red lips
• chronic acne
• hair bumps
• numbness
• rash
• reddening of skin
• swelling of lips
• tingling skin

Other side effects not mentioned may also occur in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

• Vaniqa

Pharmacologic Class: Ornithine Decarboxylase Inhibitor

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

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

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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 miss a dose of this medicine, 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.