Vaniqa
Information
The
problem of unwanted facial hair extends beyond the normal need for
bleaching, tweezing, hot
waxing or the use of other depilatory applications. Many women with
excess facial hair suffer from low self-confidence and/or feel less
feminine secondary to the facial hair.
Vaniqa
works by actively inhibiting an enzyme located in the root of the
hair follicle, ornithine decarboxylase, which is necessary for cellular
division and subsequently hair growth. Vaniqa does not interfere
with the female hormones. The medication works actively on growing
hair cells. These hair cells are in staggered growth patterns, therefore,
Vaniqa may take 4-8 weeks to become fully effective. Women should
continue to use their normal depilatory applications until Vaniqa
becomes fully affective.
Women
may continue to use their daily moisturizer, sunscreens, skin rejuvenation
medications, cosmetics etc. in conjunction with Vaniqa. Individuals
should wait approximately five minutes following the application
of Vaniqa, and then apply their products in a normal fashion. (please
consult your dermatologist prior to applying other prescription
medications such as cortisone, etc.)
It
is important to note that Vaniqa did not show to increase sensitivity
to the sun in clinical studies. Potential side effects of Vaniqa
include but are not limited to the following such as stinging, burning
or itching sensations and redness (more likely if immediately applied
after shaving), folliculitis and acne. These are unusual and affect
less than 1% of all users.
Vaniqa
is not recommended in children under the age of 12 or in pregnant
or nursing women. If you are in your child-bearing years you should
consult with your gynecologist/obstetrician prior to using the medication.
Individuals should
apply Vaniqa twice a day to areas where excessive hair is prevalent.
The use of Vaniqa should be limited to the area surrounding the
lips and under the chin. Following application the treated area
should not be washed for at least 4 hours. The medication should
not be reapplied within an eight-hour period. Clinical studies have
shown that unwanted facial hair will return to before treatment
values approximately eight weeks following the discontinued use
of the medication.
Individuals will
realize that Vaniqa is working usually within the first eight weeks
of treatment. Most women notice that they are using their depilatory
applications agents less frequently during this time period. Clinical
studies have shown significant results in more than 60% of those
individuals treated. While Caucasian women have had a slightly better
rate of response than African American women, Vaniqa has still been
successful for all races involved in clinical studies. Studies were
conducted with Caucasians and African Americans, Hispanics, Asians,
and Native Americans.
Additional Information
This section contains
more information concerning VANIQA that you should read
prior to beginning treatment. This section does not list all the
benefits and risks of VANIQA and does not take the place of discussions
with your physician or healthcare professional about your condition
or your treatment. If you have questions, talk with your healthcare
professional.
What is VANlQA?
VANIQA (pronounced
“VAN-i-ka”) is a prescription medication applied to the
skin for the reduction of unwanted facial hair in women.
The active ingredient in VANIQA is eflornithine hydrochloride. VANIQA
also contains ceteareth-20, cetearyl alcohol, dimethicone, glyceryl
stearate, methylparaben, mineral oil, PEG-100 stearate, phe-noxyethanol,
propylparaben, stearyl alcohol and water.
How
does VANIQA work?
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
con-tinuation 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 VANIQA?
You should not use
VANIQA if you are allergic to any of the ingredients
in the cream. All ingredients are listed on the tube and at the
beginning of this leaflet. You should not use VANIQA if you are
less than 12 years of age.
What should you tell your physician before using VANIQA?
If you are allergic
to any of the ingredients, tell your physician. If you
are pregnant or plan to become pregnant, discuss with your physician
whether you should use VANIQA during pregnancy. No clinical studies
have been performed in pregnant women. If you are breast-feeding,
consult your physician before using VANIQA. It is not known if VANIQA
is passed to infants through breast milk. If you are taking any
prescription medicines, non-prescription medicines or using any
facial or skin creams, check with your physician before use of VANIQA.
How
should I use VANIQA?
Use VANIQA only
for the condition for which it was prescribed by your
physician. Do not give it to other people or allow other people
to use it. You will need to continue your normal procedures for
hair removal until desired results have been achieved. You may then
be less bothered by the time spent in removing hair or the frequency
of hair removal.
VANIQA is to be used twice daily, at least eight hours apart, or
asdirected by your physician. VANIQA is for external use only.
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
(eflornithine hydrochloride) Cream, 13.9%.
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 physician. 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 physician. 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 physician.
What are the possible side effects of VANIQA?
VANIQA may cause
temporary redness, stinging, burning, tingling or rash
on areas of the skin where it is applied. Folliculitis (hair bumps)
may also occur. If these persist, consult your physician.
How
should VANIQA be stored?
VANIQA (eflornithine
hydrochloride) Cream, 13.9%, 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.
This medicine was prescribed for your particular condition. Do not
use it for another condition or give it to anyone else. This
summary does not include everything there is to know about VANIQA.
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