| 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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