Dysport® is the latest aesthetic product to be approved by the U.S.
Food and Drug Administration for treatment of glabellar lines – commonly known as
frown lines. Approved in April, 2009, Dysport® has a history of use
in other countries since 1991. Dysport® is not a dermal filler, but
it is often used in combination with non-surgical facelifts, facial contouring,
and liquid face lift procedures. Dysport® is a simple, non surgical
treatment that can temporarily smooth moderate to severe frown lines and wrinkles
between the brows in adults less than 65 years of age.

With approximately 11 million botulinum toxin procedures performed in the U.S.,
its popularity continues to grow, and is the leading non-surgical cosmetic medical
procedure globally.(1)

Dysport® works by stopping the signal from the nerves to the muscles,
ultimately resulting in a reduction of muscle activity and temporarily preventing
contraction of the muscles that cause frown lines. Dysport® is a
purified form of botulinum toxin that has been shown to deliver temporary improvement
in moderate to severe frown lines, even with repeat treatments. Treatments typically
take 5-10 minutes, and there is little or no downtime after injection. Although
results may vary after treatment, improvement is typically visible within days in
moderate to severe frown lines between the brows. Results can last up to 4 months.
It is recommended that you wait at least 90 days between Dysport®

In the hands of an experienced injector, Dysport® can be used in
combination with dermal fillers to produce even more dramatic results by gently
lifting facial features and contouring of the face, often referred to as a liquid
face lift or non surgical face lift. Using Dysport® to relax the
depressor muscles allows the levators to gain control, and allowing medical practitioners
to produce a subtle lift in the treated area.

It is advisable to select a healthcare professional who has performed at least hundreds
of botulinum toxin procedures because techniques developed with experience can result
in more natural, relaxed results. Inexperienced practitioners may be more likely
to leave you with a “frozen” look, or to drop a brow, or to leave you with more
uneven and unnatural looking results. We have determined a number of medical practitioners
nationally who have extensive experience with botulinum toxin procedures. To see
a list of experienced healthcare professionals in your area, or to receive a special
discount on your next Dysport® procedure, click the following link:  Locate
a Specialist

Dysport® Procedure

Dysport® is injected with tiny needles and the procedure is so quick,
physicians do not usually numb the area being treated. However, in sensitive areas
such as around the lips, some healthcare professionals may apply topical anesthesia
or ice for numbing just prior to treatment. A Dysport® treatment
typically takes just a few minutes to inject the fluid into the targeted area with
fine-gauge needles. Within days, most patients will notice improvement in moderate
to severe facial lines.

As the cosmetic medical industry continues to evolve, leading physicians in the
U.S. now combine Dysport® with other aesthetic procedures such as
dermal fillers and laser therapy, resulting in improved outcome, lower cost and
maximum effectiveness for their patients. Using Dysport® in the combination
therapy, the reduced muscle movement in targeted areas helps to slow the dissipation
of dermal fillers and lengthen filler benefits.

Extending Dysport® Effects

To maintain the effects gained by Dysport® treatment, it is usually
recommended that the patient return for maintenance treatments every three to five
months – depending on individual results, the physician technique, and the area
to be treated. It is recommended that you should wait at least 90 days between Dysport®
treatments. (2) Patients may be able to reduce the amount of Dysport®
required for each treatment by scheduling regular maintenance visits to their physician
when they begin to see or feel excess movement in the treated area.

Dysport® History

Dysport® has a history of therapeutic use internationally since 1991,
used to treat patients with cervical dystonia. It was approved for aesthetic use
outside of the U.S. in 2001, and is used in over 36 countries. In 2004, Dysport®
was studied for safety in more than 2400 U.S. aesthetic patients, and received US
FDA approval in 2009 for the temporary improvement in the appearance of moderate
to severe glabellar lines (forehead wrinkles) in adult patients less than 65 years
of age.



Do not take Dysport® if you are allergic to any of the ingredients
in Dysport®. Consult with your physician for a complete list of ingredients.
Do not take Dysport® if you are allergic to cow’s milk protein, had
an allergic reaction to any other botulinum toxin product, or have a skin infection
at the planned site. Dysport® may not be right for you if you have
had surgical changes to your face, very weak muscles in the treatment area, your
face looks very different from side to side, the injection site is inflamed, you
have droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin,
or if your wrinkles can’t be smoothed by spreading them apart. (2) Consult your
physician for a complete list of side effects and to determine if Dysport®
is right for you. Be sure to tell your physician about all of your medical conditions,
including if you have: a disease that affects your muscles and nerves, breathing
problems, swallowing problems, bleeding problems, diabetes, a problem with your
heart rate, plan to have facial surgery, have had surgery on your face, weakness
of your forehead muscles, drooping eyelids, or any other change in the way your
face normally looks.

Distant Spread of Toxin Effect: Postmarketing reports indicate that the effects
of Dysport and all botulinum toxin products may spread from the area of injection
to produce symptoms consistent with botulinum toxin effects. These may include asthenia,
generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia,
dysarthria, urinary incontinence, and breathing difficulties. These symptoms have
been reported hours to weeks after injection. Swallowing and breathing difficulties
can be life threatening, and there have been reports of death. The risk of symptoms
is probably greatest in children treated for spasticity, but symptoms can also occur
in adults treated for spasticity and other conditions, particularly in those patients
who have underlying conditions that would predispose them to these symptoms. In
unapproved uses, including spasticity in children and adults, and in approved indications,
cases of spread of effect have been reported at doses comparable to those used to
treat cervical dystonia and at lower doses.

Dysport is contraindicated in patients with hypersensitivity to any botulinum toxin
product or excipients, allergy to cow’s-milk protein, or infection at the proposed
injection site.

The potency Units of Dysport are not interchangeable with other preparations of
botulinum toxin products and, therefore, Units of biological activity of Dysport
cannot be compared to or converted into Units of any other botulinum toxin products.
Recommended dose and frequency of administration should not be exceeded. Immediate
medical attention may be required in cases of respiratory, speech, or swallowing
difficulties. Concomitant neuromuscular disorder may exacerbate clinical effects
of treatment. Dysport contains human albumin. Based on effective donor screening
and product manufacturing processes, Dysport carries an extremely remote risk for
transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob
disease (CJD) also is considered extremely remote. No cases of transmission of viral
diseases or CJD have ever been identified for albumin. The possibility of an immune
reaction when injected intradermally is unknown. The safety of Dysport for the treatment
of hyperhidrosis has not been established.

Patients receiving concomitant treatment of Dysport and aminoglycosides or other
agents interfering with neuromuscular transmission (e.g., curare-like agents), or
muscle relaxants, should be observed closely because the effect of botulinum toxin
may be potentiated. Use of anticholinergic drugs may potentiate systemic anticholinergic
effects. The effect of administering different botulinum neurotoxins during the
course of treatment with Dysport is unknown.

The most commonly observed adverse reactions (>5% of patients) with Dysport for
the treatment of cervical dystonia are muscular weakness, dysphagia, dry mouth,
injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia,
injection site pain, and eye disorders.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at 1-877-DYSPOR1
(877-397-7671). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.

Please see full Prescribing Information, including
Boxed Warning
, and
Medication Guide