BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indication:
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines
between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).
IMPORTANT SAFETY INFORMATION:
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have
any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
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Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the
highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
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Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss
of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia),
trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car,
operate machinery, or do other dangerous activities.
The dose of BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.
Serious and or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms,
or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you
become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients);
had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the
planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia
gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing)
and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead
muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become
pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known
if BOTOX® Cosmetic passes into breast milk).
Human albumin and spread of viral diseases. BOTOX® Cosmetic contains albumin, a protein component of human blood. The potential risk of
spreading viral diseases [e.g. Creutzfeldt-Jakob Disease (CJD)] via human serum albumin is extremely rare. No cases of viral diseases
or CJD have ever been reported in association with human serum albumin.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.
Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told
your doctor that you have received BOTOX® Cosmetic in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections
of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past
(be sure your doctor knows exactly which product you received);
have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a sleep medicine.
Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache,
neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids,
and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.
LATISSE®(bimatoprost ophthalmic solution) 0.03% Important Information
Indication
LATISSE® is a prescription treatment for hypotrichosis (inadequate or not enough lashes) used to grow eyelashes
longer, fuller, darker.
IMPORTANT SAFETY INFORMATION
If you use/used prescription products for any eye pressure problems,use LATISSE® under doctor care.LATISSE®
may cause increased brown pigmentation of the colored part of the eye which is likely permanent.Eyelid skin
darkening may occur which may be reversible. Only apply at the base of the upper eyelashes. DO NOT APPLY to the lower
lid. Hair may grow on skin that LATISSE® frequently touches.If you have eye problems/surgery,consult your doctor about use of
LATISSE®.Common side effects are itchy and eyes.If discontinued, lashes gradually return to previous appearance
You are encourgaed to report negative side effects of prescriptions drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full LATISSE® Prescribing information.
JUVÉDERM® Important Information
Indication
JUVÉDERM® injectable gel is injected in the areas of facial tissue where moderate to severe facial wrinkles
and folds occur to temporarily add volume to skin,which may give appereance of a smoother surface.
IMPORTANT SAFETY INFORMATION
Most side effects are mild or modearte in nature , and their duration is short lasting (7days or less).The Most
common side effects include,but are not limited to , temporary injection-site reactions such as redness,
pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching and discoloration.As with all skin-injection
procedures, there is a risk of infection
To Report a problem with JUVÉDERM® , please call Allergan Product Surveillance at 1-800-624-4261
For more information, please see the About Safety page at www.juvederm.com or call the Allergan Product Support line at 1-800-433-8871.
JUVÉDERM® injectable gel is available by prescription only.