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:
-
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
-
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 [eg 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 Medication Guide.
LATISSE® Indication
LATISSE® solution is a prescription treatment for
hypotrichosis used to grow eyelashes, making them longer, thicker and darker.
Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes.
LATISSE® Important Safety Information
If you are using, or have used, prescription products for any eye pressure problems, only use
LATISSE® under close doctor care. LATISSE® use 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 eyelid.
Hair growth may occur in other skin areas that LATISSE® solution frequently touches. If you
develop or experience any eye problems or have eye surgery, consult your doctor immediately
about continued use of LATISSE®. The most common side effects after using LATISSE® solution
are itchy eyes and/or eye redness. If discontinued, lashes will gradually return to their previous appearance.
Please click here for
full LATISSE® Prescribing Information.
Important JUVÉDERM® Safety Information
JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM®
Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for
correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Treatment side effects are usually mild to moderate, lasting 7 days or less, and include temporary injection-site reactions such as redness,
pain, firmness, swelling, and bumps. JUVÉDERM® is not for people with severe allergies.
For more information, please click on the About Safety link at www.juvederm.com
or call the Allergan Product Support line at 1-877-345-5372.
JUVÉDERM® injectable gel is available by prescription only.
Information about NATRELLE®
The NATRELLE® Collection of Breast Implants is indicated for females for breast augmentation and breast reconstruction.
