BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
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 Boxed Warning and Medication Guide.
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
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.
JUVÉDERM® XC and JUVÉDERM VOLUMATM XC Important Information
JUVÉDERM® XC injectable gel is for injection into areas of facial tissue where moderate to severe
facial wrinkles and folds occur to temporarily add volume to the skin, especially around the nose and mouth.
JUVÉDERM VOLUMATM XC injectable gel is for deep injection in the cheek area to correct age-related volume
loss in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive JUVÉDERM® XC or JUVÉDERM VOLUMATM XC?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to
the proteins (gram-positive bacterial proteins) used to make the hyaluronic acid (HA) in these products. Do not use
JUVÉDERM® XC or JUVÉDERM VOLUMATM XC if you are allergic to lidocaine.
What precautions should my doctor advise me about?
- The safety of JUVÉDERM® XC and JUVÉDERM VOLUMATM XC injectable gels for use during pregnancy or in women who are breastfeeding has not been studied
- The safety of JUVÉDERM® XC for use in patients under 18 years and JUVÉDERM VOLUMATM XC for patients under 35 years or over 65 years has not been studied
- The safety and effectiveness of JUVÉDERM® XC for treatment of areas other than facial wrinkles and folds (such as lips) have not been established in clinical studies
- The safety and effectiveness of JUVÉDERM VOLUMATM XC for treatment in areas other than the cheek area have not been established in clinical studies
- The safety of JUVÉDERM® XC and JUVÉDERM VOLUMATM XC in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid
formations) and pigmentation disorders has not been studied, and use may result in additional scars or changes in pigmentation
- The safety of JUVÉDERM VOLUMATM XC in patients with very thin skin in the cheek area and the safety of repeat treatments in patients has not been studied
- There is a possible risk of inflammation at the treatment site if laser procedures and chemical peeling are performed after treatment
- Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects
- Tell your doctor if you are on therapy used to decrease the body's immune response (immunosuppressive therapy). Use of these products may result in an increased risk of infection
- Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
- Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment with JUVÉDERM VOLUMATM XC
What are possible side effects?
For JUVÉDERM® XC, most side effects are mild or moderate in nature, and last 7 days or less. The most common
side effects include temporary injection-site reactions such as: redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising,
itching, and discoloration.
For JUVÉDERM VOLUMATM XC, side effects are moderate (uncomfortable), and generally last 2 to 4 weeks. The most
common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising,
pain, redness, discoloration, and itching.
As with all skin-injection procedures, there is a risk of infection.
To report a side effect with JUVÉDERM® XC or JUVÉDERM VOLUMATM XC, 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 Medical Information line at 1-800-433-8871.
JUVÉDERM® XC and JUVÉDERM VOLUMATM XC injectable gels are available by prescription only.