LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® is an FDA-approved treatment to grow eyelashes for people with inadequate or not enough lashes.
Important Safety Information
Do not use LATISSE® if you are allergic to one of its ingredients. If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. May cause brown darkening of the colored part of the eye which is likely permanent. LATISSE® may cause eyelid skin darkening which may be reversible. Only apply at base of upper lashes. DO NOT APPLY to lower lid. Hair may grow outside the treatment area. If you have eye problems/surgery, consult your doctor. Common side effects include itchy and red eyes. If discontinued, lashes gradually return to previous appearance.
These are not all the possible side effects of LATISSE®. For more information, please talk to your doctor.
Please see LATISSE® full Product Information.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. 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, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other 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, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive 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 ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and 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; have 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 (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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.
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 (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids and eyebrows, and swelling of your eyelids.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-433-8871.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.
JUVÉDERM® Injectable Gel Fillers Important Information
JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over 21.
JUVÉDERM® XC and JUVÉDERM VOLLURE™ XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM VOLLURE™ XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC is for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® injectable gel formulation?
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 lidocaine or the Gram-positive bacterial proteins used in these products.
What precautions should my doctor advise me about?
- Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied
- The safety of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years, the safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels in patients under 18 years, and the safety of JUVÉDERM VOLLURE™ XC and JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied
- The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area, JUVÉDERM® XC and JUVÉDERM VOLLURE™ XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in clinical studies
- Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
- Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures 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 immunosuppressive therapy used to decrease the body’s immune response, as 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, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment
What are possible side effects?
The most commonly reported side effects with JUVÉDERM® injectable gels included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM VOLBELLA® XC, dryness was also reported. For JUVÉDERM VOLUMA® XC, most side effects were moderate and lasted 2 to 4 weeks. For JUVÉDERM® XC, JUVÉDERM VOLLURE™ XC, and JUVÉDERM® Ultra XC injectable gels, most side effects were mild or moderate and lasted 14 days or less. For JUVÉDERM VOLBELLA® XC, most side effects were mild or moderate and lasted 30 days or less.
One of the risks with using these products is unintentional injection into a blood vessel, and, while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871. Please visit Juvederm.com or talk to your doctor for more information.
Available by prescription only.
Natrelle® Breast Implants Important Information
Who may get breast implants (INDICATIONS)?
Natrelle® Breast Implants are approved for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants.
- Breast augmentation for women at least 18 years old for saline-filled implants.
Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
- Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
IMPORTANT SAFETY INFORMATION
Who should NOT get breast implants (CONTRAINDICATIONS)?
Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing.
What else should I consider (WARNINGS)?
Breast implants are not lifetime devices or necessarily a one-time surgery. You may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent. Breast implants may affect your ability to produce milk for breastfeeding. Silicone-filled implants may rupture without symptoms. You should have MRI examinations 3 years after surgery and then every 2 years thereafter in order to detect ruptures. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning or hardening. Talk to your doctor about removing ruptured implants. Inform any other doctor if you have implants.
What types of conditions require more study (PRECAUTIONS)?
Caution: Notify your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher: autoimmune diseases, a weakened immune system, planned radiation therapy to the breast or planned chemotherapy following breast implant placement, conditions/medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue or a clinical diagnosis of depression, other mental health disorders, body dysmorphic disorder or eating disorders. These disorders should be resolved or stabilized prior to surgery.
What are some complications with breast implants (COMPLICATIONS)?
Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling. Talk to your doctor about other complications.
Talk to your doctor. For more information see the Patient Brochures at www.allergan.com/labeling/usa.htm or call the Allergan Product Support line at 1-800-433-8871.
To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.
Natrelle® Breast Implants are available by prescription only.