JUVÉDERM® XC AND JUVÉDERM VOLUMA® XC IMPORTANT SAFETY 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 VOLUMA® 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 VOLUMA® 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 VOLUMA® XC if you are allergic to lidocaine.
What precautions should my doctor advise me about?
- The safety of JUVÉDERM® XC and JUVÉDERM VOLUMA® 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 VOLUMA® 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 VOLUMA® XC for treatment in areas other than the cheek area have not been established in clinical studies
- The safety of JUVÉDERM® XC and JUVÉDERM VOLUMA® 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 VOLUMA® 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 health care professional 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 health care professional 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 VOLUMA® 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 VOLUMA® 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 VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.
JUVÉDERM® XC and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.
BOTOX® COSMETIC (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe frown lines between the eyebrows and moderate to severe crow’s feet lines in adults.
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, 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 or both at the same time.
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 asMyobloc® (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).
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; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).
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.
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® is a prescription treatment for hypotrichosis (inadequate or not enough lashes) to grow eyelashes longer, fuller, darker.
Important Safety Information
If you use/used prescription products for 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 and may be reversible. Only apply at the base of upper lashes. DO NOT APPLY to 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 red eyes. If discontinued, lashes gradually return to previous appearance.
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 click here for LATISSE® full Product Information.
Natrelle® Breast Implant Indications and Important Safety Information
Natrelle® Breast Implants are indicated 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)?
- Women with active infection anywhere in their body.
- Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.
- Women who are currently pregnant or nursing.
What else should I consider (WARNINGS)?
- Breast implants are not lifetime devices, and not necessarily a one-time surgery.
- Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implant(s) removed and not replaced, 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 breastfeed, either by reducing or eliminating milk production.
- Rupture of a silicone-filled breast implant is most often silent and may not be detected by you or your doctor. You should have an MRI 3 years after your surgery and then every 2 years after that for as long as you have your breast implants to determine if rupture is present. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement.
- With breast implants, a routine screening mammography and self-examinations for breast cancer will be more difficult. Ask your doctor to help you distinguish the implant from your breast tissue. 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. Tell your doctor of these symptoms and remove ruptured implants.
- Inform any other doctor who treats you of the presence of your implants to minimize the risk of damage to the 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 (for example, lupus and scleroderma).
- A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease).
- Planned chemotherapy following breast implant placement.
- Planned radiation therapy to the breast following breast implant placement.
- Conditions that interfere with wound healing and blood clotting.
- Reduced blood supply to breast tissue.
- Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients with a diagnosis of depression or other mental health disorders should wait for resolution or stabilization of these conditions prior to undergoing breast implantation 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.