Important Safety Information for Dysport
Dysport is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information you should know about Dysport?
Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. Symptoms can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control. Swallowing and breathing problems can be life threatening and there have been reports of death. You are at the highest risk if these problems are pre-existing before injection.
These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow’s milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®, have a skin infection at the planned injection site, under 18 years of age, or are pregnant or breastfeeding.
The dose of Dysport is not the same as the dose of any other botulinum toxin product and cannot be compared to the dose of any other product you may have used.
Tell your doctor about any swallowing or breathing difficulties and all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert-Eaton syndrome, which may increase the risk of serious side effects including difficulty swallowing and difficulty breathing.
Tell your doctor about all of your medical conditions, including if you have surgical changes to your face, very weak muscles in the treatment area, any abnormal facial change, injection site inflammation, droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, wrinkles that can’t be smoothed by spreading them apart, or if you are pregnant or breastfeeding or planning to become pregnant or breastfeed.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first.
Especially tell your doctor if you: have received any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), in the last four months or any 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.
Common Side Effects
The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.
Ask your doctor if Dysport is right for you.
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 Dysport Full Prescribing Information
including Medication Guide
Important Safety Information for the Restylane Family
The Restylane family of products includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, and Restylane® Defyne.
Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips in patients over the age of 21.
Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21.
Restylane® Silk is for lip augmentation and for correction of perioral wrinkles in patients over the age of 21.
Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.
Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.
Are there any reasons why I should not use products within the Restylane® family? (Contraindications)
To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use products within the Restylane family if:
- You have severe allergies with a history of severe reactions (anaphylaxis)
- You are allergic to lidocaine or to any of the gram-positive bacterial proteins used to make hyaluronic acid
- You are prone to bleeding or have been diagnosed with a bleeding disorder
Are there other precautions that I should discuss with my doctor?
- Tell your doctor if you are breastfeeding, pregnant, or trying to become pregnant. The safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
- Restylane, Restylane-L, Restylane® Lyft with Lidocaine, Restylane Refyne and Restylane Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are also intended for lip enhancement. Treatments in other areas of the face have not been evaluated in clinical studies.
- The safety and effectiveness of Restylane® Silk for areas other than the lips and perioral area have not been evaluated in clinical studies
- Tell your doctor if you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general.
- 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 any medications to decrease your body’s immune response (immunosuppressive therapy). Using these medications may increase your risk of bruising or bleeding at the gel injection site.
- Tell your doctor if you are using any “blood thinners” such as aspirin, warfarin, or any other medications that affect bleeding. Using these medications may increase your risk of bruising or bleeding at the gel injection site.
- The use of these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of product in these areas could delay healing or make your skin problems worse.
What are the possible side effects?
The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, and itching at the injection site. These are typically mild in severity and typically resolve in less than 7 days in nasolabial folds and less than 14 days in lips. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.
One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, 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 of the skin.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any of the Restylane products, please call Galderma Laboratories, L.P at 1-855-425-8722.
The Restylane family of products is available only through a licensed practitioner. View Complete Instructions for Use.
Important Safety Information for Sculptra Aesthetic
Indication: Sculptra® Aesthetic (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.
Sculptra Aesthetic should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.
Sculptra Aesthetic has unique injection requirements and should only be used by a trained physician. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.
Sculptra Aesthetic should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra Aesthetic should not be injected into the red area (vermillion) of the lip or in the peri-orbital area.
The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported.
Sculptra Aesthetic is available only through a licensed practitioner. View the Complete Instructions for Use.