Important Safety Information for Dysport
Dysport® (abobotulinumtoxinA) 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
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 ofthe 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. Serious allergic reactions have occurred with the use of Dysport. Dry eye has also
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 at DysportUSA.com.
Important Safety Information for the Restylane Family
The Restylane family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Kysse, Restylane® Refyne, Restylane® Defyne, and Restylane® Contour.
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.
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. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss.
Restylane® Silk is for lip augmentation and for correction of perioral wrinkles.
Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles.
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.
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. Restylane® Defyne is also indicated for injection into the mid-to-deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.
Restylane® Contour is for cheek augmentation and for the correction of midface contour deficiencies.
Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the
Tell your doctor if you’re taking medications that lower your body’s immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.
The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, 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 Restylane® product, please call Galderma Laboratories, L.P at 1-855-425-8722.
To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.
Click here for patient information about Sculptra® (PDF)
Important Safety Information for Sculptra
Indication: Sculptra® (injectable poly-L-lactic acid (PLLA-SCA))
is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies, fine lines and wrinkles in the cheek region, and other facial wrinkles.
Sculptra 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 has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.
Sculptra 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 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 is available only through a licensed practitioner. View the complete Instructions for Use.