Important Safety Information for Dysport® (abobotulinumtoxinA) 300 Units for Injection
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.
Please read important safety information and full prescribing information, including distant spread of toxin effect boxed warning, at the bottom of the page.
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. These effects can cause symptoms of a serious condition called botulism. Symptoms of botulism 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.
The risk of symptoms is probably greatest in children and adults treated for muscle spasms, particularly in those patients who have underlying medical conditions that could make these symptoms more likely.
The toxic effects have been reported at doses similar to those used to treat muscle spasms in the neck. Lower doses, in both approved and unapproved uses, have also caused toxic effects. This includes treatment of children and adults for muscle spasms.
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® or Botox®, or have a skin infection at the planned injection site.
The dose of Dysport is not the same as the dose of any other botulinum toxin product. The dose of Dysport cannot be compared to the dose of any other botulinum toxin product you may have used.
Dysport may not be right for you if: you have surgical changes to your face, very weak muscles in the treatment area, your face looks very different from side to side, the injection site is inflamed, you have droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, or if your wrinkles can’t be smoothed by spreading them apart.
Tell your doctor about all your medical conditions, including if you have: a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert-Eaton syndrome), allergies to any botulinum toxin product or had any side effect from any botulinum toxin product in the past, a breathing problem (such as asthma or emphysema), swallowing problems, bleeding problems, diabetes, or a slow heart beat or other problem with your heart rate or rhythm, plans to have surgery, had surgery on your face, weakness of your forehead muscles (such as trouble raising your eyebrows), drooping eyelids, or any other change in the way your face normally looks. Patients with a disease that affects muscles and nerves who are treated with typical doses of Dysport may have a higher risk of serious side effects, including severe swallowing and breathing problems.
This product contains albumin taken from human plasma. Steps taken during donor screening and product manufacturing processes make the risk of spreading viral diseases extremely rare. In theory, there is also an extremely rare risk of contracting Creutzfeldt-Jakob disease (CJD). No cases of spread of viral diseases or CJD have ever been reported for albumin.
Allergic Reaction to Injecting in the Skin
It is not known if an allergic reaction can be caused by injecting Dysport into the skin. The safety of treating excessive sweating with Dysport is not known.
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.
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 in the last four months, have received injections of botulinum toxin, such as Myobloc® (rimabotulinumtoxinB) or Botox® (onabotulinumtoxinA) 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.
Use in Specific Populations
Dysport should not be used in children or in women who are pregnant or breastfeeding.
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
Indications: The Restylane family of products includes Restylane®, Restylane-L®, Restylane® Silk, Restylane® Lyft with Lidocaine, and Perlane®. Restylane, Restylane-L, Restylane Lyft with Lidocaine, and Perlane are indicated for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are indicated for mid-to-deep dermal implantation. Perlane and Restylane Lyft with Lidocaine are indicated for implantation into the deep dermis to superficial subcutis. Restylane Silk is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21. Restylane Lyft with Lidocaine is also indicated for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane and Restylane-L are also indicated for submucosal implantation for lip augmentation in patients over the age of 21.
Products in the Restylane family contain traces of gram-positive bacterial protein and are contraindicated for patients with allergies to such material or in patients with severe allergies that have required in-hospital treatment. These products should not be used by patients with bleeding disorders or by pregnant or breastfeeding women. Restylane and Restylane-L for lip enhancement and Restylane Silk should not be used by people under 22 years. Restylane-L, Restylane Silk and Restylane Lyft with Lidocaine should not be used by anyone with a known allergy to lidocaine. Products should not be injected anywhere except the dermis, superficial subcutis (Perlane and Restylane Lyft with Lidocaine only), or lip submucosa (Restylane, Restylane-L, and Restylane Silk only).
Use of products in the Restylane family at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. The most commonly observed side effects are swelling, redness, pain, bruising, tenderness, and itching at the injection site. These are typically mild in severity and typically resolve in less than 7 days. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. Do not implant into blood vessels. Use with caution in patients recently treated with anticoagulant or platelet inhibitors to avoid bleeding and bruising.
The Restylane family of products is available only through a licensed practitioner. Complete Instructions for Use for Restylane, Restylane-L, Restylane Silk, and Perlane are available at www.RestylaneUSA.com. Complete Instructions for Use for Restylane® Lyft with Lidocaine is available at www.RestylaneLyft.com
Important Safety Information Sculptra Aesthetic
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. Complete Instructions for Use are available at www.SculptraAesthetic.com.