Beauty Blog

JEUVEAU^® (prabotulinumtoxinA-xvfs)

IMPORTANT SAFETY INFORMATION

JEUVEAU 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 JEUVEAU:

• 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.

Do not use JEUVEAU if you: are allergic to any of the ingredients in JEUVEAU (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC^®), onabotulinumtoxinA (BOTOX^®/BOTOX^® Cosmetic), abobotulinumtoxinA (DYSPORT^®), or incobotulinumtoxinA (XEOMIN^®); have a skin infection at the planned injection site; or are a child.

JEUVEAU dosing units are not the same as, or comparable to, any other botulinum toxin product.

Tell your healthcare provider 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 JEUVEAU.

Tell your healthcare provider about all your medical conditions, including: any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed (it is not known if JEUVEAU can harm your unborn baby or passes into breast milk).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JEUVEAU with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received JEUVEAU in the past.

Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past and the last 4 months, and exactly which product you received (such as BOTOX, BOTOX Cosmetic, MYOBLOC, DYSPORT, or XEOMIN).

JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment with JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

JEUVEAU can cause other serious side effects including: Allergic reactions such as itching, rash, red itchy welts, wheezing, trouble breathing, asthma symptoms, or dizziness or feeling faint. Tell your healthcare provider or get emergency medical help right away if you develop wheezing or trouble breathing, or if you feel dizzy or faint. Heart problems. Irregular heartbeat and heart attack that have caused death, have happened in some people who received botulinum toxin products. Eye problems such as dry eye, reduced blinking, and corneal problems. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.

The most common side effects include: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count.

APPROVED USE

JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).

The risk information provided here is not complete. For more information about JEUVEAU, see the full Prescribing Information including BOXED WARNING, and Medication Guide, and talk to your healthcare provider.

To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1 (1-877-386-5871). 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.

*Your Club Evolus membership covers 20 units of Jeuveau per treatment, with a minimum of 90 days between each treatment. Units do not accrue if you wait more than 90 days between treatments. You will pay your provider directly for any additional treatments you receive. Cannot be combined with any other offer. Club Evolus members will be automatically opted out of Evolus Rewards™ upon enrollment. You can manage your Club Evolus account and payment method through your club.evolus.com login. If you cancel within the first three months a $100 cancellation fee will apply. Your Club Evolus membership is non-transferable and payments are non-refundable.

EVOLYSSE™

Approved Uses

EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM are injected into the skin to smooth wrinkles that form in dynamic areas of the face, especially between the nose and corners of the mouth (NLFs), in adults 22 and older.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive treatment with EVOLYSSE injectable hyaluronic acid products?

Do not use EVOLYSSE products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or Gram-positive bacterial proteins.

What precautions should my doctor advise me about?

• Minimize exposure to extreme heat or cold as doing so may cause temporary redness, swelling, and/or itching at the injection site.

• Tell your doctor if you are using medication that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site.

• Tell your doctor if you are planning laser treatment, chemical peel, or any other procedure after treatment as there is a possible risk of an inflammatory reaction at the treatment site.

• EVOLYSSE products are intended for dynamic wrinkles and folds such as NLFs. The safety and effectiveness for other treatment areas have not been established.

• Tell your doctor if you are on therapy used to decrease your immune response, which can increase risk of infection with treatment.

• Tell your doctor if you are pregnant or breastfeeding. The safety for use during pregnancy or in women who are breastfeeding has not been studied.

• Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation.

• Tell your doctor if you have a history of cold sores. Any injections, including EVOLYSSE products, around the mouth may trigger a recurrence of your cold sores.

• The use of EVOLYSSE products where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed until healing is complete. Use of EVOLYSSE products where these are present could delay healing or make your skin problems worse.

What are the possible side effects of treatment?

The most commonly reported side effects with EVOLYSSE products were tenderness, swelling, bruising, redness, lumps, pain, discoloration, itching, and headache. Most side effects were mild and went away on their own within 1 week.

What are other possible adverse events?

As with all skin injection procedures, there is a risk of infection.

One of the risks with using these products is unintentional injection into a blood vessel. Although the chances of this happening are very small, complications can be serious and may be permanent, and include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should call your doctor immediately.

To report a side effect with any EVOLYSSE product, please call the Evolus Customer Experience at 1-877-386-5871.

EVOLYSSE products are available only by a licensed physician or properly licensed practitioner.

For complete patient label information, please visit EvolusRx.com