PrabotulinumtoxinA, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles.

PrabotulinumtoxinA is used to temporarily lessen the appearance of facial wrinkles (frown lines between the eyebrows) in adults.

PrabotulinumtoxinA may also be used for purposes not listed in this medication guide.

The botulinum toxin contained in prabotulinumtoxinA can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe eye irritation, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing.

PrabotulinumtoxinA (Jeuveau) should be given only by a trained medical professional, even when used for cosmetic purposes.

prabotulinumtoxinA is injected into a muscle by a healthcare provider. Jeuveau injections should be spaced at least 3 months apart.

The effects of a Jeuveau injection are temporary. Your symptoms may return completely within 3 months. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

Do not seek Jeuveau injections from more than one medical professional at a time. If you switch healthcare providers, tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

Usual Adult Dose for Glabellar Lines:

20 Units per treatment session divided into 5 equal IM injections of 4 Units each:
-Two injections in each corrugator muscle (one into inferomedial and one into superior middle)
-One injection in the procerus muscle

Retreatment should be administered no more frequently than every three months

Comments:
-The cumulative dose of botulinum toxin should be considered if other botulinum toxin products are or have been used for other indications.

Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity.

You should not be treated with prabotulinumtoxinA if you are allergic to it, or if:

• you have an infection in the area where the medicine will be injected; or

• you have ever had an allergic reaction to any product that contains botulinum toxin, such as Botox, Dysport, Myobloc, or Xeomin.

Tell your doctor if you have ever had:

• other botulinum toxin injections such as Dysport or Myobloc (especially in the last 4 months);

• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

• myasthenia gravis;

• Lambert-Eaton syndrome;

• a side effect after prior use of botulinum toxin;

• a breathing disorder such as asthma or emphysema;

• problems with swallowing;

• facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);

• bleeding problems;

• heart disease; or

• surgery (especially on your face).

Tell your doctor if you are pregnant or breastfeeding.

PrabotulinumtoxinA is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

If you have a planned surgery, tell your surgeon ahead of time about when you last received prabotulinumtoxinA.

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

prabotulinumtoxinA may cause muscle weakness, vision problems, or dizziness. These effects can occur within hours or weeks after you receive a Jeuveau injection.

Avoid driving or hazardous activity until you know how this medicine will affect you.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in Jeuveau can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these side effects (up to several hours or several weeks after an injection):

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

• trouble breathing, talking, or swallowing;

• loss of bladder control;

• hoarse voice, drooping eyelids;

• vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light); or

• chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats.

Common side effects of prabotulinumtoxinA may include:

• headache;

• drooping eyelids;

• increased white blood cell counts; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect prabotulinumtoxinA, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.