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Brand Names: Xeomin

Generic Name: incobotulinumtoxinA (Pronunciation: IN koe BOT ue LYE num TOX in A)

• What is incobotulinumtoxinA (Xeomin)?
• What are the possible side effects of incobotulinumtoxinA (Xeomin)?
• What is the most important information I should know about incobotulinumtoxinA (Xeomin)?
• What should I discuss with my healthcare provider before taking incobotulinumtoxinA (Xeomin)?
• How is incobotulinumtoxinA given (Xeomin)?
• What happens if I miss a dose (Xeomin)?
• What happens if I overdose (Xeomin)?
• What should I avoid while taking incobotulinumtoxinA (Xeomin)?
• What other drugs will affect incobotulinumtoxinA (Xeomin)?
• Where can I get more information?

What is incobotulinumtoxinA (Xeomin)?

IncobotulinumtoxinA, also called botulinum toxin type A, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

IncobotulinumtoxinA is used to treat cervical dystonia (severe spasms in the neck muscles).

IncobotulinumtoxinA is also used to treat certain eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

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

What are the possible side effects of incobotulinumtoxinA (Xeomin)?

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

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

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

• trouble breathing, talking, or swallowing;
• hoarse voice, drooping eyelids;
• blurred vision, double vision;
• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• loss of bladder control;
• wheezing, tightness in your chest;
• eye pain or irritation;
• severe skin rash or itching; or
• feeling like you might pass out.

Less serious side effects may include:

• neck pain;
• dry eyes;
• headache, tired feeling;
• diarrhea;
• eyelid swelling or bruising, blinking less than usual; or
• pain, redness, or swelling where the injection was given.

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.

What is the most important information I should know about incobotulinumtoxinA (Xeomin)?

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

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to 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.

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS (Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, a breathing disorder, trouble swallowing, facial muscle weakness, a change in the appearance of your face, seizures, bleeding problems, heart disease, if you have had or will have surgery, or if you have ever received other botulinum toxin injections such as Botox, Dysport, or Myobloc.

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

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