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incobotulinumtoxinA

Pronunciation: IN koe BOT ue LYE num TOX in A

Brand: Xeomin

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

You should not receive this medicine 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.

The botulinum toxin contained in this medicine 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 muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing.

What is incobotulinumtoxinA?

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), or muscle stiffness in the elbows, wrists, fingers, ankles, or toes.

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 is also used to treat chronic drooling (sialorrhea).

IncobotulinumtoxinA is also used to temporarily lessen the appearance of facial wrinkles (sometimes called "frown lines") between the eyebrows.

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

What should I discuss with my healthcare provider before taking incobotulinumtoxinA?

You should not be treated with incobotulinumtoxinA 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.

Tell your doctor if you have ever had a side effect after receiving a botulinum toxin in the past.

Tell your doctor if you have ever had:

  • other botulinum toxin injections such as Botox, Dysport, or Myobloc (especially in the last 4 months);
  • amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
  • myasthenia gravis;
  • Lambert-Eaton syndrome;
  • a breathing disorder such as asthma or emphysema;
  • problems with swallowing;
  • facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
  • a change in the normal appearance of your face;
  • a seizure disorder;
  • bleeding problems;
  • heart disease; or
  • surgery (especially on your face).

IncobotulinumtoxinA 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.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

IncobotulinumtoxinA is not approved for use by anyone younger than 18 years old.

How is incobotulinumtoxinA given?

This medicine is injected into a muscle or into a gland. A healthcare provider will give you this injection once every 12 to 16 weeks. IncobotulinumtoxinA injections should be spaced at least 3 months apart.

Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.

Your injections may be given into more than one area at a time, depending on the condition being treated.

While receiving injections for eye muscle conditions, you may need to use eye drops, ointment, a special contact lens or other device to protect the surface of your eye. Follow your doctor's instructions.

It may take up to 7 days after injection before neck muscle spasm symptoms begin to improve.

The effects of a botulinum toxin 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 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 medicine more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

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

What happens if I overdose?

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 severe muscle weakness, trouble swallowing, weak or shallow breathing, or loss of movement in any part of your body.

What should I avoid while taking incobotulinumtoxinA?

Avoid going back to your normal physical activities too quickly after receiving an injection.

This medicine may impair your vision or depth perception. Avoid driving or hazardous activity until you know how this medicine will affect you.

What are the possible side effects of incobotulinumtoxinA?

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, 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 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;
  • hoarse voice, drooping eyelids;
  • blurred vision, double vision;
  • seizure;
  • vision changes, eye pain or irritation;
  • wheezing, tightness in your chest;
  • eyelid swelling, crusting or drainage from your eyes, problems with vision;
  • feeling like you might pass out; or
  • loss of strength, loss of bladder control.

Common side effects may include:

  • dry mouth, tooth problems;
  • muscle weakness, body aches;
  • vision problems;
  • feeling short of breath;
  • trouble swallowing;
  • dry eyes, drooping eyelids;
  • headache, neck pain;
  • increased blood pressure;
  • diarrhea; 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.

What other drugs will affect incobotulinumtoxinA?

Other medicines can increase some of the side effects of incobotulinumtoxinA. Tell your doctor about all your other medicines, especially:

  • cold or allergy medicine;
  • muscle relaxers;
  • sleeping pills;
  • bronchodilators;
  • bladder or urinary medicines; or
  • irritable bowel medicines.

This list is not complete. Other drugs may affect incobotulinumtoxinA, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about incobotulinumtoxinA.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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