incobotulinumtoxinA

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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 medication 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. Some of these effects can occur up to several weeks after an injection.

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). IncobotulinumtoxinA is also used to treat muscle spasms (stiffness) in the arms.

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

To make sure incobotulinumtoxinA is safe for you, tell your doctor if you have:

  • 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;
  • if you have had or will have surgery (especially on your face); or
  • if you have ever received other botulinum toxin injections such as Botox, Dysport, or Myobloc (especially in the last 4 months).

IncobotulinumtoxinA is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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 is not known whether incobotulinumtoxinA passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is incobotulinumtoxinA given?

This medication is injected into a muscle. A doctor, nurse, or other healthcare provider will give you this injection. IncobotulinumtoxinA injections should be spaced at least 3 months apart.

Botulinum toxin injections should be given only by a trained medical professional.

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

While receiving botulinum toxin injections for an 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 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.

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.

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?

This medication may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.

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

What are the possible side effects of incobotulinumtoxinA?

Get emergency medical help if you have 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 botulinum toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these 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 strength, 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.

Common 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 other drugs will affect incobotulinumtoxinA?

Other medications such as cold or allergy medicine, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, and irritable bowel medicines can increase some of the side effects of incobotulinumtoxinA. Tell your doctor if you regularly use any of these medications.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with incobotulinumtoxinA, especially:

  • a blood thinner such as warfarin, Coumadin, Jantoven; or
  • an injected antibiotic--amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.

This list is not complete. Other drugs may interact with incobotulinumtoxinA, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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.

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