Generic Name: incobotulinumtoxinA (IN koe BOT ue LYE num TOX in A)
Brand Names: Xeomin
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 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 is the most important information I should know about incobotulinumtoxinA?
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.
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 you can safely receive incobotulinumtoxinA, tell your doctor if you have any of these other conditions:
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.
FDA pregnancy category C. It is not known whether botulinum toxin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether botulinum toxin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling 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.
IncobotulinumtoxinA side effects
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.
IncobotulinumtoxinA Dosing Information
Usual Adult Dose for Cervical Dystonia:
Initial total dose: 120 Units
In a placebo-controlled trial utilizing initial incobotulinumtoxinA doses of 120 Units and 240 Units, no meaningful difference in effectiveness was demonstrated between the doses.
In previously treated patients, their past dose, response to treatment, duration of effect, and adverse event history should be taken into consideration when determining the incobotulinumtoxinA dose.
In the treatment of cervical dystonia, incobotulinumtoxinA is usually injected into the sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or the trapezius muscle(s). This list is not exhaustive, as any of the muscles responsible for controlling head position may require treatment. The dose and number of injection sites in each treated muscle should be individualized based on the number and location of the muscle(s) to be treated, the degree of spasticity/dystonia, muscle mass, body weight, and response to any previous botulinum toxin injections.
The frequency of incobotulinumtoxinA repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks.
Usual Adult Dose for Blepharospasm:
The recommended initial total dose of incobotulinumtoxinA should be the same dose as the patient's previous treatment of onabotulinumtoxinA (Botox), although responses to incobotulinumtoxinA and onabotulinumtoxinA (Botox) may differ in individual patients.
In a placebo-controlled trial in which patients were dosed with the same number of Units as they had received previously with onabotulinumtoxinA (Botox), the mean dose per eye was about 33 Units (range 10 to 50 Units), and the mean number of injections per eye was 6. The maximum dose per eye in the controlled trials was 50 Units, with a range of 10 to 50 Units. In the controlled trial, few patients received a total dose of greater than 75 Units.
If the previous dose of Botox is not known, the initial dose of incobotulinumtoxinA should be between 1.25 to 2.5 Units/injection site.
The total initial dose of incobotulinumtoxinA in both eyes should not exceed 70 Units (35 Units/eye).
The number and location of injection sites should be based on the severity of blepharospasm, and previous dose and response to onabotulinumtoxinA (Botox) injections. Subsequent dosing should be tailored to the individual patient, based on response, up to a maximum dose of 35 Units per eye.
IncobotulinumtoxinA dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA (Botox).
The frequency of incobotulinumtoxinA repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks.
Usual Adult Dose for Glabellar Lines:
The total recommended incobotulinumtoxinA dose is 20 units per treatment session divided into five equal intramuscular injections of 4 units each. The five injection sites are: 2 injections in each corrugator muscle and 1 injection in the procerus muscle.
Retreatment with incobotulinumtoxinA should be administered no more frequently than every 3 months.
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 other medications you have recently used, especially:
a blood thinner such as warfarin (Coumadin, Jantoven); or
an injected antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), paromomycin (Humatin, Paromycin), streptomycin, tobramycin (Nebcin, Tobi).
This list is not complete and there may be other drugs that can interact with incobotulinumtoxinA. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
More incobotulinumtoxinA resources
- IncobotulinumtoxinA Side Effects (in more detail)
- IncobotulinumtoxinA Use in Pregnancy & Breastfeeding
- IncobotulinumtoxinA Drug Interactions
- IncobotulinumtoxinA Support Group
- 0 Reviews for IncobotulinumtoxinA - Add your own review/rating
- IncobotulinumtoxinA Professional Patient Advice (Wolters Kluwer)
- IncobotulinumtoxinA MedFacts Consumer Leaflet (Wolters Kluwer)
- Xeomin Prescribing Information (FDA)
- Xeomin Consumer Overview
- incobotulinumtoxina Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information
Compare incobotulinumtoxinA with other medications
- Blepharospasm
- Cervical Dystonia
- Facial Wrinkles
Where can I get more information?
- Your doctor or pharmacist can provide more information about incobotulinumtoxinA.
See also: incobotulinumtoxinA side effects (in more detail)
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