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incobotulinumtoxinA

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

IncobotulinumtoxinA side effects

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.

See also: Side effects (in more detail)

IncobotulinumtoxinA dosing information

Usual Adult Dose for Cervical Dystonia:

Initial dose: 120 units injected (usually) into the sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or the trapezius muscle(s); however, 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.

Duration of therapy: The frequency of repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks.

Comments:
-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.
-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 dose.
-In a study of doses of 120 units and 240 units, no meaningful difference in effectiveness was demonstrated between the doses.

Use: For the treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients.

Usual Adult Dose for Blepharospasm:

-NOTE: This drug is not for intraocular use.
-The recommended initial dose should be the same as the patient's previous treatment, although responses may differ in individual patients. If the previous dose is not known, the initial dose should be between 1.25 and 2.5 units per injection site.
-The total initial dose of in both eyes should not exceed 70 units (35 units/eye).

Duration of therapy: The frequency of repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks.

Comments:
-In a trial in which patients were dosed with the same number of units as they had received previously, 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.
-The number and location of injection sites should be based on the severity of blepharospasm, and previous dose and response the injections. Subsequent dosing should be tailored to the individual patient, based on response, up to a maximum dose of 35 units per eye.
-Dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA.

Use: For the treatment of adults with blepharospasm who were previously treated with this drug.

Usual Adult Dose for Glabellar Lines:

The total recommended 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.

Duration of therapy: Retreatment should be administered no more frequently than every 3 months.

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

Usual Adult Dose for Upper Limb Spasticity:

RECOMMENDED DOSING:
CLENCHED FIST:
-Flexor digitorum superficialis: 25 to 100 units; (2 injection sites per muscle)
-Flexor digitorum profundus: 25 to 100 units; (2 injection sites per muscle)
FLEXED WRIST:
-Flexor carpi radialis: 25 to 100 units; (1 to 2 injection sites per muscle)
-Flexor carpi ulnaris: 20 to 100 units; (1 to 2 injection sites per muscle)
FLEXED ELBOW:
-Brachioradialis: 25 to 100 units; (1 to 3 injection sites per muscle)
-Biceps: 50 to 200 units; (1 to 4 injection sites per muscle)
-Brachialis: 25 to 100 units; (1 to 2 injection sites per muscle)
PRONATED FOREARM:
-Pronator quadratus: 10 to 50 units; (1 injection site per muscle)
-Pronator teres: 25 to 75 units; (1 to 2 injection sites per muscle)
THUMB-IN-PALM:
-Flexor pollicis longus: 10 to 50 units; (1 injection site per muscle)
-Adductor pollicis: 5 to 30 units; (1 injection site per muscle)
-Flexor pollicis brevis/Opponens pollicis: 5 to 30 units; (1 injection site per muscle)

Comments:
-Dosage, frequency, and number of injection sites should be individualized to the patient based on the size, number, and location of muscles to be treated, severity of spasticity, presence of local muscle weakness, patient response to previous treatment, and adverse event history with this drug.
-In spasticity patients not previously treated with botulinum toxins, initial dosing should begin at the low end of the recommended dosing range and titrated as necessary.
-Maximum total recommended dose: Up to 400 units per treatment session
-Median time to first onset of effect: Within 7 days after injection
-Maximum effect as an improvement of muscle tone: Within 3 to 4 weeks
-Repeat treatment should generally be no more frequent than every 12 to 14 weeks

Use: Upper limb spasticity

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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2016-02-11, 8:28:25 AM.

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