IncobotulinumtoxinAIncobotulinumtoxinA

IncobotulinumtoxinA Solution for injection

What is this medicine?

INCOBOTULINUMTOXINA (IN koh BOT ue LYE num TOX in AY) is a neuro-muscular blocker. This medicine is used to treat eyelid spasms and severe neck muscle spasms. It is also used to treat moderate to severe frown lines on the face.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • bleeding disorders

  • cerebral palsy

  • difficulty swallowing

  • history of surgery where this medicine is going to be used

  • infection where this medicine is going to be used

  • lung or breathing disease, like asthma

  • myasthenia gravis or other neurologic disease

  • nerve or muscle disease

  • surgery plans

  • an unusual or allergic reaction to botulinum toxin, albumin, sucrose, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

  • aminoglycoside antibiotics like gentamicin, neomycin, tobramycin

  • antihistamines for allergy, cough and cold

  • atropine

  • certain medicines for bladder problems like oxybutynin, tolterodine

  • certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

  • certain medicines for sleep

  • certain medicines for stomach problems like dicyclomine, hyoscyamine

  • certain medicines for travel sickness like scopolamine

  • certain medicines that treat or prevent blood clots like warfarin, enoxaparin, and

    dalteparin

  • ipratropium

  • muscle relaxants

  • other botulinum toxin injections

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups.

This medicine will cause weakness in the muscle where it is injected. Tell your doctor if you feel unusually weak in other muscles. Get medical help right away if you have problems with breathing, swallowing, or talking.

This medicine contains albumin from human blood. It may be possible to pass an infection in this medicine, but no cases have been reported. Talk to your doctor about the risks and benefits of this medicine.

If your activities have been limited by your condition, go back to your regular routine slowly after treatment with this medicine.

You may get muscle weakness, blurred vision, or drooping eyelids. If this happens, do not drive, use machinery, or do other dangerous activities.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • changes in vision

  • eye irritation

  • infection

  • numbness

  • speech problems

  • swallowing problems

  • trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • bruising or pain at site where injected

  • drooping eyelid

  • dry eyes or mouth

  • headache

  • muscle aches, pains

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.


 

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