IncobotulinumtoxinA 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, severe neck muscle spasms, and muscle spasms in the hands and arms. It is also used to treat moderate to severe frown lines on the face.

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.

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 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

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

What if I miss a dose?

This does not apply.

Where should I keep my medicine?

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

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

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.