IncobotulinumtoxinA Injection

What is this medication?

INCOBOTULINUMTOXINA (IN koh BOT ue LYE num TOX in AY) treats severe muscle spasms. It works by relaxing your muscles, which reduces muscle stiffness. It may also be used to treat excessive drooling caused by some conditions, such as cerebral palsy. It can be used to decrease the appearance of facial wrinkles.

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

COMMON BRAND NAME(S): Xeomin

What should I tell my care team before I take this medication?

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

• Conditions that affect your nerves or muscles, such as myasthenia gravis
• Eyelid drooping
• History of eye surgery or surgery on your face
• Lung disease
• Skin infection at the planned injection site
• Trouble speaking
• Trouble swallowing
• An unusual or allergic reaction to botulinum toxin, albumin, sucrose, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a muscle. It is given by your care team in a hospital or clinic setting.

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

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have 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 medication?

• Antihistamines for allergy, cough, and cold
• Atropine
• Certain antibiotics, such as gentamicin, neomycin, or tobramycin
• Certain medications for bladder problems, such as oxybutynin or tolterodine
• Certain medications for Parkinson disease, such as benztropine or trihexyphenidyl
• Certain medications for stomach problems, such as dicyclomine or hyoscyamine
• Certain medications for travel sickness, such as scopolamine
• Certain medications that prevent or treat blood clots, such as warfarin, enoxaparin, or dalteparin
• Ipratropium
• Medications that help you fall asleep
• Medications that relax muscles
• 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 medication?

Your condition will be monitored carefully while you are receiving this medication.

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

This medication contains albumin from human blood. Talk to your care team about the risks and benefits of this medication.

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

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 medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dryness or irritation of the eyes, eye pain, change in vision, sensitivity to light
• Spread of botulinum toxin effects—unusual weakness or fatigue, blurry or double vision, trouble swallowing, hoarseness or trouble speaking, trouble breathing, loss of bladder control

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dry mouth
• Eyelid drooping
• Headache
• Muscle pain
• Pain, redness, or irritation at injection site
• Runny or stuffy nose

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 medication?

This medication is given in a hospital or clinic. It 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.