OnabotulinumtoxinA Injection (Medical Use)

What is this medication?

ONABOTULINUMTOXINA (o na BOTT you lye num tox in eh) treats severe muscle spasms. It may also be used to prevent migraine headaches. It can treat excessive sweating when other medications do not work well enough.

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

COMMON BRAND NAME(S): Botox

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

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

• Breathing problems
• Cerebral palsy spasms
• Difficulty urinating
• Heart problems
• History of surgery where this medication is going to be used
• Infection at the site where this medication is going to be used
• Myasthenia gravis or other neurologic disease
• Nerve or muscle disease
• Surgery plans
• Take medications that treat or prevent blood clots
• Thyroid problems
• An unusual or allergic reaction to botulinum toxin, albumin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for 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 this medication 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?

• Aminoglycoside antibiotics, such as gentamicin, neomycin, tobramycin
• 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 medication?

Visit your care team for regular check ups.

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 might make your eyelids droop or make you see blurry or double. If you have weak muscles or trouble seeing do not drive a car, use machinery, or do other dangerous activities.

This medication contains albumin from human blood. It may be possible to pass an infection in this medication, but no cases have been reported. 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.

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
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• 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
• Trouble passing urine

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

• Dry mouth
• Eyelid drooping
• Fatigue
• Headache
• Pain, redness, or irritation at injection site

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 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.