OnabotulinumtoxinA Injection (Cosmetic Use)

What is this medication?

ONABOTULINUMTOXINA (o na BOTT you lye num tox in eh) decreases the appearance of facial wrinkles. It works by relaxing muscles in the face, which softens wrinkles.

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

COMMON BRAND NAME(S): Botox Cosmetic

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
• Heart problems
• History of surgery where this medication is going to be used
• Infection where this medication is going to be used
• Myasthenia gravis or other neurologic disease
• Nerve or muscle disease
• Surgery plans
• 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 injected into a muscle. It is given by a 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. Special care may be needed.

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 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.

This medication can make your muscles weak. And, this medication can 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.

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
• Change in vision
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Pain or trouble swallowing
• Wheezing or trouble breathingSide effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
• Dry eyes
• Eyelid drooping
• Headache
• Muscle weakness
• Pain, redness, or irritation at injection site
• Sensitivity to light

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.