OnabotulinumtoxinA Solution for injection

What is this medicine?

ONABOTULINUMTOXINA (o na BOTT you lye num tox in eh) is a neuro-muscular blocker. This medicine is used to treat crossed eyes, eyelid spasms, severe neck muscle spasms, ankle and toe muscle spasms, and elbow, wrist, and finger muscle spasms. It is also used to treat excessive underarm sweating, to prevent chronic migraine headaches, and to treat loss of bladder control due to neurologic conditions such as multiple sclerosis or spinal cord injury.

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:

• breathing problems

• cerebral palsy spasms

• difficulty urinating

• heart problems

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

• infection at the site where this medicine is going to be used

• myasthenia gravis or other neurologic disease

• nerve or muscle disease

• surgery plans

• take medicines that treat or prevent blood clots

• thyroid problems

• an unusual or allergic reaction to botulinum toxin, albumin, 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. While this drug may be prescribed for children as young as 12 years old 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 medicine?

• aminoglycoside antibiotics like 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 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 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 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.

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

• chest pain or tightness

• eye irritation, pain

• fast, irregular heartbeat

• infection

• numbness

• speech problems

• swallowing problems

• unusual weakness

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

• muscles aches, pains

• sensitivity to light

• tearing

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.

OnabotulinumtoxinA Solution for injection [Cosmetic Use]

What is this medicine?

ONABOTULINUMTOXINA (o na BOTT you lye num tox in eh) is a neuro-muscular blocker. It is 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:

• breathing problems

• cerebral palsy spasms

• heart problems

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

• infection where this medicine 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 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. 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 medicine?

• aminoglycoside antibiotics like 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 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.

This medicine can make your muscles weak. And, this medicine 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 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, pain

• infection

• numbness

• speech problems

• swallowing problems

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

• headache

• nausea

• sensitivity to light

• tearing

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.