AbobotulinumA Solution for injection

What is this medicine?

ABOBOTULINUMTOXINA (ay boh BOT yoo li num TOX in A) is a neuro-muscular blocker. This medicine is used to treat severe neck muscle spasms and muscle spasms in the elbow, wrist, and finger muscles. It is also used to treat frown lines or lines between the eyebrows 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

• diabetes

• 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

• an unusual or allergic reaction to botulinum toxin, albumin, cow's milk protein, 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.

A special MedGuide will be given to you with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've 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.

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

• chest pain or tightness

• eye pain, infection

• fast, irregular heartbeat

• fever, flu-like symptoms

• 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

• dry eyes or mouth

• eye irritation

• eye pointing down or up

• headache

• 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.

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.