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Brand Names: Dysport

Generic Name: abobotulinumtoxinA (Dysport) (Pronunciation: A boe BOT ue LYE num TOX in A)

• What is abobotulinumtoxinA (Dysport) (Dysport)?
• What are the possible side effects of Dysport (Dysport)?
• What is the most important information I should know about Dysport (Dysport)?
• What should I discuss with my healthcare provider before I receive Dysport (Dysport)?
• How is Dysport given (Dysport)?
• What happens if I miss a dose (Dysport)?
• What happens if I overdose (Dysport)?
• What should I avoid after receiving Dysport (Dysport)?
• What other drugs will affect Dysport (Dysport)?
• Where can I get more information?

What is abobotulinumtoxinA (Dysport) (Dysport)?

AbobotulinumtoxinA (Dysport), also called botulinum toxin type A, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Dysport is used to treat cervical dystonia (severe spasms in the neck muscles).

Dysport is also used to temporarily lessen the appearance of facial wrinkles.

Dysport may also be used for other purposes not listed in this medication guide.

What are the possible side effects of Dysport (Dysport)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in Dysport can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

• trouble breathing, talking, or swallowing;
• hoarse voice, drooping eyelids;
• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• loss of bladder control;
• problems with vision;
• crusting or drainage from your eyes;
• severe skin rash or itching;
• fast, slow, or uneven heartbeats; or
• chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious side effects may include:

• muscle weakness near where the medicine was injected;
• bruising, bleeding, pain, redness, or swelling where the injection was given;
• headache, muscle pain or stiffness, neck or back pain;
• fever, cough, sore throat, runny nose, flu symptoms,
• dizziness, drowsiness, tired feeling;
• nausea, diarrhea, stomach pain, loss of appetite;
• dry mouth, dry eyes, ringing in your ears;
• increased sweating in areas other than the underarms;
• itchy or watery eyes, increased sensitivity to light; or
• eyelid swelling or bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about Dysport (Dysport)?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin or cow's milk, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, a breathing disorder, trouble swallowing, facial muscle weakness, a change in the appearance of your face, seizures, bleeding problems, heart disease, diabetes, if you have had or will have surgery, or if you have ever received other botulinum toxin injections such as Botox or Myobloc.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

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