abobotulinumtoxinA (Dysport)

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

The botulinum toxin contained in Dysport can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

What is abobotulinumtoxinA (Dysport)?

Dysport is used in adults to treat cervical dystonia (abnormal head position and neck pain).

Dysport is also used to treat muscle spasms and stiffness (spasticity) of the arms, hands, legs, and feet in adults and children at least 2 years old. This medicine will not treat spasticity caused by cerebral palsy.

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

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

What should I discuss with my healthcare provider before I receive Dysport?

Tell your doctor if you have ever had:

• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
• myasthenia gravis;
• Lambert-Eaton syndrome;
• a breathing disorder such as asthma or emphysema;
• problems with swallowing;
• facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
• a change in the normal appearance of your face;
• a seizure disorder;
• bleeding problems;
• a heart rhythm disorder;
• diabetes;
• dry eyes after after receiving botulinum toxin in the past;
• a recent or planned surgery (especially on your face); or
• other botulinum toxin injections such as Botox, Myobloc, or Xeomin.

Dysport is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Tell your doctor if you are pregnant or breastfeeding.

How is Dysport given?

This medicine is injected into a muscle by a healthcare provider. Dysport injections should be spaced at least 3 months apart. Children should not be treated with Dysport more often than every 12 to 16 weeks.

Dysport injections may be given into more than one area at a time, depending on the condition being treated.

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

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

What happens if I miss a dose?

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving Dysport?

Dysport may impair your vision or depth perception. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid going back to your normal physical activities too quickly after receiving an injection.

What are the possible side effects of Dysport?

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 botulinum toxin injections, even for cosmetic purposes.

• trouble breathing, talking, or swallowing;
• hoarse voice, drooping eyelids;
• problems with vision;
• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• pain or burning when you urinate, red or pink urine;
• loss of bladder control; or
• vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light).

Common side effects may include:

• muscle weakness, problems with balance;
• headache, muscle or joint pain, pain in your arms or legs;
• vision changes, drooping eyelids, dry or puffy eyes;
• a reaction where the medicine was injected (pain, itching, redness, warmth, bruising, numbness, tingling, swelling);
• nausea;
• fever, cough, sore throat, runny or stuffy nose;
• voice changes, dry mouth, trouble swallowing; or
• feeling tired.

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 other drugs will affect Dysport?

Tell your doctor about all your other medicines, especially:

• an injected antibiotic -- amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.

This list is not complete. Other drugs may affect Dysport, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Do not start a new medication without telling your doctor that you have received Dysport in the past.

Where can I get more information?

Your doctor or pharmacist can provide more information about Dysport (abobotulinumtoxinA).

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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