Dysport (Abobotulinumtoxin A Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

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Dysport

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DYSPORT™
(abobotulinumtoxinA) for Injection

Distant Spread of Toxin Effect

Postmarketing reports indicate that the effects of DYSPORT (abobotulinumtoxin a injection) ™ and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

DRUG DESCRIPTION

Botulinum toxin type A, the active ingredient in DYSPORT™ (abobotulinumtoxinA), is a purifed neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinumtype A, Hall Strain. It is purifed from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein.

DYSPORT™ (abobotulinumtoxin a injection) is supplied in a single-use, sterile vial for reconstitution intended for intramuscular injection. Each vial contains 500 or 300 Units of lyophilized abobotulinumtoxinA, 125 micrograms human serum albumin and 2.5 mg lactose. DYSPORT™ (abobotulinumtoxin a injection) may contain trace amounts of cow's milk proteins [see CONTRAINDICATIONS].

One unit of DYSPORT™ (abobotulinumtoxin a injection) corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. The method for performing the assay is specifc to Ipsen's product DYSPORT™ (abobotulinumtoxin a injection) Due to differences in specifc details such as vehicle, dilution scheme and laboratory protocols for various mouse LD50 assays, Units of biological activity of DYSPORT™ (abobotulinumtoxin a injection) are not interchangeable with Units of any other botulinum toxin or any toxin assessed with any other specifc assay method [see Dosage Forms and Strengths].

What are the precautions when taking abobotulinumtoxin a injection (Dysport)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do...

Read All Potential Precautions of Dysport »

Last reviewed on RxList: 5/22/2009
This monograph has been modified to include the generic and brand name in many instances.