Dysport for Injection
Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of Dysport
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.
Botulinum toxin type A, the active ingredient in Dysport
(abobotulinumtoxinA), is a purified neurotoxin type A complex produced by
fermentation of the bacterium Clostridium botulinum type A, Hall Strain.
It is purified 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 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 may contain trace amounts of cow's milk proteins
One unit of Dysport corresponds to the calculated median
lethal intraperitoneal dose (LD50) in mice. The method for performing the assay
is specific to Ipsen's product Dysport. Due to differences in specific details such as vehicle, dilution scheme and laboratory protocols
for various mouse LD50 assays, Units of biological activity of Dysport are not
interchangeable with Units of any other botulinum toxin or any toxin assessed
with any other specific assay method [see Dosage Forms and Strengths].
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...
Read All Potential Side Effects and See Pictures of Dysport »
Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.