DYSPORT- botulinum toxin type a injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Botulinum Toxin Type A (UNII: E211KPY694) (Botulinum Toxin Type A - UNII:E211KPY694)

Available from:

Galderma Laboratories, L.P.

INN (International Name):

Botulinum Toxin Type A

Composition:

Botulinum Toxin Type A 300 U

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DYSPORT is indicated for the treatment of cervical dystonia in adults. DYSPORT is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults less than 65 years of age. DYSPORT is indicated for the treatment of spasticity in patients 2 years of age and older. DYSPORT is contraindicated in patients with: - Known hypersensitivity to any botulinum toxin products, cow's milk protein, or to any of the components in the formulation [see Warnings and Precautions (5.3)] .  This product may contain trace amounts of cow's milk protein [see Description (11)] . - Infection at the proposed injection site(s). Risk Summary There are no adequate and well-controlled clinical studies with DYSPORT in pregnant women. DYSPORT should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. DYSPORT produced embryo-fetal toxicity in relation to maternal toxicity when given to pregn

Product summary:

DYSPORT® (abobotulinumtoxinA) for Injection is a sterile, lyophilized powder supplied in a single-dose, glass vial. Unopened vials of DYSPORT must be stored refrigerated between 2°C to 8°C (36°F to 46°F). Protect from light. Do not use after the expiration date on the vial. All vials, including expired vials, or equipment used with DYSPORT  should be disposed of carefully as is done with all medical waste. DYSPORT contains a unique hologram on the carton. If you do not see the hologram, do not use the product. Instead contact 855-463-5127. Cervical Dystonia, Spasticity in Adults, and Pediatric Patients 500 Unit Vial Each vial contains 500 Units of freeze-dried abobotulinumtoxinA. Box containing 1 vial—NDC 15054-0500-1 Box containing 2 vials—NDC 15054-0500-2 300 Unit Vial Each vial contains 300 Units of freeze-dried abobotulinumtoxinA. Box containing 1 vial—NDC 15054-0530-6 Glabellar Lines Each vial contains 300 Units of freeze-dried abobotulinumtoxinA. Box containing 1 vial— NDC 0299-5962-30

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Galderma Laboratories, L.P.
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MEDICATION GUIDE
DYSPORT® (DIS-port)
(abobotulinumtoxinA)
for Injection
What is the most important information I should know about DYSPORT?
DYSPORT may cause serious side effects that can be life threatening
including:
• Problems breathing or swallowing
• Spread of toxin effects
These problems can happen within hours, or days to weeks after an
injection of DYSPORT. Call your
doctor or get medical help right away if you have any of these
problems after treatment with
DYSPORT:
1. Problems swallowing, speaking, or breathing. These problems can
happen within hours, or days to
weeks after an injection of DYSPORT usually because the muscles that
you use to breathe and swallow
can become weak after the injection. Death can happen as a
complication if you have severe problems
with swallowing or breathing after treatment with DYSPORT.
• People with certain breathing problems may need to use muscles in
their neck to help them breathe.
These patients may be at greater risk for serious breathing problems
with DYSPORT.
• Swallowing problems may last for several weeks. People who cannot
swallow well may need a feeding
tube to receive food and water. If swallowing problems are severe,
food or liquids may go into your
lungs. People who already have swallowing or breathing problems before
receiving DYSPORT have the
highest risk of getting these problems.
2. Spread of toxin effects. In some cases, the effect of botulinum
toxin may affect areas of the body away
from the injection site and cause symptoms of a serious condition
called botulism. The symptoms of
botulism include:
• loss of strength and muscle weakness all over the body
• blurred vision and drooping eyelids
• trouble saying words clearly (dysarthria)
• trouble breathing
• double vision
• hoarseness or change or loss of voice (dysphonia)
• loss of bladder control
• trouble swallowing
These symptoms can happen within hours, or days to weeks after you
receive an injection of DYSPORT.
These problems could make

Summary of Product characteristics

DYSPORT - BOTULINUM TOXIN TYPE A INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
GALDERMA LABORATORIES, L.P.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DYSPORT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DYSPORT.
DYSPORT (ABOBOTULINUMTOXINA) FOR INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: APRIL 2009
WARNING: DISTANT SPREAD OF TOXIN EFFECT
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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
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 OCCUR IN ADULTS, PARTICULARLY IN THOSE PATIENTS WHO HAVE
UNDERLYING
CONDITIONS THAT WOULD PREDISPOSE THEM TO THESE SYMPTOMS. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.2, 2.3, 2.5, 2.6)
1/2023
Warning and Precautions (5.5, 5.10)
09/2023
INDICATIONS AND USAGE
DYSPORT is an acetylcholine release inhibitor and neuromuscular
blocking agent indicated for:
the treatment of cervical dystonia in adults (1.1)
the temporary improvement in the appearance of moderate to severe
glabellar lines associated with
procerus and corrugator muscle activity in adults < 65 years of age
(1.2)
The treatment of spasticity in patients 2 years of age and older (1.3)
DOSAGE AND ADMINISTRATION
Preparation of DYSPORT Solution for Administration (2.2)
Once reconstituted, store in original container in a refrigerator 2°C
to 8°C (36°F to 46°F) and use within
24 hours
Do not freeze after reconstitution
Reconstitution instructions are specific for the 300 Unit and 500 Unit
vials
Reconstituted DYSPORT is intended for intramuscular injection only.
After reconstitution, DYSPORT
should be used for only one injection session and for only