Generic Name
OnabotulinumtoxinA
Brand Names
Dysport, Daxxify, Jeuveau, Botox, Xeomin
FDA approval date: December 15, 1989
Classification: Neuromuscular Blocker
Form: Injection, Powder
What is Dysport (OnabotulinumtoxinA)?
DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: The treatment of cervical dystonia in adults.
Approved To Treat
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Brand Information
Dysport (Botulinum Toxin Type A)
WARNING: 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 and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose [
1DOSAGE FORMS AND STRENGTHS
For injection: 300 Units or 500 Units of lyophilized powder in a single-dose vial for reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP.
2CONTRAINDICATIONS
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
- Infection at the proposed injection site(s).
3ADVERSE REACTIONS
The following serious adverse reactions are discussed below and elsewhere in labeling:
- Spread of Toxin Effect
- Lack of Interchangeability between Botulinum Toxin Products
- Hypersensitivity Reactions
- Dysphagia and Breathing Difficulties
- Facial Anatomy in the Treatment of Glabellar Lines
- Dry Eye with the Treatment of Glabellar Lines
- Pre-existing Neuromuscular Disorders
- Human Albumin and Transmission of Viral Diseases
- Intradermal Immune Reaction
- Pre-existing Conditions at the Injection Site [
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity.
The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. In addition, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies across products in this class may be misleading.
3.3Postmarketing Experience
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
4OVERDOSAGE
Excessive doses of DYSPORT may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis [
Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis.
There is no significant information regarding overdose from clinical studies.
In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100. More information can be obtained at
5DESCRIPTION
Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium
DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT
The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Swallowing, Speaking, or Breathing Difficulties, or Other Unusual Symptoms Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking or breathing), or if any known symptom persists or worsens [see Warnings and Precautions (5.1, 5.4)].
Dry Eye with the Treatment of Glabellar Lines
Inform patients that DYSPORT injection may cause eye dryness [see Warnings and Precautions (5.6)]. Advise patients to report symptoms of eye dryness (e.g., eye pain, eye irritation, photosensitivity, or changes in vision) to their doctor.
Inform patients that DYSPORT injection may cause eye dryness [see Warnings and Precautions (5.6)]. Advise patients to report symptoms of eye dryness (e.g., eye pain, eye irritation, photosensitivity, or changes in vision) to their doctor.
Ability to Operate Machinery or Vehicles
Inform patients that if loss of strength, muscle weakness, blurred vision or drooping eyelids occur, they should avoid driving a car or engaging in other potentially hazardous activities.
Inform patients that if loss of strength, muscle weakness, blurred vision or drooping eyelids occur, they should avoid driving a car or engaging in other potentially hazardous activities.
7PRINCIPAL DISPLAY PANEL - 300 UNIT
GALDERMA
Dysport (AbobotulinumtoxinA) for injection For intramuscular use
Dysport (AbobotulinumtoxinA) for injection For intramuscular use
300 UNITS/SINGLE-DOSE VIAL
1 VIAL
WARNING: Dosing units of botulinum toxins are not interchangeable between commercial products
NDC 0299-5962-30
Rx only