AbobotulinumtoxinA

AbobotulinumtoxinA
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Edzel Lorraine Co, DMD, MD[2]

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Black Box Warning

WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete Boxed Warning. Post-marketing 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.

Overview

AbobotulinumtoxinA is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of Dysport is a purified neurotoxin type A that is FDA approved for the treatment of cervical dystonia in adults, improvement of moderate to severe frown lines on the glabellar zone (eyebrows) of adults aged 65 years old or younger for a short period of time, and spasticity in people aged 2 years or older.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Common adverse reactions include difficulty in breathing, speaking, and swallowing, and spread of toxin effects..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Spasticity in Adults • Select dose based on muscles affected, severity of spasticity, and treatment and adverse reaction history with botulinum toxins • Dosing for upper limb spasticity: between 500 Units and 1000 Units • Dosing for lower limb spasticity: up to 1500 Units • The maximum recommended total dose per treatment session (upper and lower limb combined) in adults is 1500 Units • Re-treatment, based on return of clinical symptoms, should not occur in intervals of less than 12 weeks

Cervical Dystonia (2.3) • Initial dose is 500 Units given intramuscularly as a divided dose among the affected muscles • Re-treatment every 12 to 16 weeks or longer, as necessary, based on return of clinical symptoms with doses administered between 250 Units and 1000 Units to optimize clinical benefit • Re-treatment should not occur in intervals of less than 12 weeks • Titrate in 250 Unit steps according to patient’s response

Glabellar Lines (2.4) • Administer a total dose of 50 Units, divided in five equal aliquots of 10 Units each, intramuscularly to affected muscles to achieve clinical effect • Re-treatment should be administered no more frequently than every 3 months

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Spasticity in Pediatric Patients (2.6) • Select dose based on the affected muscle, severity of spasticity, and treatment and adverse reaction history with all botulinum toxins. • Recommended dosing for upper limb spasticity: 8 Units/kg to 16 Units/kg per limb. The maximum recommended total dose administered per treatment session must not exceed 16 Units/kg or 640 Units, whichever is lower. • Recommended dosing for lower limb spasticity: 10 Units/kg to 15 Units/kg per limb. Total dose per treatment session must not exceed 15 Units/kg for unilateral lower limb injections, 30 Units/kg for bilateral injections, or 1000 Units, whichever is lower. • The maximum recommended total dose per treatment session is 30 Units/kg or 1000 Units, whichever is lower. Re-treatment, based on return of clinical symptoms, should not occur in intervals of less than 3 months.

Off-Label Use and Dosage (Pediatric)

Contraindications

• With an allergy to Dysport or any ingredients of Dysport
• Cow's milk allergy
• With skin infection
• With an allergic reaction to botolinum toxin products such as Xeomin ((incobotulinumtoxinA), Myobloc, or Botox (onabotulinumtoxinA).

Warnings

WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete Boxed Warning. Post-marketing 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.

• 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

Adverse Reactions

Clinical Trials Experience

Cervical Dystonia Adverse Effects

• General disorders and administration site conditions
  • Injection site discomfort
  • Fatigue
  • Injection site pain

• Musculoskeletal and connective tissue disorders
  • Muscular weakness
  • Musculoskeletal pain

• Gastrointestinal disorders
  • Dysphagia
  • Dry mouth

• Nervous system disorders
  • Headache

• Respiratory, thoracic and mediastinal disorders
  • Dysphonia

Glabellar Lines

• Eye Disorders
  • Eyelid Edema
  • Eyelid Ptosis

• Gastrointestinal Disorders
  • Nausea

• General Disorders and Administration Site Conditions
  • Injection Site Pain
  • Injection Site Reaction

• Infections and Infestations
  • Nasopharyngitis
  • Upper Respiratory Tract Infection
  • Sinusitis

• Investigations
  • Blood Present in Urine

• Nervous System Disorders
  • Headache

Upper Limb Spasticity

• Infections and infestations
  • Influenza
  • Infection

• Musculoskeletal and connective tissue disorders
  • Muscular weakness
  • Pain in extremity
  • Back pain

• Nervous system disorders
  • Headache
  • Convulsion
  • Syncope
  • Hypoesthesia
  • Partial seizures

• General disorders and administration site conditions
  • Fatigue
  • Asthenia

• Injury, poisoning and procedural complications
  • Fall
  • Injury
  • Contusion

• Gastrointestinal disorders
  • Diarrhea
  • Constipation

• Investigation
  • Blood triglycerides increased

• Respiratory, thoracic and mediastinal disorders
  • Cough

• Vascular disorders
  • Hypertension

• Psychiatric disorders
  • Depression

Postmarketing Experience

• Vertigo
• Photophobia
• Influenza-like illness
• Amyotrophy
• Muscle atrophy
• Burning sensation
• Facial paresis
• Hypoesthesia
• Erythema
• Dry eye
• Excessive granulation

tissue. Hypersensitivity reactions including anaphylaxis have been reported.

Drug Interactions

• Concomitant use of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission or muscle relaxants, should be observed closely because effect of Dysport may be potentiated.*Anticholinergic drugs may potentiate systemic anticholinergic effects.
• The effect of administering different botulinum neurotoxins during the

course of treatment with Dysport is unknown.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There are no adequate and well-controlled clinical studies with Dysport in pregnant women.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of AbobotulinumtoxinA in women who are pregnant.

Labor and Delivery

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated populations is unknown.

Nursing Mothers

No data exist on the medical use of abobotulinumtoxinA during breastfeeding. However, it is not detectable systemically after intramuscular use, thus excretion into breast milk is considered unlikely. Breastfeeding appears to protect infants against botulism. One infant was safely breastfed during maternal botulism and no botulinum toxin was detectable in the mother's milk or infant. Since the doses used medically are far lower than those that cause botulism, amounts ingested by the infant, if any, are expected to be small and not cause any adverse effects in breastfed infants No special precautions are required.

Pediatric Use

Cervical Dystonia

Safety and effectiveness in pediatric patients have not been established

Glabellar Lines DYSPORT is not recommended for use in pediatric patients less than 18 years of age.

Spasticity Safety and effectiveness have been established in pediatric patients 2 years of age and older. The safety and effectiveness of DYSPORT have been established by evidence from adequate and well-controlled studies of DYSPORT in patients 2 years of age and older with upper and lower limb spasticity. The safety and effectiveness of DYSPORT injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established.

Geriatic Use

Cervical Dystonia There were insufficient numbers of patients aged 65 years and over in the clinical studies to determine whether they respond differently than younger patients. In general, elderly patients should be observed to evaluate their tolerability of DYSPORT, due to the greater frequency of concomitant disease and other drug therapy.

Glabellar Lines Of the total number of subjects in the placebo-controlled clinical studies of DYSPORT, 8 (1%) were 65 years and over. Efficacy was not observed in subjects aged 65 years and over. For the entire safety database of geriatric subjects, although there was no increase in the incidence of eyelid ptosis, geriatric subjects did have an increase in the number of ocular adverse reactions compared to younger subjects (11% vs. 5%).

Adult Spasticity Upper Limb Spasticity Of the total number of subjects in placebo-controlled clinical studies of DYSPORT, 30 percent were aged 65 years and over, while 8percent were aged 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Lower Limb Spasticity Of the total number of subjects in placebo controlled clinical studies of DYSPORT, 18% (n = 115) were 65 and over, while 3% (n = 20) were 75 and over. Subjects aged 65 years and over who were treated with DYSPORT reported a greater percentage of adverse reactions as compared to younger subjects (46% versus 39%). Fall and asthenia were observed with greater frequency in older subjects, as compared to those younger (10% versus 6% and 4% versus 2%, respectively).

Gender

There is no FDA guidance on the use of AbobotulinumtoxinA with respect to specific gender populations.

Race

There is no FDA guidance on the use of AbobotulinumtoxinA with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of AbobotulinumtoxinA in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of AbobotulinumtoxinA in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of AbobotulinumtoxinA in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of AbobotulinumtoxinA in patients who are immunocompromised.

Ethnic Groups

Exploratory analyses in trials for glabellar lines in African-American subjects with Fitzpatrick skin types IV, V, or VI and in Hispanic subjects suggested that response rates at Day 30 were comparable to and no worse than the overall population.

Administration and Monitoring

Administration

• Dosing in Cervical Dystonia

The recommended initial dose of Dysport for the treatment of cervical dystonia in adults is 500 Units given intramuscularly as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin.Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Clinical studies with Dysport in cervical dystonia suggest that the peak effect occurs between two and four weeks after injection. Simultaneous guided injection of Dysport with EMG and/or ultrasound may be helpful in locating active muscles.

• Dosing in Glabellar Lines

The dose of DYSPORT for the treatment of glabellar lines in adults is a total of 50 Units given intramuscularly in five equal aliquots of 10 Units each to achieve clinical effect.

Dosing in initial and subsequent treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient’s response to previous treatment, and/or adverse reaction history with botulinum toxins. No more than 1 mL should generally be administered at any single injection site. The maximum recommended total dose (upper and lower limb combined) of DYSPORT for the treatment of spasticity in adults is 1500 Units.

Monitoring

• Dosing in Cervical Dystonia

Where dose modification is necessary for the treatment of cervical dystonia, uncontrolled open-label studies suggest that dose adjustment can be made in 250 Unit steps according to the individual patient’s response, with re-treatment every 12 weeks or longer, as necessary, based on return of clinical symptoms. Uncontrolled, open-label studies also suggest that the total dose administered in a single treatment should be between 250 Units and 1000 Units. Re-treatment, if needed, should not occur in intervals of less than 12 weeks. Doses above 1000 Units have not been systematically evaluated.

• Dosing in Glabellar Lines

The clinical effect of DYSPORT may last up to four months. Repeat dosing in clinical studies demonstrated continued efficacy with up to four repeated administrations. It should be administered no more frequently than every three months. When used for retreatment, DYSPORT should be reconstituted and injected using the same techniques as the initial treatment.

IV Compatibility

There is limited information regarding the compatibility of AbobotulinumtoxinA and IV administrations.

Overdosage

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 Symptomatic treatment may be necessary.

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 https://www.cdc.gov/laboratory/drugservice/index.html.

Pharmacology

There is limited information regarding AbobotulinumtoxinA Pharmacology in the drug label.

Mechanism of Action

DYSPORT inhibits release of the neurotransmitter, acetylcholine, from peripheral cholinergic nerve endings. Toxin activity occurs in the following sequence: Toxin heavy chain mediated binding to specific surface receptors on nerve endings, internalization of the toxin by receptor mediated endocytosis, pH-induced translocation of the toxin light chain to the cell cytosol and cleavage of SNAP25 leading to intracellular blockage of neurotransmitter exocytosis into the neuromuscular junction. This accounts for the therapeutic utility of the toxin in diseases characterized by excessive efferent activity in motor nerves. Recovery of transmission occurs gradually as the neuromuscular junction recovers from SNAP25 cleavage and as new nerve endings are formed.

Structure

Botulinum toxin type A, the active ingredient in DYSPORT, 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 nonhemagglutinin protein.

Active ingredient: (botulinum toxin Type A) Inactive ingredients: human albumin and lactose. DYSPORT may contain cow's milk protein.

Pharmacodynamics

The primary pharmacodynamic effect of DYSPORT is due to chemical denervation of the treated muscle resulting in a measurable decrease of the compound muscle action potential, causing a localized reduction of muscle activity.

Pharmacokinetics

Using currently available analytical technology, it is not possible to detect DYSPORT in the peripheral blood following intramuscular injection at the recommended doses.

Nonclinical Toxicology

Carcinogenesis Studies to evaluate the carcinogenic potential of DYSPORT have not been conducted.

Mutagenesis Genotoxicity studies have not been conducted for DYSPORT.

Impairment of Fertility In a fertility and early embryonic development study in rats in which either males (2.9, 7.2, 14.5 or 29 Units/kg) or females (7.4, 19.7, 39.4 or 78.8 Units/kg) received weekly intramuscular injections prior to and after mating, dose-related increases in pre-implantation loss and reduced numbers of corpora lutea were noted in treated females. Failure to mate was observed in males that received the high dose. The no-effect dose for effects on fertility was 7.4 Units/kg in females and 14.5 Units/kg in males (approximately one-half and equal to, respectively, the maximum recommended human dose of 1000 Units on a body weight basis).

Clinical Studies

Cervical Dystonia The efficacy of DYSPORT was evaluated in two randomized, double-blind, placebo-controlled, single-dose, parallel-group studies in treatment-naive cervical dystonia patients. The principal analyses from these trials provide the primary demonstration of efficacy involving 252 patients (121 on DYSPORT, 131 on placebo) with 36% male and 64% female. Ninety-nine percent of the patients were Caucasian.

In both placebo-controlled studies (Study 1 and Study 2), a dose of 500 Units of DYSPORT was given by intramuscular injection divided among two to four affected muscles. These studies were followed by long-term open-label extensions that allowed titration in 250 Unit steps to doses in a range of 250 to 1000 Units, after the initial dose of 500 Units. In the extension studies, re-treatment was determined by clinical need after a minimum of 12 weeks. The median time to re-treatment was 14 weeks and 18 weeks for the 75th percentile. The primary assessment of efficacy was based on the total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) change from baseline at Week 4 for both studies. The scale evaluates the severity of dystonia, patient-perceived disability from dystonia, and pain. The adjusted mean change from baseline in the TWSTRS total score was statistically significantly greater for the DYSPORT group than the placebo group at Week 4 in both studies.

Analyses by gender, weight, geographic region, underlying pain, cervical dystonia severity at baseline and history of treatment with botulinum toxin did not show any meaningful differences between groups.

Glabellar Lines Three double-blind, randomized, placebo-controlled, clinical studies evaluated the efficacy of DYSPORT for use in the temporary improvement of the appearance of moderate to severe glabellar lines. These three studies enrolled healthy adults (ages 19-75) with glabellar lines of at least moderate severity at maximum frown. Subjects were excluded if they had marked ptosis, deep dermal scarring, or a substantial inability to lessen glabellar lines, even by physically spreading them apart. The subjects in these studies received either DYSPORT or placebo. The total dose was delivered in equally divided aliquots to specified injection sites Investigators and subjects assessed efficacy at maximum frown by using a 4-point scale (none, mild, moderate, severe). Overall treatment success was defined as post-treatment glabellar line severity of none or mild with at least 2 grade improvement from baseline for the combined investigator and subject assessments (composite assessment) on Day 30. Additional endpoints for each of the studies were post-treatment glabellar line severity of none or mild with at least a 1 grade improvement from baseline for the separate investigator and subject assessments on Day 30. After completion of the randomized studies, subjects were offered participation in a two-year, open-label re-treatment study to assess the safety of multiple treatments.

Treatment with DYSPORT reduced the severity of glabellar lines for up to four months.

Study GL-1 Study GL-1 was a single-dose, double-blind, multicenter, randomized, placebo-controlled study in which 158 previously untreated subjects received either placebo or 50 Units of DYSPORT, administered in five aliquots of 10 Units. Subjects were followed for 180 days. The mean age was 43 years; most of the subjects were women (85%), and predominantly Caucasian (49%) or Hispanic (47%). At Day 30, 55% of DYSPORT-treated subjects achieved treatment success: a composite 2 grade improvement of glabellar line severity at maximum frown. In study GL-1, the reduction of glabellar line severity at maximum frown was greater at Day 30 in the DYSPORT group compared to the placebo group as assessed by both Investigators and subjects.

Study GL-2 Study GL-2 was a repeat-dose, double-blind, multicenter, placebo-controlled, randomized study. The study was initiated with two or three open-label treatment cycles of 50 Units of DYSPORT administered in five aliquots of 10 Units DYSPORT. After the open-label treatments, subjects were randomized to receive either placebo or 50 Units of DYSPORT. Subjects could have received up to four treatments through the course of the study. Efficacy was assessed in the final randomized treatment cycle. The study enrolled 311 subjects into the first treatment cycle and 142 subjects were randomized into the final treatment cycle. Overall, the mean age was 47 years; most of the subjects were women (86%) and predominantly Caucasian (80%). At Day 30, 52% of DYSPORT-treated subjects achieved treatment success: a composite 2 grade improvement of glabellar line severity at maximum frown. The proportion of responders in the final treatment cycle was comparable to the proportion of responders in all prior treatment cycles. After the final repeat treatment with DYSPORT, the reduction of glabellar line severity at maximum frown was greater at Day 30 in the DYSPORT group compared to the placebo group as assessed by both Investigators and subjects.

Study GL-3 Study GL-3 was a single-dose, double-blind, multicenter, randomized, placebo-controlled study in which 300 previously untreated subjects received either placebo or 50 Units of DYSPORT, administered in five aliquots of 10 Units. Subjects were followed for 150 days. The mean age was 44 years; most of the subjects were women (87%), and predominantly Caucasian (75%) or Hispanic (18%). At Day 30, 60% of DYSPORT-treated subjects achieved treatment success: a composite 2 grade improvement of glabellar line severity at maximum frown. In study GL-3, the reduction of glabellar line severity at maximum frown was greater at Day 30 in the DYSPORT group compared to the placebo group as assessed by both Investigators and subjects.

Geriatric Subjects In GL1, GL2, and GL3, there were 8 subjects aged 65 and older who were randomized to DYSPORT 50 Units in 5 equal aliquots of 10 Units (4) or placebo (4). None of the geriatric DYSPORT subjects were a treatment success at maximum frown at Day 30. Reference ID: 5248437 24

Spasticity in Adults

Upper Limb Spasticity

The efficacy and safety of DYSPORT for the treatment of upper limb spasticity in adults was evaluated in a randomized, multicenter, double-blind, placebo-controlled study that included 238 patients (159 DYSPORT and 79 placebo) with upper limb spasticity(Modified Ashworth Scale (MAS) score ≥2 in the primary targeted muscle group for toxin-naive patients or MAS score ≥3 in the primary targeted muscle group for toxin non-naive patients at least 4 months after the last botulinum toxin injection, of any serotype) who were at least 6 months post-stroke or post-traumatic brain injury. The median age of the patients in this study was 55 years(range 18 to 78 years), 64% were male, and 86% were Caucasian.

DYSPORT 500 Units (N=80), DYSPORT 1000 Units (N=79), or placebo (N=79) was injected intramuscularly into the affected upper limb muscles. After injection of the primary targeted muscle groups (PTMG), the remainder of the dose was injected into at least two additional upper limb muscles determined by the patient’s individual presentation. Table 20 provides the mean and range of DYSPORT doses injected and the number of injections into specific muscles of the upper limb.

The co-primary efficacy variables were muscle tone assessed by the MAS at the primary targeted muscle group at Week 4 and the Physician Global Assessment (PGA; ranges from –4 = markedly worse to +4= markedly improved) at Week 4.

Lower Limb Spasticity The efficacy of DYSPORT for the treatment of lower limb spasticity was evaluated in a randomized, multicenter, double-blind, placebo-controlled study that included 381 patients (253 DYSPORT and 128 placebo). Patients had lower limb spasticity (Modified Ashworth Scale (MAS) score ≥2 in the affected ankle joint for toxin-naive patients, or MAS score ≥3 in the affected ankle joint for toxin non-naive patients) and were at least 6 months post-stroke or post-traumatic brain injury.

The primary efficacy variable was muscle tone assessed by the MAS at the ankle joint at Week 4. The first secondary endpoint was the Physician Global Assessment at Week 4.

Spasticity in Pediatric Patients

Upper Limb Spasticity in Pediatric Patients The efficacy of DYSPORT for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age was evaluated in a double-blind, low-dose controlled, multicenter study (NCT02106351). A total of 208 patients with spasticity because of cerebral palsy who were toxin naive or non-naive (66% had prior treatment with a botulinum toxin), weighed at least 10 kgs, and had a baseline Modified Ashworth Score (MAS) of grade 2 or greater (99% patients) at the primary targeted muscle groups (PTMG) were enrolled in the modified Intention to Treat population (mITT). Patients received DYSPORT 16 Units/kg (n=70), DYSPORT 8 Units/kg (n=69), or DYSPORT 2 Units/kg (n=69) injected into the upper limb.

Lower Limb Spasticity in Pediatric Patients The efficacy of DYSPORT for the treatment of lower limb spasticity in patients 2 to 17 years of age was evaluated in a double-blind,placebo-controlled, multicenter study . A total of 235 patients with cerebral palsy causing dynamic equinus foot deformity who were toxin-naive or non-naive and had a Modified Ashworth Score (MAS) of grade 2 or greater at the ankle plantar flexors were enrolled. Patients received DYSPORT 10 Units/kg/leg (n=79), DYSPORT 15 Units/kg/leg (n=79) or placebo (n=77) injected into the gastrocnemius and soleus muscles (see Table 27). Forty-one percent of patients (n=66) were treated bilaterally and received a total lower limb DYSPORT dose of either 20 Units/kg (n=37) or 30 Units/kg (n=29). The median age of the patients in this study was 5 years (range 2 to 17 years); 60% of patients were male, and 73% were Caucasian.

The primary efficacy endpoint was the mean change from baseline in MAS in ankle plantar flexor at Week 4; a co-primary endpoint was the mean Physician’s Global Assessment (PGA) score at Week 4 (see Table 26).

the PTMG in 57% and in 43% of patients. The median age of the patients in this study was 9 years (range 2 to 17 years; 57% were between 2 and 9 years of age); 60% of patients were male, and 75% were White. The primary efficacy endpoint was the mean change from baseline in MAS in the PTMG at Week 6 (see Table 24). The secondary efficacy endpoint was the mean Physician Global Assessment (PGA) score assessed at Week 6 (Table 25). Although PGA scores numerically favored DYSPORT treatment over the low-dose control, the difference was not statistically significant.

How Supplied

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

Storage

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.

Images

Drug Images

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Package and Label Display Panel

Manufactured by: Ipsen Biopharm Ltd. Wrexham, LL13 9UF, UK U.S. License No. 1787

Distributed by: Ipsen Biopharmaceuticals, Inc. Cambridge, MA 02142 and Galderma Laboratories, L.P. Dallas, TX 75201 USA

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Patient 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.

• Dry Eye with the Treatment of Glabellar Lines

Inform patients that DYSPORT injection may cause eye dryness. 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.

Precautions with Alcohol

Alcohol-AbobotulinumtoxinA interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding AbobotulinumtoxinA Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding AbobotulinumtoxinA Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.