July 28, 2016
Recommended Topic Related To:

Dysport

"Feb. 8, 2011 -- Facelifts, breast augmentations, tummy tucks, and other cosmetic plastic surgery procedures have rebounded sharply along with an uptick in the U.S. economy, according to a new report.

The American Society of Plastic Su"...

A A A

Dysport




Dysport Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Dysport for Injection (abobotulinumtoxinA), also called botulinum toxin type A, is made from the bacteria that causes botulism and is used to treat cervical dystonia (severe spasms in the neck muscles). It is also used to temporarily lessen the appearance of facial wrinkles. Common side effects include muscle weakness near where the medicine was injected; bruising, bleeding, pain, redness, or swelling where the injection was given; headache, muscle pain or stiffness, neck or back pain, fever, cough, sore throat, runny nose, flu symptoms, dizziness, drowsiness, tired feeling, nausea, diarrhea, stomach pain, loss of appetite, dry mouth, dry eyes, ringing in your ears, increased sweating in areas other than the underarms, itchy or watery eyes, increased sensitivity to light, or eyelid swelling or bruising.

The recommended initial dose of Dysport for the treatment of cervical dystonia is 500 Units given intramuscularly as a divided dose among affected muscles. The dose of Dysport for the treatment of glabellar lines (the vertical lines between the eyebrows) is 50 Units given intramuscularly in five equal aliquots of 10 Units each to achieve clinical effect. Dysport may interact with cold or allergy medicines, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, irritable bowel medicines, or injected antibiotics. Tell your doctor all medications and supplements you use. During pregnancy, Dysport should be used only if prescribed. It is unknown if Dysport passes into breast milk. Consult your doctor before breastfeeding.

Our Dysport for Injection (abobotulinumtoxinA) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Dysport in Detail - Patient Information: Side Effects

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 injection:

  • trouble breathing, talking, or swallowing;
  • hoarse voice, drooping eyelids;
  • problems with vision;
  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
  • loss of bladder control;
  • crusting or drainage from your eyes;
  • severe skin rash or itching;
  • fast, slow, or uneven heartbeats; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious side effects may include:

  • muscle weakness near where the medicine was injected;
  • bruising, bleeding, pain, redness, or swelling where the injection was given;
  • headache, muscle pain or stiffness, neck or back pain;
  • fever, cough, sore throat, runny nose, flu symptoms,
  • dizziness, drowsiness, tired feeling;
  • nausea, diarrhea, stomach pain, loss of appetite;
  • dry mouth, dry eyes, ringing in your ears;
  • increased sweating in areas other than the underarms;
  • itchy or watery eyes, increased sensitivity to light; or
  • eyelid swelling or bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dysport (Abobotulinumtoxin A Injection)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Dysport FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed below and elsewhere in labeling:

Clinical 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.

Cervical Dystonia

The data described below reflect exposure to DYSPORT® in 357 cervical dystonia patients in 6 studies. Of these, two studies were randomized, double-blind, single treatment, placebo controlled studies with subsequent optional open label treatment in which dose optimization (250 to 1000 Units per treatment) over the course of 5 treatment cycles was allowed.

The population was almost entirely Caucasian (99%) with a median age of 51 years (range 18-82 years). Most patients (87%) were less than 65 years of age; 58.4% were women.

Common Adverse Reactions

The most commonly reported adverse reactions (occurring in more than 5% of patients who received 500 Units of DYSPORT® in the placebo controlled clinical trials) in cervical dystonia patients were: muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, and eye disorders (consisting of blurred vision, diplopia, and reduced visual acuity and accommodation). Other than injection site reactions, most adverse reactions became noticeable about one week after treatment and lasted several weeks.

The rates of adverse reactions were higher in the combined controlled and open-label experience than in the placebo-controlled trials. During the clinical studies, two patients ( < 1%) experienced adverse reactions leading to withdrawal. One patient experienced disturbance in attention, eyelid disorder, feeling abnormal and headache, and one patient experienced dysphagia.

Table 3 compares the incidence of the most frequent adverse reactions from a single treatment cycle of 500 Units of DYSPORT® compared to placebo [see Clinical Studies].

Table 3: Most Common Adverse Reactions (>5%) and Greater than Placebo in the Pooled, Double-blind Phase of Clinical Trials in Patients with Cervical Dystonia

Adverse Reaction Preferred Term DYSPORT® 500 Units
(N=173) %
Placebo
(N=182) %
Any Adverse Reaction 61 51
General disorders and administration site conditions 30 23
  Injection site discomfort 13 8
  Fatigue 12 10
  Injection site pain 5 4
Musculoskeletal and connective tissue disorders 30 18
  Muscular weakness 16 4
  Musculoskeletal pain 7 3
Gastrointestinal disorders 28 15
  Dysphagia 15 4
  Dry mouth 13 7
Nervous system disorders 16 13
  Headache 11 9
  Infections and infestations 13 9
Respiratory, thoracic and mediastinal disorders 12 8
  Dysphonia 6 2
Eye Disordersa 7 2
a The following preferred terms were reported: vision blurred, diplopia, visual acuity reduced, eye pain, eyelid disorder, accommodation disorder, dry eye, eye pruritus.

Dose-response relationships for common adverse reactions in a randomized multiple fixed-dose study in which the total dose was divided between two muscles (the sternocleidomastoid and splenius capitis) are shown in Table 4.

Table 4: Common Adverse Reactions by Dose in Fixed-dose Study in Patients with Cervical Dystonia

Adverse Reaction Preferred Term DYSPORT® Dose
Placebo 250 Units 500 Units 1000 Units
Any Adverse Event 30% 37% 65% 83%
  Dysphagia 5% 21% 29% 39%
  Dry Mouth 10% 21% 18% 39%
  Muscular Weakness 0% 11% 12% 56%
  Injection Site Discomfort 10% 5% 18% 22%
  Dysphonia 0% 0% 18% 28%
  Facial Paresis 0% 5% 0% 11%
  Eye Disordersa 0% 0% 6% 17%
a The following preferred terms were reported: vision blurred, diplopia, visual acuity reduced, eye pain, eyelid disorder, accommodation disorder, dry eye, eye pruritus.

Injection Site Reactions

Injection site discomfort and injection site pain were common adverse reactions following DYSPORT® administration.

Less Common Adverse Reactions

The following adverse reactions were reported less frequently ( < 5%).

Breathing Difficulty

Breathing difficulties were reported by approximately 3% of patients following DYSPORT® administration and in 1% of placebo patients in clinical trials during the double-blind phase. These consisted mainly of dyspnea. The median time to onset from last dose of DYSPORT® was approximately one week, and the median duration was approximately three weeks.

Other adverse reactions with incidences of less than 5% in the DYSPORT® 500 Units group in the double-blind phase of clinical trials included dizziness in 3.5% of DYSPORT®-treated patients and 1% of placebo-treated patients, and muscle atrophy in 1% of DYSPORT®-treated patients and in none of the placebo-treated patients.

Laboratory Findings

Patients treated with DYSPORT® exhibited a small increase from baseline (0.23 mol/L) in mean blood glucose relative to placebo- treated patients. This was not clinically significant among patients in the development program but could be a factor in patients whose diabetes is difficult to control.

Electrocardiographic Findings

ECG measurements were only recorded in a limited number of patients in an open-label study without a placebo or active control. This study showed a statistically significant reduction in heart rate compared to baseline, averaging about three beats per minute, observed thirty minutes after injection.

Glabellar Lines

In placebo-controlled clinical trials of DYSPORT®, the most common adverse reactions( ≥ 2%) following injection of DYSPORT® were nasopharyngitis, headache, injection site pain, injection site reaction, upper respiratory tract infection, eyelid edema, eyelid ptosis, sinusitis, and nausea.

Table 5 reflects exposure to DYSPORT® in 398 patients 19 to 75 years of age who were evaluated in the randomized, placebo- controlled clinical studies that assessed the use of DYSPORT® for the temporary improvement in the appearance of glabellar lines [see Clinical Studies]. Adverse reactions of any cause occurred in 48% of the DYSPORT®-treated patients and 33% of the placebo- treated patients.

Table 5: Most Common Adverse Reactions with > 1% Incidence in Pooled, Placebo-Controlled Trials for Glabellar Lines

Adverse Reactions by Body System DYSPORT®
n=398 (%)*
Placebo
n=496 (%)*
Any Adverse Reaction 48 33
Eye Disorders
  Eyelid Edema 2 0
  Eyelid Ptosis 2 < 1
Gastrointestinal Disorders
  Nausea 2 1
General Disorders and Administration Site Conditions
  Injection Site Pain 3 2
  Injection Site Reaction 3 < 1
Infections and Infestations
  Nasopharyngitis 10 4
  Upper Respiratory Tract Infection 3 2
  Sinusitis 2 1
Investigations
  Blood Present in Urine 2 < 1
Nervous System Disorders
  Headache 9 5
* Patients who received treatment with placebo and DYSPORT® are counted in both treatment columns.

In the overall safety database, where some patients received up to twelve treatments with DYSPORT®, adverse reactions were reported for 57% (1425/2491) of patients. The most frequently reported of these adverse reactions were headache, nasopharyngitis, injection site pain, sinusitis, URI, injection site bruising, and injection site reaction (numbness, discomfort, erythema, tenderness, tingling, itching, stinging, warmth, irritation, tightness, swelling).

Adverse reactions that occurred after repeated injections in 2-3% of the population included bronchitis, influenza, pharyngolaryngeal pain, cough, contact dermatitis, injection site swelling, and injection site discomfort.

The incidence of eyelid ptosis did not increase in the long-term safety studies with multiple re-treatments at intervals ≥ three months. The majority of the reports of eyelid ptosis were mild to moderate in severity and resolved over several weeks. [see DOSAGE AND ADMINISTRATION].

Upper Limb Spasticity

Table 6 lists the most frequently reported adverse reactions ( ≥ 2%) in any DYSPORT® dose group and more frequent than placebo in double blind studies evaluating the treatment of upper limb spasticity in adults with DYSPORT®.

Table 6: Most Common Adverse Reactions Observed in at Least 2% of Patients Treated in Pooled, Double-Blind Trials of Patients with Upper Limb Spasticity Reported More Frequently than with Placebo

Adverse Reaction Preferred Term DYSPORT® Placebo
(N=279)%
500 Units
(N=197)%
1000 Units
(N=194)%
Infections and infestations
  Nasopharyngitis 4 1 1
  Urinary tract infection 3 1 2
  Influenza 1 2 1
  Infection 1 2 1
Musculoskeletal and connective tissue disorders
  Muscular weakness 2 4 1
  Pain in extremity 0 2 1
  Musculoskeletal pain 3 2 2
  Back pain 1 2 1
Nervous system disorders
  Headache 1 2 1
  Dizziness 3 1 1
  Convulsion 2 2 1
  Syncope 1 2 0
  Hypoaesthesia 0 2 < 1
  Partial seizures 0 2 0
General disorders and administration site conditions
  Fatigue 2 2 0
  Asthenia 2 1 < 1
Injury, poisoning and procedural complications
  Fall 2 3 2
  Injury 2 2 1
  Contusion 1 2 < 1
Gastrointestinal disorders
  Diarrhea 1 2 < 1
  Nausea 2 1 1
  Constipation 0 2 1
Investigation
  Blood triglycerides increased 2 1 0
Respiratory, thoracic and mediastinal disorders
  Cough 1 2 1
Vascular disorders
  Hypertension 1 2 < 1
Psychiatric disorders
  Depression 2 3 1

Injection Site Reactions

Injection site reactions (e.g. pain, bruising, haemorrhage, injection site erythema/haematoma etc.) have occurred following administration of DYSPORT®.

Less Common Adverse Reactions

In a pooled analysis of clinical studies, adverse reactions with an incidence of less than 2% reported in DYSPORT® treatment groups included dysphagia 0.5%, gait disturbance 0.5%, hypertonia 0.5%, and sensation of heaviness 0.3%.

Postmarketing 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.

The following adverse reactions have been identified during post-approval use of DYSPORT®: vertigo, photophobia, influenza-like illness, amyotrophy, burning sensation, facial paresis, hypoesthesia, erythema, and excessive granulation tissue.

Immunogenicity

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.

Cervical Dystonia

About 3% of subjects developed antibodies (binding or neutralizing) over time with DYSPORT® treatment.

Glabellar Lines

Testing for antibodies to DYSPORT® was performed for 1554 subjects who had up to nine cycles of treatment. Two subjects (0.13%) tested positive for binding antibodies at baseline. Three additional subjects tested positive for binding antibodies after receiving DYSPORT® treatment. None of the subjects tested positive for neutralizing antibodies.

Upper Limb Spasticity

From 230 subjects treated with DYSPORT® and tested for the presence of binding antibodies, 5 subjects were positive at baseline and 17 developed antibodies after treatment. Among those 17 subjects, 10 subjects developed neutralizing antibodies. An additional 51 subjects from a separate repeat dose study were tested for the presence of neutralizing antibodies only. None of the subjects tested positive.

In total, from the 281 subjects treated in the long-term studies and tested for the presence of neutralizing antibodies, 3.6% developed neutralizing antibodies after treatment.

In the presence of binding and neutralizing antibodies to DYSPORT® some patients continue to experience clinical benefit.

Read the entire FDA prescribing information for Dysport (Abobotulinumtoxin A Injection)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Health Resources
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations