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Dysport

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Dysport




Side Effects
Interactions

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 Dysport (abobotulinumtoxin a injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No formal drug interaction studies have been conducted with DYSPORT®.

Patients treated concomitantly with botulinum toxins and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents) should be observed closely because the effect of the botulinum toxin may be potentiated. Use of anticholinergic drugs after administration of DYSPORT® may potentiate systemic anticholinergic effects such as blurred vision.

The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive weakness may be exacerbated by another administration of botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of DYSPORT®.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/17/2016

Side Effects
Interactions

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.


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