Dysport (abobotulinumtoxinA)

Potency of abobotulinumtoxinA is expressed in units of biologic activity; each unit is equivalent to the median intraperitoneal lethal dose (LD50) in mice. Units of biologic activity of abobotulinumtoxinA cannot be compared with or converted to units of other botulinum toxin preparations.

Dosage of abobotulinumtoxinA should be carefully individualized according to patient response and the particular condition being treated. The recommended dosage and frequency of abobotulinumtoxinA should not be exceeded; excessive and/or unintended neuromuscular weakness may occur if higher than recommended dosages are given. Whenever possible, the minimum effective dose should be used to reduce the risk of adverse effects.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies with abobotulinumtoxinA have been performed to date.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Neuromuscular Blocking Agents/General Anesthetics (INHL)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: General anesthetics enhance the pharmacologic effects of nondepolarizing muscle relaxants.

CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects of the nondepolarizing muscle relaxant including respiratory depression, bradycardia, hypotension, flushing, or muscle weakness.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: It may be necessary to decrease the dose of the nondepolarizing muscle relaxant. Monitor neuromuscular function and adjust the dose of the nondepolarizing muscle relaxant accordingly.

DISCUSSION: Concomitant administration of general anesthetics and nondepolarizing muscle relaxants has been shown to produce synergistic neuromuscular blocking effects of nondepolarizing muscle relaxants.

Neuromuscular Blocking Agents/Misc Antibiotics

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Aminoglycosides, bacitracin, clindamycin, lincomycin, and polymyxins may enhance the pharmacologic effects of neuromuscular blocking agents.

CLINICAL EFFECTS: May see an increase in the pharmacologic effects of neuromuscular blocking agents, including prolonged respiratory depression and apnea.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly.

DISCUSSION: Concomitant administration of aminoglycosides, bacitracin, clindamycin, lincomycin, and polymixins with neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and fatal apnea. The interaction usually occurs when the antibiotic is given prior to or concurrently with the neuromuscular blocking drug, but it may also occur when given after administration. Any antibiotic dosage or route of administration may produce respiratory depression.

Neuromuscular Blocking Agents/Quinine Derivatives

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Synergistic or additive pharmacologic activity.

CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Avoid concurrent administration of neuromuscular blocking agents and quinine derivatives during the first several hours of postoperative period. If administered, respiratory support may be needed. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

DISCUSSION: Administration of quinidine during the immediate postoperative period has been associated with respiratory paralysis and apnea.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Neuromuscular Blocking Agents/Lincosamides

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Lincosamides appear to augment the neuromuscular blocking effects of nondepolarizing muscle relaxants.

CLINICAL EFFECTS: The effects of nondepolarizing neuromuscular relaxants may be prolonged leading to profound sedation, respiratory depression, coma, and/or death.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Monitor respiratory function of the patient and provide the necessary support. In patients who have received nondepolarizing muscle relaxants, avoid use of lincosamides in the recovery room. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

DISCUSSION: Lincomycin has been reported to augment the neuromuscular blocking effect of pancuronium in seven anesthetized patients. The effect was readily antagonized by neostigmine administration. In a case report, clindamycin produced prolonged neuromuscular blockade in a patient who had received pancuronium. Neostigmine was ineffective in antagonizing the blockade.

Neuromuscular Blocking Agents/Polypeptide Antibiotics

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Synergistic pharmacologic activity. Polymyxin B affects neuromuscular transmission by blocking acetylcholine receptors. Its action is thus post-synaptic and the neuromuscular block has no antagonists. Polymyxin B causes neostigmine resistance to d-tubocurarine blockade and calcium resistance to the blockade evoked by aminoglycoside antibiotics (1,2,3,4). A pre-synaptic mechanism may also be involved with decreased release of acetylcholine.

CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

DISCUSSION: Concomitant administration of polypeptide antibiotics and neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and apnea. This interaction has been documented with colistimethate, polymyxin B, bacitracin, and vancomycin.

Neuromuscular Blocking Agents/Trimethaphan

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Additive pharmacologic effects.

CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

DISCUSSION: Available data indicate that the neuromuscular blocking effects of tubocurarine and trimethaphan may be additive.

Select Neuromuscular Blocking Agents/Hydantoins

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: It has been suggested that phenytoin increases end-plate anticholinesterase activity, resulting in higher acetylcholine concentration at the neuromuscular junction.(1)

CLINICAL EFFECTS: A higher plasma concentration of the neuromuscular blocking agent was required to effect a given level of neuromuscular blockade in patients receiving phenytoin.(2,3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients receiving hydantoin anticonvulsants should be monitored for a decreased response to the neuromuscular blocking agent. The dose of the neuromuscular blocking agent may need to be increased and/or given more frequently.(9)

DISCUSSION: In a study, patients receiving phenytoin were administered metocurine, attained 83% of maximum neuromuscular blockade compared with 98% in the control group.(1) In another study, patients maintained on phenytoin for more than one week had a significantly higher pancuronium requirement than those patients not receiving phenytoin.(1) In two separate case reports, patients maintained on phenytoin demonstrated a resistance to pancuronium and a decreased duration of neuromuscular blockade.(3,4) In a study, patients maintained on phenytoin and receiving vecuronium had a significantly shorter total duration and effect of neuromuscular blockade compared to those patients not receiving phenytoin.(5) In contrast, neither the effect nor duration of atracurium's neuromuscular blockade was affected by phenytoin.(5) Two in vitro studies showed that the neuromuscular blockade of curare and tubocurarine was potentiated by the use of phenytoin.(6,7) Ten children received a bolus dose of vecuronium 0.15mg/Kg while on phenytoin and showed a significantly increased clearance of vecuronium compared to the control group, 15.1 and 9.0 ml/Kg/min, respectively.(8) In a case report, a 58 year-old male previously stabilized on phenytoin (400 mg daily) was given an injection of vecuronium (8 mg) to induce muscle blockade during bowel surgery. While monitoring the effectiveness of vecuronium only 75% twitch height blockade was noted after seven minutes. The medication, due to its short duration and impaired effectiveness, had to be given more frequently throughout the surgery in order to maintain adequate muscle block.(9) A separate case report records a decreased response to pancuronium in a 15 year-old male, previously stabilized on phenytoin (350 mg daily), while undergoing surgery to remove a parietal tumor. Pancuronium (0.7 mg/kg) was given as a relaxant during the surgery and monitored using the train-of-four method. Intermittent doses of pancuronium (0.17 mg/kg) were given for the first hour of surgery without successful blockade apparent by the return of all four twitches within ten minutes of each dose. A second attempt at muscular blockade was made with continuous infusion atracurium (0.26-0.55 mg/kg/hour) for the duration of the surgery. Only 16 minutes after stopping the infusion, all four twitches were visible.(10)

*Known hypersensitivity to any botulinum toxin preparation or any ingredient in their formulations.

*Known hypersensitivity to cow milk protein.

*Infection at proposed injection site(s).

• Dyspnea
• Respiratory depression

• Amyotrophic lateral sclerosis
• Aspiration pneumonia
• Botulism
• Dysphagia
• Eaton-lambert syndrome
• Muscle weakness
• Myasthenia gravis
• Neuromuscular disease
• Peripheral motor neuropathy
• Urinary incontinence

• Blepharoptosis
• Blurred vision
• Bradycardia
• Diabetes mellitus
• Dysarthria
• Hoarseness
• Polyopia
• Predisposition to aspiration

Adverse effects reported in at least 5% of adult patients receiving 500 units of abobotulinumtoxinA for the treatment of cervical dystonia (and more frequently than with placebo) in clinical trials included muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, and eye disorders (blurred vision, diplopia, reduced visual acuity and accommodation).

Adverse effects reported in at least 2% of adult patients receiving abobotulinumtoxinA for cosmetic improvement of glabellar facial lines in placebo-controlled clinical trials included nasopharyngitis, headache, injection site pain, injection site reaction, upper respiratory tract infection, eyelid edema, ptosis, sinusitis, nausea, and hematuria. No evidence of cumulative adverse effects has been observed with repeated administration of abobotulinumtoxinA (with at least 85 days between treatments).

The most common adverse effect reported in at least 4% of adults receiving abobotulinumtoxinA for the treatment of upper limb spasticity was muscular weakness. The most common adverse effects reported in at least 5% of adults receiving abobotulinumtoxinA for the treatment of lower limb spasticity were falls, muscular weakness, and pain in extremity.

The most common adverse effects reported in at least 10% of pediatric patients receiving abobotulinumtoxinA for the treatment of upper limb spasticity were upper respiratory tract infection and pharyngitis.

The most common adverse effects reported in at least 10% of pediatric patients receiving abobotulinumtoxinA for the treatment of lower limb spasticity were nasopharyngitis, cough, and pyrexia.

More Frequent

• Dysphagia
• Lagophthalmos
• Muscle weakness
• Voice change

Less Frequent

• Diplopia
• Fever
• Infection

Rare or Very Rare

• Acute myocardial infarction
• Acute respiratory distress syndrome
• Anaphylaxis
• Aspiration pneumonia
• Atrioventricular block
• Botulism
• Brachial plexus disorder
• Cardiac arrhythmia
• Corneal ulcer
• Dysarthria
• Dyspnea
• Entropion
• Erythema
• Erythema multiforme
• Hearing loss
• Hematoma
• Hypersensitivity drug reaction
• Keratitis
• Muscle atrophy
• Pneumonia
• Respiratory depression
• Seizure disorder
• Serum sickness
• Urinary incontinence

More Frequent

• Back pain
• Blepharoptosis
• Bronchitis
• Cough
• Dysuria
• Ecchymosis
• Eyelid edema
• Fatigue
• Headache disorder
• Influenza
• Injection site infection
• Injection site sequelae
• Nausea
• Neck pain
• Ocular irritation
• Pharyngitis
• Rhinitis
• Upper respiratory infection
• Urinary retention
• Urinary tract infection
• Xerostomia

Less Frequent

• Pruritus of skin
• Skin rash
• Visual changes

Rare or Very Rare

• Acute abdominal pain
• Alopecia
• Anorexia
• Arthralgia
• Blurred vision
• Chest pain
• Diarrhea
• Dizziness
• Dry eye
• Edema
• Excessive granulation tissue
• Eyes vertical deviation
• Facial palsy
• Flu-like symptoms
• Gait abnormality
• General weakness
• Heavy feeling
• Hematuria
• Hyperhidrosis
• Hypertonia
• Hypoesthesia
• Madarosis of eyelid
• Malaise
• Muscle fasciculation
• Musculoskeletal pain
• Myalgia
• Paresthesia
• Peripheral neuropathy
• Photophobia
• Psoriasiform eruption
• Retrobulbar hemorrhage
• Sinusitis
• Stinging of skin
• Strabismus
• Symptoms of anxiety
• Syncope
• Tinnitus
• Urticaria
• Vertigo
• Vomiting

No enhanced messaging available.

Safety and efficacy of abobotulinumtoxinA for the treatment of cervical dystonia have not been established in pediatric patients younger than 18 years of age.

Safety and efficacy of abobotulinumtoxinA for the treatment of upper and lower limb spasticity have been established in pediatric patients 2 years of age and older. Safety and efficacy of abobotulinumtoxinA injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients have not been established.

The manufacturer states that use of abobotulinumtoxinA is not recommended for cosmetic improvement of glabellar facial lines in pediatric patients younger than 18 years of age.

There are no adequate and well-controlled clinical studies of abobotulinumtoxinA in pregnant women. In animal reproductive studies, embryofetal toxic effects (e.g., early embryonic death, stillbirth) in relation to maternal toxicity were observed in rats and rabbits treated with abobotulinumtoxinA at dosages lower than or similar to the maximum recommended human dose. AbobotulinumtoxinA should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Data on the presence of abobotulinumtoxinA in human milk, the effects on the breastfed infant, or the effects of the drug on milk production are lacking. The benefits of breastfeeding should be considered along with the mother's clinical need for abobotulinumtoxinA and any potential adverse effects on the breastfed infant from abobotulinumtoxinA or from the underlying maternal condition.

Clinical studies of abobotulinumtoxinA in patients with cervical dystonia did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. In general, dosage should be selected cautiously in geriatric patients, usually initiating therapy at the low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.

A higher incidence of adverse ocular effects (except ptosis) has been observed in geriatric individuals receiving abobotulinumtoxinA for cosmesis compared with younger adults (11 versus 5%). In clinical studies of abobotulinumtoxinA in individuals with glabellar facial lines, 1% of individuals enrolled were 65 years of age or older; treatment success was not achieved in any of these individuals. AbobotulinumtoxinA is not indicated for use in individuals 65 years of age or older for cosmetic improvement of glabellar lines.

In clinical studies evaluating abobotulinumtoxinA for the treatment of upper limb spasticity, 30% of patients were 65 years of age and older, while 8% of patients were 75 years of age and older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients, and other clinical experience revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.

In clinical studies evaluating abobotulinumtoxinA for the treatment of lower limb spasticity, 18% of patients were 65 years of age and older, while 3% of patients were 75 years of age and older. A higher incidence of adverse effects has been observed in geriatric individuals receiving abobotulinumtoxinA for lower limb spasticity compared with that in younger adults (46 versus 39%). Fall and asthenia occurred more frequently in older patients (65 years of age or older) as compared with younger patients.