(aye bo BOT yoo lin num TOKS in aye)
- Botulinum Toxin Type A
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Intramuscular:
Dysport: 300 units (1 ea); 500 units (1 ea) [contains albumin human, milk protein]
Dysport (Glabellar Lines): 300 units (1 ea [DSC]) [contains albumin human, milk protein]
Brand Names: U.S.
- Dysport (Glabellar Lines) [DSC]
- Neuromuscular Blocker Agent, Toxin
AbobotulinumtoxinA (previously known as botulinum toxin type A) is a neurotoxin produced by Clostridium botulinum, spore-forming anaerobic bacillus, which appears to affect only the presynaptic membrane of the neuromuscular junction in humans, where it prevents calcium-dependent release of acetylcholine and produces a state of denervation. Muscle inactivation persists until new fibrils grow from the nerve and form junction plates on new areas of the muscle-cell walls.
Not expected to be present in peripheral blood at recommended doses following intramuscular (IM) injection
Onset of Action
Peak effect: Cervical dystonia: 2 to 4 weeks; Upper limb spasticity: 1 week
Duration of Action
Cervical dystonia, glabellar lines: ≥4 months; Lower limb spasticity: ≥5 ½ months; Upper limb spasticity: ≥5 months
Use: Labeled Indications
Cervical dystonia: Treatment of adults with cervical dystonia.
Glabellar lines: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adults <65 years.
Lower limb spasticity: Treatment of lower limb spasticity in pediatric patients ≥2 years.
Spasticity: Treatment of spasticity in adults.
Off Label Uses
Botulinum toxin type A has been found to be objectively and subjectively effective in treating acquired nystagmus and its consequent oscillopsia and impaired vision in a few small case series and case reports. Botulinum toxin type A may be useful in certain patients who have contraindications to other therapies, but it cannot be recommended for routine symptomatic treatment of acquired nystagmus until data from controlled studies enrolling larger numbers of patients can confirm its efficacy and long-term safety.
Evidence-based guidelines recommend botulinum toxin A IM injection as an option for the treatment of anal fissures in adults who have not responded to preferred therapy. Healing rates do not appear to be affected by dose, formulation, or injection technique, although using an anterior injection location for posterior anal fissures may provide benefit over usual posterior administration. It is important to note that botulinum toxin A formulations are not interchangeable.
Botulinum toxin is safe and effective for the majority of patients with primary dystonia of the hand and has been recommended for consideration for this use by the European Federation of Neurological Societies/Movement Disorder Society-European Section Task Force. Other drug therapies are generally not effective and produce intolerable adverse effects. Larger controlled trials are needed to document optimal dosing, administration techniques, frequency of repeat treatments, and effects of long-term use. Treatment is rarely continued beyond 2 years.
Sialorrhea (drooling) (adults)
The use of botulinum toxin A for decreasing or controlling sialorrhea has demonstrated benefit in randomized controlled trials and meta-analyses in patients with various neurological conditions. EFNS guidelines on the clinical management of ALS recommend botulinum toxin A in patients refractory to first-line therapy. An AAN report classifies botulinum toxin A as probably safe and effective in Parkinson-related sialorrhea. Additional study is needed to determine the expected duration of response, potential candidates, optimal dosing regimens, and standardization of injection procedures.
Spasticity of cerebral palsy (children/adolescents)
Data in children are conflicting. The duration of response is typically 3 to 4 months, and some experts recommend dosing no more frequently than every 3 months. Because the different formulations of botulinum toxin type A are not bioequivalent, caution should be exercised in determining the appropriate dose. The potential for severe generalized weakness should also be considered.
Evidence from small, noncontrolled trials suggests some benefit with botulinum toxin A for treatment of localized tardive dyskinesia (eg, orofacial, head and neck, cervical). Evaluation of data is limited because several studies do not specify what botulinum toxin type A product was used. Use of abobotulinumtoxinA has been evaluated primarily in small noncontrolled trials and case reports demonstrating benefit in most patients. AAN clinical practice guidelines find the data inadequate to support or refute the use of botulinum toxin type A for treatment of tardive dyskinesia.
Known hypersensitivity (eg, anaphylaxis) to botulinum toxin or any component of the formulation, including cow milk protein; infection at the proposed injection site(s)
Cervical dystonia: IM: Initial: 500 units divided among affected muscles in toxin-naïve or toxin-experienced patients. May re-treat at intervals of ≥12 weeks
Dosage adjustments: Adjust dosage in 250-unit increments; do not administer at intervals <12 weeks; dosage range used in studies: 250 to 1,000 units
Glabellar lines: Adults <65 years: IM: Inject 10 units into each of 5 sites (2 injections in each corrugator muscle and 1 injection in the procerus muscle) for a total dose of 50 units; do not administer at intervals <3 months; efficacy has been demonstrated with up to 4 repeated administrations
Spasticity: IM: Individualize dose based on patient size, number and location of muscle involvement, severity of spasticity, local muscle weakness, response to prior treatment, and/or adverse reaction history. May repeat therapy at intervals ≥12 weeks; in clinical studies, the majority of patients were re-treated between 12 to 16 weeks; however, some patients had a longer duration of response (eg, 20 weeks). For upper limb spasticity, total doses of 500 and 1,000 units divided among selected muscles were used in clinical trials. For lower limb spasticity, total doses of 1,000 and 1,500 units divided among selected muscles were used in clinical trials. The maximum recommended total dose (upper and lower limbs combined) is 1,500 units.
Brachialis: 200 to 400 units (1 to 2 injections per muscle)
Brachioradialis: 100 to 200 units (1 to 2 injections per muscle)
Biceps brachii: 200 to 400 units (1 to 2 injections per muscle)
Flexor carpi radialis: 100 to 200 units (1 to 2 injections per muscle)
Flexor carpi ulnaris: 100 to 200 units (1 to 2 injections per muscle)
Flexor digitorum profundus: 100 to 200 units (1 to 2 injections per muscle)
Flexor digitorum superficialis: 100 to 200 units (1 to 2 injections per muscle)
Pronator teres: 100 to 200 units (1 injection per muscle)
Flexor digitorum longus: 130 to 200 units (1 to 2 injections per muscle)
Flexor halluces longus: 70 to 200 units (1 injection per muscle)
Gastrocnemius, medial head: 100 to 150 units (1 injection per muscle)
Gastrocnemius, lateral head: 100 to 150 units (1 injection per muscle)
Soleus: 330 to 500 units (3 injections per muscle)
Tibialis posterior: 200 to 300 units (2 injections per muscle)
Anal fissure (off-label use): IM: 90 to 150 units in 2 divided doses injected into the internal anal sphincter on each side of the anterior midline (Brasinda 2004; Yiannakopoulou 2012)
Sialorrhea (off-label use): Intraglandular (Ventral) (off-label route): 15 to 75 units injected per gland (submandibular, parotid or both) either unilaterally or bilaterally with intervals of 4 to 6 months between treatments (Reddihough 2010; Vashishta 2010).
Tardive dyskinesia (off-label use): IM: 20 to 50 units injected per site (total dosage range: 80 to 100 units). Dose, duration, and number of injections are dependent on muscle size and severity (Hennings 2008; Rapaport 2000). Subsequent doses up to 80 units have been used in order to find the optimum dosage (Slotema 2008). Additional data may be necessary to further define the role of abobotulinumtoxinA in the treatment of this condition.
Cervical dystonia: Refer to adult dosing. No specific adjustment recommended.
Glabellar lines: Not recommended in patients ≥65 years of age.
Spasticity: Refer to adult dosing.
Lower limb spasticity: Children ≥2 years and Adolescents: IM: Individualize dose based on patient size, number and location of muscles involved, severity of spasticity, local muscle weakness, response to prior treatment and/or adverse reaction history. May repeat therapy at intervals ≥12 weeks; in clinical studies, the majority of patients were re-treated between 16 to 22 weeks; however, some patients had a longer duration of response.
Total dose per treatment session: 10 to 15 units/kg per limb. Maximum total dose per treatment session: 15 units/kg for unilateral injections, 30 units/kg for bilateral injections, or 1,000 units, whichever is less. Divide total dose administered between the affected muscles; distribute dose across >1 injection site in any single muscle if possible; do not administer >0.5 mL in any single injection site. Recommended dose range per muscle per limb:
Gastrocnemius: 6 to 9 units/kg (up to 4 injections per muscle per limb)
Soleus: 4 to 6 units/kg (up to 2 injections per muscle per limb)
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely as abobotulinumtoxin A is not expected to be present in peripheral blood at recommended doses following intramuscular (IM) injection.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely as abobotulinumtoxin A is not expected to be present in peripheral blood at recommended doses following intramuscular (IM) injection.
Reconstitute with sterile, preservative free 0.9% sodium chloride. No more than 2.5 mL of diluent should be introduced into the vial. Swirl gently to dissolve; do not shake. Preparation instructions vary by indication and strength; use appropriate reconstitution methods. Use immediately after reconstitution in the syringe.
Cervical dystonia: Reconstitute 300-unit vial with 0.6 mL of diluent to obtain a concentration of 500 units/mL (50 units per 0.1 mL); reconstitute 500-unit vial with 1 mL of diluent to obtain a concentration of 500 units/mL (50 units per 0.1 mL); alternatively, may reconstitute 500-unit vial with 2 mL of diluent to obtain a concentration of 250 units/mL (25 units per 0.1 mL).
Glabellar lines: Reconstitute 300-unit vial with 2.5 mL of diluent to obtain a concentration of 10 units per 0.08 mL (12 units per 0.1 mL); alternatively, may reconstitute 300-unit vial with 1.5 mL of diluent to obtain a concentration of 10 units per 0.05 mL (20 units per 0.1 mL).
Lower limb spasticity:
Adults: Reconstitute 300-unit vial with 1.5 mL of diluent or 500-unit vial with 2.5 mL of diluent to obtain a concentration of 200 units/mL; or reconstitute 300-unit vial with 3 mL of diluent to obtain a concentration of 100 units/mL Alternatively, the 500-unit vial can be further diluted to obtain a concentration of 100 units/mL. To do this, reconstitute the 500-unit vial with 5 mL of diluent. Using a 5 mL syringe, draw up an additional 2.5 mL of the diluent; then draw up 2.5 mL of the reconstituted solution. Do not invert; mix gently.
Pediatrics (2 years and older): Reconstitute 300-unit vial with 1.5 mL of diluent or 500-unit vial with 2.5 mL of diluent to obtain a concentration of 200 units/mL. Further dilution may be required to achieve the final volume for injection.
Upper limb spasticity: Reconstitute 300-unit vial with 1.5 mL of diluent to obtain a concentration of 200 units/mL; or reconstitute 300-unit vial with 3 mL diluent to obtain a concentration of 100 units/mL. Reconstitute the 500-unit vial with 2.5 mL of diluent to obtain a concentration of 200 units/mL. Alternatively, the 500-unit vial can be further diluted to obtain a concentration of 100 units/mL. To do this, reconstitute the 500-unit vial with 5 mL of diluent. Using a 5 mL syringe, draw up an additional 2.5 mL of the diluent; then draw up 2.5 mL of the reconstituted solution. Do not invert; mix gently.
Cervical dystonia: Use an appropriately sized gauge needle to administer intramuscularly. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Simultaneous EMG-guided application may be helpful in locating active muscle not identified by physical examination alone.
Glabellar lines: Use a 30-gauge needle to administer intramuscularly. Apply pressure on the superior medial orbital rim, and inject into each of 5 sites (2 injections in each corrugator muscle and 1 in the procerus muscle). Ensure injected volume/dose is accurate and where feasible keep to a minimum. Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Medial corrugator injections should be at least 1 cm above the bony supraorbital ridge. Do not inject toxin closer than 1 cm above the central eyebrow.
Spasticity (upper or lower limb): Use an appropriately sized sterile syringe and needle to administer intramuscularly. Although actual location of the injection sites can be determined by palpation, the use of an injection guiding technique (eg, electromyography or electrical stimulation) is recommended to target the injection sites. Do not administer >0.5 mL for pediatric patients (lower limb spasticity) or >1 mL for adult patients (upper or lower limb spasticity) in any single injection site.
Contains lactose; patients allergic to cow's milk protein should not receive product.
Store undiluted vials under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light. After reconstitution, store vials in original container under refrigeration, protect from light, and use within 24 hours (does not contain preservative); single-use vials. Do not freeze after reconstitution.
Aminoglycosides: May enhance the neuromuscular-blocking effect of AbobotulinumtoxinA. Monitor therapy
Anticholinergic Agents: May enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Neuromuscular-Blocking Agents: AbobotulinumtoxinA may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
OnabotulinumtoxinA: May enhance the adverse neuromuscular effect of AbobotulinumtoxinA. Monitor therapy
RimabotulinumtoxinB: AbobotulinumtoxinA may enhance the adverse neuromuscular effect of RimabotulinumtoxinB. Monitor therapy
Cervical dystonia: Frequency not always defined.
Cardiovascular: Decreased heart rate
Central nervous system: Voice disorder (≤28%), fatigue (12%), headache (11%), facial paresis (≤11%), dizziness (4%)
Endocrine & metabolic: Increased serum glucose
Gastrointestinal: Dysphagia (15% to 39%), xerostomia (13% to 39%)
Immunologic: Antibody development (binding or neutralizing; 3%)
Infection: Infection (13%)
Local: Discomfort at injection site (13% to 22%), pain at injection site (5%)
Neuromuscular & skeletal: Myasthenia (11% to 56%), musculoskeletal pain (7%), amyotrophy (1%)
Ophthalmic: Eye disease (≤17%; includes accommodation disorder, blurred vision, decreased visual acuity, diplopia, dryness, pain, pruritus)
Respiratory: Dyspnea (3%; onset: ~1 week; duration: ~3 weeks)
Glabellar lines: 1% to 10%:
Central nervous system: Headache (9%)
Dermatologic: Contact dermatitis (2% to 3%)
Gastrointestinal: Nausea (2%)
Genitourinary: Hematuria (2%)
Immunologic: Antibody development (<1%)
Infection: Influenza (2% to 3%)
Local: Pain at injection site (3%), discomfort at injection site (2% to 3%), injection site reaction (2% to 3%), swelling at injection site (2% to 3%)
Ophthalmic: Blepharoptosis (2%), eyelid edema (2%)
Respiratory: Nasopharyngitis (10%), upper respiratory tract infection (3%), bronchitis (2% to 3%), cough (2% to 3%), pharyngolaryngeal pain (2% to 3%), sinusitis (2%)
Upper limb spasticity: Frequency not always defined; as reported with doses of 500 units to 1,000 units.
Cardiovascular: Hypertension (1% to 2%), syncope (1% to 2%)
Central nervous system: Myasthenia (2% to 4%), dizziness (3%), falling (3%), depression (2% to 3%), convulsions (2%), fatigue (2%), headache (2%), hypoesthesia (2%), seizure (partial; ≤2%), abnormal gait (<1%), feeling of heaviness (<1%), hypertonia (<1%)
Endocrine & metabolic: Increased serum triglycerides (1% to 2%)
Gastrointestinal: Constipation (2%), nausea (2%), diarrhea (1% to 2%), dysphagia (<1%)
Genitourinary: Urinary tract infection (3%)
Hematologic & oncologic: Bruise (1% to 2%)
Immunologic Antibody development (7%; neutralizing: ≤4%)
Infection: Infection (2%), influenza (2%)
Local: Injection site reaction
Neuromuscular & skeletal: Musculoskeletal pain (3%), back pain (2%), limb pain (2%), weakness (1% to 2%)
Respiratory: Nasopharyngitis (4%), cough (2%)
Miscellaneous: Accidental injury (2%)
Lower limb spasticity: As reported in children and adolescents.
Infection: Influenza (10% to 14%)
Respiratory: Upper respiratory tract infection (20%), nasopharyngitis (9% to 16%), cough (7% to 14%), pharyngitis (11%)
Miscellaneous: Fever (7% to 12%)
1% to 10%:
Central nervous system: Epilepsy (≤7%), seizure (≤7%), myasthenia (5%)
Gastrointestinal: Vomiting (6% to 8%), nausea (2% to 5%), viral gastroenteritis (2% to 4%)
Immunologic: Antibody development (4%; neutralizing: 2%)
Infection: Varicella (5%)
Neuromuscular & skeletal: Limb pain (7%)
Otic: Otic infection (4%)
Respiratory: Bronchitis (7% to 8%), rhinitis (5%), viral respiratory tract infection (2% to 5%), oropharyngeal pain (2% to 4%)
Any indication: Postmarketing and/or case reports (Limited to important or life-threatening): Burning sensation, connective tissue disease (excessive granulation tissue), erythema, photophobia, vertigo
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions may occur rarely; immediate treatment (including epinephrine 1 mg/mL) should be available.
• Antibody formation: Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy.
• Cardiovascular events: Rarely, arrhythmia and myocardial infarction have been reported with use of onabotulinumtoxinA (another botulinum toxin formulation), sometimes in patients with preexisting cardiovascular disease.
• Dysphagia: Common when used for cervical dystonia and may persist for several weeks after administration. In severe cases, patients may require alternative feeding methods (eg, feeding tube). Risk factors include smaller neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae. Risk of aspiration resulting from severe dysphagia is increased in patients when swallowing is already compromised. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia.
• Systemic toxicity: [US Boxed Warning]: Distant spread of botulinum toxin beyond the site of injection has been reported; dysphagia and breathing difficulties have occurred and may be life threatening; other symptoms reported include asthenia, blurred vision, diplopia, dysarthria, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence which may develop within hours or weeks following injection. Risk likely greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions. Systemic effects have occurred following use in approved and unapproved uses including lower than the maximum recommended total dose. Immediate medical attention required if respiratory, speech, or swallowing difficulties appear.
• Neuromuscular disease: Use with caution in patients with neuromuscular diseases (eg, myasthenia gravis, Eaton-Lambert syndrome) and neuropathic disorders (eg, amyotrophic lateral sclerosis).
• Ocular diseases: Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration when treating blepharospasm. Retrobulbar hemorrhages may occur from needle penetration into orbit when treating strabismus; spatial disorientation, double vision, or past-pointing may occur if one or more extraocular muscles are paralyzed. Covering the affected eye may help. Careful testing of corneal sensation, avoidance of lower lid injections, and treatment of epithelial defects are necessary. Use caution in patients with angle closure glaucoma.
• Respiratory disease: Use extreme caution in patients with preexisting respiratory disease; treatment of cervical dystonia using botulinum toxin may weaken accessory muscles that are necessary for these patients to maintain adequate ventilation. Serious breathing difficulties, including respiratory failure, have been reported. Risk of aspiration resulting from severe dysphagia is increased in patients with decreased respiratory function.
Dosage form specific issues:
• Albumin: Product contains albumin and may carry a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease.
• Lactose: Product may contain lactose; do not administer to patients allergic to cow's milk protein.
• Product interchangeability: Botulinum products (abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) are not interchangeable; potency units are specific to each preparation and cannot be compared or converted to any other botulinum product.
• Elderly: Temporary reduction in glabellar lines: Efficacy was not observed in older adults (≥65 years of age) and an increased frequency of ocular adverse events was reported in older adults compared to younger adults.
• Pediatric: Lower limb spasticity: Safety and effectiveness of injection into proximal muscles of the lower limb have not been established.
• Chronic therapy: Long-term effects of chronic therapy unknown.
• Injection site: Use with caution if there is inflammation or excessive weakness or atrophy at the proposed injection site(s); use is contraindicated if infection is present.
• Hyperhidrosis: Safety in the treatment of hyperhidrosis has not been established. The possibility of an immune reaction resulting from an intradermal injection is unknown.
• Temporary reduction in glabellar lines: Appropriate use: Do not use more frequently than every 3 months. Patients with marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart were excluded from clinical trials. Use with caution in patients with surgical alterations to the facial anatomy. Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration. Spatial disorientation, double vision, or past pointing may occur if one or more extraocular muscles are paralyzed.
Adverse events have been observed in animal reproduction studies.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience injection site irritation, headache, nausea, dizziness, flu-like signs, painful extremities, common cold symptoms, reduced blinking, rhinitis, rhinorrhea, pharyngitis, dry eyes, or dry mouth. Have patient report immediately to prescriber signs of infection, seizures, hematuria, change in voice, difficulty swallowing, difficulty breathing, difficulty speaking, severe muscle pain, muscle weakness, loss of strength and energy, vision changes, eye pain, depression, severe eye irritation, blurred vision, urinary incontinence, diplopia, or drooping eyelids (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.
More about abobotulinumtoxinA
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- Drug class: skeletal muscle relaxants
Other brands: Dysport