Class: Botulinum toxin
- Injection, lyophilized powder for solution 300 units
- Injection, lyophilized powder for solution 500 units
Blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings.
Not expected to be present in peripheral blood at measurable levels following IM injection at recommended doses.
Indications and Usage
Treatment of cervical dystonia in adults to decrease severity of abnormal head position and neck pain in toxin-naive and previously treated patients; temporary improvement in appearance of moderate to severe glabellar lines associated with corrugator or procerus muscle activity in patients 65 y or younger.
Achalasia; acquired nystagmus; facial lines and wrinkles; gustatory sweating; hand dystonia; headache (tension-type); palmar hyperhidrosis; sialorrhea; spasticity of cerebral palsy.
Infection at the proposed injection site(s); hypersensitivity to any botulinum toxin preparation or ingredient in the formulations, including cow's milk protein.
Dosage and AdministrationDysport
Cervical Dystonia Adults
IM 500 units initially as a divided dose among affected muscles. Make dosage adjustments in 250 unit steps according to patient's response, with re-treatment every 12 wk or longer. Usual dosage is 250 to 1,000 units every 12 wk or longer.Glabellar Lines Adults
IM 50 units in 5 equal aliquots of 10 units each. Administer no more frequently than every 3 mo.
- The potency units of abobotulinumtoxinA are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of abobotulinumtoxinA cannot be compared with or converted into units of any other botulinum toxin products assessed with any other specific assay method.
- For IM injection only.
- For cervical dystonia, limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia.
- For glabellar lines, use a 30-gauge needle; inject 10 units into 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle.
- Reconstitute powder for injection following manufacturer's guidelines using preservative-free sodium chloride 0.9% injection.
- Discard vial if vacuum does not pull diluent into vial.
- Follow institutional or organizational procedures for discarding medical waste and disposing of unused solution, vials, and equipment used for drug administration.
- Do not exceed recommended dosages or frequencies of administration.
Store vials in refrigerator (36° to 46°F). Protect from light. Administer within 4 h of reconstitution; during this period, store solution under refrigeration. Do not freeze reconstituted solution.
Drug InteractionsAminoglycosides (eg, gentamicin), drugs interfering with neuromuscular transmission (eg, magnesium sulfate, quinidine, succinylcholine)
The effects of abobotulinumtoxinA may be potentiated. Use with caution. Closely monitor the patient.Anticholinergic agents (eg, atropine)
Use of anticholinergic agents after abobotulinumtoxinA administration may potentiate systemic anticholinergic effects (eg, blurred vision). Use with caution.Botulinum neurotoxin (eg, botulinum toxin type B)
Administration of a different botulinum neurotoxin at the same time or within several months of each other may exacerbate excessive neuromuscular weakness. Use with caution. Closely monitor the patient.Muscle relaxants (eg, metaxalone)
Excessive weakness may be exaggerated. Use with caution. Closely monitor the patient.Nondepolarizing muscle relaxants (eg, tubocurarine)
Neuromuscular action may be enhanced, resulting in protracted respiratory depression. Use with caution. Closely monitor the patient.
Fatigue (12%); headache (11%); dizziness (4%), hypoesthesia, malaise, vertigo (postmarketing).
Contact dermatitis (2% to 3%); erythema, excessive granulation tissue (postmarketing).
Eye disorders (17%); pharyngolaryngeal pain (2% to 3%); eyelid edema, eyelid ptosis (2%); blurred vision, diplopia, photophobia (postmarketing).
Dysphagia, dry mouth (39%); nausea (2%).
Blood in urine (2%).
Injection-site discomfort (22%); pain (5%); reaction (3%); swelling (2% to 3%).
Muscle weakness (56%); musculoskeletal pain (7%); muscle atrophy (1%).
Dysphonia (28%); nasopharyngitis (10%); breathing difficulties, upper respiratory tract infection (3%); bronchitis, cough (2% to 3%); sinusitis (2%).
Facial paresis (17%); infections and infestations (13%); influenza (2% to 3%); amyotrophy, burning sensation, hypersensitivity, influenza-like illness (postmarketing).
The effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, blurred vision, breathing difficulties, diplopia, dysarthria, dysphagia, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence. 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, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable with those used to treat cervical dystonia and at lower doses.
Closely monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis (ALS), or neuromuscular junction disorders (eg, myasthenia gravis, Lambert-Eaton syndrome) when administering botulinum toxin.
Safety and effectiveness have not been established.
Use with caution for the treatment of cervical dystonia. Efficacy was not observed for the treatment of glabellar lines.
Because this product contains albumin, a derivative of human blood, it carries a remote risk of viral disease transmission.
Use with caution in patients with surgical alterations to the facial anatomy, excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, inflammation at injection site(s), ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
Dysphagia and breathing difficulties
May occur within hours to weeks after injection. Dysphagia may persist for several months. Death as a complication of severe dysphagia has been reported. Risk may be increased in patients with smaller neck muscle mass and patients requiring bilateral injections into sternocleidomastoid muscle.
Treatment may cause formation of neutralizing antibodies.
Use with caution in patients with peripheral motor neuropathic disease, ALS, or neuromuscular junctional disorders (eg, myasthenia gravis) because of increased risk of systemic effects, including dysphagia and respiratory compromise.
May occur. To reduce the complication of ptosis, avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes, and place corrugator injections at least 1 cm above the bony supraorbital ridge.
Neuromuscular weakness with a variety of symptoms, including muscle weakness and muscle paralysis.
- Advise patients to read the Medication Guide before starting therapy and with each re-treatment.
- Advise patients being treated for cervical dystonia that improvement should occur within the first 2 wk following treatment, and max improvement should occur within about 6 wk. Advise patients that beneficial effects may last 3 mo before re-treatment is needed.
- Advise patients being treated for glabellar lines that improvement should occur within the first couple of days following treatment and that beneficial effects may last 3 to 4 mo.
- Advise patients or caregivers to immediately seek medical assistance if swallowing, speech, or breathing problems develop.
- Advise patients to report intolerable injection-site reactions or unusual symptoms to their health care provider.
- Counsel patients to avoid driving or engaging in other potentially hazardous activities if loss of strength, muscle weakness, blurred vision, or drooping eyelids occur.
- Inform patients that botulinum toxin injections may cause dyspnea or mild to severe dysphagia, with risk of aspiration.
- Advise patients to seek immediate medical attention if eye pain or irritation occurs following injection.
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