Version May 2024
Glabellar lines: IM: Inject 4 units into each of the 5 sites (2 injections in each corrugator muscle and 1 in the procerus muscle) for a total dose of 20 units per treatment session. Do not administer more frequently than every 3 months.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Not approved for use in patients ≥65 years of age.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Nervous system: Headache (3%)
Respiratory: Upper respiratory tract infection (1%)
<1%:
Dermatologic: Folliculitis, urticaria, xeroderma
Endocrine & metabolic: Increased serum potassium
Gastrointestinal: Constipation, nausea, oral herpes simplex infection
Hematologic & oncologic: Bruise, hematoma
Local: Injection-site reaction (including bleeding at injection site, bruising at injection site, discomfort at injection site, hematoma at injection site, inflammation at injection site, injection-site infection, injection-site nodule, injection-site pruritus, pain at injection site, residual mass at injection site, swelling at injection site, tenderness at injection site)
Nervous system: Dizziness, facial pain, facial paresis, hypoesthesia, migraine, pain, paresthesia, tension headache
Ophthalmic: Blepharoptosis, blepharospasm, conjunctival hemorrhage, dry eye syndrome, eye pain, eyelid edema, periorbital hematoma, visual field defect
Respiratory: Flu-like symptoms, pneumonia, sinus headache, streptococcal pharyngitis
Miscellaneous: Fever, swelling
Frequency not defined:
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, serum sickness)
Nervous system: Myasthenia
Ophthalmic: Blurred vision
Hypersensitivity to letibotulinumtoxinA or any component of the formulation; infection or inflammation at the proposed injection site(s).
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Serious and/or immediate hypersensitivity reactions (eg, anaphylaxis, serum sickness, urticaria, soft-tissue edema, dyspnea) have occurred (rare). If a reaction occurs, discontinue and institute immediate treatment.
• Antibody formation: Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy.
• Cardiovascular events: Use with caution in patients with cardiovascular disease; arrhythmia and myocardial infarction (some fatal) have been reported following administration of botulinum toxin products. Some of these patients had risk factors, including preexisting cardiovascular disease.
• Distant spread of toxin effect: [Canadian Boxed Warning]: The effects of letibotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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 occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
• Dysphagia: Treatment can result in swallowing or breathing difficulties; may occur within hours to weeks and persist for several months and require use of a feeding tube. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Risk factors include small neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae.
• Ophthalmic effects: Dry eye, reduced tear production, reduced blinking, and corneal disorders may occur with botulinum toxins; persistent symptoms may require ophthalmologic evaluation.
Disease-related concerns:
• Neuromuscular disease: Avoid use in patients with myasthenia gravis. Use with caution in patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, Lambert-Eaton syndrome). Risk of adverse events, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise, may be increased.
• Respiratory disease: Use extreme caution in patients with preexisting respiratory disease; treatment with 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.
Special populations:
• Older adult: Not approved for patients ≥65 years of age.
Dosage form specific issues:
• Albumin: Product contains albumin and may carry a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease.
• Product interchangeability: [Canadian Boxed Warning]: The term “Unit” upon which dosing of letibotulinumtoxinA is based, is a specific measurement of toxin activity that is unique to the formulation of letibotulinumtoxinA. Therefore, the Units used to describe letibotulinumtoxinA activity are different from those used to describe that of other botulinum toxin preparations and the Units representing letibotulinumtoxinA activity are not interchangeable with other products.
Other warnings/precautions:
• Appropriate use: [Canadian Boxed Warning]: Follow the recommended dosage and frequency of administration for letibotulinumtoxinA. Do not inject into a blood vessel. Do not use more frequently than every 3 months.
• Experienced personnel: [Canadian Boxed Warning]: LetibotulinumtoxinA should only be administered by physicians with the appropriate qualifications and experience in the use of botulinum toxin products. Physicians should be familiar with the patient's anatomy and any alterations to the anatomy.
• Injection site: Use with caution if there is inflammation or excessive weakness or atrophy at the proposed injection site(s). Use with caution in patients who have surgical alterations to the facial anatomy, 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.
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular:
Letybo: 100 units (1 ea) [contains albumin human]
IM: Use a 30- to 31-gauge needle to administer IM. Inject into each of the 5 sites (2 injections in each corrugator muscle and 1 injection in the mid-line 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. Do not inject closer than 1 cm above the supraorbital rim or the central eyebrow. Refer to manufacturer's labeling for additional administration details.
Note: Not approved in the United States.
Glabellar lines: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults <65 years of age.
ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
Botulinum products are not interchangeable; potency differences may exist between the products.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminoglycosides: May enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Risk C: Monitor therapy
Anticholinergic Agents: Botulinum Toxin-Containing Products may enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the neuromuscular-blocking effect of other Botulinum Toxin-Containing Products. Risk C: Monitor therapy
Muscle Relaxants (Centrally Acting): May enhance the adverse/toxic effect of Botulinum Toxin-Containing Products. Specifically, the risk for increased muscle weakness may be enhanced. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Botulinum Toxin-Containing Products may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Adverse events were observed in animal reproduction studies.
Because data related to the use of botulinum toxins for cosmetic procedures during pregnancy are limited, use is generally avoided (Garg 2022; Morgan 2006; Trivedi 2017).
It is not known if letibotulinumtoxinA is present in breast milk.
Breastfeeding is not recommended by the manufacturer.
Difficulty with swallowing, speaking, breathing, or muscle weakness or paralysis in areas other than the targeted area; ophthalmic effects (eg, eye dryness, eye irritation, photophobia, changes in vision).
LetibotulinumtoxinA (botulinum toxin type A) is a neurotoxin, produced by Clostridium botulinum, spore-forming anaerobic bacillus, that blocks cholinergic transmission at the neuromuscular junction and inhibits the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by letibotulinumtoxinA.
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