Letybo

Drug overview for LETYBO (letibotulinumtoxina-wlbg):

Generic name: LETIBOTULINUMTOXINA-WLBG (BOT-ue-LYE-num)
Drug class: Neuromuscular Blockers
Therapeutic class: Locomotor System

LetibotulinumtoxinA-wlbg is an acetylcholine release inhibitor and a neuromuscular blocking agent.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for LETYBO (letibotulinumtoxina-wlbg) have been approved by the FDA:

Indications:
Glabellar lines

Professional Synonyms:
Brow furrow
Rhytides of glabellar skin

The following dosing information is available for LETYBO (letibotulinumtoxina-wlbg):

Dosing
Administration
Dosing Information
Generic

*The potency units of letibotulinumtoxinA-wlbg for injection are specific to the preparation and assay utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of letibotulinumtoxinA-wlbg cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay.

*Prior to IM injection, reconstitute each freeze-dried vial of the drug with the required amount of sterile, preservative-free 0.9% Sodium Chloride Injection, USP to achieve a reconstituted solution at a concentration of 4 Units/0.1 mL.

Administer within 24 hours of reconstitution.

*The total recommended dose of letibotulinumtoxinA-wlbg is 20 Units per treatment session divided into five equal IM injections of 4 Units each (two injections in each corrugator muscle and one injection in the procerus muscle).

*LetibotulinumtoxinA-wlbg should be administered no more frequently than every 3 months. Consideration of the cumulative dose is necessary when treating adult patients with letibotulinumtoxinA-wlbg for glabellar lines if other botulinum toxin products are or have been used to treat other indications approved for those products.

*The safe and effective use of letibotulinumtoxinA-wlbg depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques.

*See Full Prescribing Information for additional instructions on preparation and administration.

No enhanced Administration information available for this drug.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for LETYBO (letibotulinumtoxina-wlbg):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 3 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Misc Antibiotics/Neuromuscular Blocking Agents 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.	AMIKACIN SULFATE, BETHKIS, COLISTIN SULFATE, GENTAMICIN SULFATE, GENTAMICIN SULFATE IN NS, HUMATIN, KANAMYCIN SULFATE, KITABIS PAK, NEOMYCIN SULFATE, PAROMOMYCIN SULFATE, STREPTOMYCIN SULFATE, TIGECYCLINE, TOBI, TOBI PODHALER, TOBRAMYCIN, TOBRAMYCIN SULFATE, TYGACIL
General Anesthetics (Inhl)/Neuromuscular Blocking Agents 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.	DESFLURANE, FORANE, ISOFLURANE, SEVOFLURANE, SUPRANE, TERRELL, ULTANE
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.	NUEDEXTA, QUALAQUIN, QUINIDINE GLUCONATE, QUINIDINE SULFATE, QUININE HCL, QUININE SULFATE

There are 3 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
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.	BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC, COLISTIMETHATE, COLISTIMETHATE SODIUM, COLY-MYCIN M PARENTERAL, POLYMYXIN B SULFATE, TYZAVAN, VANCOMYCIN, VANCOMYCIN HCL, VANCOMYCIN HCL-0.9% NACL, VANCOMYCIN HCL-D5W
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.	CLEOCIN HCL, CLEOCIN PEDIATRIC, CLEOCIN PHOSPHATE, CLINDAMYCIN (PEDIATRIC), CLINDAMYCIN HCL, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE-D5W, CLINDAMYCIN-0.9% NACL, LINCOCIN, LINCOMYCIN HCL
Hydantoins/Select Neuromuscular Blocking Agents 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)	CEREBYX, DILANTIN, DILANTIN-125, FOSPHENYTOIN SODIUM, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED

The following contraindication information is available for LETYBO (letibotulinumtoxina-wlbg):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

*Patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the letibotulinumtoxinA-wlbg formulation. *The presence of infection at the proposed injection site(s).

There are 0 contraindications.

There are 8 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Amyotrophic lateral sclerosis
Atherosclerotic cardiovascular disease
Dysphagia
Eaton-lambert syndrome
Myasthenia gravis
Neuromuscular disease
Peripheral motor neuropathy
Respiratory depression

There are 0 moderate contraindications.

The following adverse reaction information is available for LETYBO (letibotulinumtoxina-wlbg):

Overview
Severe
Less Severe

Adverse reaction overview.

The most common adverse reaction is headache (2%).

There are 2 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Botulism

There are 22 less severe adverse reactions.

More Frequent	Less Frequent
Blepharoptosis Headache disorder	Injection site inflammation Injection site sequelae

Rare/Very Rare
Blepharospasm Bronchitis Conjunctival hemorrhage Constipation Dizziness Dry eye Dry skin Folliculitis Migraine Muscle weakness Nausea Paresthesia Periorbital edema Pharyngitis Pneumonia Sinusitis Urticaria Visual field defect

The following precautions are available for LETYBO (letibotulinumtoxina-wlbg):

Pediatric
Pregnant
Lactation
Geriatric

The safety and effectiveness of letibotulinumtoxinA-wlbg in pediatric patients have not been established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Available data from case reports with letibotulinumtoxinA-wlbg use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Systemic exposure following intramuscular injection of letibotulinumtoxinA-wlbg was not assessed. In an animal reproduction study, intramuscular administration of letibotulinumtoxinA-wlbg to rats during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses 3 times the maximum recommended human dose (MRHD).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

There are no data regarding the presence of letibotulinumtoxinA-wlbg in human or animal milk, its effects on the breastfed infant, or the effects on milk production. Systemic exposure following intramuscular injection of letibotulinumtoxinA-wlbg was not assessed. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for letibotulinumtoxinA-wlbg and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

The 3 clinical trials of letibotulinumtoxinA-wlbg included 148 subjects 65 years of age and older. Although no clinically meaningful differences in safety or efficacy were observed between older and younger subjects, clinical studies of letibotulinumtoxinA-wlbg did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently from younger subjects.

Glabellar lines
L98.8	Other specified disorders of the skin and subcutaneous tissue