Letibotulinumtoxina-wlbg

What Letibotulinumtoxina-wlbg is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

LETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. LETYBO is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity …

— FDA label: Letybo, Hugel, Inc., effective November 18, 2024. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, powder, lyophilized, for solution, intramuscular), Letybo, Hugel, Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: DISTANT SPREAD OF TOXIN EFFECT. Read it on the full label →

Letibotulinumtoxina-wlbg boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including LETYBO, 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.

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LETYBO is not approved for the treatment of spasticity or any conditions other than glabellar lines [see Warnings and Precautions (5.1)]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of all botulinum toxin products, including LETYBO, 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. LETYBO is not approved for the treatment of spasticity or any conditions other than glabellar lines. (5.1)

— FDA label: Letybo, Hugel, Inc., effective November 18, 2024. Read the full label on DailyMed →

Letibotulinumtoxina-wlbg side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Spread of Toxin Effects [see Warnings and Precautions (5.1)] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.4)] Cardiovascular System Adverse Reactions [see Warnings and Precautions (5.5)] Increased Neuromuscular Compromise in Patients with Pre-Existing Neuromuscular Disorders [see Warnings and Precautions (5.6)] Dysphagia and Dyspnea [see Warnings and Precautions (5.7)] Ophthalmic Adverse Reactions in Patients Treated for Glabellar Lines [see Warnings and Precautions (5.9)] The most common adverse reaction is headache (2%).

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact HUGEL at 1‑888-674-5355 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the three randomized, placebo-controlled, Phase 3 clinical trials that assess the use of LETYBO for the temporary improvement in the appearance of moderate to severe glabellar lines (BLESS I, II and III), 911 out of the 955 subjects who received a single dose treatment of 20 Units LETYBO and 310 out of the 317 subjects who received a single dose of placebo were included in safety analyses [see Clinical Studies (14)]. Table 2 lists the adverse reactions reported in more than one subject in the LETYBO group compared to the placebo in the placebo-controlled trials. Most adverse reactions occur within the first week following injection of LETYBO and while generally transient, may have a duration of several months or longer. Table 2: Adverse Reactions Reported in More Than One Subject in the LETYBO Group Compared to the Placebo Group in BLESS I, II and III Adverse Reaction Treatment LETYBO BLESS I, II, III N=911 n (%) PLACEBO BLESS I, II, III N=310 n (%) Headache* 17 (2%) 2 (1%) Brow ptosis** 3 (<1%) 0 Eyelid ptosis 3 (<1%) 0 Blepharospasm 2 (<1%) 0 * Includes headache, head discomfort, migraine, and procedural headache. ** Includes brow ptosis and brow heaviness. The most frequently reported injection site reactions included administrative site swelling, facial pain, folliculitis, periorbital hematoma; and injection site bruising, reaction, pain, hematoma, nodule, pruritus, and mass. BLESS I, II and III also included an open label, extension part with LETYBO. The extension allowed subjects who had completed the double-blind portion of the trials to receive up to 3 additional elective LETYBO 20-Unit treatments for moderate to severe glabellar lines over a 48-week period. Treatments were separated by at least a 3-month period. Of the 1,129 subjects enrolled in the open label extension part of the trials, the median number of treatments was 3. The adverse reaction profile was comparable to that reported in the randomized, single dose, double blind part of the trials. Headache was the most common adverse reaction, reported in 2% of subjects, followed by injection site reactions (1%) [including contusion/bruising, administration site swelling, facial pain, periorbital hematoma, skin swelling; and injection site reaction, bruising, hematoma, mass, and nodule] and eyelid ptosis in 0.5% of subjects.

— FDA label: Letybo, Hugel, Inc., effective November 18, 2024. This is part of the section. Read the full label on DailyMed →

Letibotulinumtoxina-wlbg drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

No drug interaction studies have been conducted with LETYBO. Certain drugs may potentiate the effects of LETYBO which may result in excessive neuromuscular weakness and heighten systemic anticholinergic effects.

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Use caution with concurrent use of LETYBO with the following products and monitor closely for excessive neuromuscular weakness: Aminoglycosides or other agents interfering with neuromuscular transmission Anticholinergic drugs Botulinum neurotoxin products administered as the same time or within several months of LETYBO Muscle relaxants administered before or after administration of LETYBO Aminoglycoside antibiotics, anticholinergic agents, or any other agents that interfere with neuromuscular transmission may potentiate the effect of LETYBO; co-administer only with caution and close observation. (7)

— FDA label: Letybo, Hugel, Inc., effective November 18, 2024. Read the full label on DailyMed →

Letibotulinumtoxina-wlbg dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

The recommended dose is 0.1 mL (4 Units) by intramuscular injection into each of five sites, for a total dose of 20 Units (2.2, 2.3) 2.1 Important Administration Instructions The potency Units of LETYBO (letibotulinumtoxinA-wlbg) for injection are specific to the preparation and assay utilized.

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They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of LETYBO cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay [see Warnings and Precautions (5.2) and Description (11)]. LETYBO should be administered no more frequently than every three months. Consideration of the cumulative dose is necessary when treating adult patients with LETYBO 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 LETYBO depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques.LETYBO After reconstitution, only use each LETYBO vial for one injection session and for only one patient. Discard any remaining solution in vial immediately after administration. Reconstitution instructions are provided specifically for the 50 Unit and the 100 Unit vials (Table 1) 2.2 Recommended Dosage The total recommended dose is 20 Units per treatment session divided into five equal intramuscular injections of 4 Units each (two injections in each corrugator muscle and one injection in the procerus muscle). 2.3 Preparation and Dilution Technique LETYBO is supplied in a single-dose 50 or 100-Unit vial. Prior to intramuscular injection, reconstitute each freeze-dried vial of LETYBO 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 (see Table 1). Table 1: Dilution Instructions for LETYBO Vials (50 and 100 Units) Vial Amount of Diluent* Added Resulting Dose Units per 0.1 mL 50 Units 1.25 mL 4 Units 100 Units 2.5 mL 4 Units *Preservative-free 0.9% Sodium Chloride Injection, USP Slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Dispose of any unused diluent. Gently mix LETYBO with 0.9% sodium chloride injection, USP by rotating the vial. Reconstituted LETYBO is clear and colorless, and free of particulate matter. Inspect visually the reconstituted LETYBO for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or discolored or contains flakes or particles. Administer LETYBO within 24 hours after reconstitution. During this time period, store unused reconstituted LETYBO in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze reconstituted LETYBO. 2.4 Administration The upper eyelid margin position should be carefully examined for separation or weakness of the levator palpebrae superioris muscle.

— FDA label: Letybo, Hugel, Inc., effective November 18, 2024. This is part of the section. Read the full label on DailyMed →

Letibotulinumtoxina-wlbg in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Available data from case reports with LETYBO 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 [see Clinical Pharmacology (12.3)].

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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) (see Data). 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. Data Animal Data An embryofetal development study was conducted in rats with letibotulinumtoxinA-wlbg. For comparison of animal to human doses based on a body weight comparison, the MRHD is set at 20 Units/subject (0.34 Units/kg for an average 60 kg subject). Administration to pregnant rats once daily during organogenesis (gestation days 5 to 16) caused decreased fetal body weight and decreased fetal skeletal ossification at doses ≥1 Unit/kg (3 times the MRHD. These treatment related effects were associated with maternal toxicity.

— FDA label: Letybo, Hugel, Inc., effective November 18, 2024. Read the full label on DailyMed →

When Letibotulinumtoxina-wlbg should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

LETYBO is contraindicated in: Patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the LETYBO formulation [see Warnings and Precautions (5.4)]. The presence of infection at the proposed injection site(s).

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Known hypersensitivity to any botulinum toxin preparation or to any of the components in the LETYBO formulation (4) Infection at the injection site (4) 4.1 Known Hypersensitivity to Botulinum Toxin BRANDNAME is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [see Warnings and Precautions (5.4)]. 4.2 Infection at the Injection Site(s) BRANDNAME is contraindicated in the presence of infection at the proposed injection site(s).

— FDA label: Letybo, Hugel, Inc., effective November 18, 2024. Read the full label on DailyMed →

Letibotulinumtoxina-wlbg overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Excessive doses of LETYBO may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles. Symptoms of overdose are likely not to be present immediately following injection.

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Should accidental injection or oral ingestion occur, or overdose be suspected, the person should be medically supervised for several weeks for signs and symptoms of systemic muscular weakness or paralysis. In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100.

— FDA label: Letybo, Hugel, Inc., effective November 18, 2024. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Hugel, Inc.2 products

FDA approval history

• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Letybo, Hugel, Inc., effective November 18, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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