LETYBO 50 U/1
letibotulinumtoxinA-wlbg · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Hugel, Inc.
LETYBO is a injection, powder, lyophilized, for solution containing letibotulinumtoxina-wlbg at 50 U/1, taken intramuscular. Manufactured by Hugel, Inc..
Key Facts
- Brand Name
- LETYBO
- Generic Name
- letibotulinumtoxinA-wlbg
- NDC Code (Product)
81165-050- Manufacturer
- Hugel, Inc.
- Strength
- 50 U/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA761225
- Drug Class
- Acetylcholine Release Inhibitor [EPC]; Neuromuscular Blocker [EPC]
- Marketing Start
- 07/30/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 in adult patients. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. 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…
Contraindications
4 CONTRAINDICATIONS 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). 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).
Drug Interactions
7 DRUG INTERACTIONS 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. 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 )
Adverse Reactions
6 ADVERSE REACTIONS 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%). ( 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…
Frequently Asked Questions
What is LETYBO used for?
LETYBO contains letibotulinumtoxinA-wlbg. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is LETYBO a controlled substance?
LETYBO is not classified as a controlled substance by the DEA.
What is the generic name for LETYBO?
The generic name for LETYBO is letibotulinumtoxinA-wlbg. There are no other listed brand versions of letibotulinumtoxinA-wlbg.
What is the NDC code for LETYBO 50 U/1?
The NDC (National Drug Code) for LETYBO 50 U/1 is 81165-050, listed by Hugel, Inc..
Other LETYBO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)