Letibotulinumtoxina-wlbg
Generic Name: letibotulinumtoxina-wlbg
Brand Names:
Letybo
11 DESCRIPTION LetibotulinumtoxinA-wlbg is an acetylcholine release inhibitor and a neuromuscular blocking agent. LetibotulinumtoxinA-wlbg is a 900 kDa botulinum toxin type A, produced from fermentation of Clostridium botulinum . LETYBO (letibotulinumtoxinA-wlbg) for injection is supplied as a sterile, preservative-free, white, freeze-dried powder in a single-dose vial for intramuscular use after reconstitution.
Overview
11 DESCRIPTION LetibotulinumtoxinA-wlbg is an acetylcholine release inhibitor and a neuromuscular blocking agent. LetibotulinumtoxinA-wlbg is a 900 kDa botulinum toxin type A, produced from fermentation of Clostridium botulinum . LETYBO (letibotulinumtoxinA-wlbg) for injection is supplied as a sterile, preservative-free, white, freeze-dried powder in a single-dose vial for intramuscular use after reconstitution.
Uses
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
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.
Side Effects
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%).
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 w...
Warnings
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. 5 WARNINGS AND PRECAUTIONS Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur. ( 5.1 , 5.3 , 5.7 ) Potency Units of LETYBO are not interchangeable with other preparations of botulinum toxin products. ( 5.2 , 11 ) Potential serious adverse reactions after LETYBO injections for unapproved uses. ( 5.3 ) If a hypersensitivity reaction occurs, discontinue LETYBO and immediately initiate appropriate therapy. ( 5.4 ) Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease. 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).
Pregnancy
8.1 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 )] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LETYBO (letibotulinumtoxinA-wlbg) for injection is a sterile, white, freeze-dried powder supplied in a single-dose vial in the following sizes: Carton containing one 50 Units/vial (NDC 81165-050-01) Carton containing one 100 Units/vial (NDC 81165-100-01) Storage and Handling Unopened LETYBO vials should be stored in a refrigerator between 2°C to 8°...
Frequently Asked Questions
What is Letibotulinumtoxina-wlbg used for?▼
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 )
What are the side effects of Letibotulinumtoxina-wlbg?▼
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%).
Can I take Letibotulinumtoxina-wlbg during pregnancy?▼
8.1 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 )] .
What are the important warnings for Letibotulinumtoxina-wlbg?▼
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. 5 WARNINGS AND PRECAUTIONS Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur. ( 5.1 , 5.3 , 5.7 ) Potency Units of LETYBO are not interchangeable with other preparations of botulinum toxin products. ( 5.2 , 11 ) Potential serious adverse reactions after LETYBO injections for unapproved uses. ( 5.3 ) If a hypersensitivity reaction occurs, discontinue LETYBO and immediately initiate appropriate therapy. ( 5.4 ) Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease. 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).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.