Letibotulinumtoxina

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.

LETYBO blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine. When injected intramuscularly at therapeutic doses, LETYBO is internalized into the nerve terminal, translocates into the neuronal cytosol where it cleaves SNAP25, a protein necessary for synaptic membrane docking and subsequent release of acetylcholine which produces a dose dependent decrease of muscle function. Recovery of muscle function is gradual due to degradation of the neurotoxin and formation of axonal sprouts. Muscle reinnervation occurs, leading to a slow reversal of the pharmacological effects of LETYBO.

The recommended dose is 0.1 mL (4 Units) by intramuscular injection into each of five sites, for a total dose of 20 Units 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. 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.

LETYBO is contraindicated in: Patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the LETYBO formulation. 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. Infection at the injection site

Boxed 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. Spread of toxin effects, swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Potency Units of LETYBO are not interchangeable with other preparations of botulinum toxin products. Potential serious adverse reactions after LETYBO injections for unapproved uses. If a hypersensitivity reaction occurs, discontinue LETYBO and immediately initiate appropriate therapy.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Spread of Toxin Effects Hypersensitivity Reactions Cardiovascular System Adverse Reactions Increased Neuromuscular Compromise in Patients with Pre-Existing Neuromuscular Disorders Dysphagia and Dyspnea Ophthalmic Adverse Reactions in Patients Treated for Glabellar Lines The most common adverse reaction is headache (2%).

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.

Unopened LETYBO vials should be stored 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.