LETYBO
Generic Name/API: Botulinum toxin type A
Manufacturer: Hugel, Inc.
Dosage Forms & Strength & Pack Size:
For Injection: 50 Units or 100 Units freeze-dried powder in a single-dose vial
Storage:
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.
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.
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. ( 5.5)
Concomitant neuromuscular disorder may exacerbate clinical effects of treatment. ( 5.6)
Use with caution in patients with compromised respiratory function or dysphagia ( 5.7)
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