Personnel and Equipment for Monitoring and Resusciation and Risks From Concomitant Use with Opioid Analgesics

Personnel and Equipment for Monitoring and Resuscitation

• Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.1)] .
• Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.1)] .
• BYFAVO has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.1)] .
• Resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of BYFAVO [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.1)].

Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics

• Concomitant use of benzodiazepines, including BYFAVO, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation [see WARNINGS AND PRECAUTIONS (5.2), DRUG INTERACTIONS (7.1)] .