Byfavo Generic Name & Formulations
Mechanism of Action
Byfavo Dosage and Administration
Byfavo Boxed Warnings
Should be administered only by trained personnel in procedural sedation, detection/management of airway obstruction, hypoventilation, and apnea. Have resuscitative drugs/equipment, supportive ventilation, reversal agent (eg, flumazenil) readily available. Give supplemental oxygen through the recovery period. Continuously monitor for cardiorespiratory effects (esp. in those with obstructive sleep apnea, elderly, ASA-PS III or IV patients). Severe hepatic impairment. Elderly. Pediatric neurotoxicity. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants; consider interrupting breastfeeding, pumping and discarding breast milk during and for 5hrs after administration.
Byfavo overall maximum plasma concentration (Cmax) after IV administration of 0.01 to 0.5 mg/kg was 189 to 6,960 ng/mL, and overall area under the concentration versus time curve from time 0 to infinity (AUC0-∞) was 12.1 to 452 ng∙h/mL; Byfavo cumulative dose versus Byfavo total exposure (AUC0-∞) suggested a close to dose-proportional relationship. Metabolite Cmax was achieved ~20–30 minutes post dose.
Byfavo volume of distribution (Vz) was 0.76 to 0.98 L/kg. Plasma protein binding of Byfavo was >91%, primarily to human serum albumin.
Byfavo has a terminal elimination half-life from plasma of 37–53 minutes and mean distribution half-life (t1/2α) is between 0.5 and 2 minutes. In colonoscopy patients, ~0.003% Byfavo is excreted unchanged in urine, and 50–60% is excreted in urine as the metabolite CNS7054.
Byfavo Adverse Reactions
Byfavo Clinical Trials
Byfavo Patient Counseling