Anesthetics:

Indications for: BYFAVO

Induction and maintenance of procedural sedation lasting 30mins or less.

Adult Dosage:

Individualize. Titrate to achieve clinical response. Give by IV inj. Induction: 5mg over 1min; for American Society of Anesthesiologists Physical Status (ASA-PS) III or IV: 2.5–5mg over 1min. Maintenance (as needed): 2.5mg over 15secs; for ASA-PS III or IV: 1.25–2.5mg over 15secs. Must wait ≥2mins prior to administration of any supplemental dose.

Children Dosage:

<18yrs: not established.

Boxed Warning:

Personnel and equipment for monitoring and resuscitation. Risks from concomitant use with opioid analgesics and other sedative-hypnotics.

BYFAVO Warnings/Precautions:

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 Classification:

Benzodiazepine.

BYFAVO Interactions:

Increased risk of profound sedation, respiratory depression, coma, and death with concomitant CNS depressants, including opioid analgesics, other benzodiazepines, propofol; monitor continuously during and through recovery period; titrate Byfavo when concomitant with opioid analgesics and sedative-hypnotics.

Adverse Reactions:

Hypotension, hypertension, diastolic hyper- or hypotension, systolic hypertension, hypoxia; hypersensitivity reactions.

Metabolism:

The main route of metabolism of Byfavo is via conversion to primary inactive metabolite CNS7054, which is then subject to hydroxylation and glucuronidation. Conversion to CNS7054 is mediated by tissue carboxylesterases (primarily type 1A), with no meaningful contribution by cytochrome P450 enzymes. The half-life of the metabolite was 2.4–3.8 hours.

Drug Elimination:

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.

Generic Drug Availability:

NO

How Supplied:

Single-patient-use vial (12mL)—10