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LUSEDRA is a Schedule IV controlled substance indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. LUSEDRA is an aqueous solution intended for intravenous administration as a sedative-hypnotic agent. It is sterile, nonpyrogenic, clear, colorless, and iso-osmotic. The solution contains 35 mg/mL of fospropofol disodium. Fospropofol disodium is a water-soluble prodrug of propofol, chemically described as 2,6-diisopropylphenoxymethyl phosphate, disodium salt.1

Safety and effectiveness in pediatric patients have not been established because LUSEDRA has not been studied in persons <18 years of age. LUSEDRA is not recommended for use in this population.1

Important Safety Information

INDICATION
LUSEDRA® is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) in adult patients undergoing diagnostic or therapeutic procedures.

IMPORTANT SAFETY INFORMATION
LUSEDRA should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the diagnostic or therapeutic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.

The following serious adverse reactions have been reported with the use of LUSEDRA:

Respiratory Depression

LUSEDRA may cause loss of spontaneous respiration. Apnea was reported in 1/455 (<1%) patients treated with LUSEDRA using the standard or modified dosing regimen. In patients treated with greater than the recommended LUSEDRA dose, apnea was reported in 14/556 (3%).

Hypoxemia

LUSEDRA may cause hypoxemia detectable by pulse oximetry. Hypoxemia was reported in 20/455 (4%) patients treated with LUSEDRA using the standard or modified dosing regimen. Hypoxemia was reported among patients who retained the ability to respond purposefully to their health care provider following administration of LUSEDRA. Therefore, retention of purposeful responsiveness did not prevent patients from becoming hypoxemic following administration of LUSEDRA. In patients treated with greater than the recommended LUSEDRA dose, hypoxemia was reported in 151/556 (27%).

Patient Unresponsiveness to Vigorous Tactile or Painful Stimulation

LUSEDRA has not been studied for use in general anesthesia. However, administration of LUSEDRA may inadvertently cause patients to become unresponsive or minimally responsive to vigorous tactile or painful stimulation. The incidence of patients who became minimally responsive or unresponsive to vigorous tactile or painful stimulation was 7/183 (4%) for colonoscopy and 24/149 (16%) for bronchoscopy. The duration of minimal or complete unresponsiveness ranged from 2 to 16 minutes in colonoscopy patients and from 2 to 20 minutes in bronchoscopy patients.

Hypotension

Hypotension following the use of LUSEDRA may occur. Hypotension was reported in 18/455 (4%) patients treated with LUSEDRA using the standard or modified dosing regimen. In patients treated with greater than the recommended LUSEDRA dose, hypotension was reported in 31/556 (6%). Patients with compromised myocardial function, reduced vascular tone, or who have reduced intravascular volume may be at an increased risk for hypotension.

The use of supplemental oxygen is recommended in all patients receiving LUSEDRA. Airway assistance maneuvers may be required. As with other sedative-hypnotic agents, LUSEDRA may produce additive cardiorespiratory effects when administered with other cardiorespiratory depressants such as benzodiazepines and narcotic analgesics. Use lower doses of LUSEDRA in patients who are ≥65 years of age or who have severe systemic disease. When LUSEDRA is used at greater than recommended doses, the incidence of serious adverse reactions is increased. The most common adverse reactions (reported in greater than 20%) are paresthesia and pruritus.

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Reference: 1. LUSEDRA [package insert]. Woodcliff Lake, NJ: Eisai Inc.; 2009.

INDICATION
LUSEDRA® is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) in adult patients undergoing diagnostic or therapeutic procedures.

IMPORTANT SAFETY INFORMATION
LUSEDRA should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the diagnostic or therapeutic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.

The following serious adverse reactions have been reported with the use of LUSEDRA:

Respiratory Depression

LUSEDRA may cause loss of spontaneous respiration. Apnea was reported in 1/455 (<1%) patients treated with LUSEDRA using the standard or modified dosing regimen. In patients treated with greater than the recommended LUSEDRA dose, apnea was reported in 14/556 (3%).

Hypoxemia

LUSEDRA may cause hypoxemia detectable by pulse oximetry. Hypoxemia was reported in 20/455 (4%) patients treated with LUSEDRA using the standard or modified dosing regimen. Hypoxemia was reported among patients who retained the ability to respond purposefully to their health care provider following administration of LUSEDRA. Therefore, retention of purposeful responsiveness did not prevent patients from becoming hypoxemic following administration of LUSEDRA. In patients treated with greater than the recommended LUSEDRA dose, hypoxemia was reported in 151/556 (27%).

Patient Unresponsiveness to Vigorous Tactile or Painful Stimulation

LUSEDRA has not been studied for use in general anesthesia. However, administration of LUSEDRA may inadvertently cause patients to become unresponsive or minimally responsive to vigorous tactile or painful stimulation. The incidence of patients who became minimally responsive or unresponsive to vigorous tactile or painful stimulation was 7/183 (4%) for colonoscopy and 24/149 (16%) for bronchoscopy. The duration of minimal or complete unresponsiveness ranged from 2 to 16 minutes in colonoscopy patients and from 2 to 20 minutes in bronchoscopy patients.

Hypotension

Hypotension following the use of LUSEDRA may occur. Hypotension was reported in 18/455 (4%) patients treated with LUSEDRA using the standard or modified dosing regimen. In patients treated with greater than the recommended LUSEDRA dose, hypotension was reported in 31/556 (6%). Patients with compromised myocardial function, reduced vascular tone, or who have reduced intravascular volume may be at an increased risk for hypotension.

The use of supplemental oxygen is recommended in all patients receiving LUSEDRA. Airway assistance maneuvers may be required. As with other sedative-hypnotic agents, LUSEDRA may produce additive cardiorespiratory effects when administered with other cardiorespiratory depressants such as benzodiazepines and narcotic analgesics. Use lower doses of LUSEDRA in patients who are ≥65 years of age or who have severe systemic disease. When LUSEDRA is used at greater than recommended doses, the incidence of serious adverse reactions is increased. The most common adverse reactions (reported in greater than 20%) are paresthesia and pruritus.