Generic Name: fospropofol disodium
Date of Approval: December 12, 2008
Company: Eisai Corporation of North America
Treatment for: Monitored Anesthesia Care (MAC) Sedation
FDA Approves Lusedra
The U.S. Food and Drug Administration (FDA) has approved Lusedra (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.
About Lusedra (fospropofol disodium) Injection
Lusedra (fospropofol disodium) Injection is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase enzymes in the body into propofol. Lusedra is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation 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. Patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. Facilities for providing cardiopulmonary resuscitation must be immediately available.
The following serious adverse reactions have been reported with the use of Lusedra.
- Hypotension was reported in 18/455 (4%) patients treated with Lusedra using the standard or modified dosing regimen.
- Patients with compromised myocardial function, reduced vascular tone, or who have reduced intravascular volume may be at an increased risk for hypotension.
- Hypoxemia was reported in 20/455 (4%) patients treated with Lusedra using the standard or modified dosing regimen. Retention of purposeful responsiveness did not prevent patients from becoming hypoxemic following administration of Lusedra.
- Respiratory depression
- Apnea was reported in 1/455 (< 1%) patients treated with Lusedra using the standard or modified dosing regimen.
- Loss of purposeful responsiveness
- 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.
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 cardio-respiratory effects when administered with other cardio-respiratory depressants such as benzodiazepines and narcotic analgesics. When Lusedra is used at greater than the recommended doses, the incidence of serious adverse reactions is increased.
The most common adverse reactions (reported in greater than 20%) are paresthesia and pruritis.
Highlights of Lusedra Prescribing Information
These highlights do not include all the information needed to use Lusedra safely and effectively. See full prescribing information for Lusedra.
Indications and Usage
Lusedra is a sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.
Dosage and Administration
- Use supplemental oxygen in all patients undergoing sedation with Lusedra. Continuously monitor with pulse oximetry, electrocardiogram, and frequent blood pressure measurements.
- Standard dosing regimen: initial intravenous bolus dose of 6.5 mg/kg followed by supplemental doses of 1.6 mg/kg as needed. No initial dose should exceed 16.5 mL; no supplemental dose should exceed 4 mL.
- Modified dosing regimen [for patients who are ≥65 years of age or who have severe systemic disease (ASA P3 or P4)]: 75 % of the standard dosing regimen.
- Administer supplemental doses only when patients can demonstrate purposeful movement in response to verbal or light tactile stimulation and no more frequently than every 4 minutes.
- Adults who weigh >90 kg should be dosed as if they are 90 kg; adults who weigh <60 kg should be dosed as if they are 60 kg.
- Intended for single use administration only.
Dosage Forms and Strengths
Injection, solution containing 1,050 mg fospropofol disodium per 30 mL.
Warnings and Precautions
- A person trained in the administration of general anesthesia and not involved in the conduct of the diagnostic/therapeutic procedure should manage treatment of patients with Lusedra.
- Respiratory depression
Most common adverse reactions (> 20 %) are paresthesia and pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Eisai, Inc. at 1-888-422-4743 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
As with other sedative-hypnotic agents, Lusedra may produce additive cardio-respiratory effects when administered with other cardio-respiratory depressants such as benzodiazepines and narcotic analgesics.
Use in Specific Populations
- Patients ≥65 years of age should receive the modified dosing regimen.
- Patients with severe systemic disease (ASA P3 or P4) should receive the modified dosing regimen.
Patient Counseling Information
Paresthesias (including burning, tingling, stinging) and/or pruritus, usually manifested in the perineal region are frequently experienced upon injection of the initial dose of Lusedra. Inform the patient that these sensations are typically mild to moderate in intensity, last a short time, and require no treatment. Requirement for a patient escort should be considered. The decision as to when patients who have received Lusedra, particularly on an outpatient basis, may again engage in activities requiring complete mental alertness, coordination and/or physical dexterity (e.g. operate hazardous machinery, sign legal documents or drive a motor vehicle) must be individualized.