Fospropofol
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Overview
Fospropofol is a general anesthetic that is FDA approved for the {{{indicationType}}} of monitored anesthesia care sedation.. Common adverse reactions include cardiovascular: hypoxemia (1% to 27% ), dermatologic: pruritus (16% to 28% ), neurologic: paresthesia (49% to 74%).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Monitored anesthesia care sedation: healthy adults or adults with mild systemic disease (American Society of Anesthesiology physical status of P1 or P2) 18 to 65 years of age, initiation, 6.5 mg/kg IV bolus followed immediately by supplemental infusion; patients weighing less than 60 kg should be dosed at 60 kg and patients weighing greater than 90 kg should be dosed at 90 kg.
- Monitored anesthesia care sedation: healthy adults or adults with mild systemic disease (American Society of Anesthesiology physical status of P1 or P2) 18 to 65 years of age, supplemental, 1.6 mg/kg IV no more frequently than every 4 min as needed to achieve the desired level of sedation; patients weighing less than 60 kg should be dosed at 60 kg and patients weighing greater than 90 kg should be dosed at 90 kg.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Fospropofol in adult patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Fospropofol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- Safety and effectiveness of fospropofol injection has not been established in pediatric patients
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Fospropofol in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Fospropofol in pediatric patients.
Contraindications
None.
Warnings
Monitoring
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.
5.2 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 [see Dosage and Administration (2.2, 2.3)]. In patients treated with greater than the recommended LUSEDRA dose, apnea was reported in 14/556 (3%).
Supplemental oxygen is recommended for all patients receiving LUSEDRA. Dosages of LUSEDRA must be individualized for each patient and titrated to effect [see Dosage and Administration (2.1) and Clinical Pharmacology (12.2)]. Use lower doses of LUSEDRA in patients who are ≥65 years of age or who have severe systemic disease [see Dosage and Administration (2.3)]. The additive cardiorespiratory effects of narcotic analgesics and sedative-hypnotic agents should be considered when administered concomitantly with LUSEDRA.
Patients should be assessed for their ability to demonstrate purposeful response while sedated with LUSEDRA as patients who are unable to do so may lose protective reflexes. Airway assistance maneuvers may be required in the management of respiratory depression (see Table 4).
5.3 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 [see Dosage and Administration (2.2, 2.3)]. 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%).
The risk of hypoxemia is reduced by appropriate positioning of the patient and the use of supplemental oxygen in all patients receiving LUSEDRA. Airway assistance maneuvers may be required in the management of hypoxemia (see Table 4). The additive cardiorespiratory effects of narcotic analgesics and other sedative-hypnotic agents should be considered when administered concomitantly with LUSEDRA.
5.4 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 sedated for colonoscopy who became minimally responsive or unresponsive to vigorous tactile or painful stimulation was 7/183 (4%). The duration of minimal or complete unresponsiveness in colonoscopy patients ranged from 2 to 16 minutes. Among patients sedated for bronchoscopy, the incidence of patients who became minimally or completely unresponsive to vigorous tactile or painful stimulation was 24/149 (16%). The duration of minimal to complete unresponsiveness in bronchoscopy patients ranged from 2 to 20 minutes.
5.5 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 [see Dosage and Administration (2.2, 2.3)]. 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. A secure intravenous access catheter and supplemental volume replacement fluids should be readily available during the procedure. Additional pharmacological management may be necessary.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Fospropofol Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Fospropofol Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Fospropofol Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Fospropofol in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fospropofol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Fospropofol during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Fospropofol in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Fospropofol in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Fospropofol in geriatric settings.
Gender
There is no FDA guidance on the use of Fospropofol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Fospropofol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Fospropofol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Fospropofol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Fospropofol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Fospropofol in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Fospropofol Administration in the drug label.
Monitoring
There is limited information regarding Fospropofol Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Fospropofol and IV administrations.
Overdosage
There is limited information regarding Fospropofol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Fospropofol Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Fospropofol Mechanism of Action in the drug label.
Structure
There is limited information regarding Fospropofol Structure in the drug label.
Pharmacodynamics
There is limited information regarding Fospropofol Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Fospropofol Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Fospropofol Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Fospropofol Clinical Studies in the drug label.
How Supplied
There is limited information regarding Fospropofol How Supplied in the drug label.
Storage
There is limited information regarding Fospropofol Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Fospropofol Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Fospropofol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Fospropofol Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Fospropofol Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.