LUSEDRA

LUSEDRA — fospropofol disodium injection
Eisai, Inc

1 INDICATIONS AND USAGE

LUSEDRATM (fospropofol disodium) injection is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Guidelines

  • Administer LUSEDRA intravenously as a bolus injection.
  • Use supplemental oxygen for all patients undergoing sedation with LUSEDRA.
  • Individualize the dosage of LUSEDRA and titrate to the level of sedation required for the procedure.
  • In adults aged 18 to <65 years who are healthy or have mild systemic disease as categorized by the American Society of Anesthesiologists (ASA P1 or P2), the standard dosing regimen of LUSEDRA should be followed [see Standard Dosing Regimen for Sedation (2.2) ].
  • In adults who are ≥ 65 years of age or who have severe systemic disease (ASA P3 or P4), the modified dosing regimen should be followed [see Modified Dosing Regimen for Sedation in Patients ≥ 65 years or Those with Severe Systemic Disease (2.3) ].
  • Administer supplemental doses of LUSEDRA based on the patient’s level of sedation and the level of sedation required for the procedure. Give 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. Use only the minimum dosage required to facilitate the procedure.
  • Consider the potential for worsened cardiorespiratory depression prior to using LUSEDRA concomitantly with other drugs that have the same potential (e.g., sedative-hypnotics or narcotic analgesics) [see Warnings and Precautions (5.2, 5.3)].
  • In clinical studies, an opioid premedication (fentanyl citrate 50 mcg intravenously) was administered five minutes prior to the initial dose of LUSEDRA.

2.2 Standard Dosing Regimen for Sedation

In adults aged 18 to <65 years who are healthy or have mild systemic disease (ASA P1 or P2)1 , the standard dosing regimen of LUSEDRA is an initial intravenous bolus of 6.5 mg/kg followed by supplemental doses of 1.6 mg/kg intravenously (25% of initial dosage) as needed to achieve the desired level of sedation as shown in Table 1.

The dosage of LUSEDRA is limited by lower and upper weight bounds of 60 kg and 90 kg. Adults who weigh >90 kg should be dosed as if they weigh 90 kg. No initial dose should exceed 16.5 mL; no supplemental dose should exceed 4 mL. Adults who weigh <60 kg should be dosed as if they weigh 60 kg. Dosages lower than those specified for the lower weight limit may be used to achieve lesser levels of sedation. In clinical studies, an opioid premedication (fentanyl citrate 50 mcg IV) was administered five minutes prior to the initial dose of LUSEDRA.

Table 1. Standard Dosing Regimen, Adults 18 to <65 Years of Age Who are Healthy or Have Mild Systemic Disease (ASA P1 or P2)
Initial Dose Supplemental Dose No more frequently than every 4 min.
Weight (kg) mg mL mg mL
Note: Doses in this table are rounded to the nearest half-milliliter volume to facilitate practical measurement; hence, they may differ slightly from the dose recommended on the basis of mg/kg.
≤60 385 11 105 3
61 to 63 402.5 11.5 105 3
64 to 65 420 12 105 3
66 to 68 437.5 12.5 105 3
69 to 71 455 13 105 3
72 to 74 472.5 13.5 122.5 3.5
75 to 76 490 14 122.5 3.5
77 to 79 507.5 14.5 122.5 3.5
80 to 82 525 15 140 4
83 to 84 542.5 15.5 140 4
85 to 87 560 16 140 4
88 to 89 577.5 16.5 140 4
≥90 577.5 16.5 140 4

2.3 Modified Dosing Regimen for Sedation in Patients ≥65 years or Those with Severe Systemic Disease (ASA P3 or P4)

Adults 65 years of age or those with severe systemic disease (ASA P3 or P4)1 should receive initial and supplemental intravenous dosages of 75% of the standard dosing regimen, as presented in Table 2. LUSEDRA is administered intravenously as a bolus injection. In clinical studies, an opioid premedication (fentanyl citrate 50 mcg IV) was administered five minutes prior to the initial dose of LUSEDRA.

Table 2. Modified Dosing Regimen, Ages ≥ 65 Years Or Those with Severe Systemic Disease (ASA P3 or P4)
Initial Dose Supplemental Dose No more frequently than every 4 min.
Weight (kg) mg mL mg mL
Note: Doses in this table are rounded to the nearest half-milliliter volume to facilitate practical measurement; hence, they may differ slightly from the dose recommended on the basis of mg/kg.
≤60 297.5 8.5 70 2
61 to 62 297.5 8.5 70 2
63 to 64 315 9 87.5 2.5
65 to 66 315 9 87.5 2.5
67 to 69 332.5 9.5 87.5 2.5
70 to 73 350 10 87.5 2.5
74 to 77 367.5 10.5 87.5 2.5
78 to 80 385 11 105 3
81 to 84 402.5 11.5 105 3
85 to 87 420 12 105 3
88 to 89 437.5 12.5 105 3
≥90 437.5 12.5 105 3

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