TABLE 4.
Infusion-related reactions in neutropenic patients receiving AmBisome
| Reaction | No. (%) of infusion-related reactions in the following dosage cohorta:
|
||||
|---|---|---|---|---|---|
| 1.0 mg/kg (n = 86) | 2.5 mg/kg (n = 61) | 5.0 mg/kg (n = 97) | 7.5 mg/kg (n = 87) | Total (n = 331) | |
| Temp elevation of ≥1°C | 1 (1.2) | 0 | 9 (9) | 5 (6) | 15 (5) |
| Chills | 4 (5) | 0 | 3 (3) | 0 | 7 (2) |
| Rigors | 0 | 1 (1.6) | 4 (4) | 1 (1.1) | 6 (2) |
| Nausea | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 0 | 0 | 0 | 0 | 0 |
| Headache | 0 | 0 | 0 | 0 | 0 |
| Hypotensionb | 0 | 1 (1.6) | 0 | 0 | 1 (0.3) |
| Hypertensionc | 0 | 0 | 1 (1) | 2 (2) | 3 (0.9) |
| Dyspnea on infusion | 0 | 0 | 1 (1) | 1 (1.1) | 2 (0.6) |
| Transient localized urticaria | 0 | 0 | 2 (2) | 0 | 2 (0.6) |
| Generalized flushing reaction | 0 | 0 | 2 (2) | 0 | 2 (0.6) |
| Premedicationd required for reaction | 0 | 0 | 4 (4) | 0 | 4 (1.2) |
a
Infusion-related reactions are defined as reactions developing during infusion of the study drug. n, number of infusions.
b
Defined as a >25% decrease in systolic blood pressure.
c
Defined as a >25% increase in systolic blood pressure.
d
Benadryl, 50 mg given intravenously. (No other premedications were administered prior to the study drug.)