Table 3.
Adverse Effects of Glucarpidase From Select Clinical Trials and Compassionate Use Experiences*
| Study | Patients (n) | Reported Adverse Drug Effects (n, %) |
|---|---|---|
| DeAngelis LM, et al. (1996)25 | 4 | Rash (n = 1, 25%) |
| Widemann BC, et al. (1997)26 | 20 | Flushing (n = 2, 10%) Head pressure (n = 1, 5%) Minimal burning of face/extremities (n = 1, 5%) Shaking (n = 1, 5%) Tingling fingers (n = 1, 5%) Warmth (n = 2, 10%) |
| Buchen S, et al. (2005)28 | 58 | Flushing (n = 2, 3.4%) Shaking (n = 1, 1.7%) |
| Widemann BC, et al. (2010)31 | 100 | Erythema and pruritus of face and legs (n = 1, 1%) Flushing (n = 2, 2%) Head pressure (n = 1, 1%) Minimal burning of face and extremities (n = 1, 1%) Neck rash within a day after glucarpidase (n = 1, 1%) Numbness/burning sensation around penis (n = 1, 1%) Shaking (n = 1, 1%) Tingling fingers (n = 1, 1%) Warmth (n = 2, 2%) |
| Manufacturer’s Studies 1 and 210 | 290 | Blurred vision (n = 1, <1%) Diarrhea (n = 1, <1%) Flushing (n = 5, 2%) Headache (n = 2, 1%) Hypersensitivity (n = 1, <1%) Hypertension (n = 1, <1%) Hypotension (n = 2, 1%) Nausea/vomiting (n = 5, 2%) Paresthesia (n = 7, 2%) Rash (n = 1, <1%) Throat irritation and throat tightness (n = 1, <1%) Tremor (n = 1, <1%) |
| Widemann BC, et al. (2012)11 | 429 | Flushing (1.8%) Headache (1%) Paresthesia (2%) |