Safety - Adverse Reactions
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Clinical trials experience
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)
Adverse reactions occurring in 2% or greater of patients receiving ZERBAXA in a Phase 3 HABP/VABP clinical trial
Adverse reactions | ||
---|---|---|
ZERBAXAaN=361 n (%) | Meropenem N=359 n (%) | |
Hepatic transaminase increasedb | 43 (11.9) | 26 (7.2) |
Renal impairment/renal failurec | 32 (8.9) | 22 (6.1) |
Diarrhea | 23 (6.4) | 25 (7.0) |
Intracranial hemorrhaged | 16 (4.4) | 5 (1.4) |
Vomiting | 12 (3.3) | 10 (2.8) |
Clostridioides difficile colitise | 10 (2.8) | 2 (0.6) |
- aThe ZERBAXA for injection dose was 3 g intravenously every 8 hours, adjusted to match renal function where appropriate.
- bIncludes alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, hypertransaminasaemia, liver function test abnormal.
- cIncludes acute renal failure, anuria, azotemia, oliguria, prerenal failure, renal failure, renal impairment.
- dIncludes cerebellar hemorrhage, cerebral hematoma, cerebral hemorrhage, hemorrhage intracranial, hemorrhagic stroke, hemorrhagic transformation stroke, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma.
- eIncludes Clostridioides difficile colitis, Clostridioides difficile infection, Clostridioides test positive.
Less common adverse reactions in a Phase 3 HABP/VABP clinical trial
- Investigations: blood alkaline phosphatase increased, gamma-glutamyltransferase increased, Coombs direct test positive
Laboratory values
The development of a positive direct Coombs test may occur during treatment with ZERBAXA. The incidence of seroconversion to a positive direct Coombs test was 0.2% in patients receiving ZERBAXA and 0% in patients receiving the comparator in the cUTI and cIAI clinical trials. The incidence of seroconversion to a positive direct Coombs test was 31.2% in patients receiving ZERBAXA and 3.6% in patients receiving meropenem in the HABP/VABP clinical trial. In clinical trials, there was no evidence of hemolysis in patients who developed a positive direct Coombs test in any treatment group.
Complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis
ZERBAXA was evaluated in Phase 3 comparator-controlled clinical trials of cIAI and cUTI, which included a total of 1015 patients treated with ZERBAXA (1.5 g every 8 hours, adjusted based on renal function where appropriate) and 1032 patients treated with comparator (levofloxacin 750 mg daily in cUTI or meropenem 1 g every 8 hours in cIAI) for up to 14 days. The mean age of treated patients was 48 to 50 years (range 18 to 92 years), across treatment arms and indications. In both indications, about 25% of the subjects were 65 years of age or older. Most patients (75%) enrolled in the cUTI trial were female, and most patients (58%) enrolled in the cIAI trial were male. Most patients (>70%) in both trials were enrolled in Eastern Europe and were White.
The most common adverse reactions (5% or greater in either indication) occurring in patients receiving ZERBAXA were nausea, diarrhea, headache, and pyrexia. The table below lists adverse reactions occurring in 1% or greater of patients receiving ZERBAXA in Phase 3 cIAI and cUTI clinical trials.