Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity reactions [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.3) ] Adult cIAI, cUTI and HAB/VABP Patients : The most common adverse reactions in adult patients (≥5% in either the cIAI or cUTI indication) are nausea, diarrhea, headache, and pyrexia.
The most common adverse reactions (≥5% in the HABP/VABP indication) are increase in hepatic transaminases, renal impairment/renal failure, and diarrhea.
( 6.1 ) Pediatric cIAI and cUTI Patients: The most common adverse reactions in pediatric patients (≥7% in either the cIAI or cUTI indication) are thrombocytosis, diarrhea, pyrexia, leukopenia, abdominal pain, vomiting, increased aspartate aminotransferase, and anemia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and also may not reflect rates observed in practice.
Adult Patients 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.
5 WARNINGS AND PRECAUTIONS Decreased efficacy was observed in a Phase 3 cIAI trial in a subgroup of patients with baseline CrCl of 30 to 50 mL/min.
Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly.
( 5.1 ) Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs.
Exercise caution in patients with known hypersensitivity to beta-lactam antibacterial drugs.
If an anaphylactic reaction to ZERBAXA occurs, discontinue the drug and institute appropriate therapy.
Like all medications, Zerbaxa can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: