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 adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] Clostridi oid e s difficile -Associated Diarrhea [ see Warnings and Precautions ( 5.3 ) ] Central Nervous System Reactions [ see Warnings and Precautions ( 5.4 ) ] Adult Patients : The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting.
The most common adverse reactions (3%) in cUTI patients are diarrhea and nausea.
The most common adverse reactions (≥ 5%) in HABP/VABP patients were diarrhea and vomiting.
( 6.1 ) Pediatric Patients (aged 3 months to less than 18 years) : The most common adverse reactions (≥ 3%) in pediatric patients aged 3 months and older were vomiting, diarrhea, rash, and infusion site phlebitis.
( 6.1 ) Pediatric Patients (less than 3 months of age) : The most common adverse reactions (>3 %) in pediatric patients less than 3 months of age were vomiting and increased transaminases.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial s 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 may not reflect the rates observed in practice.
Clinical Trials Experience in Adult Patients AVYCAZ was evaluated in six active-controlled clinical trials in patients with cIAI, cUTI, including pyelonephritis, or HABP/VABP.
These trials included two Phase 2 trials, one in cIAI and one in cUTI, as well as four Phase 3 trials, one in cIAI, one in cUTI (Trial 1), one in cIAI or cUTI due to ceftazidime non-susceptible pathogens (Trial 2), and one in HABP/VABP.
Data from cUTI Trial 1 served as the primary dataset for AVYCAZ safety findings in cUTI as there was a single comparator.
5 WARNINGS AND PRECAUTIONS Decreased Clinical Response in A dult cIAI P atients with B aseline CrC l of 30 to L ess T han or E qual to 50 mL/ min : Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dosage of AVYCAZ accordingly.
( 5.1 ) Hypersensitivity R eactions : Includes anaphylaxis and serious skin reactions.
Cross sensitivity may occur in patients with a history of penicillin allergy.
If an allergic reaction occurs, discontinue AVYCAZ.
( 5.2 ) Clostrid io i des difficile -associated D iarrhea (CDAD) : CDAD has been reported with nearly all systemic antibacterial agents, including AVYCAZ.
Like all medications, Avycaz 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: