Zerbaxa Special Precautions

Impaired renal function: The Ceftolozane/Tazobactam (ZERBAXA) dose should be adjusted based on renal function [see Dosage & Administration].
In a subgroup analysis of a Phase 3 cIAI trial, clinical cure rates were lower in patients with baseline CrCL of 30 to ≤50 mL/min compared to those with CrCL >50 mL/min. The reduction in clinical cure rates was more marked in the Ceftolozane/Tazobactam (ZERBAXA) plus metronidazole arm compared to the meropenem arm. A similar trend was also seen in the cUTI trial. Patients with renal impairment at baseline should be monitored frequently for any changes in renal function during treatment and the dose of Ceftolozane/Tazobactam (ZERBAXA) should be adjusted as necessary.
Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with Ceftolozane/Tazobactam (ZERBAXA), make careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactams. If this product is to be given to a patient with a cephalosporin, penicillin, or other beta-lactam allergy, exercise caution because cross sensitivity has been established. If an anaphylactic reaction to Ceftolozane/Tazobactam (ZERBAXA) occurs, discontinue the drug and institute appropriate therapy.
Clostridium difficile-associated Diarrhea: Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including Ceftolozane/Tazobactam (ZERBAXA), and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile [see Adverse Reactions].
These types of infection may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea during or subsequent to the administration of Ceftolozane/Tazobactam (ZERBAXA). In such circumstances, the discontinuation of therapy with Ceftolozane/Tazobactam (ZERBAXA) and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
Development of Drug Resistant Bacteria: Prescribing Ceftolozane/Tazobactam (ZERBAXA) in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Patients with Renal Impairment: Dosage adjustment is required in patients with moderate (CrCL 30 to 50 mL/min) or severe (CrCL 15 to 29 mL/min) renal impairment and in patients with ESRD on HD [see Dosage & Administration and Precautions].
Use in Children: The safety and efficacy of Ceftolozane/Tazobactam (ZERBAXA) in children and adolescents below 18 years of age have not yet been established.
Use in Elderly: In a population pharmacokinetic analysis of ceftolozane and tazobactam, no clinically relevant differences in exposure were observed with regard to age. No dose adjustment of Ceftolozane/Tazobactam (ZERBAXA) based on age alone is recommended.
Ceftolozane/Tazobactam (ZERBAXA) is substantially excreted by the kidney and the risk of adverse reactions to Ceftolozane/Tazobactam (ZERBAXA) may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. Adjust dosage for elderly patients based on renal function [see Dosage & Administration].