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ZERBAXA® Product Monograph

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Clinical use:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA® and other antibacterial drugs, ZERBAXA® should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

Geriatrics (≥65 years of age): A higher incidence of adverse reactions was observed in patients aged 65 years and older.

Pediatrics (<18 years of age): The safety and efficacy of ZERBAXA® in patients below 18 years of age have not been established.

Contraindications:

  • Patients with known serious hypersensitivity to penicillins, cephalosporins or other beta-lactams.

Most serious warnings and precautions:

Beta-lactam antibacterial hypersensitivity: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before therapy is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins or beta-lactams should be made. If this product is to be given to a patient with a cephalosporin, penicillin or other beta-lactam allergy, caution should be exercised because cross-sensitivity has been established. If an anaphylactic reaction occurs, the drug should be discontinued and appropriate therapy instituted.

Other relevant warnings and precautions:

  • If Clostridium difficile-associated disease is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
  • Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with beta-lactam treatment. When SCAR is suspected, ZERBAXA® should be discontinued and appropriate therapy and/or measures taken.
  • Prescribing 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.
  • Use in pregnant women only if the potential benefit justifies the potential risk to the fetus.
  • Should not be administered to a nursing woman unless the expected benefit to the mother outweighs the potential risk to the infant.
  • In patients with renal impairment, dosage adjustment is required.

For more information:

Please consult the Product Monograph at https://www.merck.ca/static/pdf/ZERBAXA-PM_E.pdf for important information relating to adverse reactions, drug interactions and dosing information not discussed in this piece.

The Product Monograph is also available through our Medical Information Centre at 1-800-567-2594.