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PrZYVOXAM® (linezolid) Reimbursement/ Coverage
 DIN(s):
02243686 (3 g/bottle)
02243685 (2mg /ml injection)
02243684 (600 mg tablet)
ZYVOXAM Product Monograph
ZYVOXAM is an eligible benefit through most private insurance plans, provincial drug benefit programs and federal drug programs. The sidebar menu allows you to access specific information on coverage for ZYVOXAM including coverage/ reimbursement criteria and guidelines, limited use codes, special authorization forms, instructions and other resources.
Click on the plan or program name in the left sidebar menu to access more information.
Indications:
ZYVOXAM (linezolid) Tablets and Injection are indicated for the treatment of adult patients with the following infections, when caused by susceptible strains of the designated micro-organisms:
Note: ZYVOXAM is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected (see WARNINGS AND PRECAUTIONS in the Product Monograph).
Vancomycin-Resistant Enterococcus faecium (VREF) Infections: ZYVOXAM is indicated for the treatment of the following infections when due to VREF:
- Intra-abdominal, skin and skin-structure, and urinary tract infections (including cases associated with concurrent bacteremia).
- (see CLINICAL TRIALS section of Product Monograph).
- Note: This indication for VREF is based on non-comparative studies.
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
Community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible strains only) including cases with concurrent bacteremia or Staphylococcus aureus (methicillin-susceptible and -resistant strains).
Complicated skin and skin structure infections, including non-limb threatening diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae.
Note: ZYVOXAM has not been studied in the treatment of necrotizing fasciitis or decubitus ulcers.
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.
The above coverage criteria may not be the same as the approved indication(s) for this product. Please refer to the ZYVOXAM Product Monograph for the approved indications.
*Prior to instituting treatment with ZYVOXAM, appropriate specimens should be obtained for isolation of the causative organism(s) and for determination of susceptibility to ZYVOXAM.
In infections where concomitant Gram-negative and/or anaerobic pathogens are suspected or are known to be present, ZYVOXAM must be used in combination with an appropriate antibiotic in order to provide adequate antimicrobial coverage.
If clinically indicated, treatment with ZYVOXAM may be started empirically before results of susceptibility testing are available. Local epidemiology and susceptibility patterns may help in the selection of empiric therapy. Once culture results become available antimicrobial therapy can be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOXAM and other antibacterial drugs, ZYVOXAM should be used only to treat infections that are proved or suspected to be caused by susceptible bacteria. Because the inappropriate use of antibiotics can increase organism resistance, prescribers should carefully consider alternatives before initiating treatment with ZYVOXAM in an outpatient setting.
ZYVOXAM (linezolid) Tablets and Injection are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components.
The most common clinical trial adverse events in patients treated with ZYVOXAM were diarrhea (incidence across studies: 2.8 to 11.0%), headache (incidence across studies: 0.5 to 11.3%) and nausea (incidence across studies: 3.4 to 9.6%). Please see Product Monograph for a complete list of adverse events.
Lactic acidosis has been reported with the use of ZYVOXAM. Patients who develop recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level while receiving ZYVOXAM should receive immediate medical attention.
An imbalance in mortality was seen in patients treated with linezolid relative to
vancomycin/dicloxacillin/oxacillin in an open-label study in seriously ill patients with intravascular catheter-related infections [78/363 (21.5%) vs. 58/363 (16.0%); odds ratio 1.426, 95% CI 0.970, 2.098]. While causality has not been established, this observed imbalance occurred primarily in linezolid-treated patients in whom either Gram-negative pathogens, mixed Gram-negative and Gram-positive pathogens, or no pathogen were identified at baseline, but was not seen in patients with Gram-positive infections only.
Linezolid is not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections.
Linezolid has no clinical activity against Gram-negative pathogens and is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected; appropriate concomitant therapy is also required when anaerobic pathogens are isolated (see INDICATIONS AND CLINICAL USE).
Visual function should be monitored in all patients taking ZYVOXAM for longer than the maximum recommended duration and in all patients reporting new visual symptoms regardless of length of therapy with ZYVOXAM.
Please see Product Monograph for complete Warnings and Precautions, Dosage and Administration.
ZYVOXAM Product Monograph
Resources for Healthcare Professionals and Your Patients
The following websites are external links. DrugCoverage assumes no responsibility for the content of these sites.
Pfizer Canada Medical Information services 1-800-463-6001
© Pfizer Canada Inc. Kirkland, Quebec, H9J 2M5. Copyright in respect of Pfizer Canada Inc. materials.
ZYVOXAM® Pfizer Caribe Limited, owner/ Pfizer Canada Inc., Licensee
TM DrugCoverage is a trademark of Plasmid Biocommunications Inc.
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