Important Safety Information
ZYVOX® (linezolid) use is contraindicated in patients with known hypersensitivity to ZYVOX or any of the other product components.
ZYVOX should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid) or within 2 weeks of taking any such product.
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving ZYVOX. In cases where the outcome is known, when ZYVOX was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive ZYVOX, particularly in those who receive ZYVOX for longer than two weeks, those with pre-existing myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibiotic therapy. Discontinuation of therapy with ZYVOX should be considered in patients who develop or have worsening myelosuppression.
Peripheral and optic neuropathy have been reported primarily in patients treated with ZYVOX for longer than the maximum recommended duration of 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. If peripheral or optic neuropathy occurs, the continued use of ZYVOX in these patients should be weighed against potential risks.
Spontaneous reports of serotonin syndrome including fatal cases have been reported with the co-administration of ZYVOX and serotonergic agents. Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome or neuroleptic malignant syndrome-like (NMS-like) reactions, ZYVOX should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, bupropion, or buspirone.
In some cases, a patient already receiving a serotonergic antidepressant or buspirone may require urgent treatment with ZYVOX. If alternatives to ZYVOX are not available and the potential benefits of ZYVOX outweigh the risks of serotonin syndrome or NMS-like reactions, the serotonergic antidepressant should be stopped promptly and ZYVOX administered. The patient should be monitored for two weeks (five weeks if fluoxetine was taken) or until 24 hours after the last dose of ZYVOX, whichever comes first. The patient should also be monitored for discontinuation symptoms of the antidepressant.
A mortality imbalance was seen in an investigational study in ZYVOX-treated patients with catheter-related bloodstream infections. ZYVOX is not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections. ZYVOX 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.
Clostridium difficile associated diarrhea has been reported with use of nearly all antibacterial agents, including ZYVOX, and may range in severity from mild diarrhea to fatal colitis.
Unless patients are monitored for potential increases in blood pressure, ZYVOX should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following: directly and indirectly acting sympathomimetic, vasopressive, and dopaminergic agents.
Lactic acidosis has been reported with the use of ZYVOX. Patients receiving ZYVOX who develop recurrent nausea, vomiting, unexplained acidosis, or a low bicarbonate level should receive immediate medical evaluation.
Convulsions have been reported in patients treated with ZYVOX. In some of these cases, a history of seizures or risk factors for seizures was reported.
Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents when treated with ZYVOX, a reversible, non-selective MAO inhibitor. While a causal relationship between ZYVOX and hypoglycemia has not been established, diabetic patients should be cautioned of potential hypoglycemic reactions when treated with ZYVOX. If hypoglycemia occurs, a decrease in the dose of insulin or oral hypoglycemic agent, or discontinuation of oral hypoglycemic agent, insulin, or ZYVOX may be required.
Prescribing ZYVOX in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The most commonly reported adverse events (>5%) in adults across phase 3 clinical trials were diarrhea, nausea, and headache.
ZYVOX® (linezolid) formulations are indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms. ZYVOX 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.
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae.
Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. ZYVOX has not been studied in the treatment of decubitus ulcers.
Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia.
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes.
Community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible strains only).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX and other antibacterial drugs, ZYVOX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Please see full Prescribing Information.
*Terms and Conditions
By using the ZYVOXassist Coupon (“The Coupon”), you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- »The Coupon is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state health care programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico, formerly known as “La Reforma de Salud”)
- »The Coupon is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs
- »This one-time coupon has a maximum benefit of $1000. If a patient’s co-pay is $1001 or less, the patient is responsible for paying $1. If a patient’s co-pay is $1500, the patient is responsible for $500 ($1500 – $1000 = $500)
- »You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- »Coupon is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law
- »The Coupon cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
- »The Coupon will be accepted only at participating pharmacies
- »The Coupon is not health insurance
- »This Coupon is good only in the US and Puerto Rico
- »The Coupon is limited to 1 per person during this offering period and is not transferable
- »Pfizer reserves the right to rescind, revoke, or amend the program without notice
- »No membership fees
- »The Coupon and program expire 12/31/2018
For help with the ZYVOX Coupon, call 1-855-830-9257, or write: ZYVOXassist Coupon Program, 2250 Perimeter Park Drive, Suite 300,
The information provided in this website is intended only for health care professionals in the United States. The products discussed herein may have different product labeling in different countries.