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ABOUT RELENZA
RELENZA Resistance Profile
As noted earlier, RELENZA will represent 20% of the Strategic National Stockpile procurement of antivirals.[36] The reason is simple: diversity of antivirals.
Emergence of resistance is a potentially significant issue when considering widespread use of antivirals for the treatment and/or prophylaxis of influenza. Some of the currently circulating H5N1 (avian flu) strains in southeastern Asia have already acquired resistance to the earlier class of antivirals.
RELENZA Resistance:
- Resistance to RELENZA has not been observed in immunocompetent individuals treated with RELENZA in clinical studies or in clinical practice. Only one case of resistance to zanamivir has been reported to date. This was in a child with a compromised immune system[39]
- Some viruses resistant to other neuraminidase inhibitors retain sensitivity to RELENZA.[40] A resistant virus (H274Y mutant) with these characteristics has been identified in several patients with H5N1 influenza infection in Vietnam[41]
Note: Clinical efficacy can only be concluded from clinical trials. No data are available on the use of RELENZA in patients infected with H5N1. Given the difficulty of conducting clinical trials with potential pandemic flu strains, to date, no clear evidence exists to show whether RELENZA or Tamiflu® (oseltamivir phosphate) is effective for treating patients with H5N1 infection or for prophylaxis of people exposed to H5N1.
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How to Use RELENZA Step-by-Step
Important Safety Information About RELENZA
RELENZA IS NOT RECOMMENDED FOR TREATMENT OR PROPHYLAXIS OF INFLUENZA IN INDIVIDUALS WITH UNDERLYING AIRWAY DISEASE (SUCH AS ASTHMA OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE).
- Serious cases of bronchospasm, including fatalities, have been reported during treatment with RELENZA in patients with and without underlying airway disease. Many of these cases were reported during postmarketing, and causality was difficult to assess
- RELENZA SHOULD BE DISCONTINUED IN ANY PATIENT WHO DEVELOPS BRONCHOSPASM OR DECLINE IN RESPIRATORY FUNCTION; immediate treatment and hospitalization may be required
- Safety and efficacy have not been demonstrated in patients with high-risk underlying medical conditions
- Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible
- If treatment with RELENZA is considered for a patient with underlying airway disease, the potential risks and benefits should be carefully weighed. If a decision is made to prescribe RELENZA for such a patient, this should be done only under conditions of careful monitoring of respiratory function, close observation, and appropriate supportive care including availability of fast-acting bronchodilators
- Common adverse events in treatment and prophylaxis studies with RELENZA were nausea, diarrhea, sinusitis, viral respiratory infections, headaches, nasal signs and symptoms. The incidence of these adverse events was similar in both groups for RELENZA and placebo-treated groups
- Please see complete Prescribing Information for RELENZA
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