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
RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease.
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
