Established Safety Profile
During Treatment with RELENZA

Summary of Adverse Events ≥1.5% Incidence
During Treatment in Adults and Adolescents [1]

Adverse Event	RELENZA 10 mg BID (%) (n = 1,132)	Placebo (%) (n = 1,520)
Headaches	2	3
Diarrhea	3	4
Nausea	3	3
Vomiting	1	2
Nasal signs and symptoms	2	3
Bronchitis	2	3
Cough	2	3
Sinusitis	3	2
Ear, nose, and throat infections	2	2
Dizziness	2	<1

Summary of Adverse Events ≥1.5% Incidence
During Treatment in Pediatric Patients [1]

Adverse Event	RELENZA 10 mg BID (%) (n = 291)	Placebo (%) (n = 318)
Ear, nose and throat infections	5	5
Ear, nose and throat hemorrhage	<1	2
Asthma	<1	2
Cough	<1	2
Vomiting	2	3
Diarrhea	2	2
Nausea	<1	2

next: RELENZA’S Mechanism of Action

Important Safety Information 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 Click here for Complete Prescribing Information for RELENZA.