Established Safety Profile During
Prophylaxis Use with RELENZA

10-Day Family/Household Prophylaxis Studies

	Contact Cases
Adverse Event	RELENZA    (%)    (n = 1,068)	Placebo (%)    (n = 1,059)
Lower respiratory
Viral respiratory infections	13	19
Cough	7	9
Neurologic
Headaches	13	14
Ear, nose, and throat
Nasal signs and symptoms	12	12
Throat & tonsil discomfort & pain	8	9
Nasal inflammation	1	2
Musculoskeletal
Muscle pain	3	3
Endocrine and metabolic
Feeding problems (decreased or     increased appetite and anorexia)	2	2
Gastrointestinal
Nausea and vomiting	1	2
Non-site specific
Malaise and fatigue	5	5
Temperature regulation disturbances     (fever and/or chills)	5	4
*In prophylaxis studies symptoms associated with influenza-like illness were captured as adverse events; subjects were enrolled during a winter respiratory season during which time any symptoms that occurred were captured as adverse events.

28-Day Community Prophylaxis Studies

	Contact Cases
Adverse Event	RELENZA (%) (n = 2,231)	Placebo (%) (n = 2,239)
Neurologic
Headaches	24	26
Ear, nose, and throat
Throat & tonsil discomfort & pain	19	20
Nasal signs and symptoms	12	13
Ear, nose, and throat infections	2	2
Lower respiratory
Cough	17	18
Viral respiratory infections	3	4
Musculoskeletal
Muscle pain	8	8
Musculoskeletal pain	6	6
Arthralgia & articular rheumatism	2	<1
Endocrine and metabolic
Feeding problems (decreased or     increased appetite and anorexia)	4	4
Gastrointestinal
Nausea and vomiting	2	3
Diarrhea	2	2
Non-site specific
Temperature regulation disturbances     (fever and/or chills)	9	10
Malaise and fatigue	8	8
*In prophylaxis studies symptoms associated with influenza-like illness were captured as adverse events; subjects were enrolled during a winter respiratory season during which time any symptoms that occurred were captured as adverse events.

next: Treatment of Influenza A and B

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.