Important Safety Information about RELENZA

Some people have had bronchospasm (wheezing) or serious breathing problems when they used RELENZA. Many but not all of these people had previous asthma or other pulmonary disease. RELENZA has not been shown to shorten the time of flu in people with these diseases. Because of the risk of side effects and because it has not been shown to help them, RELENZA is not best for people with chronic respiratory disease such as asthma or chronic obstructive pulmonary disease (COPD).

If you develop symptoms such as wheezing or shortness of breath, stop using RELENZA and contact your doctor right away.

If you have diseases like asthma and chronic obstructive pulmonary disease and your doctor has prescribed RELENZA, you should have a fast-acting, inhaled bronchodilator available for your use. If you are scheduled to use an inhaled bronchodilator at the same time as RELENZA, use the inhaled bronchodilator before using RELENZA.

Other kinds of infections can appear like influenza or occur along with influenza, and need different kinds of treatment. Contact your doctor if you feel worse or develop new symptoms during or after treatment, or if your flu symptoms do not start to get better.

In studies, the most common side effects with RELENZA have been headaches; diarrhea; nausea; vomiting; nasal irritation; bronchitis; cough; sinusitis; ear, nose, and throat infections; and dizziness. Other side effects that have been reported, but were not as common, include rashes and allergic reactions, some of which were severe.

People with influenza may be at increased risk of seizures, confusion, or abnormal behavior early in their illness. Therefore, patients should be observed for signs of unusual behavior, and a healthcare professional contacted if needed.

This list of side effects is not complete. Your doctor or pharmacist can discuss with you a more complete list of possible side effects with RELENZA. Talk to your doctor promptly about any side effects you have.