Zanamivir

RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for: Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. Prophylaxis of influenza in patients aged 5 years and older. Important Limitations of Use: Not recommended for treatment or prophylaxis of influenza in: • Individuals with underlying airways disease. Not proven effective for: • Treatment in individuals with underlying airways disease. • Prophylaxis in nursing home residents. Not a substitute for annual influenza vaccination. Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA.

Zanamivir is an antiviral drug with activity against influenza virus.

Indication Dose Treatment of Influenza 10 mg twice daily for 5 days Prophylaxis: Household Setting 10 mg once daily for 10 days Community Outbreaks 10 mg once daily for 28 days Note: The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation).

RELENZA is contraindicated in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins. Do not use in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins.

• Bronchospasm: Serious, sometimes fatal, cases have occurred. Not recommended in individuals with underlying airways disease. Discontinue RELENZA if bronchospasm or decline in respiratory function develops. • Allergic Reactions: Discontinue RELENZA and initiate appropriate treatment if an allergic reaction occurs or is suspected. • Neuropsychiatric Events: Patients with influenza, particularly pediatric patients, may be at an increased risk of seizures, confusion, or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. • High-Risk Underlying Medical Conditions: Safety and effectiveness have not been demonstrated in these patients.

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Bronchospasm. • Safety information in patients with underlying airways disease. • Allergic-like reactions. The most common adverse events reported in greater than 1.5% of subjects treated with RELENZA and more commonly than in subjects treated with placebo are: • Treatment Trials – sinusitis, dizziness. • Prophylaxis Trials – fever and/or chills, arthralgia, and articular rheumatism.

The concurrent use of RELENZA with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of potential interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of RELENZA, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of RELENZA. Live attenuated influenza vaccine, intranasal: • Do not administer until 48 hours following cessation of RELENZA. • Do not administer RELENZA until 2 weeks following administration of the live attenuated influenza vaccine, unless medically indicated.

Store at 25 ° C (77 ° F), excursions permitted to 15 ° to 30 ° C (59 ° to 86 ° F).