RELENZA

Absorption and Bioavailability Pharmacokinetic studies of orally inhaled zanamivir indicate that approximately 4% to 17% of the inhaled dose is systemically absorbed. The peak serum concentrations ranged from 17 to 142 ng/mL within 1 to 2 hours following a 10‑mg dose. The area under the serum concentration versus time curve (AUC∞) ranged from 111 to 1,364 ng

• hour/mL.

DistributionZanamivir plasma protein binding is less than 10% and the blood to plasma ratio is 0.56. The volume of distribution i...

14.1 Treatment of Influenza Adults and Adolescents The efficacy of RELENZA 10 mg inhaled twice daily for 5 days in the treatment of influenza has been evaluated in placebo-controlled trials conducted in North America, the Southern Hemisphere, and Europe during their respective influenza seasons. The magnitude of treatment effect varied between trials, with possible relationships to population-related factors including amount of symptomatic relief medication used. Populations Studied: The principal Phase 3 trials enrolled 1,588 subjects aged 12 years and older (median age 34 years, 49% male, 91...

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Bronchospasm [see Warnings and Precautions ( 5.1 )] .
• Safety information in patients with underlying airways disease [see Warnings and Precautions ( 5.1 )].
• Allergic-like reactions [see Warnings and Precautions ( 5.2 )] . 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...

RELENZA is contraindicated in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins [see Warnings and Precautions ( 5.2 ), Description ( 11 )] . Do not use in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins. ( 4 )

• 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. ( 5.1 )
• Allergic Reactions: Discontinue RELENZA and initiate appropriate treatment if an allergic reaction occurs or is suspected. ( 5.2 )
• Neuropsychiatric Events: Patients with influenza, particularly pediatric patients, may be at an increased risk of seizures, confusion, or abnormal be...

7 DRUG INTERACTIONS 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 antiv...