자나미비르(미분화)

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. ( 1.1 ) Prophylaxis of influenza in patients aged 5 years and older. ( 1.2 ) Important Limitations of Use: Not recommended for treatment or prophylaxis of influenza in: • Individuals with underlying airways disease. ( 5.1 ) Not proven effective for: • Treatment in individuals with underlying airways disease. ( 1.3 ) • Prophylaxis in nursing home residents. ( 1.3 ) Not a substitute for annual influenza vaccination. ( 1.3 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA. ( 1.3 ) 1.1 Treatment of Influenza RELENZA (zanamivir) inhalation powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients aged 7 years and older who have been symptomatic for no more than 2 days. 1.2 Prophylaxis of Influenza RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged 5 years and older. 1.3 Important Limitations of Use • RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm [see Warnings and Precautions ( 5.1 )] . • RELENZA has not been …

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 behavior early in their illness. Monitor for signs of abnormal behavior. ( 5.3 ) • High-Risk Underlying Medical Conditions: Safety and effectiveness have not been demonstrated in these patients. ( 5.4 ) 5.1 Bronchospasm RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways 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 airways 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. Some patients without prior pulmonary disease may also have respiratory abnormalities from acute respiratory infection that could resemble adverse drug reactions or increase patient …

8.1 Pregnancy Risk Summary Available data from published studies suggest that use of RELENZA during pregnancy is not associated with an increased risk of birth defects or adverse maternal or fetal outcomes. However, these studies are limited by their small sample sizes, which preclude a definitive assessment of the risk (see Data). There are risks to the mother and fetus associated with influenza infection in pregnancy (see Clinical Considerations) . In animal reproduction studies, no adverse developmental effects were observed with intravenous or subcutaneous administration of zanamivir at exposures 300 and 150 times, respectively, the systemic exposure at the maximum recommended human …