ABOUT RELENZA

RELENZA Indications and
Important Safety Information[38]

RELENZA is administered by oral inhalation, using the DISKHALER® device. Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible. If RELENZA is prescribed for children, it should be used only under adult supervision and instruction, and the supervising adult should first be instructed by a healthcare professional.

INDICATIONS AND USAGE

Treatment of Influenza: RELENZA is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than 2 days (see Description of Clinical Studies and Precautions in the RELENZA Prescribing Information).

Prophylaxis of Influenza: RELENZA is indicated in adults and pediatric patients 5 years of age and older for prophylaxis of influenza.

Important Information on Use of RELENZA:

• RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airway disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm
   
• RELENZA has not been proven effective for treatment of influenza in individuals with underlying airway disease
   
• RELENZA has not been proven effective for prophylaxis of influenza in the nursing home setting
   
• RELENZA is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control’s Immunization Practices Advisory Committee

 
Important Safety Information About RELENZA

• 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
  
• Safety and efficacy have not been demonstrated in patients with high-risk underlying medical conditions
  
• 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
  
• Please see complete Prescribing Information for RELENZA