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RELENZA for the Treatment
of Influenza A and B
RELENZA is indicated for the treatment of uncomplicated acute illness due to influenza A and B virus in adults and children (7 years and older) who have been symptomatic no more than 2 days.
Shortened the duration of influenza
RELENZA shortened the course of major influenza symptoms by up to 1 day (in a study in North America) and by 1.5 days (in a study in Southern Hemisphere countries) in adolescents and adults compared to placebo. [8,9] Additional evidence of efficacy was provided in a study in Europe. [14]
RELENZA shortened duration of major symptoms by 1.5 days in adults and adolescents compared to placebo
Study Characteristics
- Randomized, double-blind, placebo-controlled study conducted in Australia, New Zealand, and South Africa among patients 12 years of age or older.
- Study groups: inhaled RELENZA 10 mg (N = 161 influenza-positive patients) or placebo (N = 160 influenza-positive patients) twice daily for 5 days.
- Compared with placebo, zanamivir relieved influenza symptoms a median of 1.5 days earlier in influenza-positive patients (P=.004).
- The primary efficacy endpoint was length of time to alleviation of illness, which was defined as absence of fever, feverishness, mild or no headache, cough, myalgia, and sore throat for at least 24 hours. [9]
Drug delivery to the primary site of viral replication
RELENZA is for administration to the respiratory tract—the primary site of influenza viral replication [10]—by oral inhalation via the DISKHALER® Inhalation Device.
RELENZA is well-tolerated
RELENZA is well-tolerated, with side effects comparable to placebo. [6] For information on adverse events during treatment, click here.
For information about serious adverse events such as bronchospasm and allergic-like reactions and for safety information in patients with underlying airways disease, see Prescribing Information for RELENZA.
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RELENZA’S Safety Profile During Treatment
Important Safety Information
RELENZA IS NOT RECOMMENDED FOR TREATMENT OR PROPHYLAXIS OF INFLUENZA IN INDIVIDUALS WITH UNDERLYING AIRWAY 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 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
- RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease.
- 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
Click here for Complete Prescribing Information for RELENZA.
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