Relenza Special Precautions

Due to the limited number of patients with severe asthma or with other chronic respiratory disease, patients with unstable chronic illnesses or immunocompromised patients (see Pharmacology: Pharmacodynamics under Actions) who have been treated, it has not been possible to demonstrate the efficacy and safety of RELENZA in these groups. Due to limited and inconclusive data, the efficacy of RELENZA in the prevention of influenza in the nursing home setting has not been demonstrated. The efficacy of zanamivir for the treatment of elderly patients ≥65 years has also not been established (see Pharmacology: Pharmacodynamics under Actions).
There have been very rare reports of patients being treated with RELENZA who have experienced bronchospasm and/or decline in respiratory function which may be acute and/or serious. Some of these patients did not have any previous history of respiratory disease. Any patients experiencing such reactions should discontinue RELENZA and seek medical evaluation immediately.
Due to the limited experience, patients with severe asthma require a careful consideration of the risk in relation to the expected benefit, and RELENZA should not be administered unless close medical monitoring and appropriate clinical facilities are available in case of bronchoconstriction. In patients with persistent asthma or severe COPD, management of the underlying disease should be optimised during therapy with RELENZA.
Should zanamivir be considered appropriate for patients with asthma or chronic obstructive pulmonary disease, the patient should be informed of the potential risk of bronchospasm with RELENZA and should have a fast acting bronchodilator available. Patients on maintenance inhaled bronchodilating therapy should be advised to use their bronchodilators before taking RELENZA (see Dosage & Administration).
Zanamivir inhalation powder must not be made into an extemporaneous solution for administration by nebulisation or mechanical ventilation. There have been reports of hospitalised patients with influenza who received a solution made with zanamivir inhalation powder administered by nebulisation or mechanical ventilation, including a fatal case where it was reported that the lactose in this formulation obstructed the proper functioning of the equipment. Zanamivir inhalation powder must only be administered using the device provided (see Dosage & Administration).
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
RELENZA is not a substitute for influenza vaccination and the use of RELENZA must not affect the evaluation of individuals for annual vaccination. The protection against influenza only lasts as long as RELENZA is administered. RELENZA should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza is circulating in the community.
RELENZA is effective only against illness caused by influenza viruses. There is no evidence for the efficacy of RELENZA in any illness caused by agents other than influenza viruses.
Neuropsychiatric events have been reported during administration of RELENZA in patients with influenza, especially in children and adolescents. Therefore, patients should be closely monitored for behavioural changes and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see Adverse Reactions).
Effects on ability to drive and use machines: Zanamivir has no or negligible influence on ability to drive and use machines.