If a decision is made to prescribe RELENZA for a patient with asthma or chronic obstructive pulmonary disease, the patient should be made aware of the risks and should have a fast-acting bronchodilator available.
Neuropsychiatric Events Inform patients with influenza the flu , particularly children and adolescents, they may be at an increased risk of seizures, confusion, or abnormal behavior early in their illness. These events are uncommon but may result in accidental injury to the patient. Instructions For Use Instruct patients in use of the delivery system. Instructions should include a demonstration whenever possible. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenesis In 2-year carcinogenicity studies conducted in rats and mice using a powder formulation administered through inhalation, zanamivir induced no statistically significant increases in tumors over controls.
The maximum daily exposures in rats and mice were approximately 23 to 25 and 20 to 22 times, respectively, greater than those in humans at the proposed clinical dose based on AUC comparisons. Mutagenesis Zanamivir was not mutagenic in in vitro and in vivo genotoxicity assays which included bacterial mutation assays in S.
Zanamivir did not impair mating or fertility of male or female rats, and did not affect the sperm of treated male rats. The reproductive performance of the F1 generation born to female rats given zanamivir was not affected. There are no adequate and well-controlled studies of zanamivir in pregnant women. Zanamivir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pre- and post-natal developmental studies were performed in rats dosed from Day 16 of pregnancy until litter Day 21 to No malformations, maternal toxicity, or embryotoxicity were observed in pregnant rats or rabbits and their fetuses.
Because of insufficient blood sampling timepoints in rat and rabbit reproductive toxicity studies, AUC values were not available. In a subchronic study in rats at the mg-per-kg-per-day IV dose, the AUC values were greater than times the human exposure at the proposed clinical dose.
There was an increase in the incidence rates of a variety of minor skeleton alterations and variants in the exposed offspring in this study. Based on AUC measurements, the 80 mg-per-kg dose produced an exposure greater than 1, times the human exposure at the proposed clinical dose. However, in most instances, the individual incidence rate of each skeletal alteration or variant remained within the background rates of the historical occurrence in the strain studied.
Zanamivir has been shown to cross the placenta in rats and rabbits. In these animals, fetal blood concentrations of zanamivir were significantly lower than zanamivir concentrations in the maternal blood. Nursing Mothers Studies in rats have demonstrated that zanamivir is excreted in milk.
However, nursing mothers should be instructed that it is not known whether zanamivir is excreted in human milk. Pediatric Use Treatment Of Influenza Safety and effectiveness of RELENZA for treatment of influenza have not been assessed in pediatric patients younger than 7 years, but were studied in a Phase III treatment trial in pediatric subjects, where children aged 5 to 12 years received zanamivir or placebo [see Clinical Studies ].
Adolescents were included in the 3 principal Phase III adult treatment trials. In these trials, 67 patients were aged 12 to 16 years. No definite differences in safety and efficacy were observed between these adolescent patients and young adults. Neither of two 6-year-olds and one of two 7- year-olds produced measurable PIFR. Because of the risk of side effects and because it has not been shown to help them, Relenza is not generally recommended for people with chronic respiratory disease.
Anyone who develops bronchospasm worsening respiratory symptoms such as wheezing and shortness of breath should stop taking the drug and call their health-care provider.
Patients with underlying respiratory disease should have a fast-acting inhaled bronchodilator available when taking Relenza. The content on this page has been supplied to canadianpharmacyking by an independent third party contracted to provide information for our website. If you require any advice or information about the drugs on this page, a medical condition or treatment advice, you should always speak to a health professional. Please note that not all products, including any referenced in this page, are shipped by our affiliated Canadian Pharmacy.
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