Dectova · 4.1 Therapeutic indications · 1

HOS-217235 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile The safety profile of zanamivir is based primarily on data from a single Phase II and a single Phase III study, with support from Phase I studies, a compassionate use programme, and adverse drug reactions reported for inhaled zanamivir. The frequency of adverse reactions is based on the number of reports in the adult population receiving zanamivir 600 mg twice daily intravenously in the Phase II and Phase III studies. Adverse reactions are listed by MedDRA system organ class. The most commonly reported adverse reactions considered possibly or probably related to zanamivir are alanine aminotransferase increased (2%), aspartate aminotransferase increased (1%), hepatocellular injury (1%), diarrhoea (1%) and rash (1%). The most important serious adverse reaction was hepatocellular injury, observed in two patients (< 1%). Tabulated list of adverse reactions The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from available data). System Organ Class Adverse reactions Frequency Immune system disorders oropharyngeal oedema not known facial oedema anaphylactic/anaphylactoid reactions Psychiatric disorders abnormal behaviour not known hallucinations delirium Nervous system disorders convulsions not known depressed level of consciousness Gastrointestinal disorders diarrhoea common Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate common aminotransferase (AST) increased hepatocellular injury alkaline phosphatase increased uncommon Skin and subcutaneous tissue rash common disorders urticaria u

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HOS-217231 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-217230 · has-indication-information · PDF-Seite 2

Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥ 6 months) when: • The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or • Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient. Dectova should be used in accordance with official guidance.

HOS-217233 · has-interaction-information · PDF-Seite 6

The potential for interactions with other medicines is low, based on the known elimination pathway of zanamivir. Zanamivir is not a substrate, inhibitor or inducer of cytochrome P450 isoenzymes nor a substrate or inhibitor of renal and hepatic transporters at clinically relevant concentrations (see section 5.2).

HOS-217234 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are limited data from the use of zanamivir in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Reproductive studies performed in rats and rabbits indicated that placental transfer of zanamivir occurs and there was no evidence of teratogenicity. Results from a rat peri- and postnatal study showed no clinically meaningful impairment of offspring development. However, there is no information on placental transfer in humans. As experience is limited, the use of Dectova in pregnancy should only be considered if the possible benefit to the patient is thought to outweigh any possible risk to the foetus. Breast-feeding It is unknown whether zanamivir is excreted in human milk. In rats, zanamivir has been shown to be secreted in low amounts into milk. As experience is limited, the use of zanamivir in breast-feeding mothers should be considered only if the possible benefit to the mother is thought to outweigh any possible risk to the child. Fertility Animal studies indicate no clinically meaningful effects of zanamivir on male or female fertility. 6

HOS-217232 · has-warning-information · PDF-Seite 5

Renal impairment Zanamivir is eliminated by renal clearance, therefore the dose of Dectova when administered intravenously must be reduced in patients with renal impairment (see section 4.2). All patients must have their renal function assessed before and regularly during treatment. Serious hypersensitivity reactions Anaphylactic reactions and serious skin reactions (including erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with zanamivir (see section 4.8). If any hypersensitivity reaction occurs during infusion of Dectova, the infusion must be stopped immediately and appropriate management should be instituted. Neuropsychiatric events Influenza can be associated with a variety of neurological and behavioural symptoms. Neuropsychiatric events, including seizures, delirium, hallucination and abnormal behaviour, have been reported during administration of zanamivir 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 section 4.8). Resistance in immunocompromised patients Treatment emergent resistance is rare with zanamivir (see section 5.1). Selection of influenza resistant viruses is more likely to occur following treatment with antiviral medicinal products in immunocompromised patients, including treatment with Dectova; it is, therefore, important to monitor for resistance and consider switching to alternative therapies where appropriate. 5 Limitations of the clinical data The efficacy of Dectova for the treatment of complicated influenza A or B virus infection in adults and children aged from 6 months has been inferred from: • the in vitro activity of zanamivir; • clinical and virological activity of zanamivir compared to placebo in a human influenza challenge study; • levels of zanamivir in broncho-epithelial lining fluid and serum zanamivir from a broncho-alveolar lavage study; • serum zanamivir levels from patients with complicated influenza (see section 5.1). Risk of bacterial infections Dectova has not been shown to reduce the risk of bacterial complications associated with influenza infection. Excipients This medicinal product contains 70.8 mg sodium per vial, equivalent to 3.54% of the WHO recommended

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