Alpivab

Posology Alpivab should be administered as a single intravenous dose within 48 hours of the onset of symptoms of influenza. The recommended single intravenous dose of peramivir depends on age and body weight as shown in Table 1. 2).

Table 2:

Peramivir dose for adults and adolescents (from 13 years and 50 kg) based on absolute GFR Absolute Glomerular Filtration Rate (GFR)* Recommended single dose ≥50 600 mg 30 to 49 300 mg 10 to 29 200 mg *Absolute GFR not adjusted for body surface area In adults and adolescents (from 13 years and 50 kg) with chronic renal impairment maintained on haemodialysis, peramivir should be administered after dialysis at a dose adjusted for renal function (Table 2).

There are insufficient clinical data available in children and adolescents aged less than 13 years or with body weight less than 50 kg with renal impairment to be able to make any dosing recommendation. 2). Paediatric population The safety and efficacy of peramivir in children aged under 2 years has not yet been established.

No data are available. Method of administration Alpivab is administered via intravenous infusion for 15 to 30 minutes. 6.

Summary of the safety profile The most important serious adverse reactions associated with peramivir in patients are anaphylaxis and skin reactions, including erythema multiforme and Stevens-Johnson Syndrome. 4 %). Tabulated list of adverse reactions Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).

Table 3:

Adverse reactions in studies investigating peramivir for treatment of uncomplicated influenza in adults System Organ Class (SOC) Adverse Reaction According to Frequency* Common Uncommon Rare Unknown Blood and lymphatic system disorders neutrophil count decreased Immune system disorders anaphylactic reaction*, anaphylactic shock*Medicinal Product no longer authorised 6 System Organ Class (SOC) Adverse Reaction According to Frequency* Common Uncommon Rare Unknown Metabolism and nutrition disorders blood lactate dehydrogenase increased decreased appetite, blood albumin decreased, blood chloride increased, blood glucose decreased, blood lactate dehydrogenase decreased, blood potassium increased, blood sodium increased, blood uric acid increased, protein total increased Psychiatric disorders insomnia abnormal behaviour*, delirium* Nervous system disorders hypoaesthesia, paraesthesia Eye disorders vision blurred Cardiac disorders electrocardiogram QT prolonged Gastrointestinal disorders nausea, vomiting abdominal pain upper, abdominal discomfort, gastritis Hepatobiliary disorders increased gamma- glutamyltransferase liver disorder*, alanine aminotransferase increased*, aspartate aminotransferase increased* Skin and subcutaneous tissue disorders dermatitis, drug eruption, eczema, urticaria erythema multiforme dermatitis exfoliative*, Stevens-Johnson syndrome* Musculoskeletal and connective tissue disorders arthralgia, blood creatine phosphokinase increased Renal and urinary disorders blood urea increased, blood present in urine, urobilin present in urine, blood creatinine increased, urine ketone body increased acute kidney injury*, renal impairment* General disorders and administration site conditions chest discomfort, fatigue *These events reported from post-authorization use occurred with different dosage and dosing schedule to that described in the SmPC.

8). If any hypersensitivity reaction occurs during infusion of peramivir, the infusion must be stopped immediately and appropriate management should be instituted. Neuropsychiatric events Delirium, hallucinations and abnormal behaviour have been reported in patients with influenza who were receiving peramivir.

These events were reported primarily among paediatric patients and often had an abrupt onset and rapid resolution. The contribution of peramivir to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behaviour.

Reduced renal functionMedicinal Product no longer authorised 4 Acute renal failure, renal failure, pre-renal failure, renal disorder, anuria, nephritis, and increased blood creatinine have been reported in patients with influenza who were receiving peramivir.

Most of the cases occurred in elderly patients with comorbidities and multiple concomitant medicinal products. The contribution of peramivir to these events has not been established. Patients with influenza and already existing diseases should be closely monitored for renal function.

Limitations of the clinical data The efficacy of peramivir as a single dose treatment for uncomplicated influenza was demonstrated in a single placebo-controlled study conducted in 300 adult patients in Japan during the 2007/2008 influenza season.

1). Available data do not support a conclusion that peramivir is effective in patients with influenza B or in patients with complicated influenza. Resistance to peramivir Influenza A/H1N1 viruses that contain the H275Y mutation have reduced susceptibility to peramivir and oseltamivir.

In a clinical trial, no statistically significant clinical benefit could be demonstrated for peramivir over placebo in patients infected with the A/H1N1 virus containing the H275Y mutation. 1). Risk of bacterial infections There is no evidence for efficacy of peramivir in any illness caused by agents other than influenza viruses.

1.