RAPIVAB

What it is

Rapivab is peramivir. It is supplied as a 200 mg per 20 mL concentrate solution for infusion. Rapivab is a clear, colourless, sterile, isotonic solution. Rapivab is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells.

Approved indications

— Treatment of acute influenza infection in adults and children 2 years and older who have been symptomatic for no more than two days.

Dosing overview

The recommended dose of Rapivab in adult and adolescent patients 13 years of age or older is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes. The recommended dose of Rapivab in paediatric patients 2 to 12 years of age is 12 mg/kg (up to a maximum dose of 600 mg), administered via intravenous infusion for 15 to 30 minutes. The Rapivab dose should be reduced for patients with baseline creatinine clearance below 50 mL/min. For adults and adolescents 13 years and older with creatinine clearance of 30–49 mL/min, the recommended dose is 200 mg, and for creatinine clearance of 10–29 mL/min, 100 mg. For paediatric patients 2 to 12 years of age, the doses are 4 mg/kg and 2 mg/kg respectively, up to a maximum of 600 mg.

Key safety warnings

Rare cases of serious skin reactions, including erythema multiforme, have been reported with Rapivab in clinical studies and in post-marketing experience. Cases of anaphylaxis and Stevens-Johnson Syndrome have been reported in post-marketing experience with Rapivab. Discontinue Rapivab and institute appropriate treatment if anaphylaxis or a serious skin reaction occurs or is suspected. Influenza can be associated with hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur in uncomplicated influenza as well. There have been post-marketing reports of delirium and abnormal behaviour leading to injury in patients with influenza who were receiving neuraminidase inhibitors, including Rapivab. Patients with influenza should be closely monitored for signs of abnormal behaviour. There is no evidence for efficacy of Rapivab in any illness caused by agents other than influenza viruses. Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Rapivab has not been shown to prevent such complications.

Contraindications

Rapivab is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product.

Regulatory history

Rapivab (peramivir 200 mg / 20 mL concentrate for intravenous infusion) was first registered on the ARTG on 21 March 2018. An AusPAR (Australian Public Assessment Report) was approved on 16 March 2018. The Pharmaceutical Benefits Advisory Committee considered Rapivab for the treatment of acute uncomplicated influenza in November 2014 and did not recommend it, citing uncertain clinical benefit and high and uncertain cost-effectiveness. Rapivab is subject to additional monitoring in Australia.