OSMIVIR

What it is

Osmivir is a capsule formulation containing oseltamivir phosphate, available in strengths of 30 mg, 45 mg, and 75 mg. The 75 mg capsule has a cream cap and brown body, the 45 mg capsule has a grey opaque cap and body, and the 30 mg capsule has a light yellow opaque cap and body.

Approved indications

— Treatment of infections due to influenza A and B viruses in adults and children including full-term neonates. — Prevention of influenza in adults and children aged 1 year and older.

Dosing overview

Treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection. Osmivir may be taken with or without food, although taking with food may enhance tolerability in some patients. **Treatment of influenza:** The recommended oral dose of Osmivir capsules in adults and adolescents 13 years of age and older is 75 mg twice daily, for 5 days.

**Prophylaxis of influenza:** The recommended oral dose of Osmivir for prevention of influenza following close contact with an infected individual is 75 mg once daily for 10 days. The recommended dose for prevention during a community outbreak of influenza is 75 mg once daily, with safety and efficacy demonstrated for up to six weeks.

Key safety warnings

There is no current evidence for the safety or efficacy of oseltamivir in persons with complications of an acute influenza episode such as viral or bacterial pneumonia, and such patients may require extensive supportive and adjunctive care, with antiviral therapy not shown to reduce the need for such care and monitoring. Efficacy of oseltamivir in the treatment of subjects with chronic cardiac diseases or respiratory diseases has not been established. Convulsion and delirium have been reported during oseltamivir administration in patients with influenza, predominantly in children and adolescents, often with abrupt onset and rapid resolution; in rare cases these events resulted in accidental injury or fatal outcome, but the contribution of oseltamivir is unknown, and three separate large epidemiological studies confirmed that influenza-infected patients receiving oseltamivir are at no higher risk of developing neuropsychiatric events compared to influenza-infected patients not receiving antivirals. Patients with influenza should be closely monitored for signs of abnormal behaviour throughout the treatment period. Elevated liver enzymes have been reported in patients with influenza-like illness receiving oseltamivir.

Contraindications

Osmivir is contraindicated in patients with known hypersensitivity to oseltamivir phosphate or to any components of the product.

PBS listing

Information regarding PBS listing for Osmivir is not provided in the available source documents.

Regulatory history

Osmivir oseltamivir phosphate capsules in strengths of 30 mg, 45 mg, and 75 mg were first listed on the ARTG on 4 March 2022.