TALMINEX

What it is

TALMINEX is oseltamivir phosphate available as hard gelatin capsules for oral use. It is available in three strengths: 75 mg capsules containing 98.5 mg oseltamivir phosphate (equivalent to 75 mg oseltamivir), 45 mg capsules containing 59.1 mg oseltamivir phosphate (equivalent to 45 mg oseltamivir), and 30 mg capsules containing 39.4 mg oseltamivir phosphate (equivalent to 30 mg oseltamivir). TALMINEX is a neuraminidase inhibitor antiviral, and its active metabolite is a selective inhibitor of influenza virus neuraminidase enzymes.

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

For treatment in adults and adolescents aged 13 years and older, the recommended oral dose is 75 mg twice daily for 5 days. For prevention of influenza following close contact with an infected individual, the recommended dose is 75 mg once daily for 10 days. For prevention during a community outbreak, the recommended dose is 75 mg once daily. In children aged 1 to less than 13 years, treatment dosing is weight-adjusted, ranging from 30 mg twice daily for those weighing 15 kg or less, to 75 mg twice daily for those weighing more than 40 kg. For children under 1 year of age, the recommended dose for treatment is 3 mg/kg twice daily for 5 days. For immunocompromised patients (adults and children aged 1 year and older) during treatment, the recommended duration is 10 days. For seasonal prophylaxis in immunocompromised patients aged 1 year and older, the recommended duration is 12 weeks.

Key safety warnings

There is no current evidence for the safety or efficacy of oseltamivir in persons with complications of acute influenza such as viral or bacterial pneumonia. Such patients may require extensive supportive and adjunctive care, and antiviral therapy has not been shown to reduce the need for such care and monitoring. Convulsion and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety and nightmares) have been reported during oseltamivir administration in patients with influenza, predominantly in children and adolescents. These events often had an abrupt onset and rapid resolution. In rare cases, these events resulted in accidental injury and some resulted in a fatal outcome; however, the contribution of oseltamivir to those events is unknown. Such neuropsychiatric events have also been reported in patients with influenza who were not taking oseltamivir. 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. Hypersensitivity reactions such as allergic skin reactions including dermatitis, rash, eczema and urticaria, erythema multiforme, allergy, anaphylactic/anaphylactoid reactions, face oedema, Stevens-Johnson-Syndrome and toxic epidermal necrolysis have been reported during post-marketing use.

Contraindications

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

PBS listing

No information regarding PBS listing, item numbers, restriction types, or ex-manufacturer prices is provided in the available source documents.

Regulatory history

TALMINEX was first listed on the ARTG on 25 February 2020, with three registered variants: 75 mg, 45 mg and 30 mg capsules in blister pack presentation (licence category RE).