KOZENIS

What it is

KOZENIS contains tafenoquine succinate and is available as 150 mg film-coated tablets and 50 mg film-coated dispersible tablets . Tafenoquine is an 8-aminoquinoline that eradicates Plasmodium vivax liver hypnozoites, preventing the relapse of malaria . KOZENIS is subject to additional monitoring in Australia, which will allow quick identification of new safety information .

Approved indications

— Radical cure (prevention of relapse) of Plasmodium vivax malaria in combination with chloroquine .

Dosing overview

Adults, adolescents and children weighing greater than 35 kg receive a single 300 mg dose (two 150 mg tablets) on Day 1 or Day 2 of the 3 day course of chloroquine . For adolescents and children aged 2 years or older weighing more than 10 kg to 35 kg, the recommended dose of tafenoquine dispersible tablets is determined according to weight: 100 mg (two 50 mg dispersible tablets) for children weighing more than 10 to 35 kg, and 200 mg (four 50 mg dispersible tablets) for children weighing more than 20 to 35 kg, taken as a single dose on Day 1 or Day 2 of the 3 day course of chloroquine . KOZENIS should be taken with food to increase systemic absorption . In the event of vomiting within 60 minutes after dosing, a repeat dose should be given .

Key safety warnings

All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing KOZENIS . Due to the risk of haemolytic anaemia in patients with G6PD deficiency or unknown G6PD status, quantitative G6PD testing must be performed before prescribing, and KOZENIS should be withheld from patients with G6PD enzyme levels less than 70 per cent of normal . Mild to moderate psychiatric adverse reactions such as anxiety and abnormal dreams have been reported in clinical trials; whilst there were no reports of serious psychiatric adverse reactions in clinical trials following a single 300 mg dose, cases of depression and psychosis have occurred following higher single doses of tafenoquine, mostly in subjects with a previous history of psychiatric disorders . Caution is advised when administering KOZENIS to patients with a current or past history of serious psychiatric disorders, and individual patient risk-benefit should be assessed . Serious hypersensitivity reactions such as angioedema and urticaria have been observed with administration of KOZENIS . KOZENIS should not be re-administered if hypersensitivity reactions occur . Asymptomatic elevations in methaemoglobin have been observed in clinical studies, and if signs or symptoms of methaemoglobinaemia occur, appropriate therapy should be instituted .

Contraindications

KOZENIS is contraindicated in patients with G6PD deficiency or unknown G6PD status due to the risk of haemolytic anaemia . KOZENIS is contraindicated in pregnancy . KOZENIS is contraindicated during breastfeeding of an infant who is G6PD deficient or if the G6PD status of the infant is unknown . KOZENIS is contraindicated in patients with known hypersensitivity to tafenoquine, other 8-aminoquinolines, or any component of the formulation .

Regulatory history

KOZENIS tafenoquine 150 mg film-coated tablets were first listed on the ARTG on 13 September 2018 . The 50 mg film-coated dispersible tablet formulation was first listed on the ARTG on 9 March 2022 . The TGA approved the extension of indications for KOZENIS to include children aged 6 months and older for the radical cure of Plasmodium vivax malaria, along with registration of the new 50 mg dispersible tablet formulation, on 8 March 2022 .