KODATEF

What it is

KODATEF is tafenoquine succinate oral film-coated tablets. Each tablet contains 125.5 mg of tafenoquine succinate equivalent to 100 mg of tafenoquine free base. Each KODATEF tablet is a dark pink, capsule-shaped, film-coated tablet debossed with "TQ100" on one side and plain on the other. The film-coated tablets are for oral administration.

Approved indications

— Prevention of malaria in adults 18 years of age and above for up to 6 months of continuous dosing.

Dosing overview

Malaria prophylaxis with KODATEF consists of a loading dose of 200 mg once daily for three days before travelling to a malarious area, a maintenance dose of 200 mg once weekly while in the malarious area (starting seven days after the last loading dose), and a final terminal dose of 200 mg in the week following exit from the malarious area, seven days after the last maintenance dose. Individuals need to complete the full course of KODATEF including loading and terminal doses. KODATEF film-coated tablets should be swallowed whole and not chewed or broken apart. KODATEF film-coated tablets can be taken with or without food although KODATEF taken with food may be associated with better gastrointestinal tolerance.

Key safety warnings

All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing tafenoquine. G6PD deficiency should be excluded before prescribing KODATEF due to the risk of haemolytic anaemia in patients with G6PD deficiency. In clinical trials, declines in haemoglobin levels have been reported in patients with normal G6PD enzyme levels. Monitor patients for clinical signs or symptoms of haemolysis. Advise patients to discontinue KODATEF and seek medical attention if signs of haemolysis occur. KODATEF should not be used in subjects with a history of serious psychosis or current psychotic symptoms, delusions or hallucinations. If psychosis or other serious psychiatric events occur while taking KODATEF, urgent medical advice should be sought. In patients receiving KODATEF in clinical trials, adverse psychiatric reactions included sleep disturbances (2.5%), depression/depressed mood (0.3%), and anxiety (0.2%). Haemoglobin decreases by 0.66 g/dL have been frequently reported in clinical trials of KODATEF. Asymptomatic elevations in methaemoglobin, characteristically increases to >1% but below 10%, have been observed in the clinical trials of KODATEF. Discontinuation of KODATEF treatment is recommended if signs and symptoms of methaemoglobinaemia occur, followed by medical advice and appropriate medical therapy. Gastrointestinal effects including diarrhoea (13% of subjects), vomiting (4%), and gastroesophageal reflux disorder (2%), occurred at a greater frequency in KODATEF-treated subjects than in placebo subjects in clinical trials. Administration of KODATEF with food may ameliorate these gastrointestinal effects.

Contraindications

Individuals with G6PD deficiency or unknown G6PD status are contraindicated due to the risk of haemolytic anaemia. Pregnancy and lactation are contraindicated. Subjects with current or history of psychosis are contraindicated. Known hypersensitivity to tafenoquine, other 8-aminoquinolines, or any other component of KODATEF formulation is contraindicated.

Regulatory history

KODATEF was first approved on 12 September 2018. ARTG registration 293438 for KODATEF tafenoquine (as succinate) 100 mg tablet blister pack was first listed on 2018-09-19 (licence category RE). The AusPAR approval date was 2018-09-13. The TGA approved Kodatef for the prevention of malaria in adults 18 years of age and above for up to 6 months of continuous dosing, concluding that its benefits outweigh the risks. This medicinal product is subject to additional monitoring in Australia, which allows quick identification of new safety information.