Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 150 mg) |
Drug Class | Antimalarials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.
Latest News
Summary
- Krintafel (tafenoquine) is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-9]
- Tafenoquine at a dose of 300 mg in a 60 kg adult showed a 70% maximal hypnozoiticidal effect, with an estimated 90% reduction in Plasmodium vivax recurrence at a 7.5 mg/kg dose (450 mg); a 300 mg dose demonstrated a recurrence risk ratio of 0.32 (95% CI 0.12-0.88) compared to no treatment.
- Tafenoquine (200 mg weekly) significantly reduced Plasmodium spp. infection with a protective efficacy between 77.9% and 100%, comparable to mefloquine (250 mg weekly); a 200 mg/day loading dose for 3 days was effective for malaria prevention in short-term travelers.
- Meta-analyses indicated tafenoquine is not inferior to primaquine in preventing P. vivax relapse, showing similar efficacy up to six months, with single-dose 300 mg tafenoquine equating to 15 mg/day primaquine for 14 days in effectiveness.
- Adverse events (AEs) for tafenoquine were comparable in frequency and severity to comparator arms, with common nervous system AEs including headache and dizziness occurring in about 11.4% of patients, and psychiatric AEs, primarily insomnia, reported in 3.8% of users.
- No significant risk of serious adverse events (SAEs) was observed with tafenoquine compared to primaquine or placebo; no serious or severe neuropsychiatric adverse events (NPAEs) were reported with tafenoquine (300 mg)/chloroquine. However, evidence indicated an increased, reversible, asymptomatic vortex keratopathy with prolonged tafenoquine exposure.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Krintafel (tafenoquine) Prescribing Information. | 2023 | GlaxoSmithKline, Research Triangle Park, NC |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Tafenoquine for the radical cure and prevention of malaria: the importance of testing for G6PD deficiency. | 2020 | The Medical Journal of Australia |
Drug interactions with antimalarial medications in older travelers: a clinical guide. | 2020 | Chapman University School of Pharmacy |
Guidance for using tafenoquine for prevention and antirelapse therapy for malaria - United States, 2019. | 2019 | Morbidity and Mortality Weekly Report |
Tafenoquine and G6PD: a primer for clinicians. | 2019 | Journal of Travel Medicine |