Drug profile
Tafenoquine
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Table 2: How to Replace Missed Doses of ARAKODA Dose(s) Missed How to Replace
Missed Dose(s): 1 Loading dose 1 dose of 200 mg (2 of the 100 mg tablets) so that
a total of 3 daily loading doses have been taken.
Source: This line points to a numbered table that this card does not show - read
that table in the label before you dose. US FDA label for tafenoquine (Arakoda),
section 'dosage and administration', retrieved 2026-08-29
- Begin maintenance dose 1 week after the last loading dose. 2 Loading doses 2 doses
of 200 mg (2 of the 100 mg tablets) on 2 consecutive days so that a total of 3
daily loading doses have been taken.
Source: US FDA label for tafenoquine (Arakoda), section 'dosage and
administration', retrieved 2026-08-29
- Begin maintenance dose 1 week after the last loading dose. 1 Maintenance (weekly)
dose 1 dose of 200 mg (2 of the 100 mg tablets) on any day up to the time of the
next scheduled weekly dose. 2 Maintenance (weekly) doses 1 dose of 200 mg (2 of
the 100 mg tablets) on any day up to the time of the next scheduled weekly dose.
Source: US FDA label for tafenoquine (Arakoda), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Safety and effectiveness of ARAKODA in pediatric patients have not been
established.
Source: US FDA label for tafenoquine (Arakoda), section 'pediatric use', retrieved
2026-08-29
- • All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD)
deficiency prior to prescribing ARAKODA. ( 2.1 ) • Pregnancy testing is
recommended for females of reproductive potential prior to initiating treatment
with ARAKODA.
Source: US FDA label for tafenoquine (Arakoda), section 'dosage and
administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- Other reported clinical experience has not identified differences in responses
between the elderly and younger patients [see Clinical Pharmacology ( 12.3 )] .
8.6 Renal Impairment The pharmacokinetics of ARAKODA have not been studied in
patients with renal impairment.
Source: US FDA label for tafenoquine (Arakoda), section 'use in specific
populations', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- If ARAKODA is administered to such patients, monitoring for adverse reactions
associated with ARAKODA is needed [see Warnings and Precautions ( 5 ), Adverse
Reactions ( 6 )] . 8.7 Hepatic Impairment The pharmacokinetics of ARAKODA have not
been studied in patients with hepatic impairment.
Source: US FDA label for tafenoquine (Arakoda), section 'use in specific
populations', retrieved 2026-08-29
PREGNANCY
- Risk Summary The use of ARAKODA during pregnancy may cause hemolytic anemia in a
fetus who is G6PD-deficient.
Source: US FDA label for tafenoquine (Arakoda), section 'pregnancy', retrieved
2026-08-29
- Treatment with ARAKODA during pregnancy is not recommended.
Source: US FDA label for tafenoquine (Arakoda), section 'pregnancy', retrieved
2026-08-29
- If a pregnancy is detected during ARAKODA use, discontinue ARAKODA as soon as
possible and switch to an alternative prophylactic drug for malaria during
pregnancy [see Warnings and Precautions ( 5.2 )] .
Source: US FDA label for tafenoquine (Arakoda), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- Lactation : Advise women not to breastfeed a G6PD-deficient infant or infant with
unknown G6PD status during treatment and for 3 months after the last dose of
ARAKODA.
Source: US FDA label for tafenoquine (Arakoda), section 'use in specific
populations', retrieved 2026-08-29
- In a pre- and postnatal development study in rats, tafenoquine administered
throughout pregnancy and lactation produced maternal toxicity and a reversible
decrease in offspring body weight gain and decrease in motor activity at 18
mg/kg/day, which is equivalent to about 0.6 times the clinical dose based on body
surface area comparisons.
Source: US FDA label for tafenoquine (Arakoda), section 'use in specific
populations', retrieved 2026-08-29
- There is no information regarding the presence of ARAKODA in human milk, the
effects of the drug on the breastfed infant, or the effects of the drug on milk
production.
Source: US FDA label for tafenoquine (Arakoda), section 'use in specific
populations', retrieved 2026-08-29