{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "tafenoquine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      },
      {
        "text": "• 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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      },
      {
        "text": "Treatment with ARAKODA during pregnancy is not recommended.",
        "source": "US FDA label for tafenoquine (Arakoda), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/tafenoquine.json",
        "verbatim": true
      }
    ]
  }
}