Clinical Information
Gen. Code and Des.
78708 tafenoquine succinate ORAL TABLET 100 MG
GCN and Des.
45083 tafenoquine succinate ORAL TABLET 100 MG
Strength
100MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8300800 ANTIMALARIALS
Active Ingredients
17663 tafenoquine succinate 106635818
Inactive Ingredients
2272 mannitol 69658
Malaria Prophylaxis
Arakoda (tafenoquine) is an 8-aminoquinoline antimalarial drug indicated for the prophylaxis of malaria in patients aged 18 years and older. ARAKODA tablets contain 100 mg of tafenoquine (equivalent to 125.5 mg of tafenoquine succinate) and are dark pink, film-coated, capsule-shaped, and debossed with 'TQ100" on one side.
ARAKODA tablets are packed in polyamide aluminum and PVC formable laminate backed blisters with a polyethylene terephthalate aluminum foil cover. Each blister card contains 8 tablets. Each package contains 2 blister cards (16 tablets) housed in a contiguous outer paperboard child-resistant carton component (NDC 71475-257-01).
Storage
Store at 20�C to 25�C (68�F to 77�F). Temperature excursions are permitted to 15�C to 30�C (59�F to 86�F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense only in the original carton. These highlights do not include all the information needed to use ARAKODA� safely and effectively. See full prescribing information for ARAKODA�.
ARAKODA� (tafenoquine) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older. (1)
DOSAGE AND ADMINISTRATION
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All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing ARAKODA. (2.1)
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Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with ARAKODA. (2.1)
Regimen Name
Timing
Dosage
Loading regimen
For each of the 3 days before travel to a malarious area
200 mg (2 of the 100 mg tablets) once daily for 3 days
Maintenance regimen
While in the malarious area
200 mg (2 of the 100 mg tablets) once weekly � start 7 days after the last loading regimen dose
Terminal prophylaxis regimen
In the week following exit from the malarious area
200 mg (2 of the 100 mg tablets) one-time 7 days after the last maintenance dose
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Administer ARAKODA with food. (2.2)
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See full prescribing information for instructions on how to replace missed doses. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg of tafenoquine (3)
CONTRAINDICATIONS
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G6PD deficiency or unknown G6PD status (4)
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Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown (4, 8.2)
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Patients with a history of psychotic disorders or current psychotic symptoms (4, 5.4)
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Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA. (4)
WARNINGS AND PRECAUTIONS
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Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis. (5.1)
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G6PD Deficiency in Pregnancy or Lactation: ARAKODA may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA through breast milk. Check infant's G6PD status before breastfeeding begins. (5.2, 8.1, 8.2)
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Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. (5.3)
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Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA therapy and, evaluation by a mental health professional as soon as possible. (5.4)
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Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA. If hypersensitivity reactions occur, institute appropriate therapy. (5.5)
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Delayed Adverse Reactions: Due to the long half-life of ARAKODA (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration. (5.6, 12.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence ?1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, anxiety. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1-888-834-0225 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters (7.1)
USE IN SPECIFIC POPULATIONS
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. (5.2, 8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 6/2019
