Current and future solutions for infectious diseases

60° Pharmaceuticals (60P) was founded with the goal of developing medicines for tropical diseases, including those considered neglected by the World Health Organization. In 2018, we took a huge step toward meeting our goals when our first product was approved for use by the US Food and Drug Administration.¹

ARAKODA^® (tafenoquine) is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.¹

Making prophylaxis for malaria simpler and more effective

There has long been a need for new drugs for malaria prevention. Existing options:

• Were not able to prevent malaria in all endemic regions or protect against multiple types of the disease
• Did not have utility against both the disease-causing and latent forms of the parasite responsible for malaria

ARAKODA^® (tafenoquine) tablets, launched in 2019, meets all these needs.¹

Learn More About ARAKODA.

Download the Product Monograph.

Important Safety Information

Contraindications 
ARAKODA^® should not be administered to:

• G6PD deficiency or unknown G6PD status
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown
• Patients with a history of psychotic disorders or current psychotic symptoms
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA^®

Warnings and Precautions

• 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.
• 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.
• Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.
• 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.
• Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA^®. If hypersensitivity reactions occur, institute appropriate therapy.
• 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.

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 and anxiety.

Drug Interactions 
Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters.

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^®.

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.

Please see full Prescribing Information.

Reference 1. Arakoda^® [package insert]. Washington, DC; 60 Degrees Pharmaceuticals LLC: 2018.