ARALEN (chloroquine phosphate)

Self-Administration

FDA approved indication:
  • Treatment of uncomplicated malaria due to susceptible strains of Plasmodium vivax, Plasmodium malariae, Plasmodium ovale, and Plasmodium falciparum; prophylaxis of malaria (in geographic areas where chloroquine resistance is not present).
  • Treatment of extraintestinal amebiasis.
For any indications not mentioned above:
  • Requests for non-FDA approved uses require evidence-based literature support from at least 2 peer-reviewed sources
Patients must meet the following criteria for the indication(s) above:
  • Malaria
    • Diagnosis of malaria or malaria chemoprophylaxis (for patients who are traveling) by infectious disease specialist as confirmed by chart note documentation, AND
    • Chart note documentation of treatment plan
  • Extraintestinal amebiasis
    • Diagnosis of amebiasis by infectious disease specialist as confirmed by chart note documentation, AND
    • Chart note documentation of treatment plan
Dosing:
  • Malaria
    • Chemoprophylaxis: 
      • 500 mg (300 mg base) weekly on the same day each week; begin 1 to 2 weeks prior to exposure; continue while in an endemic area and for 4 weeks after leaving an endemic area 
      • Treatment, uncomplicated: 1 g (600 mg base) on day 1, followed by 500 mg (300 mg base) 6, 24, and 48 hours after the first dose. 
        • Note: For the treatment of chloroquine-sensitive P. vivax and P. ovale, concomitant therapy with an 8-aminoquinoline (eg, primaquine) is necessary
  • Extraintestinal amebiasis
    • 1 g (600 mg base) daily for 2 days followed by 500 mg daily (300 mg base) for at least 2 to 3 weeks
Contraindications:
  • Known hypersensitivity to 4-aminoquinoline compounds
  • Retinal or visual field changes of any etiology
Duration/approval:
  • Approval duration is based on FDA indication and patient diagnosis

Last review date: May 19, 2020

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