ARALEN (chloroquine phosphate)

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