PLAQUENIL (hydroxychloroquine)

PLAQUENIL (hydroxychloroquine)

Self-Administration

FDA approved indication:

• Treatment of chronic discoid erythematosus and systemic lupus erythematosus in adults
• Treatment of uncomplicated malaria caused by susceptible strains of Plasmodium vivax, Plasmodium malariae, Plasmodium ovale, and Plasmodium falciparum; prophylaxis of malaria in geographic areas where chloroquine resistance is not reported
• Treatment of acute and chronic rheumatoid arthritis in adults.

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:

• Systemic lupus erythematosus (SLE)
  • Diagnosis of SLE by a rheumatologist (prescriber does not have to be rheumatologist) as confirmed by chart note documentation, AND
  • If new start, chart note documentation of treatment plan
• 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 
• Rheumatoid arthritis
  • Diagnosed by a rheumatologist (prescriber does not have to be rheumatologist), AND
  • If new start, chart note documentation of treatment plan

Dosing:

• Systemic lupus erythematosus
  • 200 to 400 mg daily as a single daily dose or in 2 divided doses. 
    • Note: should not receive a daily dose >5 mg/kg/day using actual body weight or 400 mg, whichever is lower
• Malaria
  • Chemoprophylaxis:
  • 400 mg once weekly on the same day each week; begin 1 to 2 weeks before travel to malarious area; continue therapy while in malarious area and for 4 weeks after leaving the area (CDC 2018).
  • Treatment, uncomplicated: 
    • 800 mg once, followed by 400 mg at 6, 24, and 48 hours after initial dose (total dose: 2 g) (CDC 2019; WHO 2015).
• Rheumatoid arthritis
  • 200 to 400 mg daily as a single daily dose or in 2 divided doses (Kumar 2013). 
    • Note: Due to the risk of retinal toxicity, most patients should not receive a daily dose >5 mg/kg/day using actual body weight or 400 mg, whichever is lower

Contraindications:

• Known hypersensitivity to 4-aminoquinoline compounds
• Retinal or visual field changes of any etiology

Duration/approval:

• 1 year, based on FDA approved dosing