What is the recommended dose of Hydroxychloroquine (Plaquenil) in Systemic Lupus Erythematosus (SLE)?

From the Guidelines

Hydroxychloroquine should be prescribed at a dose not exceeding 5 mg/kg of actual body weight per day for patients with systemic lupus erythematosus (SLE). The recommended dose is based on the most recent and highest quality study, which suggests that doses above 5 mg/kg per day increase the risk of retinal toxicity 1. For most adult patients, this translates to 200 mg once or twice daily. Treatment should begin with 400 mg daily (often split into two 200 mg doses) for the first few weeks to months, followed by a maintenance dose of 200 mg daily once disease activity is controlled. Some patients may require continued treatment with 400 mg daily for adequate disease control. Hydroxychloroquine should be taken with food to reduce gastrointestinal side effects. The medication works by modulating immune activity, reducing inflammation, and preventing lupus flares. It has been shown to reduce mortality, prevent organ damage, and decrease the need for steroids in SLE patients 1. Regular monitoring is essential, including baseline and annual eye examinations after 5 years of use (or sooner in high-risk patients) to check for retinopathy, which is a rare but serious potential side effect. Full therapeutic benefits may take 3-6 months to become apparent, so patients should be counseled to continue the medication even if immediate improvement isn't noticed.

Key considerations for hydroxychloroquine use in SLE patients include:

• The dose should not exceed 5 mg/kg per day to minimize the risk of retinal toxicity
• Patients with a history of retinal disease or those taking other medications that may increase the risk of retinal toxicity should be monitored more closely
• Hydroxychloroquine may be used in pregnancy, but the benefits and risks should be carefully weighed
• The medication should be taken with food to reduce gastrointestinal side effects
• Regular monitoring of kidney function and blood counts is recommended, especially in patients with pre-existing kidney disease or those taking other medications that may increase the risk of kidney damage.

In terms of specific patient populations, the following considerations should be taken into account:

• Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency should be monitored for signs of hemolysis
• Patients with estimated glomerular filtration rate (eGFR) <30 ml/min per 1.73 m² should have their dose reduced by 25%
• Patients with a history of cardiovascular disease or those at high risk for cardiovascular events should be monitored closely for signs of cardiotoxicity.

Overall, hydroxychloroquine is a valuable medication for the treatment of SLE, but its use should be carefully monitored and adjusted based on individual patient needs and risk factors.

From the FDA Drug Label

1. 4 Dosage for Systemic Lupus Erythematosus in Adults

The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses.

The recommended dose of hydroxychloroquine for Systemic Lupus Erythematosus (SLE) in adults is 200 mg once daily or 400 mg once daily, or in two divided doses 2.

From the Research

Hydroxychloroquine Dose in SLE

• The daily dose of hydroxychloroquine (HCQ) associated with the best compromise between efficacy and safety is a matter of debate 3.
• A study found that the mean starting dose of HCQ was 206 mg/day, and the mean weight-adjusted starting dose of HCQ was 3.1 mg/kg/day, with no patients treated with doses ≥5 mg/kg/day 4.
• The use of HCQ at stable doses of 200 mg/day (or 3.0-3.5 mg/kg/day) as the background therapy in patients with systemic lupus erythematosus (SLE) resulted in the majority of patients achieving prolonged remission 4.
• Current guidelines recommend using a HCQ dose less than 5.0 mg/kg/day to reduce the risk of retinopathy 5.
• A study found that higher HCQ blood levels were protective against flare occurrence, and patients with low oral HCQ dosage tend to have more flares, although the difference was not statistically significant 5.

Weight-Adjusted Dose

• The mean weight-adjusted dose of HCQ per patient did not differ between those who did and did not achieve prolonged remission (2.9 vs 3 mg/kg/day, p=0.5) 4.
• The daily dose of HCQ associated with the best compromise between efficacy and safety is a matter of debate, with a recommended dose of ≤5 mg/kg/day actual body weight 3.

Clinical Outcomes

• HCQ use is associated with less disease activity, flares, damage, and improved survival in SLE 6.
• HCQ use is also associated with better patient-reported health outcomes, including quality of life and less impact on daily life, with effects mediated through disease activity 6.