From the Guidelines
The recommended dose of hydroxychloroquine is 800 mg (12 mg/kg) per day, as evaluated in a phase II trial involving 40 patients with steroid-refractory cGVHD, with a response rate of 53% among the 32 evaluable patients 1. When considering the use of hydroxychloroquine, it is essential to weigh the benefits against the potential risks, particularly the risk of retinal toxicity with long-term use.
- The efficacy of hydroxychloroquine has been demonstrated in patients with skin, oral, and/or liver involvement, with limited efficacy in the treatment of GI manifestations.
- The highest response rates were observed in patients with skin, oral, and/or liver involvement.
- The risk of retinal toxicity, including chloroquine retinopathy, is a significant concern with long-term use, emphasizing the need for periodic ophthalmologic assessment during treatment.
- Dose adjustments and regular monitoring are crucial to minimize the risk of adverse events and ensure the safe use of hydroxychloroquine. The use of hydroxychloroquine requires careful consideration of the potential benefits and risks, as well as regular monitoring to minimize the risk of adverse events, particularly retinal toxicity 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Hydroxychloroquine Dose
- The dose of hydroxychloroquine for COVID-19 prophylaxis is still being researched, with one study suggesting an 800 mg loading dose followed by 400 mg twice or 3 times weekly to maintain weekly troughs above the half maximal effective concentration (EC50) in > 50% of subjects at steady-state 2.
- In a post-exposure prophylaxis setting, a dose of 800 mg loading dose followed in 6 hours by 600 mg, then 600 mg daily for 4 more days achieved daily troughs above EC50 in > 50% subjects 2.
- These doses are higher than recommended for malaria chemoprophylaxis, and clinical trials are needed to establish safety and efficacy 2.
- There is no specific information on the dose of hydroxychloroquine for other conditions such as rheumatic autoimmune disorders, but the drug is commonly used to treat these conditions 3, 4, 5, 6.
Safety and Efficacy
- The safety and efficacy of hydroxychloroquine for COVID-19 treatment is still uncertain, with some studies suggesting potential adverse effects such as cardiotoxicity and conduction defects 4.
- Hydroxychloroquine is generally well-tolerated for the treatment of rheumatic autoimmune disorders, but severe life-threatening adverse effects have been reported 4.
- The use of hydroxychloroquine in COVID-19 should be discouraged outside clinical trials under strict medical supervision 4.