From the Guidelines
The goal cumulative dose of isotretinoin should be at least 220mg/kg to minimize the risk of relapse, as evidenced by a prospective study of 180 patients with severe acne 1. This cumulative dose is typically achieved by administering 0.5-1mg/kg/day, divided into two daily doses with food, over a period of several months. The treatment should continue until the cumulative dose is reached, rather than relying solely on a fixed duration of treatment. Key factors to consider when determining the optimal dosage include the severity of acne, patient age, and gender, as well as the potential for side effects. Some patients, such as those with mild to moderate acne, may be effectively treated with lower cumulative doses, while others with very severe or resistant acne may require higher doses. Regular monitoring for side effects, including dry skin, lips, and eyes, as well as potential changes in lipid profiles and liver function, is crucial throughout the treatment period. Additionally, monthly pregnancy tests are mandatory for female patients due to the medication's teratogenic effects. It is also important to note that younger age at initial treatment and male gender are associated with an increased risk of relapse, and that continuing treatment for at least two months after achieving no evidence of activity may result in a decreased frequency of relapse 1. The goal of treatment is to achieve long-term remission of severe acne, and the cumulative dose of 220mg/kg has been shown to be associated with decreased rates of relapse 1.
From the FDA Drug Label
The recommended dosage range for isotretinoin capsules is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. The goal mg/kg of isotretinoin is 0.5 to 1 mg/kg/day.
- The dose may be adjusted according to response of the disease and/or the appearance of clinical side effects.
- Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated 2.
From the Research
Goal mg/kg of Isotretinoin
The goal mg/kg of isotretinoin is typically in the range of 0.5-1.0 mg/kg/day for 5-6 months, with a cumulative dose of 120-150 mg/kg 3, 4, 5. However, some studies suggest that higher doses, such as 1.3 mg/kg/day or greater, may be more effective in achieving acne clearance and preventing relapse 3.
Key Findings
- A study published in 2012 found that isotretinoin prescribed at 1.5 mg/kg/day or greater for 5-6 months, with a cumulative total dose of 290 mg/kg, is safe and effective compared to current standard dosing practices 3.
- Another study published in 2021 found that mild liver enzyme elevations during isotretinoin therapy do not worsen in most cases, and that acne patients with isotretinoin may not need continued testing when experiencing low-grade liver enzyme abnormalities 6.
- A systematic review and meta-analysis published in 2022 found that conventional dose isotretinoin improves the odds of prolonged remission in adults with mild-to-moderate acne vulgaris compared to low doses 5.
Dosage Considerations
- The optimal cumulative dose of isotretinoin required to induce remission appears to vary with severity 4.
- Higher doses of isotretinoin, such as 1.3 mg/kg/day or greater, may be more effective in achieving acne clearance and preventing relapse, but may also increase the risk of side effects 3.
- The dose of isotretinoin should be individualized based on the patient's response to treatment and the presence of any side effects 7.