From the FDA Drug Label
Table 4 Lopinavir and Ritonavir Oral Solution Daily Dosage Recommendations in Pediatric Patients 14 days to Less Than 18 Years Without Concomitant Efavirenz, Nevirapine, or Nelfinavir Patient Age Based on Weight (mg/kg) Based on BSA (mg/m2)Frequency 14 days to 6 months 16/4 300/75 Given twice daily Older than 6 months to less than 18 years Less than 15 kg12/3 230/57.5 Given twice daily 15 kg to 40 kg10/2. 5
For a 15 kg child with Human Immunodeficiency Virus (HIV), the recommended dose of Kaletra (lopinavir/ritonavir) is 10/2.5 mg/kg given twice daily, without concomitant efavirenz, nevirapine, or nelfinavir 1.
- The dose is calculated based on the patient's weight.
- The recommended frequency is twice daily.
- The dose should not exceed the recommended adult daily dose of 400/100 mg (5mL) twice daily.
From the Research
For a 15 kg child with HIV, the recommended dose of Kaletra (lopinavir/ritonavir) is 12 mg/kg of lopinavir component twice daily, as this dosing has been shown to provide adequate viral suppression and is well-tolerated in pediatric patients 2. This translates to approximately 180 mg of lopinavir (15 kg × 12 mg/kg) twice daily. Kaletra is available as an oral solution (80 mg lopinavir/20 mg ritonavir per mL), so the child would need 2.25 mL of the solution twice daily. Alternatively, if using tablets, the closest appropriate dosing would be the 100 mg/25 mg tablets, with two tablets given twice daily. The medication should be administered with food to enhance absorption and reduce gastrointestinal side effects. It's essential to maintain consistent dosing times to ensure stable drug levels in the blood. Common side effects include diarrhea, nausea, and vomiting, which typically improve over time. Regular monitoring of liver function, lipid levels, and viral load is necessary to assess treatment efficacy and detect potential toxicities. Kaletra should always be used as part of a complete antiretroviral regimen, not as monotherapy, to prevent development of viral resistance. Some key considerations for the use of Kaletra in pediatric patients include:
- The importance of using the oral solution formulation in younger children or those who have difficulty swallowing tablets
- The need for careful monitoring of liver function and lipid levels due to the potential for Kaletra to cause hepatotoxicity and dyslipidemia
- The importance of maintaining adherence to the prescribed dosing regimen to ensure optimal viral suppression and prevent the development of resistance. However, the most recent and highest quality study, 3, does not directly address the dosing of Kaletra in pediatric patients, but rather focuses on the safety and pharmacokinetics of long-acting injectable cabotegravir or rilpivirine in adolescents with HIV. Therefore, the recommendation for Kaletra dosing in a 15 kg child with HIV is based on the available evidence from older studies, such as 2. It is essential to consult with a pediatric infectious disease specialist or a healthcare provider with expertise in HIV management to determine the best treatment approach for each individual child. In addition to Kaletra, other antiretroviral medications, such as dolutegravir, may be considered as part of a complete antiretroviral regimen, depending on the child's specific needs and medical history 4, 5. Overall, the goal of HIV treatment in children is to achieve and maintain viral suppression, prevent disease progression, and minimize the risk of transmission to others. By working closely with a healthcare provider and adhering to the prescribed treatment regimen, children with HIV can lead healthy and active lives.