- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Liquid formulation:
Kaletra taken at 300/75 mg/m² twice daily and 230/57.5 mg/m² twice daily has been studied in a total of 53 children, varying in age from 6 months to 12 years. The AUC, Cmax and Cmin in the steady state for lopinavir were 72.6 ± 31.1 μg•hour/ml, 8.2 ± 2.9 μg/ml and 3.4 ± 2.1 μg/ml respectively after Kaletra at 230/57.5 mg/m² twice daily without nevirapine (n=12) and 85.8 ± 36.9 μg•hour/ml, 10.0 ± 3.3 and 3.6 ± 3.5 μg/ml respectively after 300/75 mg/m² twice daily with nevirapine (n=12). The therapy with 230/57.5 mg/m² twice daily without nevirapine and the therapy with 300/75 mg/m² twice daily with nevirapine gave plasma concentrations of lopinavir that were the same as those obtained in adult patients who received a regime of 400/100 mg twice daily without nevirapine.
Tablet
There is little pharmacokinetic data available about children younger than 2 years. The pharmacokinetics of Kaletra 100/25 mg tablets taken twice daily as a weight-based dose has been studied in a total of 53 paediatric patients, without nevirapine. The averages ± standard deviations for lopinavir in the steady state for the AUC, Cmax and C12 were 112.5±37.1μ g•h/ml, 12.4±3.5 μg/ml and 5.71±2.99 μg/ml respectively.
The therapy with twice daily weight-based doses without nevirapine and the therapy with 300/75 mg/m² twice daily with nevirapine gave plasma concentrations of lopinavir that were comparable to those obtained in adult patients who received a regime of 400/100 mg twice daily without nevirapine. Once-daily dosing of Kaletra has not been studied in children.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| HIV without nevirapine, efavirenz or fosamprenavir |
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| HIV with nevirapine, efavirenz or fosamprenavir |
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| HIV in ARV naive patients |
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
The liquid formulation contains 150 mg/ml propylene glycol and 356.3 mg/ml ethanol.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Nucleosides and nucleotides excl. reverse transcriptase inhibitors | ||
|---|---|---|
| J05AB01 | ||
| J05AB04 | ||
| J05AB11 | ||
| J05AB14 | ||
| Protease inhibitors | ||
|---|---|---|
| J05AE10 | ||
| J05AE03 | ||
| Nucleoside and nucleotide reverse transcriptase inhibitors | ||
|---|---|---|
| J05AF10 | ||
| J05AF05 | ||
| J05AF01 | ||
| Non-nucleoside reverse transcriptase inhibitors | ||
|---|---|---|
| J05AG01 | ||
| Neuraminidase inhibitors | ||
|---|---|---|
| J05AH02 | ||
| Antivirals for treatment of HIV infections, combinations | ||
|---|---|---|
| J05AR02 | ||
| Other antivirals | ||
|---|---|---|
| J05AX12 | ||
| J05AX08 | ||
| ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS | ||
|---|---|---|
| J05AR02 | ||
| Antivirals for treatment of HCV infections | ||
|---|---|---|
| J05AP57 | ||
| J05AP08 | ||
| J05AP55 | ||
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References
- CBO, Richtlijn antiretrovirale therapie, www.cbo.nl, herziene versie december 2007
- Antiretroviral Therapy and Medical Management of HIV-Infected Children, Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, www.aidsinfo.nih.gov , 2010, http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf.
- PENTA Steering Commitee, PENTA 2009 guidelines for the use of antiretroviral therapy, HIV Medicine, 2009, 10, 591-613
- Bamford, A., et al (PENTA Steering Committee) (2015), Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life., HIV Med., doi:10.1111
- Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children., Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection., Available at www.aidsinfo.nih.gov, Accessed Oct 3, 2019
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM), Voorlopig Behandeladvies COVID-19 - March 3rd, 2020
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Changes
Changes
