The FDA has approved a new drug called Kaletra for the treatment of HIV-1 infection. Kaletra contains two medicines: lopinavir and ritonavir. It is for adults and children aged 14 days and older. It must be used together with other antiretroviral drugs. The approval is based on studies showing that Kaletra can lower the amount of HIV in the blood. However, how well it works depends on the patient's specific virus and treatment history. Doctors should use resistance testing to decide if Kaletra is right for each patient. Kaletra comes as tablets and an oral solution. The once-daily dose is not recommended for patients with certain resistance patterns or those taking specific other medicines. It is also not recommended for pregnant women. Children should take it twice a day. The oral solution must be taken with food and should not be used with polyurethane feeding tubes. This approval gives patients and doctors another tool to manage HIV. But it is not a cure. Patients should talk to their doctor to see if Kaletra is a good option for them. They should also discuss any other medicines they take and any health conditions they have.
FDA approved Kaletra (lopinavir/ritonavir) for HIV-1 Infection in Patients 14 Days and OlderFDA approved Kaletra to treat HIV in adults and children 14 days and older.
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The FDA has approved Kaletra (lopinavir/ritonavir) for the treatment of HIV-1 infection in adults and pediatric patients aged 14 days and older, to be used in combination with other antiretroviral agents. The approval is based on data demonstrating efficacy in suppressing viral load, though the label emphasizes that genotypic or phenotypic testing and treatment history should guide use. The number of baseline lopinavir resistance-associated substitutions affects virologic response. Kaletra is available as tablets and oral solution. The once-daily regimen is not recommended in patients with certain resistance substitutions, in combination with carbamazepine, phenobarbital, phenytoin, efavirenz, nevirapine, or nelfinavir, and in pregnant women. The twice-daily regimen is recommended for pediatric patients. The oral solution must be taken with food and is not recommended for use with polyurethane feeding tubes.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide use. The number of baseline lopinavir resistance-associated substitutions affects virologic response.
Tablets may be taken with or without food, swallowed whole. Oral solution must be taken with food. Adults: Total recommended daily dosage is 800/200 mg given once or twice daily. Once daily not recommended in patients with three or more lopinavir resistance-associated substitutions, in combination with carbamazepine, phenobarbital, phenytoin, efavirenz, nevirapine, or nelfinavir, or in pregnant women. Pediatric patients (14 days and older): Twice daily dosing based on body weight or body surface area; once daily not recommended. Oral solution not recommended in neonates before postmenstrual age of 42 weeks and postnatal age of at least 14 days. Pregnancy: 400/100 mg twice daily in patients with no documented lopinavir-associated resistance substitutions.
Trial data not available in label.
Not reported in label.
Kaletra is an HIV-1 protease inhibitor used in combination with other antiretroviral agents for HIV-1 infection. Its use should be guided by resistance testing and treatment history.
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