KALETRA- lopinavir and ritonavir tablet, film coated
KALETRA- lopinavir and ritonavir solution
1 INDICATIONS AND USAGE
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).
The following points should be considered when initiating therapy with KALETRA:
The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see Microbiology (12.4) and Clinical Studies (14)].
Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Microbiology (12.4)]. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)].
2 DOSAGE AND ADMINISTRATION
2.1 General Administration Recommendations
KALETRA tablets may be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed. KALETRA oral solution must be taken with food.
2.2 Dosage Recommendations in Adults
Considerations in Determining KALETRA Once Daily vs. Twice Daily Dosing Regimen:
KALETRA can be given as once daily or twice daily dosing regimen in patients with less than three lopinavir resistance-associated substitutions.
KALETRA must be given as twice daily dosing regimen in patients with three or more resistance-associated substitutions.
Table 1 includes the recommended once daily dosing regimen and Tables 2 and 3 include the recommended twice daily dosing regimen.
KALETRA once daily dosing regimen is not recommended in:
Adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Microbiology (12.4)].
In combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7.3)].
In combination with efavirenz, nevirapine, or nelfinavir [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)].
In pregnant women [see Dosage and Administration (2.4), Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].
The dose of KALETRA must be increased when administered in combination with efavirenz, nevirapine or nelfinavir.