KALETRA is a fixed-dose combination drug coupling lopinavir with ritonavir. This product is a protease inhibitor (PI) used to treat human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral medications. Ritonavir inhibits the CYP3A-mediated metabolism of lopinavir. As a result, there is increased plasma levels of lopinavir. Lopinavir targets HIV-1 activity by competitive inhibition of HIV protease, an enzyme involved in viral replication.
KALETRA is available in oral tablets, which are taken with or without food, and cannot be crushed or chewed. An oral solution is available as well. Dosing considerations and drug combinations for using KALETRA are detailed in the package insert. This includes indications for adults, pregnant women, and pediatric patients (14 days of age and older). It has been shown that this product can help for post-exposure prophylaxis following occupational or non-occupational exposure to HIV, including sexual assault.
Hepatotoxicity has been observed in patients taking KALETRA. Fatalities have occurred. Monitoring should take place for liver function before and during therapy. This is of greater importance in patients with underlying hepatic disease, including hepatitis B and C, or marked transaminase elevations. It has been shown that HIV-positive patients be screened for Hepatitis B virus (HBV) and Hepatitis C virus (HCV) at the time of diagnosis. Co-infection with HIV and HBV or HCV should be treated with antiretroviral therapy targeting both viruses, and should continue indefinitely to achieve optimal suppression of HIV and prevention of HBV or HCV exacerbation.
A pregnancy registry is in place for women who take antiretroviral medicines during pregnancy. The purpose of the pregnancy registry is to collect information about the health of the patient and the baby. HIV-infected women should not breast-feed their infants due to the possibility the baby could be infected with HIV transmission through the breast milk.
KALETRA can cause pancreatitis which could lead to death. Patients with advanced HIV-1 disease may have an increased risk of high triglyceride levels and pancreatitis. Patients with a history of pancreatitis are at increased risk. As well, electrical activity and heart rhythm changes can occur when taking KALETRA. This can result in serious heart problems. Those patients with a history of abnormal heart rhythm are at greater risk. Also, blood glucose levels may increase while on KALETRA therapy. New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia have all been reported. A complete list of potential adverse effects and drug-drug interactions are included in the package insert and should be consulted by prescribers.
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