Lopinavir and ritonavir is indicated in combination with other ARV agents for the treatment of HIV-1 infection in adults and pediatric patients (6 months and older weighing at least 15 kg).
Limitations of Use: Phenotypic testing as well as Genotypic testing treatment history should guide the use of lopinavir and ritonavir.
Warning & Precautions: Some crucial warning and precautions are as follows:
Risk of Serious Side Effects Due to Drug Interactions: Initiation of lopinavir ritonavir combination, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of drugs metabolized by the CYP3A in such patients who are already taking lopinavir and ritonavir, may increase the plasma concentrations of medications
metabolized by CYP3A. If someone initiates such medications that inhibit or induce the CYP3A may boost or down the concentrations of lopinavir ritonavir tablets, respectively. These interactions could lead to:
Significant clinical side effects, potentially leading to the hazardous as well as life-threatening, or fatal events from the greater exposures of concomitant drugs.
Possible development of resistance and loss of therapeutic effects.
Significant clinical side effects from greater exposures of the combined lopinavir and ritonavir.
Patients with Hemophilia: Increased bleeding, including hemarthrosis and spontaneous skin hematomas have been reported in patients with hemophilia type A and B treated with PIs. In a few patients additional factor VIII was given.
Body Fat Redistribution: In some cases body fat accumulation such as breast enlargement, central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, and "cushingoid appearance" have been reported as well as observed in patients taking antiretroviral therapy. The mechanism as well as long-term consequences of these events are not specified yet. AWarnings and precautions of lopinavir Ritonavir tablets
Lopinavir and ritonavir is indicated in combination with other ARV agents for the treatment of HIV-1 infection in adults and pediatric patients (6 months and older weighing at least 15 kg).
Limitations of Use: Phenotypic testing as well as Genotypic testing treatment history should guide the use of lopinavir and ritonavir.
Immune Reconstitution Syndrome: In patients who have been treated with combination antiretroviral therapy including lopinavir ritonavir tablets, immune reconstitution syndrome has been observed. During initial phases of the combinational ARV treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as cytomegalovirus, Mycobacterium avium infection, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis) which may necessitate further evaluation and treatment.
Additionally, a few autoimmune disorders which are as Guillain-Barré syndrome, polymyositis and graves’ disease have been calculated in order to occur in the setting of immune reconstitution, however, the time to onset is much more flexible, and can appear several months after the initiation of the treatment.
Lipid Elevations: Treatment with combined lopinavir and ritonavir has resulted in large increases in the concentration of total cholesterol and triglycerides. Triglyceride as well as cholesterol testing should be performed prior to starting the therapy of lopinavir and ritonavir and at periodic intervals during therapy. Lipid disorders always should be managed as clinically appropriate, taking into account any potential drug-drug interactions with lopinavir and ritonavir and HMG-CoA reductase inhibitors.
QT Interval Prolongation: In some patients postmarketing cases of torsade de pointes and QT interval prolongation have been reported although causality of lopinavir and ritonavir could not be established. Uses should be avoided in patients with congenital long QT syndrome, those with hypokalemia, and with other drugs that prolong the QT interval.
Diabetes Mellitus/Hyperglycemia: New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported during post-marketing surveillance in HIV-1 infected patients receiving protease inhibitor therapy. Some patients required either dose adjustments Or initiation of insulin or oral hypoglycemic agents for treating as well as managing these events. In a few cases, diabetic ketoacidosis has observed. In some cases, patients with discontinued PIs therapy, hyperglycemia persisted. Because all such events have been observed and reported voluntarily during the clinical observations and practices, estimates of frequency never be made and also a causal relationship in between protease inhibitor therapy and all such events has not been specified. A precise monitoring should be considered for new onset diabetes mellitus or an exacerbation of diabetes mellitus and hyperglycemia in patients treated with the combined lopinavir and ritonavir.