Kaletra is a fixed-dose combination antiretroviral medication specifically formulated for the treatment of human immunodeficiency virus (HIV-1) infection in both adult and pediatric patients aged 14 days and older. It combines two potent protease inhibitors, lopinavir and ritonavir, working synergistically to suppress viral replication and increase CD4 cell counts. This medication is a cornerstone of highly active antiretroviral therapy (HAART) regimens, offering robust viral suppression with a well-established efficacy and safety profile. Kaletra is typically prescribed in combination with other antiretroviral agents to create a comprehensive treatment strategy tailored to individual patient needs and resistance patterns.

Features

• Contains lopinavir 200 mg and ritonavir 50 mg per tablet
• Available in tablet and oral solution formulations
• Fixed-dose combination for simplified dosing
• Requires no refrigeration for tablets (oral solution must be refrigerated)
• Bioavailability enhanced by ritonavir boosting
• Manufactured under strict quality control standards

Benefits

• Provides potent suppression of HIV-1 replication through dual protease inhibition
• Helps maintain or increase CD4+ T-cell counts, supporting immune function recovery
• Reduces viral load to undetectable levels with proper adherence
• Lowers the risk of HIV-related complications and disease progression
• May help prevent HIV transmission to others when viral load is suppressed
• Offers flexible dosing options suitable for various patient populations

Common use

Kaletra is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents in adults and pediatric patients 14 days of age and older. It is commonly used in both treatment-naïve and treatment-experienced patients, particularly those who may benefit from a boosted protease inhibitor regimen. The medication is often prescribed when resistance testing indicates susceptibility to lopinavir or when other first-line regimens are not suitable. Kaletra may also be used in certain prevention contexts, such as post-exposure prophylaxis, under specific medical guidance.

Dosage and direction

The recommended adult dosage is 400 mg lopinavir/100 mg ritonavir (two tablets) twice daily with food. For treatment-naïve adults, an alternative dosage of 800 mg lopinavir/200 mg ritonavir (four tablets) once daily with food may be considered. Pediatric dosing is based on body weight or body surface area and must be calculated precisely according to prescribing guidelines. Tablets should be swallowed whole and not chewed, broken, or crushed. The oral solution should be administered using the provided dosing syringe or cup. Always take Kaletra with food to enhance absorption and maintain consistent therapeutic levels.

Precautions

Patients should undergo appropriate resistance testing before initiating therapy. Liver function should be monitored regularly, particularly in patients with pre-existing hepatic impairment. Pancreatitis has been reported; monitor for symptoms including nausea, vomiting, and abdominal pain. May cause exacerbation of pre-existing diabetes mellitus or hyperglycemia. Fat redistribution may occur with long-term use. Patients with hemophilia may experience increased bleeding episodes. Use with caution in patients with known cardiac conduction abnormalities or structural heart disease. Contains alcohol in the oral solution formulation; consider alternative options for patients with alcohol dependence or liver disease.

Contraindications

Kaletra is contraindicated in patients with known hypersensitivity to lopinavir, ritonavir, or any component of the formulation. Coadministration with drugs highly dependent on CYP3A or CYP2D6 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Specifically, concurrent use with alfuzosin, amiodarone, bepridil, cisapride, colchicine (in patients with renal or hepatic impairment), dronedarone, ergot derivatives, flecainide, lovastatin, lurasidone, methylergonovine, midazolam (oral), pimozide, propafenone, quinidine, ranolazine, sildenafil (for pulmonary arterial hypertension), simvastatin, St. John’s wort, triazolam, or voriconazole is contraindicated.

Possible side effect

Common side effects include diarrhea, nausea, vomiting, abdominal pain, headache, and asthenia. Laboratory abnormalities may include elevated triglycerides, elevated cholesterol, elevated liver enzymes, and hyperglycemia. Less common but serious side effects include pancreatitis, severe skin reactions, hepatotoxicity, and cardiac conduction abnormalities. Some patients may experience redistribution/accumulation of body fat. The oral solution may cause taste perversion. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.

Drug interaction

Kaletra is a potent inhibitor of CYP3A and CYP2D6 and may increase plasma concentrations of drugs metabolized by these enzymes. Significant interactions occur with other antiretroviral agents, particularly other protease inhibitors and non-nucleoside reverse transcriptase inhibitors. Dose adjustments may be necessary when coadministered with rifabutin, atorvastatin, clarithromycin, or certain antidepressants. May reduce effectiveness of oral contraceptives; alternative contraceptive methods should be considered. Interacts with various anticonvulsants, sedative/hypnotics, and immunosuppressants. Concurrent use with PDE5 inhibitors may require dose adjustment and increased monitoring for adverse events.

Missed dose

If a dose is missed within 6 hours of the scheduled time, take the missed dose immediately with food. If more than 6 hours have passed, skip the missed dose and resume the regular dosing schedule. Do not double the next dose to make up for a missed dose. Consistent adherence to the prescribed dosing schedule is crucial for maintaining viral suppression and preventing the development of drug resistance. Patients should contact their healthcare provider if multiple doses are missed or if adherence becomes challenging.

Overdose

There is limited experience with Kaletra overdose. Maximum reported doses include 24 tablets (4,800 mg lopinavir/1,200 mg ritonavir) with no serious adverse events. However, overdose may potentially exacerbate known adverse effects, particularly gastrointestinal symptoms and electrolyte imbalances. Treatment should be supportive and include monitoring of vital signs and ECG. If ingestion occurs recently, activated charcoal may be considered. Lopinavir is highly protein-bound and unlikely to be significantly removed by dialysis. Contact poison control center for latest guidance on management of antiretroviral overdose.

Storage

Store tablets at room temperature (20-25°C or 68-77°F); excursions permitted between 15-30°C (59-86°F). Keep in original container with desiccant, tightly closed. Protect from excessive moisture and light. Oral solution should be refrigerated (2-8°C or 36-46°F); do not freeze. If stored at room temperature, use within 2 months. Keep all medications out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Properly dispose of unused medication according to local regulations.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Kaletra is a prescription medication that should be used only under the supervision of a qualified healthcare provider. Treatment decisions should be based on individual patient characteristics, resistance testing, and comprehensive medical evaluation. The prescribing physician should be consulted for specific dosage recommendations and monitoring requirements. Actual product labeling may contain additional information and should be consulted before prescribing.

Reviews

Clinical trials demonstrate Kaletra’s efficacy in achieving and maintaining viral suppression in diverse patient populations. In study M98-863, 75% of treatment-naïve patients receiving Kaletra plus stavudine and lamivudine achieved viral load <400 copies/mL at 48 weeks compared to 63% with nelfinavir-based regimen. Long-term extension studies show durable response with maintained suppression through 7 years of treatment. Real-world evidence supports its effectiveness in treatment-experienced patients with documented protease inhibitor resistance. Patients report generally good tolerability, though gastrointestinal side effects remain a consideration. Healthcare providers appreciate the well-characterized resistance profile and flexibility in dosing regimens.