Kaletra is a fixed-dose combination antiretroviral medication containing lopinavir and ritonavir, designed for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients. As a protease inhibitor boosted by ritonavir, it plays a critical role in suppressing viral replication, increasing CD4 cell counts, and reducing HIV-related morbidity and mortality. It is indicated for use in combination with other antiretroviral agents as part of a comprehensive HIV treatment strategy, adhering to current clinical guidelines. Kaletra offers a well-established efficacy and safety profile, supported by extensive clinical data and real-world use.

Features

• Fixed-dose combination of lopinavir 200 mg and ritonavir 50 mg per tablet
• Available in tablet and oral solution formulations
• Ritonavir-boosted to enhance lopinavir pharmacokinetics
• Does not require refrigeration for tablets (oral solution must be refrigerated)
• Dosing flexibility with twice-daily administration
• Manufactured under strict quality control standards

Benefits

• Provides potent and durable suppression of HIV-1 viral load
• Helps restore and preserve immune function through increased CD4+ cell counts
• Reduces the risk of HIV disease progression and opportunistic infections
• Offers a high genetic barrier to resistance compared to some other antiretroviral classes
• Supported by long-term clinical trial data and real-world evidence
• Contributes to improved quality of life and long-term survival for people living with HIV

Common use

Kaletra is used as part of combination antiretroviral therapy (cART) for the treatment of HIV-1 infection. It is commonly prescribed for both treatment-naïve and treatment-experienced patients, including those who have developed resistance to other protease inhibitors. The medication may be used in special populations such as pregnant individuals for prevention of perinatal HIV transmission, under careful medical supervision. It is also utilized in certain post-exposure prophylaxis (PEP) regimens following potential HIV exposure.

Dosage and direction

The recommended adult dosage is 400 mg lopinavir/100 mg ritonavir (two tablets) twice daily taken with or without food. For treatment-naïve patients, alternative dosing of 800 mg lopinavir/200 mg ritonavir (four tablets) once daily may be considered. Pediatric dosing is based on body weight or body surface area and should be calculated precisely according to prescribing guidelines. Tablets should be swallowed whole and not chewed, crushed, or broken. The oral solution should be administered using the provided dosing syringe or cup. Dosage adjustments may be necessary for patients with hepatic impairment or when co-administered with certain other medications.

Precautions

Patients should be monitored for potential development of drug-resistant HIV when virologic failure occurs. Use with caution in patients with pre-existing liver disease, including hepatitis B or C co-infection, due to risk of hepatic toxicity. May cause exacerbation of pre-existing diabetes mellitus or hyperglycemia. Monitor lipid parameters as treatment may increase cholesterol and triglycerides. May cause redistribution/accumulation of body fat. Use with caution in patients with underlying structural heart disease or conduction system abnormalities. Contains alcohol in the oral solution; caution in patients with alcohol abuse or dependence.

Contraindications

Kaletra is contraindicated in patients with known hypersensitivity to lopinavir, ritonavir, or any component of the formulation. Concomitant use with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These include alfuzosin, amiodarone, cisapride, ergot derivatives, lovastatin, simvastatin, pimozide, quinidine, sildenafil (for pulmonary arterial hypertension), triazolam, and oral midazolam. Contraindicated with colchicine in patients with renal or hepatic impairment.

Possible side effect

Common adverse reactions 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, hepatotoxicity, PR interval prolongation, and cardiac conduction abnormalities. Allergic reactions including rash and Stevens-Johnson syndrome have been reported. The oral solution may cause taste perversion due to alcohol content.

Drug interaction

Kaletra is a strong inhibitor of CYP3A and CYP2D6 and may increase plasma concentrations of drugs metabolized by these enzymes. Concurrent use with other medications that induce or inhibit CYP3A may alter lopinavir concentrations. Significant interactions occur with anticonvulsants, antimycobacterials, sedative/hypnotics, ergot derivatives, GI motility agents, neuroleptics, PDE5 inhibitors, and certain statins. May reduce effectiveness of oral contraceptives; alternative contraception methods recommended. Interacts with many antiretroviral agents including other protease inhibitors, NNRTIs, and entry inhibitors.

Missed dose

If a dose is missed within 6 hours of the scheduled time, the patient should take the missed dose immediately and then resume the regular dosing schedule. If more than 6 hours have passed, the patient should 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 regimen is critical for maintaining virologic suppression and preventing development of drug resistance.

Overdose

There is limited experience with Kaletra overdose. Reported experiences include events similar to known adverse reactions. If overdose occurs, the patient should be monitored for evidence of toxicity and supportive treatment administered. Since lopinavir and ritonavir are highly protein-bound, dialysis is unlikely to be effective in removing them from circulation. Management should include general supportive measures including monitoring of vital signs and observation of clinical status. Contact a poison control center for current guidance on management.

Storage

Store tablets at room temperature between 15-30°C (59-86°F) in the original container. Keep tightly closed and protect from moisture. The oral solution should be refrigerated at 2-8°C (36-46°F) until opened; avoid freezing. After opening, the oral solution can be stored at room temperature (below 25°C/77°F) for up to 2 months. Keep all medications out of reach of children and pets. Do not use beyond the expiration date printed on the packaging.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with a qualified healthcare professional familiar with the patient’s complete medical history. The prescribing physician should be consulted for specific dosing recommendations and management of adverse effects. Patients should not alter their medication regimen without medical supervision.

Reviews

Clinical studies have demonstrated Kaletra’s efficacy in achieving and maintaining virologic suppression in both treatment-naïve and treatment-experienced patients. The MONARK study showed 80% of treatment-naïve patients achieved viral load <50 copies/mL at 48 weeks. The MAXCMP1 trial demonstrated comparable efficacy to other boosted protease inhibitors in treatment-experienced patients. Real-world evidence supports its long-term durability and tolerability profile. Healthcare providers report satisfaction with its efficacy and manageable side effect profile when used appropriately within treatment guidelines. Patient-reported outcomes indicate improved quality of life with sustained virologic control.