Kaletra (lopinavir and ritonavir)
Pronunciation: pronunciation varies by local usage.
- Generic name
- lopinavir and ritonavir
- Brand names
- KALETRA
- Drug class
- HIV-1 protease inhibitor combination (lopinavir boosted with ritonavir)
- Form
- Film-coated tablet and oral solution
- Route
- Oral
- Legal status
- Prescription-only medicine
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What lopinavir and ritonavir is and how it works
Kaletra is a fixed-dose combination of lopinavir (an HIV-1 protease inhibitor) and ritonavir (a pharmacokinetic booster that increases lopinavir levels). It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
It is indicated for adults and pediatric patients 14 days of age and older. Treatment is prescribed and monitored by the treating clinician.
Mechanism of action: how lopinavir and ritonavir works
Lopinavir is an HIV-1 protease inhibitor. Ritonavir inhibits CYP3A-mediated metabolism of lopinavir, increasing its plasma concentrations and providing a pharmacokinetic boost. (1)
What lopinavir and ritonavir is used for
HIV-1 infection
Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days of age and older. (1)
Before taking lopinavir and ritonavir
Do not take / not appropriate for
- The following medicines are contraindicated with Kaletra due to the risk of serious or life-threatening interactions: alfuzosin, cisapride, ergot derivatives (e.g., dihydroergotamine, ergotamine), lovastatin, simvastatin, pimozide, triazolam, orally administered midazolam, rifampin, St. John's Wort, or sildenafil (when used for pulmonary arterial hypertension). Anyone taking or being considered for one of these medicines should tell the prescribing clinician or pharmacist promptly so they can determine whether Kaletra can be used safely. (all products) (1)
Tell your clinician about
- All other medicines, including over-the-counter products, herbal supplements, and especially other HIV medicines (e.g., efavirenz, nevirapine), anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin), fluticasone, methadone, and tenofovir.
- Any history of liver disease, hepatitis B or C, heart rhythm problems, pancreatitis, or high cholesterol/triglycerides.
- If you are pregnant, plan to become pregnant, or are breastfeeding.
- Any signs of infection or inflammatory condition after starting treatment (possible immune reconstitution).
How to take lopinavir and ritonavir
- Take Kaletra exactly as prescribed by your clinician. The dose depends on age, weight, and other medicines you are taking.
- Tablets must be swallowed whole and not chewed, broken, or crushed. They may be taken with or without food.
- The oral solution must be taken with food.
- Any question about changing the dose or whether treatment should continue should be directed to the prescribing clinician.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
Information on missed dose management is not available from the research notes. Contact your prescribing clinician for instructions if you miss a dose.
Overdose
No specific overdose information is available from the research notes. If an overdose is suspected, seek immediate medical attention or contact a poison control center.
Side effects
Common side effects include diarrhea, nausea, abdominal pain, asthenia, vomiting, headache, and dyspepsia. Serious side effects can also occur and require prompt medical evaluation.
Diarrhea, nausea, vomiting, abdominal pain
What to notice: Loose stools, stomach discomfort, indigestion. These are the most frequently reported side effects.
What to do: If symptoms are severe or persistent, contact your clinician. (1)
Asthenia (weakness) and headache
What to notice: Unusual tiredness, lack of energy, headaches.
What to do: Discuss persistent or bothersome symptoms with your clinician. (1)
Liver problems
What to notice: Specific symptoms were not extracted from the supplied research notes; the notes support an increased risk of liver enzyme elevations and hepatic decompensation, particularly with underlying hepatitis B or C co-infection or pre-existing liver disease.
What to do: Contact your clinician promptly; liver function monitoring is recommended. (1)
Pancreatitis
What to notice: Specific symptoms were not extracted from the supplied research notes; the notes report pancreatitis, including fatal cases, with marked triglyceride elevation as a risk factor.
What to do: Seek prompt medical evaluation; pancreatitis can be serious. (1)
Heart rhythm changes
What to notice: Specific symptoms were not extracted from the supplied research notes; the notes report cases of second- or third-degree atrioventricular block and torsade de pointes.
What to do: Report promptly to your clinician, especially if you have pre-existing conduction system disease or take other medicines affecting heart rhythm. (1)
Immune reconstitution inflammatory syndrome (IRIS)
What to notice: Specific symptoms were not extracted from the supplied research notes; the notes describe IRIS as the immune system responding to previously indolent opportunistic or other infections, typically during the initial phase of combination antiretroviral treatment.
What to do: Report to your clinician for evaluation. (1)
Serious warnings
Severe liver problems — emergency
Symptoms: Specific emergency symptoms were not extracted from the supplied research notes; the notes support a liver-injury risk requiring monitoring.
Action: Seek emergency medical attention immediately. (1)
Severe pancreatitis — emergency
Symptoms: Specific emergency symptoms were not extracted from the supplied research notes; the notes support a pancreatitis risk associated with triglyceride elevation.
Action: Seek emergency medical attention immediately. (1)
Severe heart rhythm disturbance — emergency
Symptoms: Specific emergency symptoms were not extracted from the supplied research notes; the notes support reports of atrioventricular block and torsade de pointes.
Action: Call emergency services immediately. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Other HIV medicines (efavirenz, nevirapine) | Co-administration with efavirenz or nevirapine requires an increased Kaletra dose. Once-daily Kaletra dosing is not recommended with these agents. | The treating clinician will determine the specific increased-dose regimen. (1) |
| Tenofovir | Co-administration may increase tenofovir plasma concentrations, potentially increasing the risk of tenofovir-associated adverse reactions. | Your clinician should monitor for tenofovir-related side effects. (1) |
| Methadone | Kaletra may reduce methadone plasma levels, potentially leading to withdrawal symptoms. | Your clinician may need to adjust the methadone dose. (1) |
| Inhaled or intranasal fluticasone | Co-administration is not recommended due to the risk of systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. | Co-administration should be assessed by the prescribing clinician, who can weigh the benefits and risks and arrange appropriate monitoring, rather than being decided by the reader. (1) |
| Medicines that prolong the QT/PR interval | Additive heart rhythm effects may occur, increasing the risk of serious arrhythmias. | Your clinician should review all your medicines and determine whether additional monitoring is needed. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Kaletra should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry exists; talk to your clinician about enrollment. (1)
Breastfeeding
Mothers with HIV should not breastfeed to avoid postnatal HIV transmission, and because of the potential for serious adverse reactions in the breastfed infant. (1)
Children and adolescents (14 days to 18 years)
Dosing is based on body weight, age, and concomitant antiretroviral therapy. The oral solution is used for younger children; tablets are only for those who can swallow them whole. Treatment is prescribed and monitored by the treating clinician. (1)
People with liver disease or hepatitis B/C co-infection
May be at increased risk of liver enzyme elevations and hepatic decompensation. Liver function should be closely monitored. (1)
People with pre-existing heart rhythm disorders
Cases of atrioventricular block and torsade de pointes (a serious heart rhythm disturbance) have been reported. Use with caution if you have pre-existing conduction system disease or take other medicines affecting heart rhythm. Discuss with your clinician if you have any conduction abnormalities. (1)
Monitoring
Before starting
- Liver function and lipid profile are clinician considerations relevant to Kaletra treatment; the supplied research notes do not specify their exact pre-treatment timing.
- Review all concomitant medications for potential interactions, especially CYP3A substrates or inducers.
- HIV-1 resistance-profile assessment and eligibility for once-daily dosing should be determined by the treating clinician; detailed resistance-associated-substitution criteria were not extracted from the supplied research notes.
- Pregnancy and breastfeeding status are relevant to discuss with the prescriber; the supplied research notes do not specify a documentation or registry-counseling requirement before starting.
During treatment
- Liver enzyme monitoring is relevant given the hepatotoxicity risk, particularly with underlying liver disease or hepatitis B/C co-infection; the supplied research notes do not specify a testing schedule.
- Monitor lipid profiles due to risk of elevation; manage as appropriate.
- Watch for signs of pancreatitis.
- Observe for immune reconstitution inflammatory syndrome (IRIS), especially soon after starting therapy.
- Review any new concomitant medications for potential interactions.
- For patients on concomitant tenofovir, monitor for tenofovir-associated adverse reactions, per the supplied research notes.
- Use with caution if co-administered with other QT/PR-prolonging medicines or in patients with pre-existing conduction system disease; the supplied research notes do not specify an ECG-monitoring protocol.
Storage
Storage information was not included in the research notes. Refer to the product packaging and prescribing information.
Professional information
Clinician-facing context only. Always refer to the complete local prescribing information for exact dosing, contraindications, and monitoring.
United States (FDA)
Indication: HIV-1 infection, adults
Dose summary: Standard adult dose: 400 mg/100 mg (two 200/50 mg tablets) twice daily. In select patients without certain resistance-associated substitutions, 800 mg/200 mg once daily may be considered. Total daily dose 800/200 mg.
Renal context: Detailed renal-impairment dosing was not extracted from the supplied research notes; this remains unresolved. (1)
United States (FDA)
Indication: HIV-1 infection, pediatric (14 days to <6 months)
Dose summary: Using oral solution: 16 mg/4 mg per kg or 300 mg/75 mg per m² twice daily.
Renal context: No specific pediatric renal dosing information available from research notes. (1)
United States (FDA)
Indication: HIV-1 infection, pediatric (6 months to 18 years, without interacting NNRTIs)
Dose summary: Using oral solution: 230 mg/57.5 mg per m² twice daily. This regimen applies to children without concomitant efavirenz, nevirapine, amprenavir, or nelfinavir; the supplied research notes do not specify dosing for children on these concomitant medicines — refer to full prescribing information.
Renal context: No specific pediatric renal dosing information available from research notes. (1)
Hepatic guidance
Detailed hepatic-impairment dose-adjustment guidance was not extracted from the supplied research notes; this remains unresolved. Patients with underlying hepatitis B or C co-infection or pre-existing liver disease may be at increased risk for hepatic decompensation, per the research notes.
Overdose note
No specific overdose-management information (including whether an antidote exists) was provided in the supplied research notes. Contact a poison control center or emergency care for suspected overdose. (1)
Frequently asked questions
Can I take Kaletra tablets with food?
Kaletra tablets may be taken with or without food. However, the oral solution must be taken with food. (1)
I take many other medicines. Is it safe to take Kaletra with them?
Kaletra has many important drug interactions. Some medicines are absolutely contraindicated, while others require dose adjustments or close monitoring. You must tell your clinician about all medicines, including over-the-counter products and herbal supplements. (1)
Can I take Kaletra if I am pregnant?
Kaletra should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry exists to monitor outcomes. Discuss with your HIV specialist. (1)
What should I do if I notice signs of an infection after starting Kaletra?
You may experience immune reconstitution inflammatory syndrome (IRIS), where your improving immune system reacts to a previously hidden infection. Report any new symptoms such as fever, swollen glands, or cough to your clinician. (1)
What is the mechanism of action of lopinavir and ritonavir?
Lopinavir is an HIV-1 protease inhibitor. Ritonavir inhibits CYP3A-mediated metabolism of lopinavir, increasing its plasma concentrations and providing a pharmacokinetic boost. (1)
What is the generic name of Kaletra (lopinavir and ritonavir)?
The generic name is lopinavir and ritonavir. It is sold under brand names including KALETRA. (1)
What class of drug is lopinavir and ritonavir?
Kaletra (lopinavir and ritonavir) is classed as: HIV-1 protease inhibitor combination (lopinavir boosted with ritonavir). (1)
References
- KALETRA (lopinavir and ritonavir) tablet, film coated and oral solution — full prescribing informationU.S. National Library of Medicine (DailyMed) · United States · accessed 2026-08-05 · source 1
- KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [ABBVIE INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Lopinavir and Ritonavir — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Lopinavir and Ritonavir — FDA approval record (Drugs@FDA ANDA204739)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- lopinavir and ritonavir — RxNorm normalized drug concept (RXCUI 284640)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient lopinavir and ritonavir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Kaletra