Drug Database: Lopinavir / Ritonavir

What is Kaletra?

Kaletra is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 14 days of age and older. Kaletra is always used in combination with other HIV medicines.

Kaletra contains two different medicines: lopinavir and ritonavir.

For more information on the use of Kaletra in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking Kaletra?

Before taking Kaletra, tell your health care provider:

• If you have ever had a serious skin rash or an allergic reaction to either of the HIV medicines in Kaletra (lopinavir or ritonavir) or any other medicines.
• If you have ever had pancreas problems.
• If you have liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have any heart problems, including a condition called congenital long QT syndrome.
• If you have low potassium in your blood.
• If you have diabetes or high blood sugar (hyperglycemia).
• If you have high cholesterol or high triglycerides. 
• If you have bleeding problems or hemophilia.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. You should not take Kaletra oral solution during pregnancy. Kaletra oral solution contains alcohol and propylene glycol, and there is no safe level of alcohol exposure during pregnancy. Kaletra tablets should not be taken on a once daily dosing schedule during pregnancy. Talk to your health care provider about the risks and benefits of taking Kaletra during pregnancy. For more information on the use of Kaletra during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Kaletra may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking Kaletra. For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John's wort) you are taking or plan to take. Kaletra may affect the way other medicines or products work, and other medicines or products may affect how Kaletra works. Taking Kaletra together with certain medicines or products may cause serious, life-threatening side effects.

How should I take Kaletra?

Kaletra comes in the following forms and strengths:

• Tablets containing 100 mg lopinavir and 25 mg ritonavir
• Tablets containing 200 mg lopinavir and 50 mg ritonavir
• Oral solution containing 80 mg/mL lopinavir and 20 mg/mL ritonavir

Take Kaletra according to your health care provider’s instructions. Do not miss a dose of Kaletra, and do not change your dose or stop taking Kaletra without first talking with your health care provider.

If you are giving Kaletra to your child, follow your health care provider’s instructions. Kaletra dosing for children is based on weight, so tell your health care provider if your child’s weight changes.

Kaletra tablets can be taken with or without food. Swallow the tablets whole. Do not chew, break, or crush the tablets.

Take Kaletra oral solution with food.

Always take Kaletra in combination with other HIV medicines.

If you have taken too much Kaletra, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room.

For more information on how to take Kaletra, see the FDA drug label. 

What should I do if I forget a dose?

If you miss a dose of Kaletra, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can Kaletra cause?

Kaletra may cause side effects. Some side effects of Kaletra can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of Kaletra include:

• Diabetes and high blood sugar (hyperglycemia).
• Increases in levels of cholesterol and triglycerides.
• Increased bleeding in people with hemophilia.
• Changes in body fat (lipodystrophy syndrome).
• Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
• Kidney stones.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Kaletra. To learn more about possible side effects of Kaletra, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should Kaletra be stored?

• Store Kaletra tablets at room temperature, 68°F to 77°F (20°C to 25°C).
• Store Kaletra oral solution in a refrigerator at 36°F to 46°F (2°C to 8°C). The refrigerated oral solution can be used until the expiration date printed on the label. Kaletra oral solution that is stored at room temperature (less than 77°F or 25°C) should be used within 2 months. Keep the oral solution away from high heat.
• Keep Kaletra in the container that it came in and keep the container tightly closed.
• Do not use Kaletra if the original seal over the container opening is broken or missing.
• Throw away Kaletra that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep Kaletra and all medicines out of reach of children.

Where can I find more information about Kaletra?

• For more information on the use of Kaletra in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
• This Patient Version drug summary is based on the following FDA label(s): Solution, tablet (film coated). The Medication Guide includes information for people taking Kaletra.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for lopinavir and ritonavir available from MedlinePlus.
• Kaletra-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.