Drug Database: Lopinavir / Ritonavir

What is Kaletra?What is Kaletra?

What is Kaletra?

Kaletra is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV 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.

Although Kaletra is FDA-approved for use in adults, it is no longer commonly used or recommended as an HIV treatment in adults. The Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV no longer contain detailed or updated information on the use of Kaletra. Please refer to the FDA drug label for additional information regarding the use of Kaletra in people with HIV. For more information on the use Kaletra in children with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV, but using HIV medicines as directed by a health care provider helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are using HIV medicines, do not cut down on, skip, or stop using them unless your health care provider tells you to. For more information about using your HIV medicines as prescribed and ways to overcome barriers to medication adherence, please read the HIVinfo fact sheet on HIV Treatment Adherence.

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

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 breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breastfeeding.
• If you are using hormone-based birth control (such as injections, vaginal rings, implants, contraceptive patches, or birth control pills). 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.

How should I take Kaletra?How should I take Kaletra?

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. While taking Kaletra, it is important to keep all your appointments with your health care provider.

If you are giving Kaletra to your child, follow your child's health care provider’s instructions. Children younger than 18 years of age should not take Kaletra on a once-daily dosing schedule, unless their health care provider has prescribed it to be taken in this way. Kaletra dosing for children is based on body weight or body weight and height. Tell your child's health care provider if your child’s weight or height changes.

Take Kaletra tablets by mouth with or without food. Swallow the tablets whole. Do not chew, break, or crush the tablets.

Take Kaletra oral solution with food. Use the supplied dosing cup or an oral syringe with mL (milliliter) markings to measure the right dose of Kaletra oral solution. Ask your pharmacist for an oral syringe if you do not have one.

Kaletra oral solution contains alcohol and propylene glycol. These substances may cause side effects in babies who take Kaletra oral solution. Contact your health care provider right away if your baby appears too sleepy or their breathing changes.

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?What should I do if I forget a dose?

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?What side effects can Kaletra cause?

What side effects can Kaletra cause?

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

• 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.
• Increases in levels of cholesterol and triglycerides.
• Changes in body fat (lipodystrophy syndrome).
• Diabetes and high blood sugar (hyperglycemia). Rarely, some people taking Kaletra may get high blood sugar, develop diabetes, or have worsening diabetes. Let your health care provider know if you have increased thirst or if you urinate more frequently while taking Kaletra.
• Liver problems. Some people taking Kaletra may develop liver problems. People with a history of hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Kaletra. Liver function tests may be done before and during treatment with Kaletra. Contact your health care provider right away if you have any of the following symptoms: yellowing of your skin or the whites of your eyes (jaundice); dark-colored urine; light-colored bowel movements; loss of appetite for several days or longer; nausea or vomiting; pain, aching, or tenderness on the right side of your stomach/abdominal area; or itching.
• Inflammation of the pancreas (pancreatitis). Pancreatitis is uncommon but may occur in some people, especially those who have certain risk factors for developing pancreatitis. Contact your health care provider right away if you develop the following symptoms: severe pain in the upper stomach/abdominal area, with or without nausea and vomiting.
• Increased bleeding in people with hemophilia.
• Kidney stones. Contact your health care provider if you have pain in your lower back or lower stomach/abdominal area, blood in your urine, or pain when urinating.
• Heart rhythm problems. Kaletra may cause heart rhythm problems. Your risk for developing this problem may be greater if you have had abnormal heart rhythm or certain types of heart problems in the past or if you take certain other medicines with Kaletra. Contact your health care provider right away if you have any of the following symptoms: dizziness; lightheadedness; changes in your heartbeat; or fainting.
• Skin rash and allergic reactions. Mild rash can occur with Kaletra. In rare cases, rashes may be severe. Contact your health care provider right away if you develop a rash while taking Kaletra. Stop taking Kaletra and get medical help right away if you develop a rash with any of the following symptoms: general ill feeling (malaise); extreme tiredness; muscle or joint aches; fever; blistering or peeling skin; blisters or sores in your mouth; redness or swelling of the eyes (conjunctivitis); swelling of your face, lips, mouth, tongue, throat, or lymph nodes; or trouble breathing or swallowing.

Tell your health care provider if you have any side effects that bother you or that do 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.

What medicines can interact with Kaletra?What medicines can interact with Kaletra?

What medicines can interact with Kaletra?

HIV medicines may interact with other medicines and supplements. Before starting Kaletra, tell your health care provider about all the prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Taking Kaletra together with certain medicines or products may cause serious side effects.

For a list of medicines that may interact with Kaletra, see the drug label or ask your health care provider or pharmacist. You can also look up potential interactions between your HIV medicines and other drugs using the HIV Drug Interaction Checker online.

How should Kaletra be stored?How should Kaletra be stored?

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 keep Kaletra tablets out of the container it came in for longer than 2 weeks, especially in areas where there is high humidity.
• 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?Where can I find more information about Kaletra?

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.