- Kaletra is used to treat adults and children at least 14 days old
- HIV treatment of choice for pregnant women
- Kaletra is given with other antiretroviral drugs to be effective
Brand Name: Kaletra
Generic Name: Lopinavir/ritonavir
Physicians prescribe Kaletra in combination with other medications to treat HIV. The U.S. Food and Drug Administration (FDA) has approved Kaletra for use by patients aged 14 days and older. Kaletra is two separate drugs, lopinavir and ritonavir, that belong to a medication class known as protease inhibitors.
Read the FDA description of Kaletra.
Kaletra works by blocking protease enzymes that are present in HIV. The lopinavir in the medication works to keep the viruses from duplicating. The ritonavir in the medication doesn’t act against HIV, but instead works with the body to maintain steady levels of lopinavir, thus maximizing that drug’s effectiveness. Kaletra is given as part of combination drug therapy for HIV. Kaletra is not a cure for HIV or AIDS, but it’s a way to slow HIV’s progression.
The adult dose of Kaletra varies depending on whether the patient has previously been treated, whether the patient is taking certain other drugs, and whether the patient has a certain measurement of resistance to treatment. Patients usually receive special testing before treatment to determine the best dose.
For patients who have previously had treatment as part of combination therapy, the adult dose is one tablet (lopinavir 400 milligrams (mg)/ritonavir 100 mg) twice daily with or without food.
For patients who have previously had treatment and who will also be taking efavirenz (Sustiva), fosamprenavir (Lexiva), nelfinavir (Viracept), or nevirapine (Viramune), the dose is one tablet (lopinavir 500 mg/ritonavir 125 mg) twice a day or lopinavir 533 mg/ritonavir 133 mg solution twice a day.
For patients who have previously had treatment and who have less than three lopinavir resistance associated substitutions, the dose is one tablet (lopinavir 800 mg/ritonavir 200 mg) once daily.
Once daily dosing is not recommended for patients who are currently receiving efavirenz, fosamprenavir, nevirapine, nelfinavir, carbamazeepine, phenobarbital or phenytoin.
Kaletra should be used with caution in patients with liver disease.
Children aged 14 days to 18 years are dosed according to body weight or body surface area (BSA). This is calculated using the child’s weight and height.
Kaletra can be taken with or without food. The oral suspension option should always be taken with food. The oral suspension also contains alcohol and propylene glycol, which can increase the risk of adverse effects in premature infants. Infants are usually 14 days old before treatment with Kaletra is started.
This information is a summary. Before starting this medication, discuss questions with your healthcare provider and make sure you understand dosage instructions.
Tell your doctor before taking Kaletra if you:
Always tell your doctor about any prescription medications or herbal remedies you are taking. Many medications adversely interact with Kaletra, and some should not be taken with it. Always review all medications, over-the-counter drugs, and herbal remedies that you take with your physician and pharmacist before taking Kaletra. Some medications that can adversely interact with Kaletra include:
Possible Adverse and Emergency Side Effects
The following are severe and emergent side effects of these medications. Contact your medical provider immediately if you experience:
Possible Nonemergency Side Effects
The following side effects may occur but do not usually represent an emergency. Discuss them with your doctor or healthcare professional if they continue or are bothersome. These include:
This list may not describe all possible side effects. Call your doctor or healthcare provider for advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Kaletra and Pregnancy
The FDA classifies Kaletra in category C, which means the effects on an unborn baby are unknown. Always notify your doctor if you are pregnant or thinking of becoming pregnant before taking Kaletra. However, the Antiretroviral Pregnancy Registry, a large study of pregnant HIV patients treated with Kaletra, did not find an increase in birth defects in the children born by these women. Consult your doctor for the most current recommendation.
Some forms of birth control pills or patches may not work as well if they are used at the same time as Kaletra. Discuss your birth control options with your doctor before taking Kaletra.
Kaletra’s manufacturer says that mothers should not breastfeed while taking Kaletra.
Kaletra and Alcohol
Note that liquid Kaletra contains a small amount of alcohol, which could interact with disulfiram (Antabuse) to trigger nausea and vomiting. Patients who must take Kaletra oral suspension should avoid alcohol.
Storage for Kaletra depends upon the type of preparation. Kaletra tablets should be stored at room temperature between 68 to 77 degrees Fahrenheit (20 to 25 degrees Celsius). Oral solutions and capsules of Kaletra should be stored in a refrigerator between the temperatures of 36 and 46 degrees Fahrenheit (2 to 8 degrees Celsius). Once opened, the oral suspension of Kaletra should be used within two months.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
FDA WARNING: SERIOUS HEALTH PROBLEMS THAT HAVE BEEN REPORTED IN PREMATURE BABIES RECEIVING LOPINAVIR/RITONAVIR (KALETRA) ORAL SOLUTION. LOPINAVIR/RITONAVIR ORAL SOLUTION CONTAINS THE INGREDIENTS ALCOHOL AND PROPYLENE GLYCOL. PREMATURE BABIES MAY BE AT INCREASED RISK FOR HEALTH PROBLEMS BECAUSE THEY HAVE A DECREASED ABILITY TO ELIMINATE PROPYLENE GLYCOL; THIS COULD LEAD TO PROBLEMS BECAUSE THEY HAVE A DECREASED ABILITY TO ELIMINATE PROPYLENE GLYCOL; THIS COULD LEAD TO ADVERSE EVENTS SUCH AS SERIOUS HEART, KIDNEY, OR BREATHING PROBLEMS. BECAUSE THE CONSEQUENCES OF USING LOPINAVIR/RITONAVIR ORAL SOLUTION IN BABIES IMMEDIATELY AFTER BIRTH CAN BE SEVERE OR POSSIBLY FATAL, THE LABEL has been REVISED TO INCLUDE A NEW WARNING.
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