Kaletra (Lopinavir/Ritonavir) for HIV

Kaletra (lopinavir/ritonavir) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children ages 14 days and older.

How Kaletra Works and How It’s Taken

Kaletra is a type of antiviral medication called an HIV-1 protease inhibitor. It contains two active ingredients, lopinavir and ritonavir. Lopinavir blocks HIV protease, an enzyme HIV needs to produce mature, infectious virus particles. Ritonavir helps increase and maintain lopinavir levels in the body.

Doctors prescribe Kaletra together with other antiretroviral medications to treat HIV-1 infection in adults and children ages 14 days and older.

HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).

Kaletra is available as tablets and an oral solution taken by mouth. The tablets may be taken with or without food and should be swallowed whole without being chewed, broken, or crushed. The oral solution must be taken with food.

Kaletra may be taken once or twice daily in adults, depending on the treatment regimen and individual factors.

Once-daily dosing is not recommended for people with three or more specified lopinavir resistance-associated substitutions, people taking certain interacting medications, or during pregnancy. Children younger than 18 should not receive Kaletra once daily.

Typical Dosing for HIV

Kaletra dosing depends on age, weight, body surface area, other medications, and certain treatment factors.

Adults typically take 800 milligrams/200 milligrams once daily or 400 milligrams/100 milligrams twice daily. Once-daily dosing is not recommended in some situations, including during pregnancy, with certain resistance-associated substitutions, or with certain interacting medicines.

Children ages 14 days to 6 months are given the oral solution twice daily. The dose is based on body weight or body surface area:

16 milligrams/4 milligrams per kilogram twice daily
300 milligrams/75 milligrams per square meter twice daily

Children older than 6 months to younger than 18 years take the oral solution based on one of these options:

Less than 15 kilograms — 12 milligrams/3 milligrams per kilogram twice daily
15 kilograms to 40 kilograms — 10 milligrams/2.5 milligrams per kilogram twice daily
Another option — 230 milligrams/57.5 milligrams per square meter twice daily

Children older than 6 months take the tablets based on one of these options:

15 kilograms to 25 kilograms — Two 100-milligram/25-milligram tablets twice daily
More than 25 kilograms to 35 kilograms — Three 100-milligram/25-milligram tablets twice daily
More than 35 kilograms — Four 100-milligram/25-milligram tablets twice daily

Children should not take Kaletra once daily.

If taken with certain medicines, Kaletra may need to be given twice daily at a higher dose when used with certain interacting antiretroviral or anti-seizure medicines.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Kaletra Side Effects

In clinical studies of Kaletra with other HIV medications, the most common side effects occurred in about 6 percent to 20 percent of people. These include:

Diarrhea
Nausea
Vomiting
Increased triglycerides (a type of fat in the blood)
Increased cholesterol (a type of fat in the blood)

Serious Side Effects and Warnings

Kaletra can cause serious side effects that may require immediate medical attention. These include:

Serious drug interactions — Kaletra can strongly affect how other medicines are broken down, which can lead to severe or life-threatening reactions.
Serious side effects in preterm newborns given the oral solution — The oral solution contains alcohol and propylene glycol, which have been linked to life-threatening heart, kidney, breathing, and nervous system problems in preterm newborns.
Pancreatitis — Inflammation of the pancreas can cause severe stomach pain, nausea, or vomiting.
Liver problems — Liver injury or worsening liver disease can be serious and has been fatal in some cases.
Heart rhythm or conduction problems — Changes in the heart’s electrical activity can occur, including QT prolongation, torsades de pointes, or atrioventricular block, which can be dangerous.
High blood sugar or diabetes — New or worsening diabetes, or high blood sugar, can occur.
Immune reconstitution syndrome — Immune system changes after starting HIV treatment can trigger inflammation or unmask infections; autoimmune disorders have also been reported.
High cholesterol and high triglycerides — Large increases in blood fats may raise the risk of complications, including pancreatitis.
Fat redistribution — Changes in body fat can occur, such as increased belly or upper-back fat, or loss of fat in the arms, legs, or face.
Increased bleeding in people with hemophilia — More bleeding episodes can occur, including bleeding into joints or under the skin.
Severe allergic reactions — Hypersensitivity reactions can occur.

Get medical help right away if you think you are having a serious reaction.

How To Save on Kaletra

Abbvie Inc, the manufacturer of Kaletra, offers the myAbbVie Assist program. Eligible people who are uninsured, have Medicare, or whose insurance doesn’t adequately cover Kaletra may be able to receive the medicine at no cost.

To learn more, visit the myAbbVie Assist program website or call 800-222-6885.

What To Know Before Taking Kaletra

Before taking Kaletra, tell your doctor if you:

Have ever had a serious skin rash or allergic reaction to lopinavir, ritonavir, or any of the ingredients in Kaletra
Have or have had problems with your pancreas
Have liver problems, including hepatitis B or hepatitis C
Have heart problems, including congenital long QT syndrome
Have low potassium levels
Have diabetes
Have high cholesterol
Have hemophilia (Kaletra may increase bleeding.)
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Kaletra can interact with other HIV medicines and medicines used for seizures, heart conditions, cholesterol, infections, erectile dysfunction, birth control, and other conditions. Some combinations may require a dose change or closer monitoring.

Do not take Kaletra if you have had a clinically significant allergic reaction to lopinavir, ritonavir, or any of its ingredients.

Do not take colchicine with Kaletra if you have kidney or liver problems.

Kaletra oral solution contains alcohol (ethanol) and propylene glycol. It should not be given to neonates before they have reached a postmenstrual age of at least 42 weeks and a postnatal age of at least 14 days.

Do not miss a dose of Kaletra. Missing doses can make HIV-1 harder to treat. If you forget a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

If you are pregnant, planning to become pregnant, or become pregnant while taking Kaletra, talk with your doctor. Kaletra oral solution should generally be avoided during pregnancy because it contains alcohol and propylene glycol.

Kaletra may reduce the effectiveness of combined hormonal birth control. People who could become pregnant should talk with their doctor about using another effective form of birth control or an additional barrier method during treatment.

A pregnancy exposure registry monitors pregnancy outcomes in people exposed to Kaletra. Healthcare providers can register pregnancies by visiting the Antiretroviral Pregnancy Registry or calling 800-258-4263.

If you are breastfeeding or planning to breastfeed, tell your healthcare provider. Do not breastfeed while taking Kaletra.

Also note that:

HIV-1 may pass to your baby if your baby does not have HIV-1.
HIV-1 may become harder to treat if your baby has HIV-1.
Your baby may have side effects from Kaletra.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Kaletra for HIV?

In clinical studies, Kaletra has been shown to lower HIV viral load when taken with other antiretroviral medicines.

Among adults who had not previously taken antiretroviral treatment, 75 percent of those taking Kaletra with other HIV medicines achieved and maintained a viral load below 400 copies per milliliter through 48 weeks. In the same study, 67 percent had a viral load below 50 copies per milliliter at 48 weeks.
In another 48-week study of adults who had not previously taken antiretroviral treatment, 78 percent of people taking Kaletra once daily and 77 percent taking it twice daily had a viral load below 50 copies per milliliter.
Among adults who had previously received antiretroviral treatment, 57 percent achieved and maintained a viral load below 400 copies per milliliter through 48 weeks in one study.

In another study of previously treated adults, 57 percent of those taking Kaletra once daily and 54 percent taking it twice daily had a viral load below 50 copies per milliliter at 48 weeks.

Individual results can vary depending on factors such as previous HIV treatment, HIV drug resistance, other medicines in the treatment regimen, and how consistently treatment is taken.

How long does Kaletra take to work for HIV?

Kaletra starts working against HIV after treatment begins, but there is no specific amount of time in which everyone taking it will reach a very low or undetectable viral load.

In clinical studies, researchers measured viral load over several weeks and months, with many participants reaching very low viral loads by 48 weeks. How quickly a person responds can vary based on their starting viral load, previous HIV treatment, drug resistance, the other HIV medicines they take, and how consistently they take their treatment.

Your doctor will monitor your viral load with blood tests to see how well your HIV treatment is working. Continue taking Kaletra and your other HIV medicines exactly as prescribed, even if you feel well.

Can Kaletra interact with other medicines used for HIV or other conditions?

Yes. Kaletra can interact with many prescription medicines, over-the-counter drugs, and herbal supplements. It affects an enzyme system called CYP3A, which can change the amount of certain medicines in the body. Some interactions can cause serious or potentially life-threatening side effects or make treatment less effective.

Medicines that should not be taken with Kaletra include:

Alfuzosin
Ranolazine
Dronedarone
Lurasidone
Pimozide
Dihydroergotamine
Ergotamine
Methylergonovine
Cisapride
Elbasvir/grazoprevir
Lovastatin
Simvastatin
Lomitapide
Suzetrigine
Sildenafil (Revatio) when used for pulmonary arterial hypertension
Triazolam
Oral midazolam
Apalutamide
Rifampin
St. John’s wort

People with kidney or liver problems should also not take colchicine with Kaletra.

Tell your doctor and pharmacist about everything you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements, before starting Kaletra or adding a new medicine.