Kaletra contains a combination of lopinavir and ritonavir. Lopinavir and ritonavir are antiviral medications that prevent the human immunodeficiency virus (HIV) from multiplying in your body.

Kaletra is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS).

Kaletra is not a cure for HIV or AIDS.

Kaletra can cause a serious heart problem, especially if you use certain other medicines at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using.

Call your doctor at once if you have a headache with chest pain, fast or pounding heartbeats, and severe dizziness.

Before taking this medicine

You should not use Kaletra if you have ever had a severe allergic reaction to lopinavir or ritonavir.

Some medicines can cause unwanted or dangerous effects when used with Kaletra. Your doctor may need to change your treatment plan if you use any of the following drugs:

• alfuzosin;

• apalutamide;

• cisapride;

• colchicine;

• dronedarone;

• elbasvir/grazoprevir;

• lomitapide;

• lurasidone, pimozide;

• ranolazine;

• rifampin;

• lovastatin, simvastatin;

• triazolam, or oral midazolam;

• sildenafil (Revatio for pulmonary arterial hypertension);

• St. John's wort; or

• an ergot medicine (ergotamine, dihydroergotamine, methylergonovine).

To make sure Kaletra is safe for you, tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• heart disease, heart rhythm disorder, or a family history of long QT syndrome;

• pancreas problems;

• diabetes;

• low levels of potassium in your blood; or

• a bleeding disorder such as hemophilia.

It is not known whether Kaletra will harm an unborn baby. But HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Kaletra on the baby.

Kaletra can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Kaletra, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Kaletra is not approved for use by anyone younger than 14 days old. Premature infants should not receive the medication until it has been 14 days after their original due date.

Take Kaletra exactly as prescribed by your doctor. Follow all directions on your prescription label, especially when giving the medicine to a child. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If a child is taking this medication, tell your doctor if the child has any changes in weight. Doses are based on weight in children.

Do not crush, chew, or break a tablet. Swallow the tablet whole.

Kaletra tablets can be taken with or without food.

Kaletra liquid should be taken with food. Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

While using this medicine, you may need frequent blood tests at your doctor's office.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store the liquid medicine in the refrigerator or at room temperature. If you store the liquid at room temperature you must use it within 60 days.

Store the tablets at room temperature, away from heat and moisture. Keep the pills in their original container with the cap tightly closed.

You should not use Kaletra if you have ever had a severe allergic reaction to lopinavir or ritonavir.

Some medicines can cause unwanted or dangerous effects when used with Kaletra. Your doctor may need to change your treatment plan if you use any of the following drugs:

• alfuzosin;

• apalutamide;

• cisapride;

• colchicine;

• dronedarone;

• elbasvir/grazoprevir;

• lomitapide;

• lurasidone, pimozide;

• ranolazine;

• rifampin;

• lovastatin, simvastatin;

• triazolam, or oral midazolam;

• sildenafil (Revatio for pulmonary arterial hypertension);

• St. John's wort; or

• an ergot medicine (ergotamine, dihydroergotamine, methylergonovine).

To make sure Kaletra is safe for you, tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• heart disease, heart rhythm disorder, or a family history of long QT syndrome;

• pancreas problems;

• diabetes;

• low levels of potassium in your blood; or

• a bleeding disorder such as hemophilia.

It is not known whether Kaletra will harm an unborn baby. But HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Kaletra on the baby.

Kaletra can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Kaletra, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Kaletra is not approved for use by anyone younger than 14 days old. Premature infants should not receive the medication until it has been 14 days after their original due date.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Kaletra oral liquid could be fatal to a child.

If you take Kaletra liquid and you also take didanosine (Videx), take the didanosine at least 1 hour before or 2 hours after you take the liquid medicine.

Kaletra liquid contains alcohol. Avoid drinking alcohol while using this medicine.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction to Kaletra: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• signs of a kidney stone - pain in your side or lower back, blood in your urine, painful or difficult urination;

• high blood sugar - increased thirst, increased urination, fruity breath odor, weight loss; or

• signs of liver or pancreas problems - loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Kaletra affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Kaletra liquid contains alcohol and propylene glycol, which may cause drowsiness or slow breathing in a baby taking this medicine. Tell your doctor if you notice these symptoms in your baby.

Kaletra can cause changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Common Kaletra side effects may include:

• nausea, vomiting, diarrhea; or

• high cholesterol or triglycerides.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with Kaletra. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• antibiotic or antifungal medicine;

• antiviral medicines to treat hepatitis C or HIV;

• cancer medicine;

• erectile dysfunction medicine;

• heart or blood pressure medicine;

• medicine to prevent blood clots;

• medicine to prevent organ transplant rejection;

• medicine to treat pulmonary arterial hypertension;

• medicine to treat severe depression or schizophrenia;

• narcotic medicine;

• seizure medicine;

• "statin" cholesterol-lowering medicine; or

• steroid medicine.

This list is not complete and many other drugs can interact with Kaletra. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.