Get to Know KALETRA

KALETRA is a prescription anti-HIV-1 medicine. It is used with other anti-HIV medications to increase the chance of treatment response in people with HIV-1 infection. KALETRA does not cure HIV infection or AIDS. People taking KALETRA may develop infections or other conditions associated with HIV infection, including opportunistic infections (for example, pneumonia and herpes virus infections).


KALETRA is a combination of 2 drugs, lopinavir and ritonavir. They work together along with other anti-HIV medicines.

Once-daily and twice-daily dosing options are available for adults taking KALETRA tablets, as prescribed by your doctor. Do not change or stop your treatment without first talking to your doctor.

  • KALETRA should not be taken once daily if you take carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), phenobarbital (Luminal®), or phenytoin (Dilantin®, Phenytek®). KALETRA also should not be taken once daily with the following HIV medicines: efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®) or nelfinavir (Viracept®)
  • KALETRA tablets should not be taken once daily if you are pregnant
  • KALETRA should not be given one time each day in children under 18 years of age. When giving KALETRA to your child, give KALETRA exactly as prescribed
  • Do not miss a dose of KALETRA. This could make the virus harder to treat. If you forget to take KALETRA, take the missed dose right away. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking your next dose at its regular time. Do not take more than one dose of KALETRA at one time
  • There may be a greater chance of developing diarrhea with the once-daily regimen as compared with the twice-daily regimen

You can take KALETRA tablets with or without food

  • Swallow KALETRA tablets whole. Do not chew, break, or crush KALETRA tablets
  • Take KALETRA oral solution with food to help it work better
  • KALETRA oral solution should not be taken if you are pregnant
  • KALETRA oral solution contains propylene glycol and a large amount of alcohol
    • KALETRA oral solution should not be given to babies younger than 14 days of age unless your doctor thinks it is right for your baby. Babies taking KALETRA oral solution may have side effects. Call your doctor right away if your baby appears too sleepy or their breathing has changed
    • If a young child drinks more than the recommended dose, it could make them sick. Contact your local poison control center or emergency room right away
    • Talk with your doctor if you take or plan to take metronidazole or disulfiram. You can have severe nausea and vomiting if you take these medicines with KALETRA
  • If you are taking both didanosine (Videx®) and KALETRA:
    • Didanosine can be taken at the same time as KALETRA tablets, without food
    • Take didanosine either one hour before or two hours after taking KALETRA oral solution

You can take the heartburn medications Prilosec® (omeprazole) and Zantac® (ranitidine), used to reduce stomach acid, while taking KALETRA

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA. Do not start taking a new medicine without telling your doctor or pharmacist. Your doctor can tell you if it is safe to take KALETRA with other medicines. Your doctor may need to change the dose of other medicines while you take KALETRA.

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Use: KALETRA® (lopinavir/ritonavir)

What is KALETRA?

KALETRA® (lopinavir/ritonavir) is a prescription HIV-1 medicine that is used with other HIV medicines to treat HIV-1 (Human Immunodeficiency Virus) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). KALETRA is a type of HIV medicine called a protease inhibitor. KALETRA contains two medicines: lopinavir and ritonavir. It is not known if KALETRA is safe and effective in children under 14 days old.

KALETRA does not cure HIV infection or AIDS. People taking KALETRA may develop infections or other conditions associated with HIV infection, including opportunistic infections (for example, pneumonia and herpes virus infections).


Important Safety Information

What is the most important information I should know about KALETRA?

KALETRA may cause serious side effects, including:
Interactions with other medicines. It is important to know the medicines that should not be taken with KALETRA. For more information, see “Who should not take KALETRA?”

Changes in your heart rhythm and the electrical activity of your heart can occur when taking KALETRA. These changes can lead to serious heart problems. Your risk for these problems may be higher if you already have a history of abnormal heart rhythm or other types of heart disease, or if you take other medicines that can affect your heart rhythm while you take KALETRA. Tell your doctor right away if you experience dizziness, lightheadedness, fainting, and/or a sensation of abnormal heartbeats.

Who should not take KALETRA?

Do not take KALETRA if you are allergic to KALETRA or any of its ingredients, including lopinavir or ritonavir. Skin rashes, some of them severe, can occur in people who take KALETRA. Tell your doctor if you had a rash when you took another medicine for HIV or if you notice any skin rash when you take KALETRA.

Do not take KALETRA if you take any of the following medicines: alfuzosin (Uroxatral®); cisapride (Propulsid®, Quicksolv®); ergot containing medicines, including ergotamine (Cafergot® and others), dihydroergotamine (D.H.E. 45® or Migranal®), and methylergonovine (Methergine®); lovastatin (Advicor®, Altoprev®, or Mevacor®); midazolam oral syrup; pimozide (Orap®); rifampin (Rifadin®, Rifamate®, Rifater®, or Rimactane®); sildenafil (Revatio®), when used for the treatment of pulmonary arterial hypertension; simvastatin (Zocor®, Vytorin®, or Simcor®); products containing St. John’s Wort (Hypericum perforatum); or triazolam (Halcion®).

Serious problems can happen if you or your child takes any of the medicines listed above with KALETRA.

What should I tell my doctor before taking KALETRA?

KALETRA may not be right for you. Tell your doctor about all of your medical conditions, including if you have any heart problems, including if you have a condition called congenital long QT syndrome; have or had pancreas problems, liver problems, including hepatitis B or hepatitis C, diabetes, hemophilia (people who take KALETRA may have increased bleeding), or low potassium in your blood; or are pregnant or plan to become pregnant.

If you take KALETRA during pregnancy, you should talk with your doctor about how you can take part in an Antiretroviral Pregnancy Registry.

Do not breastfeed, as it is not known if KALETRA can be passed to the baby through your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA. Do not start taking a new medicine without telling your doctor or pharmacist. Your doctor can tell you if it is safe to take KALETRA with other medicines. Your doctor may need to change the dose of other medicines while you take KALETRA. Tell your doctor right away if you are taking:

  • Estrogen-based contraceptives (birth control pills and patches). You should use a different type or an extra form of birth control, since birth control pills or patches may not work as well while you take KALETRA. Talk to your doctor about how to prevent pregnancy while taking KALETRA.
  • Medicines used for the treatment of erectile problems, such as avanafil (Stendra®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). There is an increased risk of certain problems when you take these medicines with KALETRA, such as low blood pressure (dizziness or fainting), vision changes, and/or erections lasting more than 4 hours. Tell your doctor right away if you experience any of these side effects.

KALETRA should not be taken once daily if you take carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®, Phenytek®), efavirenz (Atripla®, Sustiva®), nevirapine (Viramune®), or nelfinavir (Viracept®).

KALETRA tablets should not be taken once daily if you are pregnant. You should not take KALETRA oral solution if you are pregnant.

KALETRA oral solution contains propylene glycol and a large amount of alcohol.

  • KALETRA oral solution should not be given to babies younger than 14 days of age unless your doctor thinks it is right for your baby. Babies taking KALETRA oral solution may have side effects. Call your doctor right away if your baby appears too sleepy or their breathing has changed.
  • Talk with your doctor if you take or plan to take metronidazole or disulfiram. You can have severe nausea and vomiting if you take these medicines with KALETRA.

This is not a complete list of medicines about which you should tell your doctor or pharmacist. For more information, refer to the KALETRA Medication Guide. Ask your doctor or pharmacist if you are not sure what medicines you are taking. Know all the medicines that you take. Keep a list of them to show doctors and pharmacists when you get a new medicine. Do not start any new medicines while you are taking KALETRA without first talking with your doctor.

What are the possible side effects of KALETRA?

KALETRA can cause serious side effects:
KALETRA may not be right for you. Tell your doctor about all of your medical conditions.

Inflammation of the pancreas (pancreatitis), which may be serious and cause death, has occurred in some people who take KALETRA. You have a higher chance of having pancreatitis if you have had it before. Tell your doctor if you have nausea, vomiting, and/or abdominal pain, as these may be signs of pancreatitis.

Liver problems, including death, can happen in people who take KALETRA. Your doctor should do blood tests before and during your treatment with KALETRA to check your liver function. Some people with liver disease, such as hepatitis B or C, who take KALETRA may have worsening liver disease. Tell your doctor right away if you have any of the following signs and symptoms: loss of appetite, yellowing of skin or eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or stomach area (abdominal) pain.

New or more serious diabetes and high blood sugar (hyperglycemia) have occurred in some people who take protease inhibitors, including KALETRA. Tell your doctor if you notice an increase in thirst or urinate often while taking KALETRA.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your doctor right away if you start having new symptoms after starting your HIV medicine.

Large increases in certain fat (triglycerides and cholesterol) levels in the blood have occurred in some people receiving KALETRA. Your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking KALETRA and during your treatment.

Changes in body fat have been seen in some people who take anti-HIV therapy. The cause and long-term health effects of these conditions are not known at this time.

Increased bleeding has occurred in some people with hemophilia who take protease inhibitors, including KALETRA.

Common side effects of KALETRA include diarrhea, nausea, increased fats in blood (triglycerides or cholesterol), and vomiting. These are not all of the possible side effects of KALETRA.

This is the most important information to know about KALETRA. For more information, talk with your doctor.

Reference:
KALETRA [package insert]. 1697387-1790701