Important Safety Information Prescribing Information Medication Guide

A: KALETRA is a prescription medicine that is used with other antiretroviral medicines to treat human immunodeficiency virus 1 (HIV-1) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (acquired immune deficiency syndrome).

A: Antiretroviral therapy (ART) refers to medicines that treat HIV. An HIV regimen is a combination of HIV medicines used to treat HIV infection. An HIV regimen combines antiretroviral drugs from at least two different drug classes. There are seven antiretroviral drug classes, grouped according to how the drug works to attack the virus:

  1. Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
  2. Nucleoside reverse transcriptase inhibitors (NRTIs)
  3. Protease inhibitors (PIs)
  4. Fusion inhibitors
  5. CCR5 antagonists
  6. Integrase strand transfer inhibitors (INSTIs)
  7. Post-attachment inhibitors

A: The DHHS Adult and Adolescent ARV Guidelines provide recommendations for antiretroviral regimens.

A: Protease inhibitors (PIs) are a type of antiretroviral drug that may be used in antiretroviral therapy (ART). Protease inhibitors work by blocking an HIV enzyme known as protease in immature HIV. Blocking the protease enzyme prevents the immature HIV from maturing and infecting other healthy cells.

A: KALETRA is a combined formula of two medications, lopinavir and ritonavir. Lopinavir and ritonavir are protease inhibitors. Ritonavir, in combination with lopinavir, inhibits the metabolism of lopinavir, thereby providing increased levels of lopinavir.

A: KALETRA is a fixed combination of ritonavir and lopinavir. When these medications are combined, ritonavir acts to maintain the levels of lopinavir in the blood. Ritonavir enhances lopinavir by preventing the body from breaking down (metabolizing) lopinavir.

A: For antiretroviral drug combinations, or HIV regimens, it is important that you take your HIV medications every day and exactly as prescribed. Each drug, taken as part of this therapy, has specific instructions so it is important that you speak with your doctor to understand your specific instructions before starting treatment.

Find dosing and administration information on KALETRA tablets and oral solution in the KALETRA Medication Guide.

A: Take KALETRA as instructed by your doctor. KALETRA can be taken as a once-daily dose or as a twice-daily dose. KALETRA is recommended in combination with other antiretroviral agents and should be taken at the same time(s) each day. KALETRA tablets may be taken with or without food. However, KALETRA oral solution must be taken with food.

A: The common side effects of KALETRA may include:

  • Diarrhea
  • Nausea
  • Vomiting
  • Increased fats in blood (triglycerides or cholesterol)

Tell your doctor if you have these or any other persisting side effects while taking KALETRA. Read the Medication Guide for a list of possible side effects.

A: It is not known if KALETRA will harm your unborn baby. KALETRA oral solution contains alcohol. You should not take KALETRA oral solution during pregnancy because there is no safe level of alcohol exposure during pregnancy. Tell your healthcare provider if you become pregnant during treatment with KALETRA.

There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about your health and the health of your baby. Talk to your healthcare provider about how you can take part in this registry.

A: Yes, HIV-1 can be passed to the baby in breast milk. Do not breastfeed if you are HIV positive. Do not take KALETRA if you are breastfeeding or plan to breastfeed. Talk to your healthcare provider about alternative ways to feed your baby.

A: Prevention of mother-to-child transmission (PMTCT) refers to programs intended to prevent the transmission of HIV from mother to child. The use of HIV medicines and other strategies have helped to lower the risk of mother-to-child transmission of HIV. If you are pregnant, or think you may be pregnant, please consult a doctor to discuss prevention options.

*Eligibility: Available to patients with commercial prescription insurance coverage for KALETRA who meet eligibility criteria. Copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the KALETRA Savings Card and patient must call OPUS Health at 800.364.4767 to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the KALETRA Savings Program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. Please see full Terms and Conditions.

Terms and Conditions
Pharmacist Instructions: Please submit the copay card authorized for all commercially insured patients by the patient’s primary insurance as a secondary transaction to OPUS Health. When you use this card, you are confirming that you have not submitted and will not submit a claim for this prescription for reimbursement under any federal, state or government-funded healthcare program, such as Medicare (including Part D), Medicare Advantage, Medicaid, Medigap, Veterans Affairs, the Department of Defense, or TRICARE. Pharmacists with questions, please call OPUS Health at 800.364.4767.

†By texting “SAVE” from your phone to the above number, you confirm that you are 18 years of age or older and consent to receive recurring text messages from AbbVie, including service updates, medication reminders, and marketing messages. Message and data rates may apply. Your consent is not a condition of receiving goods or services. You can reply HELP for help or text STOP to unsubscribe at any time.

2 ways you can save!*

Print your card and take along with your prescription to your pharmacist

KALETRA copay card; savings 2
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Download and store your KALETRA Savings Card on your mobile device†

KALETRA Savings; Text "SAVE" to 21499

Convert 30- to 90-day Rx

If your KALETRA prescription is currently for a 30-day supply, ask your healthcare provider for a 90-day supply.

What are KALETRA® (lopinavir/ritonavir) tablets and oral solution?1

KALETRA is a prescription medicine that is used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (acquired immune deficiency syndrome). It is not known if KALETRA is safe and effective in children under 14 days old.

Important Safety Information1
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?”
  • Side effects in babies taking KALETRA oral solution. KALETRA oral solution contains alcohol (ethanol) and propylene glycol. Call your healthcare provider right away if your baby appears too sleepy or their breathing changes.
  • Inflammation of your pancreas (pancreatitis). KALETRA can cause pancreatitis, which may be serious and may lead to death. People who have high levels of a certain fat (triglycerides) have a risk for developing pancreatitis. If you have advanced HIV-1 disease, you may have an increased risk of high triglyceride levels in your blood and pancreatitis. If you have a history of pancreatitis, you may have an increased risk of it recurring during treatment with KALETRA. Tell your healthcare provider if you have any signs or symptoms of pancreatitis including nausea, vomiting, and/or stomach area (abdominal) pain.
  • Liver problems. Liver problems, including death, can happen in people who take KALETRA. Your healthcare provider should do blood tests before and during your treatment with KALETRA to check your liver function. If you have hepatitis B, hepatitis C, or other liver problems, you may have an increased risk for developing new or worsening liver problems during treatment with KALETRA. Tell your healthcare provider right away if you have any signs or symptoms of liver problems including loss of appetite, yellowing of skin or eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or stomach area (abdominal) pain.
  • 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 problems, or if you take other medicines that can affect your heart rhythm while you take KALETRA. Tell your healthcare provider right away if you experience dizziness, lightheadedness, fainting, and/or a sensation of abnormal heartbeats.

See “What are the possible side effects of KALETRA?” for more information about serious side effects.

Who should not take KALETRA?

Do not take KALETRA if you are allergic to lopinavir, ritonavir, or any ingredients in KALETRA.

Do not take KALETRA if you take any of the following medicines: alfuzosin; apalutamide; ranolazine; dronedarone; colchicine, if you have kidney or liver problems; rifampin; lurasidone; pimozide; ergot-containing medicines, including dihydroergotamine mesylate, ergotamine tartrate, methylergonovine; cisapride; elbasvir/grazoprevir; lovastatin; simvastatin; lomitapide; sildenafil (REVATIO®), when used for the treatment of pulmonary arterial hypertension; triazolam; midazolam, when taken by mouth; St. John’s Wort (Hypericum perforatum).

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

What should I tell my healthcare professional before taking KALETRA?
  • Tell your healthcare professional about all of your medical conditions, including if you have ever had a serious skin rash or an allergic reaction to medicines that contain lopinavir or ritonavir; have or had pancreas problems or liver problems, including hepatitis B or hepatitis C; have any heart problems, including if you have a condition called congenital long QT syndrome; have low potassium in your blood, diabetes, high cholesterol in your blood or hemophilia (KALETRA may cause increased bleeding); or are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
  • If you take KALETRA during pregnancy, you should talk with your healthcare provider about how you can take part in an Antiretroviral Pregnancy Registry.
    • KALETRA oral solution contains alcohol (ethanol) and propylene glycol. You should not take KALETRA oral solution during pregnancy because there is no safe level of alcohol exposure during pregnancy. Tell your healthcare provider if you become pregnant during treatment with KALETRA.
    • KALETRA may reduce how well hormonal birth control works. Females who may become pregnant should use another effective form of birth control or an additional barrier method of birth control during treatment with KALETRA.

Do not breastfeed if you take KALETRA. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider may need to change the dose of other medicines while you take KALETRA.

What are the possible side effects of KALETRA?

KALETRA can cause serious side effects including:
Diabetes and high blood sugar (hyperglycemia). You may develop new or worsening diabetes or high blood sugar during treatment with KALETRA. Tell your healthcare provider if you get any of the following signs or symptoms: urinate more often than usual, increased hunger or thirst, unusual weight loss, increase in your blood sugar levels. Your healthcare provider may need to start you on medicine to treat high blood sugar, or change your diabetes medicines.

Changes in your immune system (immune reconstitution syndrome) can happen when you start taking HIV-1 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 healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.

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

Changes in body fat can happen in some people who take anti-HIV-1 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 have taken KALETRA or similar medicines.

Skin rash, which can be severe, can happen in people who take KALETRA. Tell your healthcare provider if you have a history of skin rash with other medicines used to treat your HIV-1 infection or if you get any skin rash during treatment with KALETRA.

Kidney stones have been reported in patients taking KALETRA.

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

Please see the Full Prescribing Information, including the Medication Guide, for KALETRA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

You may also call 1-866-KALETRA for more information, or AbbVie Customer Service at 1-800-255-5162.


References: 1. KALETRA [package insert]. North Chicago, IL: AbbVie Inc. 2. AIDSinfo. US Department of Health and Human Services. What to start: choosing an HIV regimen. https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/53/what-to-start--choosing-an-hiv-regimen. Reviewed September 24, 2020. Accessed November 16, 2020. 3. AIDSinfo. US Department of Health and Human Services. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. https://aidsinfo.nih.gov/guidelines/brief-html/1/adult-andadolescent-arv/11/what-to-start. Updated December 18, 2019. Accessed November 16, 2020. 4. AIDSinfo glossary of HIV/AIDS-related terms. 9th ed. [PDF]. Rockville, MD: US Department of Health and Human Services; 2018. https://aidsinfo.nih.gov/contentfiles/glossaryhivrelatedterms_english.pdf. Accessed November 16, 2020. 5. AIDSinfo. US Department of Health and Human Services. What to start: Initial combination regimens for the antiretroviral-naive patient. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf Accessed November 16, 2020. 6. AIDSinfo. US Department of Health and Human Services. Following an HIV regimen: steps to take before and after starting HIV medicines. https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/55/following-an-hiv-regimen---steps-to-take-before-and-after-starting-hiv-medicines. Reviewed September 24, 2020. Accessed November 16, 2020. 7. UNICEF. Prevention of mother to child transmission (PMTCT). https://www.unicef.org/evaldatabase/index_95015.html. Updated 2016. Accessed November 16, 2020.

If you have any questions about AbbVie's Kaletra.com website that have not been answered click here. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only and is not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of each patient.

Please expand for Detailed Important Risk Information.

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?"