KALETRA ® 200 mg / 50 mg ( lopinavir / ritonavir ) 120 tablets

What are KALETRA® (lopinavir/ritonavir) tablets and oral solution?2
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 Information2
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. AIDSinfo. US Department of Health and Human Services. FDA-approved HIV medicines. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/fda-approved-hiv-medicines. Reviewed September 28, 2020. Accessed November 16, 2020. 2. KALETRA [package insert]. North Chicago, IL: AbbVie Inc. 3. OPUS redemption data. January 1, 2019 to June 30, 2020. 4. Zajdenverg R, Podsadecki TJ, Badal-Faesen S, et al. Similar safety and efficacy of once- and twice-daily lopinavir/ritonavir tablets in treatment experienced HIV-1-infected subjects at 48 weeks. J Acquir Immune Defic Syndr. 2010;54(2):143-151. doi:10.1097/QAI.0b013e3181cbd21e

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.

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