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:
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:
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.
Print your card and take along with your prescription to your pharmacist
Download and store your KALETRA Savings Card on your mobile device†
If your KALETRA prescription is currently for a 30-day supply, ask your healthcare provider for a 90-day supply.
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.
KALETRA may cause serious side effects, including:
See “What are the possible side effects of KALETRA?” for more information about serious side effects.
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.
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.
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.
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.
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 January 16, 2019. Accessed May 3, 2019. 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 October 25, 2018. Accessed May 3, 2019. 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 May 3, 2019. 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 October 22, 2019. 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 January 31, 2019. Accessed May 3, 2019. 7. UNICEF. Prevention of mother to child transmission (PMTCT). https://www.unicef.org/supply/index_42855.html. Updated January 30, 2017. Accessed May 3, 2019.
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Please expand for Detailed Important Risk Information.
KALETRA may cause serious side effects, including: