KALETRA qd vs bid HIV-1 RNA <50 copies/mL at Week 48 (ITT, TLOVR analysis)2,4
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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.
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.
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. 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
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Please expand for Detailed Important Risk Information.
KALETRA may cause serious side effects, including: