Taking certain medications with Kaletra could cause serious side effects that could be life threatening. Do not take Kaletra with astemizole, terfenadine, midazolam, triazolam, pimozide, cisapride, ergotamine, dihydroergotamine, ergonovine, and methylergonovine, rifampicin, amiodarone, vardenafil and products containing St. John's Wort (Hypericum perforatum).
Medical advice and approval must be sought before Kaletra is taken with medicines that lower blood cholesterol (e.g. lovastatinor simvastatin), some medicines affecting the immune system (e.g., cyclosporin, sirolimus [rapamycin], tacrolimus), various steroids (e.g., dexamethasone, fluticasone propionate, ethinyl oestradiol), other protease inhibitors, certain heart medicines such as calcium channel antagonists (e.g., felodipine, nifedipine, nicardipine), and medicines used to correct heart rhythm (e.g., bepridil, systemic lidocaine, quinidine), antifungals (e.g., ketoconazole, itraconazole), morphine-like medicines (e.g., methadone) anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital), warfarin, certain antibiotics (i.e., rifabutin, clarithromycin), certain antidepressants (e.g., trazodone) and voriconazole. Kaletra may interact with erectile dysfunction agents (e.g., sildenafil or tadalafil). Lower doses of these medicines should be prescribed in patients taking Kaletra. Kaletra may interact with digoxin (heart medicine); monitoring by a physician is recommended.
Taking Kaletra with certain medicines can cause increased levels of these other medicines in the body. This could increase or prolong their effects and/or adverse reactions, which may result in serious or life-threatening problems. Because of this, patients must tell their doctor about all medicines they are taking or planning to take, including those medicines that can be bought without a prescription and herbal preparations.
Patients using an oral contraceptive or using a patch contraceptive to prevent pregnancy should use an additional or alternative type of contraception since Kaletra may reduce the effectiveness of these products.
Pregnant or nursing mothers should not take Kaletra unless specifically directed by their doctor.
Kaletra oral solution contains 42 percent alcohol. While taking Kaletra oral solution, patients should not take any medicines that may cause a reaction with alcohol such as disulfiram.
It is important that Kaletra oral solution is taken with food. Kaletra tablets may be taken with or without food.
Cases of pancreatitis have been reported in patients taking Kaletra. Liver problems, which can be fatal, have also been reported. Patients should tell their doctor if they have had liver disease such as chronic hepatitis B or C as they are at increased risk for severe and potentially fatal liver adverse events. These patients may require blood tests for control of liver function.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Patients should contact their doctor if they notice changes in body fat.
In patients taking protease inhibitors, increased bleeding (in patients with hemophilia type A and B) has been reported.
Combination antiretroviral therapy may cause new cases of diabetes and high blood sugar or worsening of existing diabetes, as well as increased fats and raised lactic acid in the blood. The long-term risks for complications due to increases in triglycerides and cholesterol are not known at this time. In addition, large amounts of triglycerides have been considered a risk factor for pancreatitis.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. Symptoms of infection should be reported to a doctor immediately.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis. Signs and symptoms are joint stiffness, aches and pains (especially in the hip, knee and shoulder) and difficulty in movement. These symptoms require that patients contact their doctor.
In lopinavir/ritonavir adult clinical trials, the very commonly reported (>1 out of 10 persons treated) and commonly reported (less than 1 out of 10 but more than 1 out of 100 persons treated) side effects of moderate to severe intensity were diarrhea, insomnia, headache, nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder, rash, lipodystrophy, weakness and abnormal liver enzymes. This is not a complete list of reported side effects.
In children two years of age and older, the safety profile is similar to that seen in adults.
For more information about Kaletra, please consult your local prescribing information.
Storage Conditions
Kaletra tablets do not require any special storage conditions.
Kaletra oral solution: Store in a refrigerator (2 degrees - 8 degrees C). If kept outside of the refrigerator, do not store above 25 degrees C and discard any unused contents after 42 days (6 weeks). Avoid exposure to excessive heat.
Abbott and HIV/AIDS
Abbott has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood and remains a leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. Abbott has developed two protease inhibitors for the treatment of HIV.
About Abbott and Abbott Fund
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.
Abbott Fund is a philanthropic foundation established by Abbott in 1951. Abbott Fund's mission is to create healthier global communities by investing in creative ideas that promote science, expand health care and strengthen communities worldwide.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com. For more information on Abbott's HIV/AIDS programs, please visit http://www.abbott.com/HIVAIDS and http://www.abbottglobalcare.org.
Web site: http://www.abbott.com
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http://www.abbott.com/HIVAIDS
http://www.abbottglobalcare.org
Asia, North America and Latin America, Susan Beverly, +1-847-935-9096, or Europe and Africa, Dirk van Eeden, +1-847-224-1828, both of Abbott
