FDA Approval for Once-Daily Dosing of Kaletra
(lopinavir/ritonavir) for Treatment-Experienced Patients
Approval of New Dosing Option Comes As 10th Anniversary of Kaletra's First Approval Approaches|
ABBOTT PARK, Ill., April 28, 2010 /PRNewswire/ Abbott announced today that the U.S. Food and Drug Administration ( FDA ) approved once-daily dosing of Kaletra ( lopinavir/ritonavir ) for adult patients with HIVwho have previously taken antiretroviral therapy. Kaletra once-daily dosing is already indicated for adult patients new to antiretrovia treatment This gives treatment-experienced patients who have HIV that responds to Kaletra another dosing option as determined by their physician.
"Adherence to treatment is critical to the effective management of HIV," said Joseph Gathe,M.D., clinical instructor, Department of Internal Medicine, Baylor College of Medicine. "A Kaletra once-daily regimen can simplify HIV treatment and offers greater flexibility for patients."
Kaletra tablets can be taken with or without food and can be stored at room temperature, making it convenient for patients.
Approval of once-daily Kaletra for treatment-experienced patients comes as Abbott marks the 10th anniversary of the medication's original FDA approval for the treatment of HIV. The FDA granted early access approval on Sept.15, 2000. Kaletra and other protease inhibitors have become critical components of HIV combination therapy used to help patients manage HIV today. Many innovations in HIV treatment have occurred during the past decade, giving physicians and patients more treatment options.
"For more than a decade, HIV treatment was about helping people live another day, another week, another month. Now it is also about making treatment more convenient for patients," said Scott C. Brun, M.D., divisional vice president, infectious diseases, Global Pharmaceutical Research and Development, Abbott. "This approval means Kaletra tablets can now be used once or twice daily as part of combination therapy, giving treatment-experienced patients an additional dosing option to better fit their daily schedule."
Abbott's submission for once-daily dosing in treatment-experienced patients was supported by data from the M06-802 study, a 48-week, Phase 3, open-label, randomized study comparing once-daily to twice-daily dosing of Kaletra combined with other antiretrovirals in 599 treatment-experienced HIV-infected adults. The data showed comparable efficacy, safety and tolerability between once-daily and twice-daily dosing, as well as a similar rate of resistance development between the regimens.
The HIV virus can change over time and HIV resistance is the consequence of mutations that emerge in the viral proteins targeted by antiretroviral agents. The use of Kaletra once-daily should be limited to those adult patients having only very few protease inhibitor associated mutations (i.e., less than three lopinavir mutations).
Kaletra® ( lopinavir/ritonavir ) is a prescription anti-HIV-1 medicine called a protease inhibitor that contains lopinavir and ritonavir. Kaletra is used with other anti-HIV-1 medicines to increase the chance of treatment response in people with human immunodeficiency virus (HIV-1) infection. It is not known if Kaletra is safe and effective in children under 14 days old.
Kaletra does not cure HIV-1 infection or AIDS and does not reduce the risk of passing HIV-1 to others. People taking Kaletra may still get opportunistic infections or other conditions that happen with HIV-1.
Important Safety Information
Kaletra should not be taken by people who are allergic to Kaletra or any of its ingredients, including lopinavir or ritonavir.
The list of drug interactions below is not complete. People must tell their doctor about all medicines they are taking or planning to take, including those without a prescription, vitamins, and herbal products.
Serious problems or death can happen taking these medicines with Kaletra: ergot-containing medicines, including ergotamine (Cafergot® and others), dihydroergotamine (D.H.E. 45® and others), ergonovine (Ergotrate®), and methylergonovine (Methergine®); triazolam (Halcion®); midazolam oral syrup; pimozide (Orap®); lovastatin (Mevacor®); simvastatin (Zocor®); rifampin (Rimactane®, Rifadin®, Rifater®, or Rifamate®); sildenafil (Revatio®) only when used to treat pulmonary arterial hypertension; alfuzosin (Uroxatral®); or products containing St. John's wort (Hypericum perforatum).
The following medicines may need changes when taken with Kaletra: birth control pills that contain estrogen ("the pill"), birth control (contraceptive) patches, atorvastatin (Lipitor®), rosuvastatin (Crestor®), efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®;), amprenavir (Agenerase®), fosamprenavir (Lexiva®), nelfinavir (Viracept®), phenytoin (Dilantin®), carbamazepine (Tegretol®), phenobarbital, sildenafil (Viagra®), tadalafil (Cialis®, Adcirca®), vardenafil (Levitra®), rifabutin (Mycobutin®), inhaled fluticasone (Flonase®), salmeterol (Serevent®) and salmeterol in combination with fluticasone propionate (Advair®), colchicine (Colcrys®) and bosentan (Tracleer®).
Kaletra should not be administered once daily in combination with carbamazepine (Tegretol® and Epitol®), phenobarbital (Luminol®), or phenytoin (Dilantin®).
There is an increased risk of certain problems when taking medicines used for the treatment of erectile problems such as sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) with Kaletra, because the interaction with these medicines may result in an increase in their side effects, such as low blood pressure (dizziness or fainting), vision changes, and/or erections lasting more than 4 hours. People should tell their doctor right away if they experience any of these side effects.
Kaletra oral solution contains a large amount of alcohol. People should talk with their doctor if they take or plan to take metronidazole (Flagyl®) or disulfiram (Antabuse®). They can have severe nausea and vomiting if they take these medicines with Kaletra.
Kaletra can cause serious side effects:
Kaletra may not be right for everyone. People should tell their doctor about all their medical conditions.
Changes in heart rhythm and electrical activity of the heart can occur when taking Kaletra. These changes can lead to serious heart problems. The risk for these problems may be higher for people who already have a history of abnormal heart rhythm or other types of heart disease, or if they take other medicines that can affect their heart rhythm while taking Kaletra. People should tell their doctor right away if they experience dizziness, lightheadedness, fainting, and/or a sensation of abnormal heartbeats.
Liver problems, including death, can happen in people who take Kaletra. Blood tests in people who take Kaletra may show possible liver problems. People with liver disease such as hepatitis B or C who take Kaletra may have worsening liver disease. People should tell their doctor right away if they have any of the following signs and symptoms: loss of appetite, yellowing of skin or eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or stomach area (abdominal) pain.
Inflammation of the pancreas (pancreatitis), which may be serious and cause death, has occurred in some people who take Kaletra. People have a higher chance of having pancreatitis if they have had it before. People should tell their doctor if they have nausea, vomiting, and/or abdominal pain, as these may be signs of pancreatitis.
Immune reconstitution syndrome may occur after starting anti-HIV medicines, including Kaletra. This happens when people develop signs and symptoms of serious infections they already have, which may require additional treatment.
Large increases in certain fat (triglycerides and cholesterol) levels in the blood have occurred in some people receiving Kaletra. The long-term chance of getting complications such as heart attacks or strokes due to these increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time.
New or more serious diabetes and high blood sugar (hyperglycemia) have occurred in some people who take protease inhibitors, including Kaletra. People should tell their doctor if they notice an increase in thirst or urinate often while taking Kaletra.
Changes in body fat have been seen in some people who take anti-HIV 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 take protease inhibitors, including Kaletra.
Women taking birth control pills or using patches to prevent pregnancy should use an extra form or a different type of birth control since birth control pills or patches may not work as well while taking Kaletra. Women should talk to their doctor about how to prevent pregnancy while taking Kaletra.
It is not known if Kaletra will harm unborn babies. Women who are pregnant or planning to become pregnant should tell their doctor.
Women taking Kaletra during pregnancy should talk with their doctor about how they can take part in an Antiretroviral Pregnancy Registry. The purpose of the pregnancy registry is to follow the health of the mother and their baby.
Women should not breast-feed while taking Kaletra. There is a chance that HIV can be passed to the baby through breast milk and their baby may have serious side effects from Kaletra.
Common side effects of Kaletra include diarrhea, nausea, stomach area (abdominal) pain, feeling weak, vomiting, headache, and upset stomach. These are not all of the possible side effects of Kaletra.
The long-term effects of Kaletra are not known at this time.
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.
Expanding on its scientific contributions, Abbott and the Abbott Fund have invested more than $100 million in developing countries to improve the lives of people affected by HIV/AIDS through programs targeting critical areas of need, including strengthening health care systems, supporting children affected by HIV/AIDS, and advancing HIV testing and treatment. For more information on Abbott's HIV/AIDS programs, please visit www.abbott.com/HIVAIDS and www.abbottglobalcare.org.
Abbott 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 approximately 83,000 people and markets its products in more than 130 countries.