IMPORTANT CORRECTION OF DRUG
INFORMATION REGARDING Kaletra
You may have seen Abbott’s video “I Know What’s Important,” featuring an interview with Earvin “Magic” Johnson discussing his experience with KALETRA. The U.S. Food and Drug Administration (FDA) found portions of the video, including Abbott’s representation of Mr. Johnson’s experience, to be false or misleading and issued a Warning Letter asking Abbott to correct certain information in the video.
KALETRA is a prescription anti-HIV-1 medicine called a protease inhibitor and contains lopinavir and ritonavir. KALETRA is used with other anti-HIV-1 medicines to increase the likelihood 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.
According to the FDA, the video suggested that use of KALETRA allows patients who have taken HIV medicines before starting KALETRA to live a “normal life” and maintain undetectable viral loads for approximately 5 years. Abbott would like to correct this information for you:
- Abbott has not studied KALETRA beyond 2.5 years in patients who have taken HIV medicines before taking KALETRA. In patients taking HIV medicines for the first time, KALETRA has been studied for up to 7 years in a clinical study.
- People taking KALETRA may still get opportunistic infections or other serious conditions that happen with HIV infection.
- Studies have not been done to determine if KALETRA has an impact on a patient’s ability to perform daily activities or physical, social, and emotional functioning.
- Not all patients taking KALETRA should expect to have the same response as Earvin “Magic” Johnson.
- The long-term effects of KALETRA are not known.
The FDA also stated the video minimized the possible serious risks of KALETRA. Abbott would like to emphasize that KALETRA can cause serious side effects, including:
Serious problems or death can happen if you take 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; or products containing St. John's wort (Hypericum perforatum).The following medicines may need changes if you take 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®), vardenafil (Levitra®), rifabutin (Mycobutin®), inhaled fluticasone (Flonase®), salmeterol (Serevent®) and salmeterol in combination with fluticasone propionate (Advair®).
There is an increased risk of certain problems when you take medicines 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. Tell your doctor right away if you experience any of these side effects.
KALETRA oral solution contains a large amount of alcohol. Talk with your doctor if you take or plan to take metronidazole (Flagyl®) or disulfiram (Antabuse®). You can have severe nausea and vomiting if you take these medicines with KALETRA.
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 disease, or if you take other medicines that can affect your heart rhythm while you take KALETRA. Tell your doctor right away if you 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. You have a higher chance of having pancreatitis if you have had it before. Tell your doctor if you 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 you develop signs and symptoms of serious infections you 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. Tell your doctor if you 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.
If you are taking birth control pills or using patches to prevent pregnancy, you should use an extra form or a different type of birth control, since birth control pills or patches may not work as well while you take KALETRA. Talk to your doctor about how to prevent pregnancy while taking KALETRA.
It is not known if KALETRA will harm your unborn baby. If you are pregnant or planning to become pregnant, you should tell your doctor.
If you take KALETRA during pregnancy, you should talk with your doctor about how you can take part in an Antiretroviral Pregnancy Registry. The purpose of the pregnancy registry is to follow the health of you and your baby.
Do not breast-feed while taking KALETRA. There is a chance HIV can be passed to your baby through breast milk and your baby may have serious side effects from KALETRA.
Common side effects of KALETRA include diarrhea, nausea, stomach area (abdominal) pain, feeling weak, vomiting, headache, or upset stomach.
Some versions of the video included an outdated version of the KALETRA full Prescribing Information. Important updates have been made, including:
- Additional information on drug interactions was added. Remember to tell your doctor about all medicines you are taking, including prescription and non-prescription medicines, vitamins and herbal supplements.
- Information about the importance of having your blood tested for HIV resistance before starting therapy with KALETRA. This will help your doctor make decisions about your HIV medicines.
- Taking KALETRA once daily is not recommended for children under 18 years of age or for people who have taken other HIV medicines before taking KALETRA.
- It is not known if KALETRA is safe and effective in children under 14 days old.
You may order a complimentary copy of the video by calling 1-888-471-7804.
Please click here for up-to-date KALETRA Medication Guide and full Prescribing Information.
Learn more about KALETRA
Talk to your doctor or other healthcare provider, or call 1-866-KALETRA (1-866-525-3872) for additional information about 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 cannot afford your medication, contact www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.
