Brand Name: Kaletra
Other Name(s): LPV / RTV, LPV/r, ritonavir-boosted lopinavir
Drug Class: Protease Inhibitors
Kaletra can cause serious, life-threatening side effects. These include liver problems, inflammation of the pancreas (pancreatitis), heart rhythm problems, severe allergic reactions, and life-threatening drug interactions.
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Loss of appetite
- Yellowing of your skin or the whites of your eyes (jaundice)
- Dark-colored urine
- Light-colored bowel movements
- Itchy skin
- Pain in the stomach area (abdominal pain)
Contact your health care provider right away if you have any of the following symptoms that could be signs of pancreatitis:
- Pain in the stomach area (abdominal pain)
Contact your health care provider right away if you have any of the following symptoms that could be signs of heart rhythm problems:
- Sensation of abnormal heartbeats
Contact your health care provider right away if you develop a skin rash. This could be a sign of a severe allergic reaction.
Kaletra oral solution contains alcohol and propylene glycol. (An oral solution is a mixture of a medicine and a liquid that can be taken by mouth.) The added substances may cause side effects in babies taking Kaletra oral solution. Contact your health care provider right away if your baby appears too sleepy or his or her breathing has changed.
Taking Kaletra with certain other medicines may result in serious, life-threatening side effects.
While taking Kaletra, it is important to keep all of your appointments with your health care provider.
What Is Kaletra?
Kaletra is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 14 days of age and older. Kaletra is always used in combination with other HIV medicines.
Kaletra contains the following two different medicines combined in one pill:
- Lopinavir -- an HIV medicine called a protease inhibitor (PI)
- Ritonavir -- another HIV medicine, also a PI
PIs block an HIV enzyme, a type of protein, called protease. By blocking protease, the two drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body.
HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV treatment regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including Kaletra, don't cut down on, skip, or stop taking them unless your health care provider tells you to.
What Should I Tell My Health Care Provider Before Taking Kaletra?
Before taking Kaletra, tell your health care provider:
- If you are allergic to either of the HIV medicines in Kaletra (lopinavir or ritonavir) or any other medicines.
- If you have any heart problems, including a condition called congenital long QT syndrome.
- If you had or have pancreas problems.
- If you have any liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
- If you have diabetes.
- If you have hemophilia.
- If you have low potassium in your blood.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Kaletra oral solution contains alcohol and propylene glycol. Do not take Kaletra oral solution during pregnancy because there is no safe level of alcohol exposure during pregnancy. Talk to your health care provider about possible risks with taking Kaletra when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Kaletra.
- If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Kaletra may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking Kaletra. For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Kaletra may affect the way other medicines or products work, and other medicines or products may affect how Kaletra works. Taking Kaletra together with certain medicines or products may cause serious, life-threatening side effects.
How Should I Take Kaletra?
Kaletra (the brand name for the fixed-dose combination lopinavir and ritonavir) comes in tablet form in the following strengths:
- 100 mg lopinavir and 25 mg ritonavir
- 200 mg lopinavir and 50 mg ritonavir
Kaletra also comes as an oral solution containing 80 mg/mL lopinavir and 20 mg/mL ritonavir.
Take Kaletra according to your health care provider's instructions.
If you are giving Kaletra to your child, follow your health care provider's instructions. Kaletra dosing for children is based on weight and height, so tell your health care provider if your child's weight changes.
Take Kaletra oral solution with food. Pregnant women should not take Kaletra oral solution because it contains alcohol.
Always take Kaletra in combination with other HIV medicines. If you are also taking the HIV medicine didanosine (brand name: Videx; Videx EC):
- You can take didanosine at the same time as Kaletra tablets, without food.
- Take didanosine either 1 hour before or 2 hours after taking Kaletra oral solution.
If you take too much Kaletra, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
For more information on how to take Kaletra, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What Should I Do If I Forget A Dose?
If you miss a dose of Kaletra, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
What Side Effects Can Kaletra Cause?
Kaletra may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.
Some side effects of Kaletra can be serious. Serious side effects of Kaletra include liver problems, inflammation of the pancreas (pancreatitis), heart rhythm problems, severe allergic reactions, and life-threatening drug interactions. (See the WARNING box above.)
Other possible side effects of Kaletra include:
- Diabetes and high blood sugar (hyperglycemia).
- Increases in certain fat (cholesterol and triglyceride) levels in the blood (hyperlipidemia).
- Increased bleeding in people with hemophilia.
- Changes in body fat (including gain or loss of fat).
- Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Kaletra. To learn more about possible side effects of Kaletra, read the drug label or package insert or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How Should Kaletra Be Stored?
- Store Kaletra tablets at room temperature, 59°F to 86°F (15°C to 30°C). Do not keep the tablets out of the original container for longer than 2 weeks, especially in areas of high humidity. Keep the container closed tightly.
- Store Kaletra oral solution in a refrigerator at 36°F to 46°F (2°C to 8°C). The refrigerated oral solution can be used until the expiration date printed on the label. Kaletra oral solution can be stored at room temperature (less than 77°F or 25°C), but then it should be used within 2 months. Keep the oral solution away from high heat.
- Do not use Kaletra if the original seal over the container opening is broken or missing.
- Throw away Kaletra that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep Kaletra and all medicines out of reach of children.
Where Can I Find More Information About Kaletra?
More information about Kaletra is available:
- The Kaletra FDA drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking Kaletra.
- Kaletra-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
- A list of FDA-approved HIV medicines, from AIDSinfo.
Main number: 800-633-9110
Patient assistance: 800-222-6885
The above Patient Version drug summary is based on the following FDA label(s): Solution, tablet (film coated).
[Note from TheBody.com: This article was originally published by AIDSinfo on July 27, 2018. We have cross-posted it with their permission.]