WARNING:
Kaletra can cause serious, life-threatening side effects. These include liver problems, pancreatitis (inflammation of the pancreas), 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 may signal liver problems:
- Loss of appetite.
- Yellowing of your skin or the whites of your eyes (jaundice).
- Dark-colored urine.
- Pale-colored bowel movements.
- Itchy skin.
- Pain in the stomach area.
Contact your health care provider right away if you have any of the following symptoms that may signal pancreatitis:
- Nausea.
- Vomiting.
- Pain in your stomach area.
Contact your health care provider right away if you have any of the following symptoms that may signal heart rhythm problems:
- Dizziness.
- Lightheadedness.
- Fainting or feeling like you might faint.
- 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.
Babies taking Kaletra oral solution may have side effects. (Kaletra oral solution contains alcohol and propylene glycol.) Contact your health care provider right away if your baby appears too sleepy or his/her breathing has changed.
Taking Kaletra with certain other medicines may result in serious and/or 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 anti-HIV medicines.
Kaletra contains the following two anti-HIV medicines: lopinavir and ritonavir. Lopinavir and ritonavir are types of anti-HIV medicines called protease inhibitors (PIs). PIs block protease, an HIV enzyme. This prevents HIV from replicating and lowers the amount of HIV in the blood.
Kaletra does not cure HIV/AIDS. It is not known if Kaletra reduces the risk of passing HIV to other people.
What should I tell my health care provider before taking Kaletra?
Before taking Kaletra, tell your health care provider:
- If you are allergic to Kaletra, lopinavir, ritonavir, or any other medicines.
- If you have any heart problems, including congenital long QT syndrome.
- If you have any liver problems, including hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- If you have diabetes.
- If you have hemophilia.
- If you have low potassium in your blood.
- If you are pregnant or plan to become pregnant. Whether Kaletra can harm an unborn baby is unknown.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking Kaletra.
- 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 and/or life-threatening side effects.
How should I take Kaletra?
Kaletra comes in the following forms and strengths:
- Film-coated tablets of 100 mg lopinavir and 25 mg ritonavir (brand name: Kaletra).
- Film-coated tablets of 200 mg lopinavir and 50 mg ritonavir (brand name: Kaletra).
- Oral solution of 80 mg/mL lopinavir and 20 mg/mL ritonavir (brand name: Kaletra).
- Capsules of 133.3 mg lopinavir and 33.3 mg ritonavir (brand name: Kaletra). (The capsule form is currently being phased out by the manufacturer.)
Take Kaletra according to your health care provider’s instructions.
Kaletra tablets can be taken with or without food and should be swallowed whole. Do not chew, break, or crush the tablets. Take Kaletra oral solution and capsules with food.
If you are also taking the anti-HIV medicine didanosine (brand name: Videx; Videx EC):
- You can take didanosine at the same time as Kaletra tablets, with food.
- You should take didanosine either 1 hour before or 2 hours after taking Kaletra oral solution.
Always take Kaletra in combination with other anti-HIV medicines.
If you take too much Kaletra, contact your local poison control center (1-800-222-1222) 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?
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 can cause serious, life-threatening side effects. These include liver problems, pancreatitis (inflammation of the pancreas), heart rhythm problems, severe allergic reactions, and life-threatening drug interactions. (See the WARNING above.)
Other possible side effects of Kaletra include:
- Diabetes and high blood sugar (hyperglycemia).
- Changes in body fat (lipodystrophy).
- Changes in the immune system (immune reconstitution inflammatory syndrome).
- Increases in cholesterol and triglycerides (hyperlipidemia).
- Increased bleeding in people with hemophilia.
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. Ask your health care provider or pharmacist for more information on possible side effects of Kaletra.
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, 36°F to 46°F (2°C to 8°C). The oral solution can be stored at room temperature (less than 77°F or 25°C), but then it should be used within 2 months. Avoid exposure to high heat.
- Store Kaletra capsules in a refrigerator, 36°F to 46°F (2°C to 8°C). The capsules can be stored at room temperature (less than 77°F or 25°C), but then they should be used within 2 months. Avoid exposure to high heat.
- Safely throw away Kaletra that is no longer needed or expired (out of date).
- Keep Kaletra and all medicines out of reach of children.
Where can I find more information about Kaletra?
More information about Kaletra is available:
Manufacturer Information
Abbott Laboratories
847-937-6100
Last Reviewed: September 13, 2012
Last Updated: September 12, 2012