Description
Kaletra is composed of two active compounds: Ritonavir (RTV) – a first generation HIV protease inhibitor and Lopinavir (ABT-378) – second generation HIV protease inhibitor.
Indications:
- treatment of HIV type 1 infection in combination with other anti-retroviral agents.
MOA (mechanism of action):
Lopinavir and Ritonavir are both HIV protease inhibitors. Ritonavir is used as a booster of Lopinavir's action. It inhibits the metabolism of Lopinavir, thereby increasing the plasma levels of Lopinavir. Protease inhibitors bind to the protease active site and inhibit the activity of this enzyme. This averts cleavage of the viral polyproteins resulting in the formation of immature non-infectious viral particles. Ritonavir and Lopinavir are active against HIV-2.
Dosage
For adults:
The recommended dose is 400 mg/100 mg twice a day (every 12 hours), in combination with other anti-HIV agents.
Adult patients who have not previously taken other antiviral drugs can also take Kaletra tablets once daily as an 800 mg/200 mg dose.
Your doctor will advise on how many tablets should be taken.
Adult patients who have previously taken other antiviral drugs can take Kaletra tablets once daily as an 800 mg/200 mg dose if their doctor decides it is appropriate.
Kaletra must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital, and phenytoin.
Kaletra tablets can be taken with or without food.
Do not stop or change the daily dose of Kaletra without first consulting with your doctor.
For children of 2 years of age and older:
For children, your doctor will determine the right dose (number of tablets) based on the child’s height and weight:
- 15-25 kg: 2 tablets (100 mg / 25 mg) twice daily.
- 25-35 kg: 3 tablets (100 mg / 25 mg) twice daily.
- 35 kg and more: 3 tablets (100 mg / 25 mg) twice daily or 2 tablets (200 mg / 50 mg).
Kaletra tablets can be taken with or without food.
Lopinavir/Ritonavir oral solution is available for children with a BSA (body surface area) less than 0,6 m 2 or those who are unable to reliably swallow a tablet.
Some people who take Kaletra may experience:
- Liver problems. Some people taking Kaletra in combination with other anti-HIV medicines have developed liver problems. Contact your healthcare provider immediately if the signs of liver problems occur.
- Changes in the electrical activity of the heart called PR prolongation. PR prolongation can cause irregular heartbeats.
- Immune reactivation syndrome (severe immune deficiency during combination anti-retroviral therapy (CART) may lead to arousal of opportunistic infections and cause serious clinical conditions).
- Increase in cholesterol and triglyceride levels.
- Diabetes and high blood sugar (hyperglycemia). Tell your healthcare provider if you notice an increase in thirst or frequent urination.
- Change in body fat (fat accumulates in the upper back and neck (“buffalo hump”), breast, and around the middle part of your body (trunk).
- Increased bleeding for hemophiliacs.
Precautions:
HIV can be transmitted through sexual contact with HIV positive partner, blood (e.g., sharing needles, handling blood instruments, receiving blood transfusions, blood products, or organ/tissue transplants that were infected with HIV), childbirth, toiletries (razors and toothbrushes). Therefore, both HIV-positive and HIV-negative individuals are advised to have any kind of sex using a latex or polyurethane condom, avoid sharing needles or other things like toothbrushes or razors. It is important to discuss with doctor the precautions needed to avoid infecting other people as well as take precautions not to get infected.
If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom) as Kaletra may reduce the effectiveness of oral and patch contraceptives.
Women who are HIV-positive must not breastfeed because HIV infection can be passed on to the baby in breast milk.
Missing a dose
If you take Kaletra once daily: if you notice within 12 hours of the time you usually take Kaletra, you must take the tablet(s) as soon as possible. Always take the tablet with food and with a dose of your other protease inhibitor. Then take the next dose as usual. If you notice 12 hours or more after the time you usually take Kaletra, then do not take the missed dose. Wait and take the next dose, with food, at your usual time. Do not take a double dose to make up for missing one.
If you take Kaletra twice daily: if you notice within 6 hours of the time you usually take Kaletra, you must take the tablet as soon as possible. Always take the tablet with food and with a dose of your other protease inhibitor. Then take the next dose as usual. If you notice 6 hours or more after the time you usually take Kaletra, then do not take the missed dose. Wait and take the next dose, with food, at your usual time. Do not take a double dose to make up for missing one.
Overdose
If an overdose occurs and you are not feeling well, stop taking the medication immediately. You should seek emergency medical attention or contact your healthcare provider immediately.
Storage
Store Kaletra tablets or oral powder at room temperature between 68-77 degrees F (20-25 degrees C). Keep Kaletra in the original container. Do not use Kaletra if the seal over the bottle opening is broken or missing. Keep the bottle tightly closed. Throw away any unused medicine after the expiration date. Keep out of the reach of children.
