Kaletra (lopinavir, ritonavir)

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How does it work?

Kaletra capsules, tablets and oral solution all contain two active ingredients, ritonavir and lopinavir. These are both anti-HIV medicines known as protease inhibitors. However, lopinavir is the active ingredient that provides the anti-HIV activity. There is a small amount of ritonavir included in this medicine because it slows the breakdown of lopinavir by the liver. This produces higher blood levels of lopinavir to fight the virus.

AIDS (acquired immune deficiency syndrome) is caused by infection with HIV (human immunodeficiency virus). This virus invades cells of the immune system, particularly the white blood cells known as CD4 T-helper lymphocytes. These cells normally activate other cells in the immune system to fight infection. Since HIV kills CD4 T-helper cells, the body cannot fight the virus or subsequent infections.

Once the virus is inside the CD4 T-cell it multiplies, producing numerous copies of itself. An enzyme produced by the HIV virus, called protease, plays an important role in this process. Protease breaks up new protein produced by the virus, so that new copies of the virus can be assembled from the pieces. If this enzyme is stopped from working, any new virus that is produced is faulty and unable to infect more CD4 cells. Protease inhibitors, such as lopinavir, work by stopping the protease enzyme from working.

There is no cure for HIV, but Kaletra is one of a number of medicines that slows the progression of the disease from HIV to AIDS. Kaletra is used in conjunction with other anti-HIV medicines that attack the virus in different ways. This minimises the chance of the virus becoming resistant to any one medicine.

What is it used for?

- HIV infection.

Warning!

- Kaletra capsules and oral solution should be taken with food. Kaletra tablets can be taken with or without food.
- Kaletra tablets should be swallowed whole and not broken, chewed or crushed.
- Kaletra capsules and oral solution should be stored at 2-8ºc in a refrigerator. When in use they may be kept outside of the fridge, but do not store them above 25ºc, and dispose of any unused medicine after 6 weeks. (Write the date of removal from the fridge on the package.) Kaletra tablets do not need to be kept in a fridge.
- The HIV virus is very good at becoming resistant to anti-HIV medicines. For this reason it is very important that you carefully follow your doctor's instructions for taking your anti-HIV medicines, in order to maintain effective levels of the medicines in your blood. If the blood levels drop, the virus will be given more chance to replicate and develop resistance to the drugs.

Skipping even a few doses increases the risk of treatment failure, so you should try to ensure that you take all your doses at the correct time, and that you visit your doctor for repeat prescriptions before you run out.
- Treatment of HIV infection with anti-HIV medicines such as this one does not reduce the risk of transmitting the virus to other people through sexual contact or blood contamination. You should continue to use condoms to prevent transmitting the virus to your sexual partner.
- Combination antiretroviral therapy has been associated with a redistribution of body fat (lipodystrophy) in people with HIV. The long-term consequences of this are currently unknown, however your doctor may wish to monitor your body fat, and the levels of lipids (eg cholesterol and triglycerides) and sugar (glucose) in your blood, and may prescribe additional medicines for any lipid disorders that occur during treatment with this medicine. Your cholesterol and triglyceride levels will need to be checked before you start treatment with this medicine. Contact your doctor if you notice any changes in your body fat during treatment with your HIV medicines.
- Some people being treated with combination antiretroviral therapy may develop a bone condition called osteonecrosis. This condition is caused by loss of blood supply to a bone, causing death of the bone tissue. The risk of the condition is thought to be increased by corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, advanced HIV disease and long-term use of antiretroviral medicines. If you notice any joint stiffness, aches and pains (especially of the hip, knee and shoulder) or difficulty in movement while using this medicine, you should tell your doctor so this can be investigated.
- If you have any problems with your liver, in particular chronic hepatitis B or C, you should have regular blood tests to monitor your liver function while you are taking this medicine.
- Consult your doctor if you experience sudden stomach or abdominal pain, nausea or vomiting while taking this medicine, as this may be due to inflammation of the pancreas (pancreatitis), which must be treated.

Use with caution in

.

- Severely decreased kidney function.
- Liver disorders.
- Hepatitis, especially chronic hepatitis B or C.
- The blood clotting disorder haemophilia (this medicine may increase the risk of bleeding in haemophilia).
- High levels of cholesterol in the blood.
- High levels of fats called triglycerides in the blood.
- History of disorders involving the amount of fats (lipids) in the blood.
- History of inflammation of the pancreas .
- Diabetes.

Kaletra oral solution contains propylene glycol, alcohol, fructose and potassium and as a result should be used with caution in:

- People of Asian origin.
- Children.
- Alcoholism.
- Epilepsy.
- Brain damage or disease.
- Hereditary fructose intolerance.
- People on a low potassium diet.

Not to be used in

.

- Children under two years of age.
- Severely decreased liver function.

Kaletra oral solution contains propylene glycol and as a result should not be used in:

- Pregnant women.
- Liver failure.
- Kidney failure.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

- The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor.
- It is recommended that women infected with the HIV virus must not breastfeed their infants under any circumstances, in order to avoid transmission of the virus to the baby. Seek medical advice from your doctor.

Label warnings

- Kaletra capsules and oral solution should be taken with food. Kaletra tablets can be taken with or without food.

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