Agenerase (amprenavir)

How does it work?

Agenerase capsules and oral solution contain the active ingredient amprenavir, which is a type of medicine called a protease inhibitor. It is used in the treatment of HIV (human immunodeficiency virus) infection.

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 amprenavir, work by stopping the protease enzyme from working.

There is no cure for HIV, but amprenavir is one of a number of medicines that slows the progression of the disease from HIV to AIDS. Amprenavir 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.

Amprenavir should only be prescribed to people who have already received treatment with a protease inhibitor. In people who who never received a protease inhibitor, the protease inhibitor indinavir is more effective than amprenavir.

Low-doses of the protease inhibitor ritonavir are often used in combination with amprenavir. This is because ritonavir increases the blood level of amprenavir, which boosts its effect and therefore reduces the dose of amprenavir that you need to take.

What is it used for?

HIV infection.

Warning!

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 sugar (glucose) in your blood, and may prescribe additional medicines for any lipid disorders that occur during 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.

You should have regular blood tests to monitor your liver function while you are taking this medicine. This is especially important if you already have any problems with your liver, in particular chronic hepatitis B or C. Symptoms that may suggest a liver problem include persistent nausea and vomiting, abdominal pain, or the development of jaundice (a yellow colouring to the skin and the whites of the eyes). Consult your doctor if you experience any of these symptoms.

You may get a rash while taking this medicine. If the rash is mild you can continue taking the medicine and it should normally get better within a couple of weeks. Taking an antihistamine such as cetirizine may help reduce any itching and help it clear up quicker. Ask your pharmacist for advice. If your rash is more severe or you also have other symptoms you should consult your doctor, as you may need to stop treatment with this medicine.

Agenerase capsules and oral solution also contain vitamin E. For this reason taking extra vitamin E supplements is not recommended while taking this medicine.

The safety and efficacy of this medicine have not been studied in children aged under 4 years or elderly people aged over 65 years.

Use with caution in

The blood clotting disorder haemophilia (this medicine may increase the risk of bleeding in haemophilia).

Decreased liver function.

Hepatitis, especially chronic hepatitis B or C.

Diabetes.

Agenerase oral solution contains propylene glycol. For this reason, it should be used with caution in people with impaired kidney function and those with decreased ability to metabolise propylene glycol, for example people of Asian origin. This does not apply to Agenerase capsules.

Not to be used in

Known sensitivity or allergy to any ingredient.

Agenerase is not recommended for children under 4 years of age.

Due to its propylene glycol content, Agenerase oral solution must not be used in pregnant women, or people with impaired liver function, liver failure or kidney failure. This does not apply to Agenerase capsules.

Agenerase in combination with ritonavir should not be used in people who have severely decreased liver function.

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 amprenavir in pregnancy has not been established. Amprenavir should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the foetus. Seek medical advice from your doctor. Agenerase oral solution should not be used by pregnant women, due to its propylene glycol content.

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

Do not take indigestion remedies at the same time of day as this medication.

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