Viramune (nevirapine)

How does it work?

Viramune tablets and suspension contain the active ingredient nevirapine, which is a type of medicine called a non-nucleoside reverse transcriptase inhibitor. It is used in the treatment of HIV (human immunodeficiency virus) infection.

AIDS (acquired immune deficiency syndrome) is caused by infection with HIV. This virus invades cells of the immune system, particularly the white blood cells known as CD4 T-helper lymphocytes. These cells normally work to activate other cells in the immune system to fight infection. Since HIV kills CD4 T-helper cells, over time the body becomes less able to fight the virus or subsequent infections.

Once the virus is inside the CD4 T-cell it multiplies. Part of the process of viral multiplication involves the conversion of the virus genetic material, RNA, into DNA. This is achieved by a compound essential to the virus, called reverse transcriptase. Reverse transcriptase is a compound known as an enzyme. Nevirapine works by blocking the action of this enzyme, thereby interfering with the conversion of viral RNA into DNA. This stops the virus from multiplying.

There is no cure for HIV, but nevirapine is one of a number of medications that lowers the amount of virus in the body (viral load) and slows the progression of the disease from HIV to AIDS. Nevirapine is used in combination with other anti-HIV drugs that attack the HIV virus in different ways. This minimises the virus's ability to replicate and multiply, and helps prevent it becoming resistant to treatment.

The most serious side effects associated with nevirapine are skin reactions and side effects on the liver, both of which can be severe or life-threatening. The risk of experiencing these side effects is minimised by starting treatment gradually. For this reason, nevirapine must be taken just once a day for the first two weeks of treatment. If no rash is experienced in this time your doctor will then increase your dose, however if you do get a rash the dose will not be increased until the rash has cleared up.

If for any reason you stop taking this medicine for longer than seven days during treatment, the medicine will subsequently need to be re-introduced gradually, as when starting treatment. See the warnings below for further information, and make sure you talk to your doctor if you are unclear or concerned about any aspect of your treatment.

What is it used for?

HIV infection.

Warning!

This medicine is associated with serious skin reactions that can be severe or life-threatening. If they occur, these reactions usually happen in the first 18 weeks of treatment, with the majority in the first 6 weeks. Your doctor will want to monitor you closely during this time. If you experience any rash after starting treatment you must consult your doctor WITHOUT DELAY. Parents/carers of children starting this medicine should be especially vigilant as the child may not notice a rash. If you get a rash in the first two weeks of treatment your dose should not be increased until the rash clears up. If you get a severe rash, or rash accompanied by symptoms such as fever, blistering, swollen glands, mouth sores, conjunctivitis, facial swelling, muscle or joint aches, or feeling generally unwell, you must stop taking the medicine and seek medical advice immediately. You may have to permanently discontinue this medicine.

This medicine is also associated with serious side effects on the liver that can be severe or life threatening. Women and people with high CD4 cell counts are at greater risk of experiencing these side effects. If they happen, these reactions usually occur in the first 18 weeks of treatment, with the majority in the first 6 weeks. Your doctor will want to monitor you closely during this time. If you experience any of the following symptoms at any time during treatment you should stop taking this medicine and consult your doctor WITHOUT DELAY: abdominal pain/swelling, nausea, loss of appetite, yellowing of skin or eyes (jaundice), dark urine or pale stools.

You will need to have a blood test to monitor your liver function every two weeks during the first two months of treatment with this medicine, at the third month of treatment, and regularly thereafter.

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.

If for any reason you stop taking this medicine for longer than seven days, you should consult your doctor before you start taking it again. This is because after stopping for seven days, treatment must be re-started using the initial low dose you took when you first started treatment. Your doctor will need to monitor you through this period.

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.

Use with caution in

Decreased kidney function

Decreased liver function

Hepatitis, especially hepatitis B or C

Women

People with high CD4 cell counts.

Not to be used in

Severely decreased liver function

People who have previously had to stop taking this medicine due to inflammation of the liver (hepatitis), or who have had recurrent problems with their liver function due to this medicine

People who have previously had to stop taking this medicine due to a severe rash, or a rash accompanied by symptoms such as fever, blistering, swollen glands, mouth sores, conjunctivitis, facial swelling, muscle or joint aches, or feeling generally unwell.

People needing post-exposure prevention of HIV (for example following needle-stick injuries).

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 in pregnancy has not been established. It 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.

This medicine passes into breast milk. 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.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Rash

Nausea and vomiting

Fatigue

Headache

Fever (pyrexia)

Diarrhoea

Abdominal pain

Pain in the muscles (myalgia)

Allergic reactions

Alteration in results of liver function tests

Jaundice

Severe, potentially life-threatening inflammation of the liver (hepatitis) or liver failure (see warnings above)

Severe, potentially life-threatening skin reactions, eg Stevens-Johnson syndrome, toxic epidermal necrolysis (see warnings above)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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