Etravirine (TMC125)

Please read this factsheet carefully along with the patient information leaflet before taking your medicine. If you have any questions or are unsure about anything, ask your doctor or pharmacist.

Etravirine, also known as TMC125, belongs to a class of drugs called nonnucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs are used for the treatment of HIV infection, in combination with other anti-HIV drugs.

Please speak to your clinic doctor or pharmacist if you would like more information about how these drugs work. Etravirine is currently unlicensed in the UK but is available on an expanded access programme and to patients on certain clinical trials.

Before taking etravirine
Tell your doctor about:

* All other drugs you are taking, including any that you buy over the counter in a community pharmacy and any herbal medicines or recreational drugs.
* Any previous allergy to any medicines.
* If you have ever had any liver disease.
* If you are pregnant or planning a pregnancy.
* If you are breastfeeding.

Taking your etravirine

* Etravirine is available as a white to off white oval tablet containing 100mg of etravirine.
* The usual dose is 200mg (2 tablets) twice daily.
* The doses should be divided equally throughout the day: try to take the doses as close to possible to twelve hours apart, and at the same times each day.
* Etravirine should always be taken with a food.
* Etravirine works best if there is a constant amount in your blood stream. It is therefore important to take it regularly. If you forget a dose, take it as soon as you remember but do not double up the next dose.

Do not run out of etravirine. If you are going on holiday and need additional supplies, tell your doctor. When receiving a supply from pharmacy, ensure that you have an adequate supply to last until your next appointment.

Other drugs and etravirine
Etravirine is metabolised (processed in the body) by the liver. Some other drugs are metabolised in the same way. This is why it is important to tell your doctor about all the medicines that you take even if you only take them occasionally, including herbal and recreational drugs.

Examples of some drugs that are metabolised in the same way as etravirine and therefore should NOT be taken are rifampicin, ciclosporin, certain antifungals, tacrolimus, phenytoin, phenobarbitone, carbamazepine, certain benzodiazepines, St. John’s Wort (Hypericum perforatum) certain antiarrythmics and terfenadine (Triludan®).

Other examples of drugs that are metabolised in the same way as etravirine include drugs for erectile dysfunction (e.g. Viagra®), warfarin, protease inhibitors, drugs to lower cholesterol, ergotamine, and certain blood pressure medicines. Your doctor may alter your doses if you are taking one of these drugs.

Etravirine can stop oral contraceptives from working effectively so you must use an alternative form of contraception e.g. barrier methods.

Side effects
Etravirine, like all other medicines, has some side effects. The most common ones are:

* Headache
* Nausea and vomiting, diarrhoea,
* Abdominal pain and flatulence
* Fatigue
* Fever
* Dizziness, impaired concentration and/or drowsiness: If you are affected by these symptoms you should avoid driving or operating machinery.
* Skin rash: This is a common side effect of all the NNRTI's and usually resolves.

If you experience any of these side effects or any other new symptoms after starting etravirine, tell your doctor who will advise you what to do. If you decide to stop taking etravirine it is important that you tell your doctor so th at he or she can discuss other treatment options with you.

A condition called pancreatitis has occurred rarely in patients who are taking etravirine. Pancreatitis is a dangerous inflammation of the pancreas. Tell your doctor straight away if you develop stomach pain,
nausea or vomiting.

Admission to hospital
If you are admitted to hospital please bring all your medicines with you. This is especially important for anti-HIV drugs, as they have to be taken regularly. Thomas Macaulay ward of the Chelsea and Westminster Hospital now operate a self-medication programme. Some people are able to self administer their own medicines to enable them to stick to the routine they have been used to at home.

Storing your Etravirine
Etravirine should be stored at room temperature.