Clinical Author's Note (Michael Stewart) 29/06/2018: dolutegravir may harm an unborn child. Women who can become pregnant must use effective contraception whilst taking dolutegravir. The European Medicines Agency (EMA) is investigating a possible increased risk of neural tube defects in babies born to mothers who took dolutegravir during pregnancy. The review is currently ongoing. Click on the link above for more information and speak with your doctor if you have any concerns.
Dolutegravir slows the progress of HIV infection. It is one of a number of medicines that you will need to take regularly.Dolutegravir has been associated with some side-effects, particularly a rash. Your doctor will discuss this with you before you start treatment.
|Type of medicine||An integrase inhibitor antiretroviral medicine|
|Used for||Human immunodeficiency virus (HIV) infection (in adults and children over 12 years of age)|
|Also called||Tivicay®; there is also a combination tablet containing dolutegravir with abacavir and lamivudine, called Trimeq®|
Dolutegravir is an antiretroviral medicine. It is used for human immunodeficiency virus (HIV) infection. It slows the progress of HIV infection, but it is not a cure. HIV destroys cells in the body, called CD4 T cells. These cells are a type of white blood cell and are important because they are involved in protecting your body from infection. If left untreated, the HIV infection weakens your immune system so that your body cannot defend itself against bacteria, viruses and other germs. Dolutegravir is known as an integrase inhibitor antiretroviral medicine. It works by stopping an enzyme which is produced by the virus from working. The virus produces the enzyme to help it multiply in the body, so by preventing it from working, dolutegravir reduces the amount of virus in your body. This helps to maintain the health of your immune system.
Dolutegravir will be prescribed for you by a doctor who is a specialist. It is given alongside a number of other antiretroviral medicines, as part of a combination therapy. Taking three or more antiretroviral medicines at the same time is more effective than taking one alone. Taking a combination of different medicines also reduces the risk that the virus will become resistant to any individual medicine. It is vital to take them exactly as prescribed to maintain success and to help to prevent the virus from becoming resistant to the medicines. These medicines are usually taken for life.
Before taking dolutegravir
Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking dolutegravir it is important that your doctor knows:
- If you are pregnant, trying for a baby, or breastfeeding.
- If you have any problems with the way your liver works.
- If you have ever had an allergic reaction to a medicine.
- If you are taking any other medicines. This includes any medicines which are available to buy without a prescription, as well as herbal and complementary medicines.
How to take dolutegravir tablets
- Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about dolutegravir, and it will also provide you with a full list of the side-effects which you could experience from taking it.
- Take dolutegravir exactly as your doctor tells you to. The usual dose is one tablet, taken either once or twice a day. The right dose for you will depend upon what other medicines you are taking for HIV.
- Try to take the tablet at the same time(s) of day each day, as this will help you to remember to take dolutegravir regularly. If you forget to take a dose at your usual time, take it as soon as you remember (unless it is within four hours of your next dose, in which case leave out the missed dose). Do not take two doses together to make up for a forgotten dose.
- Swallow the tablet with a drink of water. Dolutegravir can be taken either with or without food, but if you are known to have resistance to some treatments, your doctor will advise you to always take your doses after a meal as it can increase the effectiveness of the tablets.
Getting the most from your treatment
- Keep your regular appointments with your doctor so that your progress can be monitored. You will need to have regular blood tests.
- It is important that you continue to take dolutegravir and your other antiretroviral treatment regularly. This will help to prevent the HIV from becoming resistant to the medicines you are taking. Even if you miss only a small number of doses, the virus can become resistant to treatment.
- If you develop any infection soon after you start the treatment, let your doctor know. As a result of taking dolutegravir, your immune system may start fighting an infection which was present before you started the treatment, but which you may not have been aware of.
- Follow carefully any advice your doctor gives to you about making lifestyle changes to reduce any risk of damage to your heart and blood vessels. These can include stopping smoking, eating healthily and taking regular exercise.
- Although treatment with antiretroviral medicines can reduce the risk of you passing HIV to others through sexual contact, it does not stop it. It is important that you use condoms.
- Dolutegravir can harm an unborn child so you must avoid getting pregnant while you are taking dolutegravir. Make sure you have discussed with your doctor which types of contraception are suitable for you and your partner. If you are a woman and want to have a family, discuss this with your doctor so that you can be given advice from a specialist about alternative treatment before you become pregnant.
- It is not uncommon for people with HIV to feel low or even depressed, especially soon after the diagnosis has been made and treatment has been started. If you have any feelings of depression you should speak with your doctor straightaway.
- Some people who have taken antiretroviral medicines (particularly over a long time) have developed a condition called osteonecrosis. This is a bone disease where bone tissue dies because there is a reduced blood supply to it. It leads to joint pains and stiffness, and can cause difficulties in movement. If you notice any of these symptoms, speak with your doctor.
- If you buy any medicines, supplements or herbal remedies 'over the counter', check with a pharmacist that they are suitable to take with dolutegravir and your other medicines. This is because some medicines interfere with antiretrovirals and can stop them from working properly. Dolutegravir should not be taken with antacid remedies: if you need to take an antacid, you should take it six hours before you take a dose of dolutegravir, or wait until two hours afterwards. Vitamin and mineral supplements must also be taken well separated from dolutegravir.
- If you are having an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking.
- Treatment for HIV is usually lifelong. Continue to take dolutegravir regularly, even if you feel well. This is to keep your immune system healthy.
Can dolutegravir tablets cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with dolutegravir. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
|Very common dolutegravir side-effects (these affect more than 1 in 10 people)||What can I do if I experience this?|
|Diarrhoea||Drink plenty of water to replace lost fluids|
|Headache||Ask your doctor or pharmacist to recommend a suitable painkiller|
|Feeling sick||Stick to simple meals - avoid fatty or spicy food|
|Common dolutegravir side-effects (these affect less than 1 in 10 people)||What can I do if I experience this?|
|Feeling dizzy or tired||Do not drive and do not use tools or machines while affected|
|Sleeping problems, wind, tummy (abdominal) discomfort, feeling depressed||If any of these become troublesome, let your doctor know|
|Itchy rash||If this becomes severe, let your doctor know straightaway (see below)|
|Changes to some blood tests||Your doctor will check for this|
Important: although it is common for people taking dolutegravir to develop a skin rash, a severe rash with blisters may be a sign of a more serious allergic-type reaction. Let your doctor know straightaway if you develop the following:
- Severe blistering rash with high temperature (fever), muscle and joint aches or pains, feeling generally unwell, mouth ulcers, conjunctivitis, dark urine, stomach pain, yellowing of your skin or the whites of your eyes (jaundice).
If you experience any other symptoms which you think may be due to dolutegravir, speak with your doctor or pharmacist for further advice.
How to store dolutegravir
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
Important information about all medicines
Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
Further reading and references
Manufacturer's PIL, Tivicay® 50 mg film-coated tablets; ViiV Healthcare UK Ltd, The electronic Medicines Compendium. Dated November 2015.
British National Formulary; 71st Edition (Mar-Sep 2016) British Medical Association and Royal Pharmaceutical Society of Great Britain, London