Envuteg Film-Coated Tablets

ENVUTEG is a combination antiretroviral medicine that is used to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children weighing at least 40 kg. HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).

Do not take ENVUTEG

• If you are hypersensitive (allergic) to dolutegravir, lamivudine or tenofovir alafenamide, or any of the ingredients in ENVUTEG (see section 6).
• If you take dofetilide. Taking ENVUTEG and dofetilide can cause side effects that may be serious or life-threatening.
• If you are taking a medicine called metformin (used for the treatment of diabetes).
• If you are taking a medicine called adefovir (used for the treatment of chronic hepatitis B).
• If you are taking a medicine called pilsicainide (used for the treatment of abnormal heartbeat – cardiac dysrhythmias).
• If you are taking a medicine called didanosine (used for the treatment of hiv infection).
• If you are pregnant or breast feeding your baby.
• If you are a woman of childbearing age.
• If you are younger than 18 years.
• If you have moderate or severe liver function.
• If you have uncontrolled kidney disease.

Warnings and precautions

Take special care with ENVUTEG:

• Too much lactic acid in your blood (lactic acidosis) is a serious but rare medical emergency that can lead to death. Tell your health care provider right away if you get these symptoms: Weakness or being more tired than usual, unusual muscle pain, being short of breath of fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
• If you have an abnormal distribution of fat in the body including central obesity; buffalo hump (a build-up of fat between the shoulder blades); muscle and facial wasting and breast enlargement in HIV patients.
• Immune reconstitution inflammatory syndrome (IRIS): the worsening of a recognised or unrecognised pre-existing infection of improved immunologic function.
• If you suffer from osteonecrosis, when blood flow to part of a bone is reduced.
• If you suffer from mitochondrial dysfunction (when the mitochondria, which is present in cells and function is to produce energy, fail to produce enough energy for the body to function properly).
• If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. If you have hepatitis B infection, liver problems may become worse after you stop taking ENVUTEG. It is important not to stop taking ENVUTEG without talking to your doctor.

Do not share medicines prescribed for you with any other person. Always take ENVUTEG exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

ENVUTEG therapy should be initiated by a health care professional experienced in the management of HIV infections.

Take ENVUTEG at the same time every day. Take ENVUTEG each day with or without food. If you take antacids, laxatives, or other medicines that contain aluminium, magnesium, or buffered medicines, ENVUTEG should be taken at least 2 hours before or 6 hours after you take these medicines. If you need to take iron or calcium supplements by mouth during treatment with ENVUTEG. If you take ENVUTEG with food, you may take these supplements at the same time that you take ENVUTEG.

If you do not take ENVUTEG with food, take ENVUTEG at least 2 hours before or 6 hours after you take these supplements.

For adults and children weighing at least 40 kg, the usual dose of ENVUTEG is one tablet each day. An extra dose of dolutegravir only may be necessary for certain populations. Your health care provider will inform you if you need to take the extra dolutegravir dose.

Stay under the care of a health care provider during treatment with ENVUTEG. Do not run out of ENVUTEG. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your health care provider or pharmacy.

Your health care professional will tell you how long your treatment with ENVUTEG will last.

If you have an impression that the effect of ENVUTEG is too strong or too weak tell your health care professional or pharmacist.

If you take more ENVUTEG than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre for help.

If you forget to take ENVUTEG

If you forget to take a dose of ENVUTEG, take it as soon as you remember and then continue as before. Do not take a double dose to make up for missed individual doses.

Effects when treatment with ENVUTEG is stopped

Do not stop treatment early because this may worsen your condition and make your body resistant to ENVUTEG.

ENVUTEG can have side effects. Not all side effects reported for ENVUTEG are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ENVUTEG, please consult your health care provider for advice.

If any of the following happens, stop taking ENVUTEG and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious reaction to ENVUTEG. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with ENVUTEG if they:
• have taken nucleoside analogue medicines in the past.
• have a history of pancreatitis.
• have other risk factors for pancreatitis.
• Call your health care provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach area pain, with or without nausea and vomiting. Your health care provider may tell you to stop giving ENVUTEG to your child if their symptoms and blood test results show that your child may have pancreatitis.
• New or worse kidney problems, including kidney failure. Your health care provider may do blood and urine tests to check your kidneys before and during treatment with ENVUTEG. Tell your health care provider if you get signs and symptoms of kidney problems, including bone pain that does not go away or worsening bone pain, pain in your arms, hands, legs or feet, broken (fractured) bones, muscle pain or weakness.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
• Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can lead to death. Tell your health care provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
• Feel very weak or tired.
• Unusual (not normal) muscle pain.
• Trouble breathing.
• Stomach pain with nausea and vomiting.
• Feel cold, especially in your arms and legs.
• Feel dizzy or light-headed.
• Have a fast or irregular heartbeat.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Trouble sleeping.
• Nausea.
• Diarrhoea.
• Tiredness.
• Headache.
• Dizziness.
• Abnormal dreams.
• Depression.
• Less frequent side effects:
• Abdominal pain.
• Abdominal discomfort.
• Winds.
• Stomach pain.
• Vomiting.
• Inflammation of the liver.
• Inflammation of the muscle tissue.
• Suicidal thoughts and behaviour.
• Kidney problems.
• Itching.
• Increase in liver enzymes in the blood.
• Frequency unknown:
• Increased weight.
• Painful joints and muscles.
• Liver failure.
• Anxiety.
• Accumulation of body fat.
• Increase in blood sugar.
• Weakness.
• Decrease in red blood cells in the blood.
• Rhabdomyolysis (breakdown of muscle fibres).
• Hair loss.
• Facial swelling, itching, and rash.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ENVUTEG.

Store all medicines out of reach of children. Store at or below 30 °C. Keep the container tightly closed.

Store in the original container until required for use. Do not store in bathrooms. Do not use after the expiry date stated on the carton/label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).