Aurotem

AUROTEM contains two active substances:

• Emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
• Tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)

AUROTEM blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply. AUROTEM therefore reduces the amount of HIV in your body. AUROTEM in combination with other medicines is for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and adolescents 12 years of age and older, who weigh at least 35 kg.

Do not take AUROTEM:

• If you are allergic (hypersensitive) to emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

Warnings and precautions

Too much lactic acid in your blood (lactic acidosis) is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or 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 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 AUROTEM. It is important not to stop taking AUROTEM without talking to your doctor. You must remain under the care of your doctor while taking AUROTEM. You can still pass on HIV when taking AUROTEM. Discuss with your doctor the precautions needed to avoid infecting other people. AUROTEM is not a cure for HIV infection. While taking AUROTEM you may still develop infections or other illnesses associated with HIV infection.

During HIV therapy such as with AUROTEM there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Children and adolescents

Do not give this medicine to children under 12 years of age or weighing less than 35 kg. The use of AUROTEM in children under 12 years of age has not been studied.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The recommended dose is:

• Adults: one tablet each day, with or without food
• Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with or without food

Do not chew, crush or split the tablet. Always take the dose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.

If you are on dialysis, take your daily dose of AUROTEM following completion of dialysis.

If you take more AUROTEM than you should

If you take more than the recommended dose of AUROTEM, you may be at higher risk of experiencing side effects (see section 4, Possible side effects). Contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can show what you have taken.

If you forget to take AUROTEM

It is important not to miss a dose of AUROTEM. If you do miss a dose: If you notice this miss dose within 18 hours of the time you usually take AUROTEM, you must take the tablet as soon as possible. Then take the next dose as usual. If you notice this miss dose, 18 hours or more after the time you usually take AUROTEM, then do not take the missed dose. Wait and take the next dose at your usual time. If you vomit less than 1 hour after taking AUROTEM, you should take another tablet.

Do not stop taking AUROTEM

Do not stop taking AUROTEM without talking to your doctor. Stopping AUROTEM can seriously affect how well future treatment works. If AUROTEM is stopped for any reason, speak to your doctor before you restart taking AUROTEM tablets. When your supply of AUROTEM starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if AUROTEM is stopped for even a short time. The disease may then become harder to treat. If you have both HIV infection and hepatitis B, it is very important not to stop taking AUROTEM without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which may be life-threatening. Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection. If you have any further questions on the use of AUROTEM, ask your doctor or pharmacist.

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

Possible serious side effects:

tell a doctor immediately any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment such as with AUROTEM is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Autoimmune disorders (the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection such as AUROTEM. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:

• Muscle weakness
• Weakness beginning in the hands and feet and moving up towards the trunk of the body
• Palpitations, tremor or hyperactivity

If you notice the side effects described above, tell your doctor immediately.

Frequent side effects

• Feeling sick (nausea)
• Abnormal dreams
• Headache
• Dizziness
• Diarrhoea
• Vomiting
• Stomach pain
• Wind (flatulence)
• Rash
• Tiredness (fatigue)

Less frequent side effects

• Swelling of the face, lips or throat with difficult breathing (angioedema)
• Itching (pruritus)
• Hives (urticaria)
• Low red blood cell count (anaemia)
• Problems with digestion resulting in discomfort after meals (dyspepsia)
• Joint pain (arthralgia)

If any of the side effects get serious tell your doctor.

Other effects that may be seen during HIV treatment: The frequency of the following side effects is not known (frequency cannot be estimated from the available data). Bone problems. Some patients taking combination antiretroviral medicines such as AUROTEM may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:

• Joint stiffness
• Joint aches and pains (especially of the hip, knee and shoulder)
• Difficulty with movement

If you notice any of these symptoms tell your doctor. During HIV therapy such as with AUROTEM there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

If you notice any side effects not mentioned in this leaflet, 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 (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of AUROTEM.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Store all medicines out of reach of children.

• Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Store at or below 30 °C.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).