Acriptega Side Effects

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Answer the side-effect intent for acriptega without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Acriptega?

Acriptega contains the active ingredient Tenofovir disoproxil fumarate/ lamivudine / dolutegravir.

• Active ingredient — Tenofovir disoproxil fumarate/ lamivudine / dolutegravir
• Registration number — 52/20.2.8/0199
• Registration holder — Viatris Healthcare (Pty) Ltd

It is approved for:

• Each film-coated tablet contains the active substances: Lamivudine Tenofovir disoproxil fumarate Dolutegravir sodium equivalent to dolutegravir ACRIPTEGA belongs to a group of medicines, known as antiretrovirals
• Combination antiretroviral medicines, such as ACRIPTEGA, are used in the treatment of HIV- 1 (human immunodeficiency virus-1) infection in adults aged 18 years and older
• ACRIPTEGA does not cure or prevent HIV infection, however, it helps to keep HIV from reproducing and appears to slow down the destruction of the immune system
• ACRIPTEGA will not keep you from spreading HIV to other people

Common side effects of Acriptega

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Headache
• Difficulty in sleeping (insomnia)
• Nausea, vomiting
• Upper abdominal pain
• Diarrhoea, flatulence
• Rash, itching
• Hair loss
• Joint pain (arthralgia)
• Muscles become weak, painful and may even cause paralysis (Muscle disorder)
• Feeling tired, weak (fatigue)
• Feeling of bodily discomfort (malaise)
• Fever
• Loss of bone mass

Less frequent side effects

• Depression Neutropenia (low white blood cell count)
• Anaemia (low red blood cell count)
• Increased bruising or bleeding (thrombocytopenia)
• Increases in enzymes produced by the liver
• Allergic reaction (hypersensitivity)
• Immune system begins to recover (immune reconstitution syndrome)
• Abdominal pain or discomfort
• Hepatitis (disease of the liver)
• Bone marrow stops making red blood cells (pure red cell aplasia)
• Redistribution/ accumulation of body fat)
• Abnormal sensation of tingling, numbness or burning (paraesthesia)
• Peripheral neuropathy (when the nerves carrying messages to and from the brain are damaged)
• Inflammation of the pancreas, which causes severe pain in the abdomen and back
• Abnormal muscle breakdown which can lead to kidney problems
• Bones are more porous than they should be (osteopenia)
• Fractures
• Abnormally low levels of phosphate in the blood (hypophosphataemia)
• Shortness of breath (dyspnoea)
• Chronic kidney disease, of kidney failure (renal insufficiency)
• Nose and throat infection
• Nasal discharge and congestion
• Increased blood sugar levels
• Feeling depressed
• Cough
• Loss of appetite

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to tenofovir disoproxil fumarate, lamivudine, dolutegravir or any of the other ingredients in ACRIPTEGA tablets
• If you have or had kidney problems
• If you are a woman of child-bearing age and not using effective contraceptives
• If you are pregnant or planning to become pregnant or breastfeeding
• If you are taking any other tenofovir-containing or other lamivudine-containing, or emtricitabine-containing, or dolutegravir containing medicines. If you are taking a medicine called adefovir dipivoxil (used for the treatment of chronic hepatitis B)
• If you are taking a medicine called dofetilide and 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 younger than 18 years of age
• If you have moderate to severe liver failure

Use with care, and tell your doctor, if

• If you are a female, overweight or have been taking nucleoside-containing medicines for a long time, as you are more likely to get lactic acidosis (build-up of lactic acid in the body)
• High cholesterol: If you have been told you have high cholesterol (certain bad fats that are too high in the blood), you could be at risk of getting heart disease or having a heart attack
• Increase blood sugar levels: ACRIPTEGA may contribute to your sugar levels increasing, this may also cause insulin resistance where the insulin levels in your pancreas have a poor response to insulin
• Increased blood lactate levels: high blood lactate levels in combination with lactic acidosis may be caused by an imbalance of oxygen that is being delivered to the tissues in your body
• Kidney problems. Before starting treatment, your doctor may order blood tests to assess your kidney function and may advise you to take ACRIPTEGA tablets less often. Do not reduce the prescribed dose unless your doctor has told you to do so. Your doctor may also order blood tests during treatment to monitor how your kidneys work
• Bone problems. Some people taking combination medicines for HIV develop a condition called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). You must contact your doctor if you experience joint aches and pain, joint stiffness or difficulty in movement. Talk to your doctor if you suffer from osteoporosis, have a history of bone fracture or if you have problems with your bones. Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells. Tell your doctor if you have bone pain or fractures. Tenofovir disoproxil may also cause loss of bone mass
• Liver problems. If you have liver problems including Hepatitis B virus infection
• Hepatitis B or C. If you have Hepatitis B or C, you are at increased risk for severe and potentially fatal liver adverse reactions
• Opportunistic infections. Signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment such as ACRIPTEGA is started. It is believed 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. If you notice any symptoms of infection, please inform your doctor immediately
• Pancreas disorders. If you develop abdominal pain, nausea, vomiting, contact your doctor as it could indicate problems with your pancreas
• Changes in body fat. Changes in body fat develop in some patients taking ACRIPTEGA. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), in the breasts and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these fat changes are not known
• Depression (including suicidal ideation). Patients should inform their doctor if they notice any symptoms of depression during treatment
• ACRIPTEGA helps to control (treat) HIV infection but is not a cure. You will need to take it every day. You must not stop taking ACRIPTEGA without first talking to your doctor. If you are concerned that you may be developing symptoms of a hypersensitivity reaction, call your doctor immediately who will advise whether you must stop taking ACRIPTEGA. You may continue to develop other infections and other illnesses associated with HIV disease. You should therefore keep in regular contact with your doctor while you are taking ACRIPTEGA
• Treatment with ACRIPTEGA has not been shown to reduce the risk of passing HIV infection to others through sexual contact or contaminated blood. If you are sexually active you should continue to use appropriate precautions to prevent this
• To protect other people from becoming infected with HIV:
• a condom must be used when you have oral or penetrative sex
• blood transfer should be avoided – for example, needles must not be shared. Children and adolescents: Do not give this medicine to children under the age of 18 years

Pregnancy and breastfeeding

• Women of childbearing potential: Women of childbearing potential should be counselled about the potential risk of birth defects of the brain and spine with dolutegravir, including consideration of using effective contraceptive measures
• Perform pregnancy testing before start of ACRIPTEGA in women of childbearing potential to exclude unintentional use of ACRIPTEGA during the first trimester of pregnancy
• If a woman plans pregnancy, the benefits and the risks of starting or continuing treatment with dolutegravir versus using another antiretroviral medicine should be discussed with her
• Pregnancy: Do not take ACRIPTEGA tablets if you are pregnant or breastfeeding (see 2
• What you need to know before you take ACRIPTEGA)
• ACRIPTEGA could seriously harm your unborn child if you fall pregnant while on treatment or if you start taking ACRIPTEGA in the first few weeks of your pregnancy

Interactions and medicines to check

The approved leaflet names these interactions.

• Other medicines that contain tenofovir disoproxil fumarate, lamivudine, dolutegravir or emtricitabine, either alone, or in other formulations. ACRIPTEGA should not be used with these medicines because they contain the same or similar active ingredients as ACRIPTEGA
• Medicines that contain didanosine. Tenofovir disoproxil fumarate (an ingredient in ACRIPTEGA) may cause the amount of didanosine in your blood to increase
• You may need to be followed more carefully if you are taking ACRIPTEGA and didanosine together. The dose of didanosine may need to be reduced
• Adefovir dipivoxil (used for the treatment of chronic hepatitis B)
• Zalcitabine (antiretroviral treatment)
• Trimethoprim, as in co-trimoxazole (an antibiotic), may cause an increase in ACRIPTEGA plasma levels. If you have no kidney disease, a dosage adjustment is not necessary
• Rifampicin (antibiotic used to treat several types of bacteria) may decrease the blood levels of dolutegravir
• Isoniazid (antibiotic used to treat tuberculosis) increased the concentration
• Polyvalent cation-containing antacids. Recommended to be administered 2 hours before or 6 hours after ACRIPTEGA
• Calcium supplements: recommended to be administered 2 hours before or 6 hours after ACRIPTEGA or taken with food
• Iron supplements: recommended to be administered 2 hours before or 6 hours after ACRIPTEGA or taken with food
• Metformin: co-administered with ACRIPTEGA may increase plasma levels of insulin
• Oral contraceptives: ACRIPTEGA does not change the concentration levels of oral contraceptives
• Methadone (a pain killer): ACRIPTEGA does not change the concentration levels of this painkiller. Some patients who are taking ACRIPTEGA may continue to experience infections and the use of antibiotics may have to be considered. ACRIPTEGA with food and drink: ACRIPTEGA can be taken without regard to food

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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