50 mg/600 mg/300 mg film-coated tablets
dolutegravir/abacavir/lamivudine
What Triumeq is and what it is used for
Triumeq is a medicine that contains three active substances used to treat HIV infection: abacavir, lamivudine, and dolutegravir. Abacavir and lamivudine belong to a group of antiretroviral medicines called nucleoside analog reverse transcriptase inhibitors (NRTIs) and dolutegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INIs).
Triumeq is used to treat HIV infection ( HIV = human immunodeficiency virus) in adults and children over the age of 12 who weigh at least 40 kg.
Before your doctor prescribes Triumeq, you will be tested to see if you have a certain type of gene called HLA B*5701. Carriers of the HLA B*5701 gene should not be treated with Triumeq. Patients with this gene are at greater risk of developing a serious hypersensitivity reaction ( allergic reaction ) if they use Triumeq (see “Hypersensitivity reactions” in section 4).
Triumeq does not cure HIV infection, but it reduces the amount of virus in the body and keeps it at a low level. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that is important for the body’s ability to fight infection.
Not everyone reacts to treatment with Triumeq in the same way. Your doctor will check how effective the treatment is for you.
What you need to know before you take Triumeq
Do not take Triumeq
- if you are allergic ( hypersensitive ) to dolutegravir, abacavir (or any other medicine containing abacavir) or lamivudine, or to any of the other ingredients of this medicine (listed in section 6). Read all information about hypersensitivity reactions in Section 4 carefully.
- if you are taking another medicine called fampridine (also called dalfampridine; used in multiple sclerosis ).
- If you think any of these apply to you, tell your doctor.
Warnings and precautions
IMPORTANT – Hypersensitivity reaction er
Triumeq contains abacavir and dolutegravir. Both of these active substances can cause a serious allergic reaction, a so-called hypersensitivity reaction. You should never take abacavir or medicines containing abacavir again if you have had a hypersensitivity reaction: it can be life-threatening.
You must read all the information under “Hypersensitivity reactions” in the text box in section 4 carefully.
On the packaging of Triumeq, there is a Warning card to alert you and the healthcare staff about hypersensitivity. Detach this card and carry it with you at all times.
Some people taking Triumeq or other combination HIV treatments are at greater risk of serious side effects than others. You need to be aware of these additional risks:
- if you have moderate or severe liver disease
- if you have previously had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Triumeq without consulting a doctor, as hepatitis A may come back)
- if you have kidney problems.
- If any of these apply to you, talk to your doctor before taking Triumeq. You may need extra checks, including blood tests, while you are taking the medicine. See section 4 for more information.
Hypersensitivity reaction to abacavir
Even patients who do not have the HLA B*5701 gene can develop a hypersensitivity reaction (a severe allergic reaction ).
- Read all information about hypersensitivity reactions in section 4 of this leaflet carefully.
Risk of heart attack
The possibility that abacavir increases the risk of having a heart attack cannot be ruled out.
- Tell your doctor if you have heart problems if you smoke, or have other diseases that can increase your risks of heart diseases, such as high blood pressure or diabetes. Do not stop taking Triumeq unless your doctor advises you to do so.
Pay attention to important symptoms
Some people who take medicines for HIV infection develop other conditions, which can be serious. These are:
- symptoms of infection and inflammation
- joint pain, stiffness, and bone problems.
You need to know the important signs and symptoms to look out for while taking Triumeq.
- Read the information under “Other possible side effects of combination therapy against HIV” in section 4 of this leaflet.
Children
This medicine must not be given to children under 12 years of age. The use of Triumeq in children under 12 years of age has not yet been studied.
Other medicines and Triumeq
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Triumeq together with the following medicines:
- fampridine (also called dalfampridine), is used to treat multiple sclerosis.
Some medicines can affect how Triumeq works, or increase the risk of side effects. Triumeq can also affect how some other medicines work.
Tell your doctor if you are taking any medicine in the following list:
- metformin, for the treatment of diabetes
- so-called antacids (acid neutralizers), medicines for indigestion and heartburn. Do not take antacids for 6 hours before taking Triumeq, or for the next 2 hours after taking Triumeq (see also section 3).
- dietary supplements or multivitamins containing calcium, iron, or magnesium. If you take Triumeq with food, you can take dietary supplements or multivitamins containing calcium, iron, or magnesium at the same time as Triumeq. If you do not take Triumeq with food, do not take dietary supplements or multivitamins containing calcium, iron, or magnesium within 6 hours before taking Triumeq, or in the next 2 hours after taking Triumeq (see also section 3).
- emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, for the treatment of HIV infection
- medicines (usual liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol, and maltitol), if taken regularly
- other medicines containing lamivudine for the treatment of HIV infection or hepatitis B infection
- cladribine used to treat hairy cell leukemia
- rifampicin, to treat tuberculosis (TB) and other bacterial infections
- trimethoprim/sulfamethoxazole, an antibiotic used to treat bacterial infections
- phenytoin and phenobarbital, for the treatment of epilepsy
- oxcarbazepine and carbamazepine, for the treatment of epilepsy and bipolar disorder
- St. John’s wort ( Hypericum perforatum ), is a herbal remedy for mild depression and mild anxiety.
- methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will be monitored for withdrawal symptoms. The methadone dose may need to be changed.
- riociguat, to treat high blood pressure in the blood vessels (pulmonary arteries) that carry blood from the heart to the lungs. Your doctor may need to lower your riociguat dose because abacavir can increase riociguat blood levels.
- Tell your doctor or pharmacist if you are taking any of these medicines. The doctor may decide that the dose needs to be changed or that you need to go for more checks.
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby:
- Talk to your doctor about the risks and benefits of taking Triumeq.
Taking Triumeq at the time of conception or during the first six weeks of pregnancy may increase the risk of a type of malformation called a neural tube defect, e.g. spina bifida (deformed spinal cord).
If you could become pregnant while receiving Triumeq:
- Talk to your doctor and discuss whether you need to use contraception, for example, condoms or birth control pills.
Tell your doctor immediately if you become pregnant or plan to become pregnant. Your doctor will review your treatment. Do not stop taking Triumeq without talking to your doctor as this may harm you and your unborn baby.
Breast-feeding
Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.
A small amount of the ingredients in Triumeq can also pass into breast milk
If you are breastfeeding or thinking about starting to breastfeed, discuss this with your doctor as soon as possible.
Driving ability and use of machinery
Triumeq can make you dizzy and have other side effects that reduce your attention.
- Do not drive or operate machinery unless you are sure that your attention has not been affected.
Important information about the contents of Triumeq tablets
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Triumeq
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- The usual dose is one tablet once daily.
Swallow the tablet with some liquid. Triumeq can be taken with or without food.
Do not take antacids within 6 hours before taking Triumeq, or in the next 2 hours after taking Triumeq. Other antacids such as ranitidine and omeprazole can be taken at the same time as Triumeq.
- Talk to your doctor for more information about antacids with Triumeq.
If you take Triumeq with food, you can take dietary supplements or multivitamins containing calcium, iron, or magnesium at the same time as Triumeq. If you do not take Triumeq with food, do not take dietary supplements or multivitamins containing calcium, iron, or magnesium within 6 hours before taking Triumeq, or in the next 2 hours after taking Triumeq.
- Talk to your doctor for more advice about taking supplements or multivitamins containing calcium, iron, or magnesium with Triumeq.
Use for children and adolescents
Children and young people between the ages of 12 and 17 who weigh at least 40 kg can take the adult dose, i.e. one tablet once daily.
If you have taken too much Triumeq
If you take too many Triumeq tablets, contact your doctor or pharmacist for advice. If possible, show them the Triumeq packaging.
If you forget to take Triumeq
If you have forgotten a dose, take it as soon as you remember. If it is time for the next dose within 4 hours, however, you should skip the dose you missed and take the next dose at the usual time. Then continue with your treatment as before.
- Do not take a double dose to make up for a missed dose.
If you have stopped taking Triumeq
If you have stopped taking Triumeq for any reason – especially if the reason is that you think you have a side effect or because you have another illness:
Talk to your doctor before you start taking the medicine again. The doctor will investigate whether your symptoms were due to a hypersensitivity reaction. If the doctor thinks there is a connection between your symptoms and a hypersensitivity reaction, you will be told not to take Triumeq or any other medicine containing abacavir or dolutegravir ever again. You must follow this advice.
If your doctor advises you to start taking Triumeq again, you may be told to take the first doses in a place where you have immediate access to medical care if needed.
Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When you are being treated for HIV, it can be difficult to determine whether a symptom is a side effect of Triumeq or other medicines you are taking, or whether it is due to the HIV infection itself. Therefore, you must talk to your doctor if your health changes in any way.
Abacavir can cause a hypersensitivity reaction (a severe allergic reaction ), especially in people who have a particular type of gene called HLA-B*5701. Even patients who do not have the HLA‑B*5701 gene can develop a hypersensitivity reaction as described in this leaflet under the heading “Hypersensitivity reactions”. You must read and understand the information about this serious reaction.
In addition to the side effects mentioned below for Triumeq, other conditions may develop during combination anti-HIV therapy.
You must read the information in this section under “Other possible side effects during combination treatment against HIV”.
Hypersensitivity reaction
Triumeq contains abacavir and dolutegravir. Both of these active substances can cause a serious allergic reaction, a so-called hypersensitivity reaction.
Such hypersensitivity reactions are more common in people taking medicines containing abacavir.
Who gets these reactions?
Anyone taking Triumeq can develop a hypersensitivity reaction, which can be life-threatening if they continue to take Triumeq.
You are more likely to develop this reaction if you have a gene called HLA B*5701 (but you can react even if you do not have this gene). You should have been tested for this gene before being prescribed Triumeq. If you know you have this gene, tell your doctor.
What are the symptoms?
The most common symptoms are:
- fever (high body temperature) and skin rash.
Other common symptoms are:
- nausea, vomiting, diarrhea, abdominal (stomach) pains, and pronounced fatigue.
Other symptoms are:
- joint or muscle pain, swollen throat, shortness of breath, sore throat, cough, temporary headache, inflammation of the eye ( conjunctivitis ), mouth sores, low blood pressure, tingling, and numbness in the hands and feet.
When do these reactions occur?
Hypersensitivity reactions can occur at any time during treatment with Triumeq but are more likely during the first 6 weeks of treatment.
Contact your doctor immediately:
1. if you get a rash OR
2. if you get symptoms from at least 2 of the following groups:
- fever
- shortness of breath, sore throat, or cough
- nausea or vomiting, diarrhea or abdominal pain
- pronounced fatigue or aches and pains or general malaise.
Your doctor may advise you to stop taking Triumeq.
If you have stopped taking Triumeq
If you have stopped taking Triumeq because of a hypersensitivity reaction, you must NEVER AGAIN take Triumeq, or any other medicine containing abacavir. If you do, you can develop dangerously low blood pressure within hours, which can lead to death. You should also never take any medicine that contains dolutegravir.
If you have stopped taking Triumeq for any reason – especially if the reason is that you think you have a side effect or because of another illness:
Talk to your doctor before you start taking the medicine again. The doctor will investigate whether your symptoms were due to a hypersensitivity reaction. If the doctor thinks there is a connection, you will be told not to take Triumeq or any other medicine containing abacavir ever again. You may also be told not to take any other medicine containing dolutegravir ever again. You must follow this advice.
Occasionally, hypersensitivity reactions have developed in people who restarted an abacavir-containing medicine but had only one of the symptoms on the Warning Card before they stopped taking it.
In very rare cases, patients who previously took medicines containing abacavir and who had no symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
If your doctor advises you to start taking Triumeq again, you may be told to take the first doses in a place where you have immediate access to medical care if needed.
If you are allergic to Triumeq, you should return any remaining Triumeq tablets for safe disposal. Consult a doctor or pharmacist.
On the packaging of Triumeq, there is a Warning card to alert you and the healthcare staff about hypersensitivity. Detach this card and carry it with you at all times.
Very common side effects are
These may occur in more than 1 in 10 people :
- headache
- diarrhea
- nausea
- sleep difficulties ( insomnia )
- lack of energy ( powerlessness ).
Common side effects are
These may occur in up to 1 in 10 people :
- hypersensitivity reaction ( see “Hypersensitivity reactions” earlier in this section )
- loss of appetite
- rash
- itching ( pruritus )
- vomiting
- stomach pain
- stomach upset
- indigestion
- flatulence ( flatulence )
- dizziness
- abnormal dreams
- nightmares
- depression (feelings of deep sadness and worthlessness)
- concern
- fatigue
- drowsiness
- fever ( high body temperature )
- cough
- irritated or runny nose
- hair loss
- pain and discomfort in muscles
- joint pain
- feeling of weakness
- general malaise.
Common side effects that can show up in blood tests are:
- elevated liver enzyme levels.
Less common side effects are
These may occur in up to 1 in 100 people :
- inflammation of the liver ( hepatitis )
- suicidal thoughts and behavior (especially in patients who previously had depression or mental problems)
- panic attack.
Less common side effects that can show up in blood tests are:
- reduced number of cells that participate in blood coagulation ( thrombocytopenia )
- the low number of red blood cells ( anemia ) or a low number of white blood cells ( neutropenia )
- increased level of sugar ( glucose ) in the blood
- increased levels of triglycerides (type of fat) in the blood.
Rare side effects are
These may occur in up to 1 in 1,000 people :
- inflammation of the pancreas ( pancreatitis )
- breakdown of muscle tissue
- liver failure (signs of this may be yellowing of the skin and whites of the eyes, or unusually dark urine)
- suicide (especially in patients who previously had depression or mental problems).
→ Talk to your doctor immediately if you experience mental health problems (see also other mental health problems above).
Rare side effects that can show up in blood tests are:
- increased levels of bilirubin (a test of liver function) in your blood
- elevated levels of an enzyme called amylase.
Very rare side effects
These may occur in up to 1 in 10,000 people :
- numbness and tingling in the skin
- the feeling of weakness in arms and legs
- skin rash, which may blister and look like small targets (dark spot in the center of a lighter area surrounded by a dark ring) ( erythema multiforme )
- a widespread skin rash with blisters and scaly skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), and a more severe form that causes skin peeling on more than 30% of the body surface ( toxic epidermal necrolysis )
- lactic acidosis (excess lactic acid in the blood)
Very rare side effects that can show up in blood tests are:
- the inability of the bone marrow to form new red blood cells ( pure erythrocyte aplasia ).
If you get a side effect ar
- Talk to your doctor. This also applies to side effects that are not mentioned in this information.
Other possible side effects are with combination treatment against HIV
Combination therapy such as Triumeq can cause other conditions to develop during HIV treatment.
Symptoms of infection and inflammation
People with advanced HIV infection ( AIDS ) have a weak immune system and the risk is greater that they will get serious infections ( opportunistic infections ). Such infections may have been “silent” and not detected by the weak immune system before treatment began. Once treatment has started, the immune system becomes stronger and can fight infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever and any of the following:
- headache
- gripe
- breathing difficulties.
In rare cases, when the immune system becomes stronger, it can also attack healthy body tissue ( autoimmune diseases ). The symptoms of autoimmune diseases can develop several months after you start taking medicines for your HIV infection. Symptoms may include:
- palpitations (fast or irregular heartbeats) or tremors
- hyperactivity (excessive restlessness and excessive movements)
- weakness that starts in the hands and feet and moves up the trunk.
If you develop symptoms of an infection and inflammation or if you notice any of the symptoms mentioned above:
- Talk to your doctor immediately. Do not take other anti-infection medicines unless the doctor has recommended them.
Joint pain, stiffness, and bone problems
Some people take combination anti-HIV therapy to develop a condition called osteonecrosis. Osteonecrosis means that parts of the bone tissue die because the blood supply to the bone is reduced. The risk of being affected by this increases if:
- the combination treatment has been going on for a long time
- anti-inflammatory medicines called corticosteroids are taken at the same time
- you drink alcohol
- the immune system is very weak
- you are overweight.
Signs of osteonecrosis are:
- stiffness in the joints
- aches and pains (especially in the hips, knees, or shoulders)
- difficulty moving.
If you get any of these symptoms:
- Tell your doctor about it.
How to store Triumeq
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and can after “EXP”.
Store in the original packaging. Moisture sensitive. Keep the jar tightly closed. Do not remove the desiccant.
No special temperature instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are dolutegravir, abacavir and lamivudine. Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir, 600 mg abacavir (as sulfate), and 300 mg lamivudine.
- Other ingredients are mannitol (E421), microcrystalline cellulose, povidone, K29/32, sodium starch glycolate, magnesium stearate, poly(vinyl) alcohol – partially hydrolyzed, titanium dioxide, macrogol/PEG, talc, black iron oxide, and red iron oxide.
Appearance and package sizes of the medicine
Triumeq film-coated tablets are purple, biconvex, oval, and debossed with “572 Tri” on one side.
The film-coated tablets are available in cans of 30 tablets.
The jar contains a desiccant to reduce moisture. Once the can has been opened, the desiccant should be left in the can, do not take it out.
There are also multipacks of 90 film-coated tablets (3 packs of 30 film-coated tablets). Not all pack sizes may be available in your country.
Marketing Authorisation Holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, The Netherlands
Manufacturer
Glaxo Wellcome, SA, Avda. Extremadura 3, 09400 Aranda De Duero, Burgos, Spain
OR
Delpharm Poznań Spółka Akcyjna ul. Grunwaldzka 189, 60-322 Poznan, Poland
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienViiV Healthcare srl/bvTel/Tel: + 32 (0) 10 85 65 00 | LithuaniaViiV Healthcare BVPhone: + 370 80000334 |
| BulgariaViiV Healthcare BVTel.: + 359 80018205 | Luxembourg/LuxembourgViiV Healthcare srl/bvBelgique/BelgiumTel/Tel: + 32 (0) 10 85 65 00 |
| Czech RepublicGlaxoSmithKline, Serophene: + 420 222 001 111cz.info@gsk.com | MagyarországViiV Healthcare BVTel.: + 36 80088309 |
| DenmarkGlaxoSmithKline Pharma A/SPhone: + 45 36 35 91 00dk-info@gsk.com | MaltaViiV Healthcare BVPhone: + 356 80065004 |
| DeutschlandViiV Healthcare GmbHTel.: + 49 (0)89 203 0038-10viiv.med.info@viivhealthcare.com | The NetherlandsViiV Healthcare BVPhone: + 31 (0)33 2081199 |
| EstoniaViiV Healthcare BVPhone: + 372 8002640 | NorwayGlaxoSmithKline iPhone: + 47 22 70 20 00 |
| GreeceGlaxoSmithKline Μονοπροσωπη AEBETel: + 30 210 68 82 100 | AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0)1 97075 0at.info@gsk.com |
| SpainLaboratorios ViiV Healthcare, SLPhone: + 34 900 923 501 es-ci@viivhealthcare.com | PolishGSK Services Sp. z o. oTel.: + 48 (0)22 576 9000 |
| FranceViiV Healthcare SASTel.: + 33 (0)1 39 17 69 69Infomed@viivhealthcare.com | PortugalVIIVHIV HEALTHCARE, UNIPESSOAL, LDAPhone: + 351 21 094 08 01viiv.fi.pt@viivhealthcare.com |
| HrvatskaViiV Healthcare BVPhone: + 385 800787089 | RomaniaViiV Healthcare BVPhone: + 40 800672524 |
| IrelandGlaxoSmithKline (Ireland) LimitedPhone: + 353 (0)1 4955000 | SlovenijaViiV Healthcare BVPhone: + 386 80688869 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicViiV Healthcare BVPhone: + 421 800500589 |
| ItalyViiV Healthcare SrlPhone: + 39 (0)45 9212611 | Finland/FinlandGlaxoSmithKline OyPhone/Tel: + 358 (0)10 30 30 30 |
| CyprusViiV Healthcare BVTel: + 357 80070017 | SwedenGlaxoSmithKline ABPhone: + 46 (0)8 638 93 00info.produkt@gsk.com |
| LatviaViiV Healthcare BVPhone: + 371 80205045 | United Kingdom (Northern Ireland)ViiV Healthcare BVPhone: + 44 (0)800 221441customercontactuk@gsk.com |