Patient Medication Information: uses, side effects, how to take - Triumeq
Serious warnings and precautions box
What TRIUMEQ is used for:
TRIUMEQ is used to treat HIV (human immunodeficiency virus) infection in adults and adolescents over the age of 12 years and weighing at least 40 kg.
Worsening of hepatitis B virus in people with HIV infection
If you have a hepatitis B infection, you should not stop taking TRIUMEQ without talking to your healthcare professional. If you have to stop taking TRIUMEQ your hepatitis may worsen. Your healthcare professional will monitor the health of your liver for several months after stopping treatment with TRIUMEQ and may give you a new medication to treat your hepatitis B infection.
Serious allergic (hypersensitivity) reactions that can be life threatening
You should be screened for the HLA-B*5701 gene variation before starting or re-starting treatment with TRIUMEQ. Patients with the HLA-B*5701 gene variation have a high risk of developing a serious allergic reaction to abacavir which is one of the medicines in TRIUMEQ. These allergic reactions can be life threatening. Serious allergic reactions have also happened in patients who do not have the HLA-B*5701 gene variation.
If you get two or more of the following groups of symptoms while taking TRIUMEQ, talk to your healthcare professional immediately to find out if you should stop taking TRIUMEQ:
| SYMPTOM(S) | |
|---|---|
| Group 1 | Fever |
| Group 2 | Rash |
| Group 3 | Nausea, vomiting, diarrhea, or abdominal (stomach area) pain |
| Group 4 | Generally ill feeling, extreme tiredness or achiness |
| Group 5 | Shortness of breath, cough or sore throat |
A list of these symptoms is on the Warning Card provided by your pharmacist. You should carry this Warning Card with you at all times. If you notice these symptoms while taking TRIUMEQ, talk to your healthcare professional immediately. Your healthcare professional may tell you to stop taking TRIUMEQ.
If you stop TRIUMEQ because of a serious allergic reaction, never take TRIUMEQ or any other medicine containing abacavir (such as ZIAGEN or KIVEXA) again, regardless of whether you have the HLA-B*5701 gene variation or not. Within hours you may experience a life threatening lowering of your blood pressure or death. If you stop TRIUMEQ for any other reason, even for a few days, and you are not allergic to TRIUMEQ, talk with your healthcare professional before taking it again. Taking TRIUMEQ again may cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.
If your healthcare professional tells you that you can take TRIUMEQ again, start taking it when you are around medical help or people who can call a healthcare professional if you need one.
How TRIUMEQ works:
TRIUMEQ contains three medicines that are used to treat HIV infection: dolutegravir, abacavir, and lamivudine. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs). Abacavir and lamivudine belong to a group of anti-retroviral medicines called nucleoside analogues reverse transcriptase inhibitors (NRTIs).
These medicines work to keep the amount of virus in your body, at a low level. This helps maintain the number of CD4+ cells in your blood. CD4+ cells are a type of white blood cell that are important in helping your body fight infection. TRIUMEQ does not cure HIV infection.
The ingredients in TRIUMEQ are:
Medicinal ingredients: dolutegravir (as dolutegravir sodium), abacavir (as abacavir sulfate), lamivudine
Non-medicinal ingredients: D-mannitol, iron oxide black, iron oxide red, macrogol/PEG, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol–part hydrolyzed, povidone K29/32, sodium starch glycolate, talc, titanium dioxide.
TRIUMEQ comes in the following dosage form:
50 mg dolutegravir / 600 mg abacavir / 300 mg lamivudine fixed dose combination tablets.
Do not use TRIUMEQ if:
- you are allergic (hypersensitive) to dolutegravir, abacavir or lamivudine, or any of the non-medicinal ingredients in TRIUMEQ (see The ingredients in TRIUMEQ are:)
- you have the HLA-B*5701 gene variation
you are taking any of these medicines:
- dofetilide, to treat heart conditions
- fampridine (also known as dalfampridine), to treat multiple sclerosis
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRIUMEQ. Talk about any health conditions or problems you may have, including if you:
- have used any medicine of the NRTI class before
- have ever had a mental health problem
- have had kidney problems
- have had liver problems, including hepatitis B or C infection
- have ever had a severe skin rash or allergic reaction to dolutegravir, abacavir or lamivudine
- have ever had high levels of acid in your blood (lactic acidosis)
- have ever had an increase in your blood sugar (glucose) or levels of fats (lipids) in your blood
- have symptoms of an infection or inflammation. These may flare up while you are on HIV treatment, or you may have even stronger reactions to new infections than normal.
Other warnings you should know about:
Liver problems: Serious liver problems including liver injury and liver failure have been seen in people taking medicines containing dolutegravir (see the Serious side effects and what to do about them table). In some cases the liver injury has led to liver transplant. While you are being treated with TRIUMEQ your healthcare professional will monitor you closely for any signs of liver problems.
Heart attack: Abacavir, one of the ingredients in TRIUMEQ, may increase your risk of heart attack. If you have heart problems, smoke or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol or diabetes, tell your healthcare professional.
Immune Reconstitution Inflammatory Syndrome: Changes to your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
Autoimmune disorders can also happen. This is when the immune system attacks healthy body tissue. Examples of this include Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), polymyositis (which affects the muscles), or autoimmune hepatitis (which affects the liver). Autoimmune disorders may occur many months after the start of treatment.
Pregnancy and Breastfeeding:
- Tell your healthcare professional if you are pregnant, or plan to become pregnant. Your healthcare professional will consider the benefit to you and the risk to your baby when taking TRIUMEQ while you are pregnant.
- There is a pregnancy registry for women who take antiretroviral medicines while they are pregnant. The purpose of this registry is to collect information about the health of you and your baby. If you do become pregnant while taking TRIUMEQ, talk to your healthcare professional about taking part in this registry.
- In babies and infants whose mothers took TRIUMEQ during pregnancy or labour, small temporary increases in blood levels of a substance called lactate have been seen. There have also been very rare reports of problems that affect the nervous system such as delayed development and seizures.
- Talk to your healthcare professional if you are breastfeeding or plan to breastfeed. Women who are HIV positive should not breastfeed because HIV infection can be passed to the baby through breast milk. TRIUMEQ can also pass into breast milk and harm your baby. Talk to your healthcare professional about how to feed your baby.
Blood tests and monitoring: You will need extra check-ups, including blood tests, while you are taking TRIUMEQ. Your healthcare professional will arrange regular blood tests to check for side effects.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TRIUMEQ:
- metformin, to treat diabetes
medicines that contain aluminum and/or calcium carbonate, magnesium or buffered medicines such as certain antacids, to treat indigestion and heartburn or certain laxatives to treat constipation:
- Taking antacids or laxatives can stop TRIUMEQ from being absorbed into your body and affect how well it works.
- TRIUMEQ should be taken at least 2 hours before or 6 hours after you take an antacid.
calcium or iron supplements (non-antacids):
- Taking these supplements at the same time as TRIUMEQ can stop TRIUMEQ from being absorbed into your body and affect how well it works.
Supplements containing calcium or iron can be taken at the same time as TRIUMEQ if you take them both with food.
Otherwise, TRIUMEQ should be taken at least 2 hours before or 6 hours after you take
- these supplements.
- etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine), or tipranavir/ritonavir to treat HIV infection
- rifampin, to treat tuberculosis (TB) and other bacterial infections
- phenytoin and phenobarbital, to treat epilepsy
- oxcarbazepine and carbamazepine, to treat epilepsy and bipolar disorder
- St. John’s wort (Hypericum perforatum), a herbal remedy to treat depression
- retinoids, to treat skin conditions
- riociguat, to treat high blood pressure in the lungs
- trimethoprim/sulphamethoxazole (co-trimoxazole), an antibiotic to treat infections
- sorbitol-containing medicines (usually liquids) used regularly
- medicines that already contain abacavir, lamivudine or emtricitabine such as 3TC, COMBIVIR, ZIAGEN, KIVEXA, TRUVADA, COMPLERA, EMTRIVA and STRIBILD
- methadone, to treat pain and drug addiction. Your healthcare professional may need to adjust your methadone dose.
How to take TRIUMEQ:
Always take TRIUMEQ exactly as your healthcare professional has told you to.
Check with your healthcare professional if you're not sure.
- You can take TRIUMEQ with or without food.
- Swallow the tablet whole with some liquid.
Usual dose:
The usual dose is one tablet once a day.
Take TRIUMEQ for as long as your healthcare professional recommends. Don’t stop unless your healthcare professional tells you to.
Overdose:
If you think you, or a person you are caring for, have taken too much TRIUMEQ, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss a dose, take it as soon as you remember. If your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. Don’t take a double dose to make up for a missed dose.
If you stopped taking TRIUMEQ:
If you stop taking TRIUMEQ for any reason, you must talk to your healthcare professional before restarting to make sure that symptoms of an allergic (hypersensitivity) reaction have not been missed. In some cases your healthcare professional will ask you to restart TRIUMEQ under direct medical supervision or in a place where you will be able to get ready access to medical care if needed.
Possible side effects from using TRIUMEQ:
These are not all the possible side effects you may feel when taking TRIUMEQ. If you experience any side effects not listed here, tell your healthcare professional.
Side effects include:
- nausea, vomiting, diarrhea, abdominal pain and bloating, gas
- stomach discomfort
- loss of appetite
- weight gain
- headache
- fever
- fatigue, unusual lack of energy
- trouble sleeping
- abnormal dreams
- hair loss
- joint and muscle pain
- dizziness
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Common | |||||
| Serious allergic reaction (Hypersensitivity reaction) to abacavir, 2 or more of the following symptoms: fever, skin rash, nausea, vomiting, diarrhea, abdominal pain, severe tiredness, achiness, general ill-feeling, sore throat, shortness of breath | ✓ | ||||
| Uncommon | |||||
| Hypersensitivity reaction: skin rash, fever, lack of energy, swelling of the mouth or face causing difficulty in swallowing or breathing, muscle or joint aches | ✓ | ||||
| Liver problems: high liver blood test results, nausea, vomiting, loss of appetite, swelling, pain, aching or tenderness on the right side below the ribs, yellowing of the skin or whites of the eyes (jaundice), dark or tea coloured urine, pale coloured stool, unusual tiredness | ✓ | ||||
Blood problems (low red or white blood cells or platelets): low red blood cell count: paleness of the skin, fatigue, rapid heart rate, shortness of breath low white blood cell count: (fever and symptoms of infection such as cough) low platelet count bruising easily, heavy bleeding increases in enzymes produced by the muscles or kidneys muscle pain and stiffness, dark urine, fatigue | ✓ | ||||
| Mental health problems: depression, feelings of sadness or unworthiness, suicidal thoughts (thoughts of hurting yourself) and behaviors (trying to hurt yourself), anxiety, feelings of worry, nervousness or unease | ✓ | ||||
| Rare | |||||
| Liver failure: yellowing of the skin or whites of the eyes (jaundice), bleeding easily, swollen abdomen, mental disorientation or confusion, sleepiness, coma | ✓ | ||||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | ✓ | ||||
| Lactic acidosis (too much lactic acid in the blood): weight loss, fatigue, malaise, loss of appetite, unusual muscle pain, feeling dizzy or lightheaded, fast or irregular heartbeat, shortness of breath, feeling unusually cold, especially in arms and legs, severe hepatomegaly (swollen and enlarged liver) with symptoms of | ✓ | ||||
| liver problems such as nausea, vomiting, abdominal pain, weakness and diarrhea | |||||
| Very Rare | |||||
| Severe skin reactions [erythema multiforme, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)]: severe rash, itching, fever, swollen lymph glands, flu-like feeling, blisters and peeling of skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine | ✓ | ||||
| Unknown | |||||
| Immune reconstitution inflammatory syndrome and Autoimmune disorders: fever, redness, rash or swelling, fatigue, joint or muscle pain, numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, chest pain or rapid heart rate, yellowing of the eyes and skin, anxiety and irritability accompanied by tremor of your hands or fingers, muscle weakness in your hips, thighs, shoulders, upper arms and neck | ✓ | ||||
| Heart attack: pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, nausea, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | ✓ | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store TRIUMEQ in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not remove the silica gel desiccant. Store up to 30˚C.
Keep out of reach and sight of children.
If you want more information about TRIUMEQ:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.viivhealthcare.com, or by calling 1-877-393-8448.
Date of Authorization: 2025-10-24
©2025 ViiV Healthcare group of companies or its licensor
Trademarks are owned by or licensed to the ViiV Healthcare group of companies
TRUVADA, COMPLERA and STRIBILD are registered trademarks of Gilead Sciences Ireland UC.
ATRIPLA is a registered trademark of Bristol-Myers Squibb and Gilead Sciences, LLC.
EMTRIVA is a registered trademark of Gilead Sciences, Inc.
ADEMPAS is a registered trademark of Bayer Inc.
INFORMATION FOR HEALTHCARE PROFESSIONALS
A copy of the warning card included with the TRIUMEQ carton is shown below.
Warning Card: Carry at all times
TRIUMEQ (dolutegravir, abacavir, and lamivudine) tablets
Patients may develop a serious allergic (hypersensitivity) reaction which can be life threatening if you continue to take TRIUMEQ. If you notice 2 or more sets of symptoms, talk to your healthcare professional immediately to see if you should stop TRIUMEQ:
| SYMPTOM(S) | |
|---|---|
| Group 1 | Fever |
| Group 2 | Rash |
| Group 3 | Nausea, vomiting, diarrhea, or abdominal (stomach area) pain |
| Group 4 | Generally ill feeling, extreme tiredness or achiness |
| Group 5 | Shortness of breath, cough or sore throat |
If you have already had this type of reaction to TRIUMEQ, never take any medicine containing abacavir, such as KIVEXA (abacavir / lamivudine) or ZIAGEN (abacavir) again. If you take any medicine containing abacavir, such as TRIUMEQ, KIVEXA or ZIAGEN again, within hours you may experience a life threatening lowering of your blood pressure or death.
Return all unused TRIUMEQ to your healthcare professionals for proper disposal.
Questions/Concerns/problèmes?
ViiV Healthcare ULC/ ViiV Soins de santé ULC www.viivhealthcare.ca