Patient Medication Information: uses, side effects, how to take - Tivicay (Viiv Healthcare, 50 mg, 5 mg)
What TIVICAY is used for:
TIVICAY is used for treatment of HIV-1 (Human Immunodeficiency Virus) infection in adults and children 4 weeks and older and weighing at least 3 kg.
TIVICAY is a type of anti-HIV medicine called an integrase inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
TIVICAY is used in combination with other anti-HIV medicines. To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your healthcare professional tells you otherwise.
How TIVICAY works:
TIVICAY blocks an enzyme which the virus (HIV) needs in order to make more virus. The enzyme that TIVICAY blocks is called HIV integrase. This helps control HIV infection.
When used with other anti-HIV medicines, TIVICAY may do two things:
- 1.
It may reduce the amount of HIV in your blood. This is called your “viral load”. -Reducing the amount of HIV in the blood may keep your immune system healthy.
-This in turn, can help your immune system to fight infection.
- 2. It may also increase the number of white blood cells, called CD4 (T) cells, that help fight the virus (HIV).
The ingredients in TIVICAY are:
Medicinal ingredients: dolutegravir (as dolutegravir sodium)
Non-medicinal ingredients:
TIVICAY tablets: D-mannitol, iron oxide yellow (25 mg and 50 mg tablets only), macrogol/PEG, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, sodium stearyl fumarate, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide.
TIVICAY dispersible tablets: Calcium sulfate dihydrate, crospovidone, hypromellose, mannitol, microcrystalline cellulose, polyethylene glycol, povidone K29/32, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, strawberry cream flavor, sucralose, titanium dioxide.
TIVICAY comes in the following dosage forms:
dispersible tablets: 5 mg
film-coated tablets: 10 mg, 25 mg, 50 mg
Do not use TIVICAY if:
- you are allergic to dolutegravir or any of the other ingredients in TIVICAY (see The ingredients in TIVICAY are)
- you are taking dofetilide to treat heart conditions, or 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 TIVICAY. Talk about any health conditions or problems you may have, including if you:
- have liver problems, including hepatitis B or C
- have a history of depression or other mental health problems
- have any other medical condition
Other warnings you should know about:
Serious Liver Problems: Serious liver problems including liver injury and liver failure have been seen in patients taking medicines containing dolutegravir. In some cases the liver injury has led to a liver transplant. While you are being treated with TIVICAY your healthcare professional will monitor you closely for any signs of liver problems. See the Serious side effects and what to do about them table, below for information on this and other serious side effects.
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 TIVICAY while you are pregnant.
- If you take TIVICAY while you are pregnant, talk to your healthcare professional about enrolling in the Antiretroviral Pregnancy Registry.
- 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 pass into breastmilk. A small amount of the ingredients in TIVICAY can also pass into your breast milk. You should not breastfeed while you are taking TIVICAY.
Immune System Changes:
- Changes to your immune system, called Immune Reconstitution Inflammatory Syndrome, can happen when you start taking medicines for HIV infection. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
- Autoimmune disorders, when the immune system attacks healthy body tissue, can also happen after you start taking medicines for HIV infection. 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 can happen many months after you start taking TIVICAY.
- See the Serious side effects and what to do about them table, below for more information on these and other serious side effects.
Blood Tests: TIVICAY can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Diving and Using Machines: Use caution when driving and using machines until you know how you respond to TIVICAY.
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 TIVICAY:
- metformin, to treat diabetes
- medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it.
calcium and iron supplements. Do not take a calcium or iron supplement during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. If you take TIVICAY with food, you can take a calcium or iron supplement at the same time as TIVICAY.
- 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
How to take TIVICAY:
Always take TIVICAY exactly as your healthcare professional has told you to. Check with your healthcare professional if you're not sure. Do not change your dose, switch from one tablet type to another, or stop taking TIVICAY without talking with your healthcare professional.
TIVICAY tablets and TIVICAY dispersible tablets can be taken with or without food.
TIVICAY tablets and TIVICAY dispersible tablets are not the same and cannot be substituted for each other. Your healthcare professional will decide which type of tablet is right for you.
Be sure to keep a supply of your anti-HIV medicines. When your TIVICAY supply starts to run low, get more from your healthcare professional or pharmacy. Do not wait until your medicine runs out to get more.
Usual dose:
Adults:
TIVICAY tablets:
- The usual dose is one 50 mg tablet, once a day.
- For adults with HIV infection that is resistant to other HIV medicines similar to TIVICAY, the usual dose is one 50 mg tablet, twice a day.
TIVICAY dispersible tablets:
- The usual dose is 30 mg, taken as 6 dispersible tablets, once a day.
- For adults with HIV infection that is resistant to other HIV medicines similar to TIVICAY, the usual dose is 30 mg, taken as 6 dispersible tablets, twice a day.
Children 4 weeks of age and older and weighing at least 3 kg: Your healthcare professional will decide on the correct dose of TIVICAY for your child, depending on the age and weight of the child.
The tablet(s) should be swallowed whole with some liquid. To reduce the risk of choking, do not let your child swallow more than one tablet at a time. If your child is unable to swallow the tablet(s), dispersible tablets should be used.
The dispersible tablets may be swallowed whole with drinking water or dispersed (dissolved) in drinking water. When swallowed whole, children should not swallow more than one dispersible tablet at a time to reduce the risk of choking. When dispersed, the amount of water will depend on the number of tablets to be taken. The tablet(s) should be fully dispersed before swallowing. Do not chew, cut or crush the tablet(s). Refer to the Instructions for Use.
Children should see their healthcare professional regularly because their TIVICAY dose may change as they get older or gain weight.
Antacid medicines
Antacids, to treat indigestion and heartburn, can stop TIVICAY from being absorbed into your body and make it less effective.
Do not take an antacid during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as TIVICAY. Talk to your healthcare professional for further advice on taking acid-lowering medicines with TIVICAY.
Calcium or iron supplements
Calcium or iron supplements can stop TIVICAY from being absorbed into your body and make it less effective.
Do not take a calcium or iron supplement during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. If you take TIVICAY with food, then you can take calcium and iron supplements at the same time as TIVICAY.
Overdose:
If you think you, or a person you are caring for, have taken too much TIVICAY, 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, but 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. DO NOT take a double dose of your medicine to make up for a missed dose.
Possible side effects from using TIVICAY:
These are not all the possible side effects you may have when taking TIVICAY. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- diarrhea
- headache
- trouble sleeping (insomnia), abnormal dreams
- nausea, vomiting
- stomach pain, stomach discomfort
- gas
- lack of energy (fatigue)
- rash
- itching
- joint pain, muscle pain
- weight gain
- 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 | |||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Uncommon | |||||
Allergic reaction: skin rash, fever, lack of energy, swelling of the mouth or face causing difficulty in breathing, muscle or joint aches | ✓ | ||||
| Liver problems (Hepatitis): nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs, yellowing of the skin or whites of the eyes, dark or tea coloured urine, pale coloured stools/ bowel movements | ✓ | ||||
| Mental health problems: depression (feelings of deep sadness and unworthiness, lack of interest in activities, fatigue, loss of appetite), anxiety, suicidal thoughts and behaviours | ✓ | ||||
| Rare | |||||
| Liver failure: nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs, yellowing of the skin and the whites of the eyes, dark or tea coloured urine, pale coloured stools/bowel movements. | ✓ | ||||
| Very Rare | |||||
Anaemia (low red blood cell count):
| ✓ | ||||
| Unknown | |||||
| Immune Reconstitution Inflammatory Syndrome: fever, redness, rash or swelling, fatigue, joint or muscle pain, numbness, tingling, or weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, chest pain or rapid heartbeat, yellowing of the skin or eyes, anxiety and irritability accompanied by tremor of your hands or fingers, muscle weakness in your hips, thighs, shoulders, upper arms and neck | ✓ | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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:
TIVICAY 5 mg dispersible tablets store up to 25 ˚C. TIVICAY 10, 25 and 50 mg tablets store up to 30 ˚C.
Store TIVICAY 5mg dispersible tablets and 10 mg tablets in the original package (HDPE bottle) in order to protect from moisture. Keep the bottle tightly closed. Do not remove the silica gel desiccant. The 5mg dispersible tablet package contains a dosing cup, an oral syringe and instructions for use.
Keep out of reach and sight of children.
If you want more information about TIVICAY:
- 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: (Drug Product Database: Access the database); the manufacturer’s website www.viivhealthcare.ca or by calling 1-877-393-8448.
Date of Authorization: 2025-10-24
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