Patient Medication Information: uses, side effects, how to take - PMS-Dolutegravir
What pms-DOLUTEGRAVIR is used for:
pms-DOLUTEGRAVIR is used for treatment of HIV-1 (Human Immunodeficiency Virus) infection in adults and children at least 6 years of age and weighing at least 40 kg.
pms-DOLUTEGRAVIR is a type of anti-HIV medicine called an integrase inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
pms-DOLUTEGRAVIR 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 pms-DOLUTEGRAVIR works:
pms-DOLUTEGRAVIR blocks an enzyme which the virus (HIV) needs in order to make more virus. The enzyme that pms-DOLUTEGRAVIR blocks is called HIV integrase. This helps control HIV infection.
When used with other anti-HIV medicines, pms-DOLUTEGRAVIR 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 pms-DOLUTEGRAVIR are:
Medicinal ingredients: dolutegravir (as dolutegravir sodium).
Non-medicinal ingredients FD & C Yellow # 6 (aluminum lake), macrogol/polyethylene glycol, mannitol, microcrystalline cellulose, polyvinyl alcohol (part hydrolyzed,) povidone, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide.
pms-DOLUTEGRAVIR comes in the following dosage forms:
Film-coated tablets: 50 mg
Do not use pms-DOLUTEGRAVIR if:
- you are allergic to dolutegravir or any of the other ingredients in pms-DOLUTEGRAVIR (see The ingredients in pms-DOLUTEGRAVIR 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 pms-DOLUTEGRAVIR. 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 pms-DOLUTEGRAVIR 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 pms-DOLUTEGRAVIR while you are pregnant.
- If you take pms-DOLUTEGRAVIR 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 pms-DOLUTEGRAVIR can also pass into your breast milk. You should not breastfeed while you are taking pms-DOLUTEGRAVIR.
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 pms-DOLUTEGRAVIR.
- 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: pms-DOLUTEGRAVIR can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Driving and Using Machines: Use caution when driving and using machines until you know how you respond to pms-DOLUTEGRAVIR.
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 pms-DOLUTEGRAVIR:
- metformin, to treat diabetes
- medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take pms-DOLUTEGRAVIR, 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 pms-DOLUTEGRAVIR, or for at least 2 hours after you take it. If you take pms-DOLUTEGRAVIR with food, you can take a calcium or iron supplement at the same time as pms-DOLUTEGRAVIR.
- 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 pms-DOLUTEGRAVIR:
Always take pms-DOLUTEGRAVIR exactly as your healthcare professional has told you to. Check with your healthcare professional if you're not sure. Do not change your dose, or stop taking pms-DOLUTEGRAVIR without talking with your healthcare professional.
pms-DOLUTEGRAVIR tablets can be taken with or without food.
Be sure to keep a supply of your anti-HIV medicines. When your pms-DOLUTEGRAVIR 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:
- 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 pms-DOLUTEGRAVIR, the usual dose is one 50 mg tablet, twice a day.
Children at least 6 years of age and weighing at least 40 kg: Your healthcare professional will decide on the correct dose of pms-DOLUTEGRAVIR 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.
Children should see their healthcare professional regularly because their pms-DOLUTEGRAVIR dose may change as they get older or gain weight.
Antacid medicines
Antacids, to treat indigestion and heartburn, can stop pms-DOLUTEGRAVIR from being absorbed into your body and make it less effective.
Do not take an antacid during the 6 hours before you take pms-DOLUTEGRAVIR, 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 pms-DOLUTEGRAVIR. Talk to your healthcare professional for further advice on taking acid-lowering medicines with pms-DOLUTEGRAVIR.
Calcium or iron supplements
Calcium or iron supplements can stop pms-DOLUTEGRAVIR 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 pms-DOLUTEGRAVIR, or for at least 2 hours after you take it. If you take pms-DOLUTEGRAVIR with food, then you can take calcium and iron supplements at the same time as pms-DOLUTEGRAVIR.
Overdose:
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 pms-DOLUTEGRAVIR:
These are not all the possible side effects you may have when taking pms-DOLUTEGRAVIR. 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
If you think you, or a person you are caring for, have taken too much pms-DOLUTEGRAVIR, 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.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking the drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| 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.
Storage:
Store between 15 to 30 ˚C. Keep out of reach and sight of children.
If you want more information about pms-DOLUTEGRAVIR:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the 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.pharmascience.com; or by calling 1-888-550-6060.
Date of Authorization: 2026-04-14
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.