Patient Medication Information: uses, side effects, how to take - Dovato

Serious warnings and precautions box

What DOVATO is used for:

DOVATO 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.

How DOVATO works:

DOVATO contains two medicines that are used to treat HIV infection: dolutegravir and lamivudine.

These medicines work together to reduce the amount of virus in your body and keep it at a low level.

This helps maintain the number of CD4+ cell count in your blood. CD4+ cells are a type of white blood cells that are important in helping your body to fight infection.

DOVATO does not cure HIV infection.

The ingredients in DOVATO are:

Medicinal ingredients: 50 mg dolutegravir (as dolutegravir sodium), 300 mg lamivudine.

Non-medicinal ingredients: hypromellose, macrogol / PEG, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

DOVATO comes in the following dosage forms:

50 mg dolutegravir / 300 mg lamivudine fixed dose combination tablets.

Worsening of hepatitis B virus in people who have HIV-1 infection

If you have a hepatitis B infection, you should not stop taking DOVATO without talking to your healthcare professional.
If you have to stop taking DOVATO your hepatitis may worsen.
Your healthcare professional will monitor your liver function for several months and may give you a new medication to treat your hepatitis B infection.

Do not use DOVATO if:

you are allergic (hypersensitive) to:
- dolutegravir (TIVICAY, TRIUMEQ or JULUCA)
- lamivudine (3TC, KIVEXA, COMBIVIR or TRIUMEQ)
- any of the other ingredients or components of the container of DOVATO. See “The ingredients in DOVATO are:”.
you are taking dofetilide (to treat heart conditions).
you are taking fampridine (also known as dalfampridine) used to treat multiple sclerosis.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DOVATO. Talk about any health conditions or problems you may have, including if you:

have had kidney or liver problems, including hepatitis B or C infection.
have ever had a severe skin rash when taking dolutegravir (TIVICAY, TRIUMEQ or JULUCA) or lamivudine (3TC, KIVEXA, COMBIVIR, or TRIUMEQ).
have ever had high levels of acid in the blood (lactic acidosis).
have ever had an increase in your blood sugar (glucose) or levels of fats (lipids) in your blood.
you have symptoms of an infection or inflammation, as these may flare up while on HIV treatment or you may have even stronger reactions to new infections than you would normally have.

Other warnings you should know about:

Pregnancy

Talk to 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 DOVATO while you are pregnant.
In babies and infants exposed to one of the ingredients in DOVATO during pregnancy or labour, small temporary increases in blood levels of a substance called lactate have been observed. There have also been very rare reports of diseases that affect the nervous system such as delayed development and seizures.
There is a registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare professional about how you can take part in this registry.

Breastfeeding

Do not breastfeed while taking DOVATO. There is a risk of passing HIV-1 to your baby if you breastfeed. DOVATO can also be passed through breast milk and harm your baby. If you are breastfeeding or planning to breastfeed, talk with your healthcare professional about the best way to feed your baby.

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 DOVATO:

antacids to treat indigestion and heartburn and laxatives to treat constipation.
- Some antacids and laxatives can stop DOVATO from being absorbed into your body and not make it work as well.
- DOVATO should be taken at least 2 hours before or 6 hours after you take an antacid or
  - laxative.
- Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as DOVATO.
calcium and iron supplements (non-antacids).
- Taking these supplements at the same time as DOVATO can stop DOVATO from being absorbed into your body and not make it work as well.
- DOVATO should be taken at least 2 hours before or 6 hours after you take these supplements.
- You can take supplements containing calcium or iron at the same time as DOVATO if you take both with food.
metformin (medicine to treat diabetes)
rifampin (medicine to treat some bacterial infections, such as tuberculosis (TB))
phenytoin and phenobarbital (medicine to treat epilepsy)
oxcarbazepine and carbamazepine (medicine to treat epilepsy and bipolar disorder)
St. John’s wort (Hypericum perforatum), a herbal remedy to treat depression
sorbitol-containing medicines (usually liquids) used regularly
trimethoprim/sulfamethoxazole (combination of medicines used to treat infections)

Talk to your healthcare professional for further advice if you are taking any of these medicines. For some of these medicines, your healthcare professional may need to adjust the dose of one of your medicines in order for it to work properly.

How to take DOVATO:

Always take DOVATO every day exactly as your healthcare professional has told you to.

DOVATO can be taken with or without food.

Check with your healthcare professional if you're not sure.

Usual dose:

The usual dose of DOVATO in adults and adolescents 12 years of age and older and weighing at least 40 kg is one tablet taken once a day.

Take DOVATO for as long as your healthcare professional recommends. Don’t stop unless your healthcare professional advises you to.

Overdose:

If you think you, or a person you are caring for, have taken too much DOVATO, 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 DOVATO 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.

Possible side effects from using DOVATO:

These are not all the possible side effects you may have when taking DOVATO. If you experience any side effects not listed here, tell your healthcare professional.

Side effects include:

headache
diarrhea
drowsiness
feeling sick (nausea)
trouble sleeping (insomnia)
anxiety
itching (pruritus)
any new infections
kidney problems
vomiting
stomach pain
stomach discomfort
intestinal gas (flatulence)
fever
feeling tired (fatigue)
muscle pain
dizziness
abnormal dream
feeling sleepy
feelings of deep sadness and unworthiness (depression)

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
Uncommon
Hypersensitivity (allergic reactions): skin rash, fever, lack of energy, swelling of the mouth or face causing difficulty in breathing, muscle or joint aches					✓
Anemia (low red blood cell count): paleness of the skin, fatigue, rapid heart rate, shortness of breath			✓
Neutropenia (low white blood cell count): fever and symptoms of infection such as cough			✓
Thrombocytopenia (low platelet count): bruising easily, heavy bleeding			✓
Liver problems and blood test results: inflammation (Hepatitis), bilirubin increase (substance produced by liver), increase of muscle enzymes (CPK), increase in a kidney function blood test result (creatinine)			✓
Rare
Lactic acidosis (high level of acid in the blood): weight loss, fatigue, malaise, abdominal pain, 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			✓
Liver failure: extremely high liver blood test results, yellowing of the skin and the whites of the eyes, dark/tea coloured urine, pale coloured stools/ bowel movements, nausea/vomiting, loss of appetite, pain, aching/tenderness on right side below ribs			✓
Suicidal thoughts or actions (mainly in patients who have had depression or mental health problems before)			✓

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:

Store DOVATO up to 30°C.

Keep out of reach and sight of children.

Do not throw any medicines away in the garbage, down the sink drain or in the toilet. Give all unused medicines to your local pharmacy for proper disposal. This will help to protect the environment.

If you want more information about DOVATO:

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.ca, or by calling 1-877-393-8448.

Date of Authorization: 2025-10-24

Trademarks are owned by or licensed to the ViiV Healthcare group of companies

Rx or OTC	Prescription (Rx)?
DIN	02491753
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Dolutegravir (dolutegravir sodium) 50 MG, Lamivudine 300 MG
Dosage form(s)	Tablet
Route(s) of administration	Oral
Drug class (WHO ATC)	J Antiinfectives for systemic use J05 Antivirals for systemic use J05A Direct acting antivirals J05AR Antivirals for treatment of HIV infections, combinations J05AR25 Lamivudine and dolutegravir
Company	VIIV HEALTHCARE ULC
Current status	Marketed
Current status date	September 9, 2019

Dovato: Uses, Side Effects and Dosage