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Juluca: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
50 mg / 25 mg
Active ingredients:
ATC code:
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

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

What JULUCA is used for:

  • JULUCA is used to treat HIV (human immunodeficiency virus) infection in adults
  • JULUCA replaces your current HIV treatment.

How JULUCA works:

JULUCA contains two medicines that are used to treat HIV infection: Dolutegravir and Rilpivirine.

These medicines work together to keep the amount of virus in your body 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. JULUCA does not cure HIV infection.

The ingredients in JULUCA are:

Medicinal ingredients: 50 mg dolutegravir (as dolutegravir sodium), 25 mg rilpivirine (as rilpivirine hydrochloride).

Non-medicinal ingredients: croscarmellose sodium, D-mannitol, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol/PEG, magnesium stearate, microcrystalline cellulose, polysorbate 20, polyvinyl alcohol-part hydrolyzed, povidone K29/32 and K30, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide

JULUCA comes in the following dosage form:

50 mg dolutegravir / 25 mg rilpivirine fixed dose combination tablets.

Do not use JULUCA if:

  • You are allergic (hypersensitive) to dolutegravir (TIVICAY or TRIUMEQ) or rilpivirine (COMPLERA, EDURANT, or ODEFSEY) or to any of the other ingredients of JULUCA. See “The ingredients in JULUCA are”.

  • You are taking any of these medicines:

    • dofetilide (to treat heart conditions).
    • fampridine (also known as dalfampridine) to treat multiple sclerosis.
    • carbamazepine, oxcarbazepine, phenobarbital, or phenytoin (also known as anticonvulsants used to treat epilepsy and prevent seizures).
    • rifampin or rifapentine (to treat some bacterial infections such as tuberculosis).
    • omeprazole, esomeprazole, lansoprazole, pantoprazole, or rabeprazole (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease).
    • Dexamethasone – more than one dose (a corticosteriod used in a variety of conditions such as inflammation and allergic reactions).
    • products that contain St John’s wort (Hypericum perforatum) (a herbal product used to treat depression).

Don’t take JULUCA with any of these medicines. Talk to your Healthcare professional first.

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

  • have ever had a mental health problem.
  • have had liver problems, including hepatitis B or C infection.
  • have ever had a severe skin rash or an allergic reaction to dolutegravir (TIVICAY or TRIUMEQ) or rilpivirine (COMPLERA, EDURANT, or ODEFSEY).

Other warnings you should know about:

Serious liver problems including liver injury and liver failure have been seen in people taking medicines containing dolutegravir (see Serious side effects and what to do about them). In some cases the liver injury has led to a liver transplant. While you are being treated with JULUCA your healthcare professional will monitor you closely for any signs of liver problems.

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 JULUCA while you are pregnant.
  • 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.
  • Talk to your healthcare professional if you are are breastfeeding or plan to breastfeed because of the risk of passing HIV-1 to your baby. Talk with your healthcare professional about the best way to feed your baby. A small amount of the ingredients in JULUCA can also pass into your breast milk. If you are taking JULUCA, do not breastfeed.

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 JULUCA:

  • metformin, to treat diabetes.

  • medicines called antacids to treat indigestion and heartburn or laxatives, or other products that contain aluminum and/or calcium carbonate, magnesium or buffered medicines.

    • Taking antacids can stop JULUCA from being absorbed into your body and not make it work as well.
    • JULUCA should be taken at least 4 hours before or 6 hours after you take an antacid.

  • calcium and iron supplements (non-antacids).

    • Taking these supplements can stop JULUCA from being absorbed into your body and not make it work as well.
    • Supplements containing calcium or iron can be taken at the same time as JULUCA and a meal.
    • Otherwise, JULUCA should be taken at least 4 hours before or 6 hours after you take these supplements.

  • famotidine, cimetidine, nizatidine, and ranitidine (H2-receptor antagonists) to treat indigestion and heartburn

    • H2-receptor antagonists can stop JULUCA from being absorbed into your body and make it not work as well.
    • JULUCA should be taken at least 4 hours before or 12 hours after you take a H2-receptor antagonist.

  • rifabutin, to treat some bacterial infections, such as tuberculosis (TB)

    • if you take rifabutin, your healthcare professional will also need to give you a dose of Edurant (rilpivirine).
    • Your healthcare professional will give you advice on how to take rifabutin with JULUCA.
  • clarithromycin, erythromycin, antibiotics used to treat bacterial infections.
  • methadone, a medicine used to treat narcotic withdrawal and dependence.
  • efavirenz, etravirine, and nevirapine (non-nucleoside reverse transcriptase inhibitors [NNRTIs]) to treat HIV infection.
  • any other medicine to treat HIV infection.

Talk to your healthcare professional for further advice if you are taking any of these medicines.

How to take JULUCA:

Always take JULUCA every day with a meal exactly as your healthcare professional has told you to. Check with your healthcare professional if you're not sure.

  • Taking JULUCA with a meal is important to help get the right amount of medicine in your body. A protein drink alone (or meal replacement drink) does not replace a meal.

Usual dose:

The usual dose of JULUCA is one tablet (50 mg dolutegravir and 25 mg rilpivirine) taken once a day with a meal.

Take JULUCA 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 JULUCA, 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 JULUCA with a meal as soon as you remember. If your next dose is due within 12 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 JULUCA:

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

The most common side effects of JULUCA are:

  • Headache
  • Diarrhea

Additional side effects that may occur include: decreased appetite, intestinal gas (wind/flatulence), stomach pain/discomfort, feeling sick (nausea), being sick (vomiting), abnormal dreams, difficulty falling asleep or staying asleep, weight gain, dizziness and/or itching.

Tell your healthcare professional if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare professional.

Serious side effects and what to do about them

Frequency/Side Effect/SymptomTalk to your healthcare professionalStop taking this drug and get immediate medical help
Frequency/Side Effect/SymptomTalk to your healthcare professionalStop taking this drug and get immediate medical help
Only if severeIn all cases
Only if severeIn all cases
Uncommon

Severe skin rash and allergic (hypersensitivity) reactions:

  • Skin rash, fever, lack of energy (fatigue), swelling of the mouth or face causing difficulty in breathing, blisters or sores in mouth, muscle or joint aches
✓

Depression or mood changes:

  • Feelings of deep sadness
  • Feelings of unworthiness
  • Have thoughts of hurting yourself (suicide)
  • Have tried to hurt yourself (behavior)
  • Anxiety; feelings of worry, nervousness or unease.
✓

Liver problems and blood test results:

  • Inflammation (Hepatitis)
  • Bilirubin increase (substance produced by liver)
  • Increase of muscle enzymes (CPK)
  • an increase in a kidney function test result (creatinine)
✓
Rare

Liver failure:

  • Extremely high liver blood test results
  • Yellowing of the skin and the whites of the eyes
  • Dark or tea coloured urine
  • Pale coloured stools/ bowel movements
  • Nausea/ vomiting
  • Loss of appetite
  • Pain, aching or tenderness on right side below the ribs
✓
Very Rare

Anaemia (low red blood cell count):

  • Paleness of skin
  • Fatigue
  • Rapid heart rate
  • Shortness of breath
✓

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 JULUCA up to 30°C
  • Store JULUCA tablets in the original bottle. Keep the bottle tightly closed and protected from moisture.
  • The bottle of JULUCA contains a silica gel desiccant to help keep your medicine dry and protect it from moisture. Do not remove the desiccant from the bottle.

Keep out of reach and sight of children.

Proper disposal:

Don’t throw away any medicines down the drain, household waste or flushed 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 JULUCA:

  • 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

© 2025 ViiV Healthcare group of companies or its licensor.

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

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02475774

Approved according to the text: October 24, 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Juluca

Rx or OTC
Prescription (Rx)?
DIN 02475774
Schedule(s) PRESCRIPTION
Active ingredient(s) Dolutegravir (dolutegravir sodium) 50 MG, Rilpivirine (rilpivirine hydrochloride) 25 MG
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. J Antiinfectives for systemic use
    1. J05 Antivirals for systemic use
      1. J05A Direct acting antivirals
        1. J05AR Antivirals for treatment of HIV infections, combinations
          1. J05AR21 Dolutegravir and rilpivirine
Company VIIV HEALTHCARE ULC
Current status Marketed
Current status date June 4, 2018

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.