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Dolutegravir with rilpivirine oral


Oral formulations containing dolutegravir (as sodium) with rilpivirine (as hydrochloride).

Drugs List

  • dolutegravir 50mg and rilpivirine 25mg tablets
  • JULUCA 50mg+25mg tablets
  • Therapeutic Indications


    Treatment of HIV infected adults



    One tablet once a day with a meal.


    Children under 18 years
    Severe hepatic impairment

    Precautions and Warnings

    Females of childbearing potential
    Patients over 65 years
    Glucose-galactose malabsorption syndrome
    Hepatitis B
    Hepatitis C
    Lactose intolerance
    Moderate hepatic impairment
    Severe renal impairment
    Torsade de pointes

    Treatment does not prevent risk of transmission of HIV
    Advise ability to drive/operate machinery may be affected by side effects
    Avoid H2 antagonists 12hrs before or 4hrs after dose
    Perform viral resistance testing before initiating therapy
    Treatment should be initiated by doctor experienced in HIV management
    Women childbearing potential: Discuss potential risk of neural tube defects
    Contains lactose
    Indigestion remedies should not be taken at the same time
    Non-significant increase in QT interval at therapeutic doses
    Exclude pregnancy prior to initiation of treatment
    Autoimmune disorders can occur many months after initiation of treatment
    Monitor for signs of osteonecrosis
    Monitor hepatic function in patients with hepatic impairment
    Monitor levels of hepatic enzymes and bilirubin
    Advise patient to seek medical advice if joint aches or pain occur
    Advise patient to seek medical advice if movement becomes difficult
    Autoimmune diseases may occur during treatment
    Inflammatory symptoms should be evaluated and treated appropriately
    Neonate exposed in utero: Risk of neural tube defects
    Risk of developing opportunistic infections
    Discontinue if drug-related rash or other hypersensitivity reactions occur
    Advise patient not to take St John's wort concurrently
    Advise to avoid calcium and antacids 6hrs before & 4hrs after dose
    Advise to avoid iron and multivitamins 6hrs before & 4hrs after dose
    Female: Ensure adequate contraception during treatment
    Advise patients that hypersensitivity reactions may be life threatening

    Use with caution when co-administered with products with a known risk of Torsade de Pointes.

    Hypersensitivity reactions have been reported with use of dolutegravir. These were characterised by rash, constitutional findings, organ dysfunction, including severe liver reactions. Dolutegravir should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop. These hypersensitivity reactions can include, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, eosinophilia, angioedema. Delay in stopping treatment may result in a life-threatening allergic reaction.

    When combination antiretroviral therapy is initiated in HIV-infected patients with severe immune deficiency, an inflammatory reaction to asymptomatic or residual opportunist pathogens may arise and can cause serious clinical conditions or aggravation of symptoms. Reactions are usually observed within the first few weeks or months after treatment initiation. Examples are cytomegalovirus retinitis, mycobacterial infections or Pneumocystis jiroveci pneumonia. Any inflammatory symptoms should be evaluated and treated appropriately.

    Pregnancy and Lactation


    Dolutegravir with rilpivirine is contraindicated during pregnancy.

    The manufacturer does not recommend using dolutegravir with rilpivirine during pregnancy. If pregnancy is detected in the first trimester during therapy, it is advised to switch to an alternative treatment unless there is no suitable alternative. Animal reproductive toxicity studies have shown dolutegravir to cross the placenta but have not shown dolutegravir to be teratogenic.

    The MHRA states that due to results from an observational study there is evidence of an increased risk of neural tube defects in babies born to mothers who became pregnant while taking dolutegravir. They advise that dolutegravir should not be prescribed to women seeking to become pregnant and that pregnancy should be excluded in women of child bearing potential before starting dolutegravir. Women of childbearing potential are advised to use effective contraception throughout treatment with dolutegravir.


    Dolutegravir with rilpivirine is contraindicated during breastfeeding.

    The manufacturer recommends that infants are not breastfed by HIV infected women in order to avoid HIV transmission. Animal studies have demonstrated that dolutegravir and rilpivirine are excreted in milk. Lactating rats dosed with a single 50mg/kg oral dose 10 days postpartum, dolutegravir was measured in milk concentrations typically higher than blood. The presence of dolutegravir and rilpivirine in human breast milk is unknown.


    Advise patients treatment with dolutegravir does not prevent the risk of transmission of HIV.

    Advise patient if they miss a dose and the next dose is not due within 12 hours they should take the missed dose as soon as possible. If the next dose is due within 12 hours, advise the patient not to take the missed dose and simply resume usual dosing.

    Advise patient if they vomit within 4 hours of a dose, another dose should be taken with a meal as soon as possible. If the patient vomits more than 4 hours after the dose, they do not need to take another dose until the next regularly scheduled dose.

    Advise patient to avoid taking St John's wort concurrently.

    Advise patients to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

    Advise patient to discontinue treatment and contact to contact a medical profession if hypersensitivity reactions occur. Hypersensitivity reactions may be life threatening.

    Advise patient to use adequate contraception during treatment.

    Advise patients their ability to drive or operate machinery may be affected by side effects.

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Acute hepatic failure
    Creatine phosphokinase increased
    Decrease in haemoglobin
    Decreased appetite
    Depressed mood
    Dream abnormalities
    Dry mouth
    Elevated amylase levels
    Elevated serum LDL cholesterol
    Elevated serum lipase
    Elevated triglyceride levels
    Hypersensitivity reactions
    Immune Reactivation/Reconstitution Syndrome
    Increase in serum transaminases
    Increase in total cholesterol
    Reduced platelet count
    Serum bilirubin increased
    Sleep disorders
    Suicidal tendencies
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2020

    Reference Sources

    Summary of Product Characteristics: Juluca 50mg/25mg film-coated tablets. ViiV Healthcare UK Ltd. Revised January 2019.

    MHRA Drug Safety Update June 2018
    Available at:
    Last accessed: 16 July 2018

    NICE Evidence Services Available at: Last accessed: 10 February 2020.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.