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Rilpivirine oral


Oral formulation of rilpivirine

Drugs List

  • EDURANT 25mg film coated tablets
  • rilpivirine 25mg film coated tablets
  • Therapeutic Indications


    HIV infection-combined with other antiretrovirals



    25mg (1 tablet) taken once daily with a meal.


    25mg (1 tablet) taken once daily with a meal.


    Children over 12 years of age
    25mg (1 tablet) taken once daily with a meal.

    Additional Dosage Information

    Missed dose:
    If the patient misses a dose of rilpivirine within 12 hours of the time it is usually taken, the patient must take rilpivirine with a meal as soon as possible and resume the normal dosing schedule.
    If a patient misses a dose of rilpivirine by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule.

    If a patient vomits within 4 hours of taking rilpivirine, another rilpivirine tablet should be taken with a meal. If a patient vomits more than 4 hours after taking rilpivirine, the patient does not need to take another dose of rilpivirine until the next regularly scheduled dose.

    Dose adjustment:
    For patients receiving rifabutin, the rilpivirine dose should be increased to 50mg (two 25mg tablets) taken once daily. When rifabutin co-administration is stopped, the rilpivirine dose should be decreased to 25mg once daily.


    Children under 12 years
    Severe hepatic impairment

    Precautions and Warnings

    Patients over 65 years
    Glucose-galactose malabsorption syndrome
    Hepatitis B
    Hepatitis C
    Lactose intolerance
    Moderate hepatic impairment
    Severe renal impairment

    Treatment does not prevent risk of transmission of HIV
    Advise ability to drive/operate machinery may be affected by side effects
    Must be used in combination with other antiretrovirals
    Treatment should be initiated by doctor experienced in HIV management
    Contains lactose
    Indigestion remedies should not be taken at the same time
    Autoimmune disorders can occur many months after initiation of treatment
    Evaluate for physical signs of fat redistribution
    Inflammatory symptoms should be evaluated and treated appropriately
    Risk of developing opportunistic infections
    Advise patient not to self medicate with antacids or acid suppressants
    Advise patient not to take St John's wort concurrently
    Avoid concurrent use of proton pump inhibitors

    Genotypic resistance testing (when available) should be carried out prior to treatment.

    Treatment with rilpivirine resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant.

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

    The combination of rilpivirine and proton pump inhibitors should be avoided as co-administration is likely to result in the loss of therapeutic effect of rilpivirine.

    The combination of rilpivirine and antacids should be used with caution. Antacids should only be administered either at least 2 hours before or at least 4 hours after rilpivirine.

    The combination of rilpivirine and H2-receptor antagonists should be used with caution. H2-receptor antagonists should be administered at least 12 hours before or at least 4 hours after rilpivirine.

    Pregnancy and Lactation


    Use rilpivirine with caution in pregnancy.

    Rilpivirine should only be used in pregnant women if the potential benefits clearly outweigh the potential risks. Studies with rilpivirine in pregnant women have shown reduced exposure of the drug, and a subsequent increase in the risk of virological failure. Viral load should be closely monitored in these patients.

    It is not known whether rilpivirine crosses the human placenta, but its molecular weight and long elimination terminal half-life suggest placental transfer may occur. No evidence of increased teratogenicity has been found in studies in rats and rabbits. A moderate amount of data indicate no malformative or feto/neonatal toxicity of rilpivirine.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Rilpivirine is contraindicated in breastfeeding.

    It is not known whether rilpivirine is excreted in human milk. Rilpivirine is excreted in the milk of rats. Because of both the potential for HIV transmission and the potential for adverse reactions in breastfed infants, mothers should be instructed not to breastfeed if they are receiving rilpivirine.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Alterations in pancreatic enzymes
    Autoimmune hepatitis
    Decrease in haemoglobin
    Decreased appetite
    Depressed mood
    Dream abnormalities
    Dry mouth
    Elevated serum LDL cholesterol
    Elevated serum lipase
    Graves' disease
    Immune Reactivation/Reconstitution Syndrome
    Increase in plasma triglyceride concentration
    Increase in serum transaminases
    Increase in total cholesterol
    Reduced platelet count
    Serum bilirubin increased
    Sleep disturbances
    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: August 2015

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 10 August 2015.

    Summary of Product Characteristics: Edurant 25mg film-coated tablets. Janssen-Cilag Ltd. Revised December 2019.

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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.