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Emtricitabine with rilpivirine and tenofovir alafenamide oral


Oral formulations of emtricitabine with rilpivirine and tenofovir alafenamide.

Drugs List

  • emtricitabine 200mg and rilpivirine 25mg and tenofovir alafenamide 25mg film coated tablets
  • ODEFSEY 200mg+25mg+25mg film coated tablets
  • Therapeutic Indications


    Non-resistant HIV in adults - viral load <100,000 HIV-1 RNA copies/mL

    Treatment of Human Immunodeficiency Virus 1 (HIV-1) infected patients without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load of less than or equal to 100,000 HIV-1 RNA copies/mL.

    As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of emtricitabine with rilpivirine and tenofovir alafenamide.



    1 tablet, once a day with food.


    Children 12 years and older weighing at least 35kg
    1 tablet, once a day with food.

    Only adolescents likely to have good adherence to therapy should be treated with an antiretroviral regime containing rilpivirine. Development of resistance and loss of future treatment options could occur with suboptimal adherence.

    Children under 12 or weighing under 35kg

    Patients with Renal Impairment

    Estimated creatinine clearance (CrCl) 15mL/minute to less than 30mL/minute

    Estimated creatinine clearance (CrCl) less than 15mL/minute and patient not on chronic haemodialysis

    Estimated creatinine clearance (CrCl) less than 15mL/minute and patient on chronic haemodialysis
    May be used with caution if benefits outweigh the risks. On days of haemodialysis, take dose after completion of haemodialysis treatment.

    Additional Dosage Information

    Advise patient if a dose has been missed within 12 hours of the time it is usually taken to take missed dose as soon as possible and resume normal dosing schedule thereafter. If more than 12 hours have passed, avoid taking the missed dose and continue treatment at next scheduled dose.

    Advise patient if they vomit within 4 hours of taking a dose to take another tablet with food. If they vomit more than 4 hours after taking a dose the patient does not need to take another dose until the next scheduled dose.


    Children under 12 years
    Weight below 35kg
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    Glucose-galactose malabsorption syndrome
    Hepatitis B
    Hepatitis C
    Lactose intolerance
    Moderate hepatic impairment

    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
    Contains lactose
    Advise patient to take with or after food
    Autoimmune disorders can occur many months after initiation of treatment
    Blood lipid and glucose levels may increase requiring treatment
    On discontinuation, may cause recurrence of hepatitis B
    Advise patient to seek medical advice if joint aches or pain occur
    Advise patient to seek medical advice if movement becomes difficult
    Inflammatory symptoms should be evaluated and treated appropriately
    Neonate exposed in utero: Risk of mitochondrial dysfunction
    Risk of developing opportunistic infections
    Discontinue if creatinine clearance below 30ml/minute
    Discontinue if hepatic function deteriorates in pts with hepatic impairment
    Advise patient not to self medicate with antacids or acid suppressants
    Advise patient not to take St John's wort concurrently
    Male & female: Ensure adequate contraception during treatment
    Take another dose if vomiting occurs within 4 hours

    Patients with hepatic impairment or chronic hepatitis B or C who are treated with combination antiretroviral therapy should be closely monitored during treatment. Patients with hepatitis B should be monitored for several months after stopping treatment. Patients with hepatic impairment have an increased risk of hepatic function abnormalities during treatment. Patients with chronic hepatitis B or C who are treated with combination antiretroviral therapy have an increased risk of developing severe and potentially fatal hepatic adverse effects. The product literature relating to concurrent treatments for hepatitis B or C should be consulted. Treatment discontinuation in patients with HIV and hepatitis B may be associated with severe acute exacerbations of hepatitis. If hepatic function deteriorates in patients with hepatic impairment, consider interrupting or discontinuing treatment.

    Blood lipid and glucose levels may increase during antiretroviral therapy. This may be linked to disease control and lifestyle. Refer to established HIV treatment guidelines for monitoring and manage lipid and glucose level disorders as appropriate.

    Treatment regimens containing nucleoside or nucleotide analogues have been reported to cause mitochondrial dysfunction in HIV-negative infants exposed in utero and/or postnatally. Adverse reactions such as haematological (anaemia, neutropenia), metabolic (hyperlactataemia, hyperlipasemia) and neurological (hypertonia, convulsions, abnormal behaviour) have been reported. Consider in children exposed to nucleoside or nucleotide analogues in utero (including HIV-negative infants) and who present with neurological symptoms or severe clinical findings of unknown cause.

    Pregnancy and Lactation


    Use emtricitabine with rilpivirine and tenofovir alafenamide with caution during pregnancy.

    The manufacturer suggests avoiding use of emtricitabine with rilpivirine and tenofovir alafenamide during pregnancy as a precaution.

    At the time of writing there is limited published information regarding the use of emtricitabine with rilpivirine and tenofovir alafenamide during pregnancy.

    Data from over 1,000 exposed outcomes in pregnant women indicate no malformations or foetal/neonatal toxicity is associated with emtricitabine. 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. Animal studies with emtricitabine with rilpivirine and tenofovir alafenamide do not indicate direct or indirect harmful effects with respect to reproductive toxicity.


    Emtricitabine with rilpivirine and tenofovir alafenamide is contraindicated during breastfeeding.

    The manufacturer does not recommend the use of emtricitabine with rilpivirine and tenofovir alafenamide during breastfeeding.

    It is recommended that HIV infected women should not breastfeed due to the risk of passing on the infection to the infant.

    Emtricitabine is excreted in breast milk. It is unknown whether rilpivirine or tenofovir alafenamide are excreted into breast milk.

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Alterations in pancreatic enzymes
    Autoimmune disorders
    Autoimmune hepatitis
    Decrease in glomerular filtration rate
    Decreased appetite
    Depressed mood
    Dream abnormalities
    Dry mouth
    Elevated serum LDL cholesterol
    Elevated serum lipase
    Elevated triglyceride levels
    Graves' disease
    Haemoglobin decrease
    Immune Reactivation/Reconstitution Syndrome
    Increase in serum ALT/AST
    Increase in serum glucose
    Increase in total cholesterol
    Inflammatory reactions
    Reduced platelet count
    Reduction in serum cortisol levels
    Rise in blood lipids
    Serum bilirubin increased
    Serum creatinine increased
    Severe skin reactions
    Skin reactions
    Sleep disorders
    Weight gain
    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: September 2019

    Reference Sources

    Summary of Product Characteristics: Odefsey 200mg/25mg/25mg film-coated tablets. Revised June 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.