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Darunavir with cobicstat, emtricitabine and tenofovir alafenamide oral


Oral formulations of darunavir with cobicistat, emtricitabine and tenofovir alafenamide.

Drugs List

  • darunavir 800mg and cobicistat 150mg and emtricitabine 200mg and tenofovir alafenamide 10mg film coated tablets
  • SYMTUZA 800mg+150mg+200mg+10mg film coated tablets
  • Therapeutic Indications


    HIV infection in adults and adolescents over 12 years: treatment

    Treatment of adults and adolescents (aged 12 years or older, with a body weight of at least 40kg) infected with HIV-1.



    One tablet once daily, taken with food.

    Additional Dosage Information

    Missed doses
    If a dose is missed, take the prescribed dose as soon as possible, but within 12 hours of the time it is usually taken. The dose should not be taken if a missed dose is noticed more than 12 hours after the time it is usually taken.


    Children under 3 years
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10

    Precautions and Warnings

    Children aged 3 to 11 years
    Children with body weight under 40kg
    Patients over 65 years
    Hepatic impairment - Child-Pugh score between 5 and 9
    Hepatitis B
    Hepatitis C

    Cirrhosis: Monitor for signs and symptoms of hepatic decompensation
    Monitor HBV levels during and after treatment in patients with co-infection
    Switch to more suitable alternative before planned pregnancy
    Treatment does not prevent risk of transmission of HIV
    Advise patient dizziness may affect ability to drive or operate machinery
    Herpes zoster reactivation possible - consider antiviral prophylaxis
    Treatment should be initiated by doctor experienced in HIV management
    Monitor blood lipids before and during treatment
    Monitor hepatic function before treatment and regularly during treatment
    Autoimmune disorders can occur many months after initiation of treatment
    Blood lipid and glucose levels may increase requiring treatment
    Monitor children exposed in utero for mitochondrial impairment
    Advise patient to seek medical advice if joint aches or pain occur
    Risk of developing opportunistic infections
    Advise patient to seek advice at first indications of pregnancy
    Consider discontinuing treatment if severe hepatic changes occur
    Discontinue if eGFR falls below 30ml/minute/1.73 m squared
    Discontinue if severe skin reaction occurs
    Advise patient not to take St John's wort concurrently
    Advise haemophiliac patients of possibility of increased bleeding
    Take another dose if vomiting occurs within one hour

    Darunavir with cobicistat, emtricitabine and tenofovir alafenamide should not be used in treatment experienced patients in the following cases:
    One or more DRV-RAMs,
    HIV-1 RNA greater than or equal to 100,000 copies/ml,
    CD4+ cell count less than 100 cells times 10 to the power 6/litre.

    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. 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.

    Patients co-infected with hepatitis B or C are at an increased risk of severe, potentially fatal hepatic adverse events. When discontinuing treatment with darunavir with cobicistat, emtricitabine and tenofovir alafenamide in these patients, monitor patients closely for several months after treatment. Hepatitis B treatment may be warranted.

    Darunavir with cobicistat, emtricitabine and tenofovir alafenamide may decrease estimated creatinine clearance, due to inhibition of creatinine secretion from renal tubules. This effect on estimated creatinine clearance may impact the clinical management of aspects of the patient's treatment, including dose adjustment of co-administered medicinal products.

    Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first months of darunavir with cobicistat, emtricitabine and tenofovir alafenamide treatment.

    Pregnancy and Lactation


    Darunavir with cobicistat, emtricitabine and tenofovir alafenamide is contraindicated during pregnancy.

    The manufacturer does not recommend darunavir with cobicistat, emtricitabine and tenofovir alafenamide treatment to be initiated during pregnancy and women who become pregnant during therapy with this product should be switched to an alternative regimen. At the time of writing there is limited published information regarding the use of darunavir with cobicistat, emtricitabine and tenofovir alafenamide during pregnancy. Potential risks are unknown.


    Darunavir with cobicistat, emtricitabine and tenofovir alafenamide is contraindicated during breastfeeding.

    Use of darunavir with cobicistat, emtricitabine and tenofovir alafenamide is contraindicated by the manufacturer. Animal data reports significant levels of darunavir with cobicistat, emtricitabine and tenofovir alafenamide in the breast milk, however presence in human breast milk and the effect on exposed infants are unknown.

    Side Effects

    Abdominal distension
    Abdominal pain
    Acute generalised exanthematous pustulosis
    Acute pancreatitis
    Allergic dermatitis
    Alterations in pancreatic enzymes
    Autoimmune hepatitis
    Cytolytic hepatitis
    Diabetes mellitus
    Dream abnormalities
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Erythematous rash
    Graves' disease
    Hepatitis (transient)
    Hypersensitivity reactions
    Immune Reactivation/Reconstitution Syndrome
    Increase in blood urea or creatinine
    Increases in hepatic enzymes
    Localised and generalised rash
    Macular rash
    Maculopapular rash
    Pruritic rash
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis


    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: December 2019

    Reference Sources

    Summary of Product Characteristics: Symtuza 800mg/150mg/200mg/10mg film-coated tablets. Janssen-Cilag Ltd. Revised July 2019.

    MHRA Drug Safety Update April 2019
    Available at:
    Last accessed: 22 May 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.