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Darunavir with cobicistat oral


Oral formulations of darunavir (as ethanolate) with cobicistat.

Drugs List

  • darunavir 800mg and cobicistat 150mg tablets
  • REZOLSTA 800mg+150mg tablets
  • Therapeutic Indications


    HIV infection-combined with other antiretrovirals



    1 tablet once a day, taken with food.


    Children aged 12 to 18 years weighing at least 40kg
    1 tablet once a day, taken with food.

    Patients with Renal Impairment

    Patients with creatinine clearance less than 70ml/minute that are being co-administered agents requiring dose adjustments based on creatinine clearance should not be treated with darunavir with cobicistat.

    Additional Dosage Information

    For patients unable to swallow the whole tablet, the tablet may be split into two pieces and should be consumed immediately after splitting.

    If a patient vomits within 4 hours of taking the medicine, another dose should be taken as soon as possible. If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose until the next regularly scheduled dose.

    Missed dose
    Advise patient if they miss a dose within 12 hours of the time it is usually taken, the patient should take the missed dose with food as soon as possible and resume normal dosing schedule. If a patient misses a dose by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.


    Children under 3 years
    Children with body weight under 40kg
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10

    Precautions and Warnings

    Children aged 3 to 12 years
    Patients over 65 years
    Hepatic impairment
    Hepatitis B
    Hepatitis C
    Renal impairment - creatinine clearance below 70ml/min

    Switch to more suitable alternative before planned pregnancy
    Treatment does not prevent risk of transmission of HIV
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment should be initiated by doctor experienced in HIV management
    Advise patient to take with or after food
    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
    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
    May cause weight gain
    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 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 4 hours

    Darunavir with cobicistat 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 per ml or CD4+ cell count less than 100 cells times 10 to the power 6 per 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.

    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.

    Pregnancy and Lactation


    Darunavir with cobicistat is contraindicated during pregnancy.

    The manufacturer does not recommend darunavir with cobicistat treatment to be initiated during pregnancy and women who become pregnant during therapy with this product should be switched to an alternative regimen.

    Treatment with cobicistat and darunavir during second and third trimester of pregnancy has shown to substantially lower darunavir exposure, which may result in virological failure and increase the risk of transmission of HIV from the mother to infant. Animal studies do not indicate harmful effects.


    Darunavir with cobicistat is contraindicated in breastfeeding.

    It is recommended that HIV infected women should not breastfeed due to the risk of passing on the infection to the infant. Due to the potential for HIV transmission and potential for adverse effects breastfeeding should not take place.

    At the time of writing, there is limited published information regarding the use of darunavir with cobicistat in breastfeeding. Animal studies have shown that darunavir is excreted in milk at high levels, which resulted in toxicity. It is not known whether darunavir is excreted in human milk. However, due to the low molecular weight and prolonged elimination half-life, it is considered likely that darunavir will be excreted in breast milk. Animal studies have shown cobicistat to be excreted in milk.

    Side Effects

    Abdominal distension
    Abdominal pain
    Acute generalised exanthematous pustulosis
    Acute renal failure
    Alterations in pancreatic enzymes
    Autoimmune hepatitis
    Creatine phosphokinase increased
    Cytolytic hepatitis
    Decrease in creatinine clearance
    Diabetes mellitus
    Dream abnormalities
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Graves' disease
    Hypersensitivity reactions
    Immune Reactivation/Reconstitution Syndrome
    Increased spontaneous bleeding (haemophiliacs)
    Increases in hepatic enzymes
    Inflammatory reactions
    Rise in blood lipids
    Serum creatinine increased
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Weight changes


    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: October 2019.

    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.

    Summary of Product Characteristics: Rezolsta 800 mg/15 mg tablets. Janssen-Cilag Ltd. Revised March 2020.

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

    NICE Evidence Services Available at: Last accessed: 25 October 2021

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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.