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Emtricitabine with tenofovir disoproxil oral


Oral formulations of emtricitabine and tenofovir disoproxil.

Drugs List

  • emtricitabine 200mg and tenofovir disoproxil 245mg film coated tablets
  • ICTASTAN 200mg+245mg film coated tablets
  • TRUVADA 200mg+245mg film coated tablets
  • Therapeutic Indications


    HIV infection in adolescents with NRTI resistance: Second line treatment
    Sexually acquired HIV infection in high risk patients: PrEP
    Treatment of HIV infected adults

    Antiretroviral combination therapy for the treatment of HIV-1 infected adults.

    HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents.

    Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk, in combination with safer sex practice.


    When one of the active substances needs to be discontinued or when dosage needs to be modified, separate preparations of emtricitabine and tenofovir disoproxil are available. For further information, refer to the individual Summary of Product Characteristics of these medicinal products.

    Not all available brands are licensed for all age groups.


    1 tablet (200mg emtricitabine and 245mg tenofovir disoproxil) to be taken every 24 hours.


    HIV-1 infected adolescents, weighing at least 35kg, with NTRI resistance or toxicities precluding the use of first line agents
    Children aged 12 to 18 years
    1 tablet (200mg emtricitabine and 245mg tenofovir disoproxil) to be taken every 24 hours.

    Patients with Renal Impairment

    Treatment of HIV infection
    Creatinine clearance 30 to 49ml per minute
    1 tablet (200mg emtricitabine and 245mg tenofovir disoproxil) to be taken every 48 hours.

    Additional Dosage Information

    If the patient vomits within 1 hour of taking emtricitabine with tenofovir disoproxil, another tablet should be taken. If the patient vomits more than 1 hour after taking emtricitabine with tenofovir disoproxil they do not need to take another dose.

    If a patient has difficulty in swallowing, emtricitabine with tenofovir disoproxil can be disintegrated in approximately 100ml of water, orange juice or grape juice and taken immediately.

    Missed dose
    Less than 12 hours
    If a patient misses a dose of emtricitabine with tenofovir disoproxil within 12 hours of the time it is usually taken, the patient should take emtricitabine with tenofovir disoproxil with food as soon as possible and resume their normal dosing schedule.
    More than 12 hours
    If a patient misses a dose of emtricitabine with tenofovir disoproxil by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose, and should simply resume the usual dosing schedule.


    Children under 12 years
    Renal impairment - creatinine clearance below 30 ml/minute
    Renal impairment - creatinine clearance below 60ml/minute - if HIV PrEP

    Precautions and Warnings

    Children under 18 years
    Weight below 35kg
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hepatitis B
    Hepatitis C
    Lactose intolerance
    Renal impairment - creatinine clearance 30-80ml/minute
    Renal impairment in children under 18 years

    Therapy cessation not recommended in decompensated liver disease/cirrhosis
    Treatment does not prevent risk of transmission of HIV
    Advise ability to drive/operate machinery may be affected by side effects
    Confirm HIV negative status before and during pre-exposure prophylaxis
    Must be used in combination with other antiretrovirals
    Not all available brands are licensed for all age groups
    Not all available brands are licensed for all indications
    Perform viral resistance testing before initiating therapy
    Treatment should be initiated by doctor experienced in HIV management
    Contains lactose
    Evaluate renal function before and during treatment
    Autoimmune disorders can occur many months after initiation of treatment
    Blood lipid and glucose levels may increase requiring treatment
    Monitor hepatic function in patients with hepatic impairment
    Monitor renal function after 2-4 weeks, 3 months and 3-6 monthly thereafter
    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
    May cause loss of bone mineral density
    May cause weight gain
    Neonate exposed in utero: Risk of mitochondrial dysfunction
    Risk of developing opportunistic infections
    Discontinue if hepatic function deteriorates in pts with hepatic impairment
    Interrupt treatment if creatinine clearance below 50 ml/minute
    Interrupt treatment if serum phosphate decreases to below 1 mg/dL
    Suspend therapy if renal function deteriorates; reinstitute when normal
    Advise patient not to take NSAIDs unless advised by clinician
    Female: Ensure adequate contraception during treatment
    Advise patient of importance of full compliance

    Emtricitabine and tenofovir disoproxil should be avoided in patients with HIV-1 that is harbouring the K65R mutation.

    Patients should have HIV status testing at least every 3 months for pre-exposure prophylaxis.

    If HIV infection or HIV exposure is suspected, use of emtricitabine and tenofovir disoproxil for prophylaxis should be delayed for one month and HIV status reconfirmed before continuing prophylaxis 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 post-natally. 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 tenofovir disoproxil with caution in pregnancy.

    The limited amount of data available on the use of emtricitabine with tenofovir disoproxil in pregnancy indicates no foetal/neonatal toxicity associated with the combined therapy. Animal data do not suggest a risk of reproductive toxicity.

    Emtricitabine crosses the placenta readily but the limited data show no evidence of teratogenicity in humans or animals. Tenofovir also crosses the placenta easily and Schaefer notes that the risk of foetal toxicity in humans is thought to be low, but there is a potential risk of bone density changes, and suggests that pregnant patients exposed to these drugs should be offered a detailed ultrasound to ascertain normal development of the foetus.

    Briggs recommends that in the incidence of pregnancy occurring during therapy for HIV-1, combined antiretroviral therapy should continue, as withdrawal or interruption of therapy may increase the emergence of resistant viral strains. Treatment of the pregnant mother with monotherapy is considered inadequate. Briggs also recommends the use of zidovudine during the intrapartum period regardless of current regimen, as this may prevent vertical transmission of HIV to the newborn.

    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 ( ).


    Emtricitabine with tenofovir disoproxil 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.

    Emtricitabine and tenofovir are excreted into breast milk. There is limited data on any impact this may have on the nursing infant.

    LactMed indicates that where no other safe feeding replacement is available, the WHO guidelines recommend that all breastfeeding women with a HIV infection should be maintained on antiretroviral therapy at least for the duration of risk for mother-to-child-transmission.

    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 pain
    Acute interstitial nephritis
    Acute tubular necrosis
    Allergic reaction
    Autoimmune disorders
    Autoimmune hepatitis
    Blood disorders
    Bone pain
    Creatine kinase increased
    Decrease in bone mineral density
    Diabetes insipidus
    Dream abnormalities
    Elevated amylase levels
    Elevated serum lipase
    Fanconi syndrome
    Graves' disease
    Hepatic impairment
    Hepatic steatosis
    Hyperpigmentation of skin
    Immune Reactivation/Reconstitution Syndrome
    Increase in creatinine
    Increase in serum ALT/AST
    Lactic acidosis
    Maculopapular rash
    Metabolic disorders
    Muscle weakness
    Proximal tubulopathy
    Pustular rash
    Renal failure
    Vesiculo-bullous reactions


    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 2018

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    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: Truvada film-coated tablets. Gilead Sciences Ltd. Revised December 2018.
    Summary of Product Characteristics: Ictastan 200mg/245mg film-coated tablets. Accord UK Ltd. Revised June 2018.

    MHRA Drug Safety Update 14 December 2015. 'Antiretroviral medicines: updated advice on body-fat changes and lactic acidosis'
    Available at:
    Last accessed: 26 October 2016

    NICE Evidence Services Available at: Last accessed: 15 October 2018

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Emtricitabine Last revised: 31 July 2018
    Last accessed: 13 October 2016

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Tenofovir Last revised: 01 October 2018
    Last accessed: 15 October 2018

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