This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Etravirine oral


Tablets containing etravirine

Drugs List

  • etravirine 100mg tablets
  • etravirine 200mg tablets
  • INTELENCE 100mg tablets
  • INTELENCE 200mg tablets
  • Therapeutic Indications


    HIV infection-combined with other antiretrovirals

    Treatment of human immunodeficiency virus type 1 (HIV-1) when used in combination with a boosted protease inhibitor and other antiretroviral drugs in antiretroviral treatment experienced patients aged 2 years and older.



    200 mg twice daily


    200 mg twice daily


    Children 2 to 18 years
    Body weight less than 10 kg: Contraindicated
    Body weight 10 kg to less than 20 kg: 100 mg twice daily
    Body weight 20 kg to less than 25 kg: 125 mg twice daily
    Body weight 25 kg to less than 30 kg: 150 mg twice daily
    Body weight equal to or greater than 30 kg: 200 mg twice daily


    Children under 2 years
    Children weighing less than 10kg
    Acute porphyria
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10

    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
    Must be used in combination with other antiretrovirals
    Treatment should be initiated by doctor experienced in HIV management
    Some formulations contain lactose
    Autoimmune disorders can occur many months after initiation of treatment
    Evaluate for physical signs of fat redistribution
    Monitor blood glucose
    Monitor serum lipids
    Advise patient to seek immediate medical advice if rash occurs
    Advise patient to seek medical advice if joint aches or pain occur
    Advise patient to seek medical advice if movement becomes difficult
    Advise patient to stop therapy & contact Dr if hypersensitivity signs occur
    Inflammatory symptoms should be evaluated and treated appropriately
    Risk of developing opportunistic infections
    Discontinue if drug-related rash or other hypersensitivity reactions occur
    Discontinue if hypersensitivity reactions occur
    Discontinue if severe skin reaction occurs
    Advise patient not to take St John's wort concurrently

    Examples of fatal severe hypersensitivity syndromes, including DRESS (Drug rash with eosinophilia and systemic symptoms) and TEN (toxic epidermal necrosis) have been reported with etravirine use. The DRESS syndrome is characterised by rash, fever, eosinophilia and systemic involvement (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, eosinophilia). The time to onset is usually 3-6 weeks after treatment starts and the outcome in most cases is favourable upon discontinuation and after initiation of corticosteroid therapy. Patients who delay in stopping treatment with etravirine after the onset of severe rash may result in a life threatening reaction. Once a patient has stopped treatment due to hypersensitivity reactions re-start of treatment with etravirine is not recommended.

    Pregnancy and Lactation


    Use etravirine with caution in pregnancy.

    Briggs suggests the etravirine should not be withheld because of pregnancy. The manufacturer suggests, based on limited data no dose adjustment is required, however caution is advised with concurrent medication or other conditions which may further increase etravirine exposure.

    When considering the treatment of HIV infected women during pregnancy, the present and future health of the mother, the prevention of maternal to foetal transmission and the limitations from the drug toxicity to the HIV-exposed foetus should be considered. The optimal antiretroviral therapy regimen for each patient depends on their HIV RNA levels, previous disease history, and obstetric history.

    At the time of writing, there is no adequate published experience concerning exposed pregnancies and their outcomes. Placental transfer has been observed in rats, however, it is not known whether placental transfer occurs in humans. Studies in animals have not indicated any direct of indirect harmful effects with respect to pregnancy, embryo or foetal development, parturition or postnatal development.

    Briggs suggests administering zidovudine during the intrapartum period regardless of current regimen, as this may prevent vertical transmission of HIV to the newborn.


    Etravirine is contraindicated during breastfeeding.

    It is not known whether etravirine is excreted into breast milk. HIV can be transmitted from mother to child through breast milk. Therefore it is recommended that HIV-infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV.


    Advise patients with swallowing difficulties etravirine tablets may be dispersed in a glass of water. Once dispersed, the dispersion should be well stirred and drunk immediately. The glass should be rinsed with water several times and each rinse should be swallowed to ensure that the entire dose is consumed.

    Advise patients that treatment does not prevent the transmission of HIV via blood contamination or sexual contact and appropriate precautions should still be used.

    Advise patients that treatment is not a cure for HIV infection and they may still develop opportunistic infections and other complications of HIV infection.

    Advise patients if a dose if missed within 6 hours of usual dosage time, the dose should be taken as soon as possible following a meal with the following dose at its normal time. If a dose is missed more than 6 hours after usual dosage time, no catch up dose should be taken and the next dose should be at the usual time.

    Advise patients if vomiting occurs within 4 hours of taking etravirine, another dose should be taken as soon as possible following a meal. If the patient vomits more than 4 hours after taking etravirine, the patient does not need to take another dose until the next scheduled time.

    Advise patients that they should not take St John's Wort during treatment with etravirine.

    Advise patients to seek medical advice if they develop joint aches and pains, joint stiffness or difficulty in movement.

    Advise patients to seek immediate medical advice if severe rash or hypersensitivity reactions occur.

    Advise patients that the ability to drive or operate machinery may be affected by side effects.

    Side Effects

    Abdominal distension
    Abdominal pain
    Angina pectoris
    Angioneurotic oedema
    Atrial fibrillation
    Attention disturbances
    Autoimmune hepatitis
    Blurred vision
    Cytolytic hepatitis
    Diabetes mellitus
    Dream abnormalities
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Dry mouth
    Dry skin
    Elevated amylase levels
    Elevated serum LDL cholesterol
    Elevated serum lipase
    Elevated triglyceride levels
    Erythema multiforme
    Facial swelling
    Gastroesophageal reflux disease
    Graves' disease
    Hepatic steatosis
    Hypersensitivity reactions
    Immune Reactivation/Reconstitution Syndrome
    Increase in plasma cholesterol
    Increase in serum ALT/AST
    Increase in serum glucose
    Joint ache
    Muscle ache
    Myocardial infarction
    Night sweats
    Oral lesions
    Peripheral neuropathy
    Reduced neutrophil count
    Renal failure
    Serum creatinine increased
    Sleep disturbances
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    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: May 2013

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Intelence 25, 100, 200mg tablets. Janssen-Cilag Ltd. Revised April 2020.

    NICE Evidence Services Available at: Last accessed: 14 October 2022

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Etravirine. Last revised: August 2, 2011
    Last accessed: May 23, 2013

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    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.