Registered Zambia · ZAMRA

Intelence

Etravirine 100.0 mg

145/043 Tablet Uncoated 100.0 mg antiinfectives for systemic use INN generic

What it does

Etravirine is an antiviral medication used to treat HIV infection.

Commonly used for: HIV infection (human immunodeficiency virus), AIDS (acquired immune deficiency syndrome)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
145/043
Registration date
2025-07-11
Expiry date
2030-07-10
Status
Registered/Compliant
Active ingredient
Etravirine 100.0 mg
Dosage form
Tablet Uncoated
Strength
100.0 mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
J05AG - Non-nucleoside reverse transcriptase inhibitors
RxNorm RxCUI
475969
Manufacturer / MAH
Janssen Ortho
Country of origin
Belgium
Manufacturer location
Janssen-Pharmaceuticalaan 3, 2440 Geel, Belgium

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:06:15 · updated 2026-09-28 03:38:17

Drug Interactions

27
Check interactions

Severe (5)

Benzodiazepines - increases exposure

Etravirine is predicted to increase the exposure to benzodiazepines (diazepam). Avoid.

Severe Theoretical

Diazepam - increases exposure

Etravirine is predicted to increase the exposure to benzodiazepines (diazepam). Avoid.

Severe Theoretical

Etravirine - decreases exposure

St John’s wort is predicted to decrease the exposure to etravirine. Avoid.

Severe Study

Mobocertinib - decreases exposure

Etravirineispredictedtodecreasetheexposureto mobocertinib.Avoid.rTheoretical

Severe Theoretical

Zanubrutinib - decreases exposure

Etravirineispredictedtodecreasetheexposureto zanubrutinib.Avoid.oTheoretical

Severe Theoretical

Moderate (7)

Atorvastatin - decreases exposure

Etravirine slightly decreases the exposure to statins (atorvastatin). Monitor and adjust dose.

Moderate Study

Fluvastatin - increases exposure

Etravirine is predicted to increase the exposure to statins (fluvastatin). Adjust dose.

Moderate Theoretical

Osimertinib - decreases exposure

Etravirine is predicted to decrease the exposure to simertinib. Use with caution or avoid.

Moderate Theoretical

Phosphodiesterase Type- - decreases exposure

Etravirine moderately decreases the exposure to phosphodiesterase type-5 inhibitors. Adjust dose.

Moderate Study

Simvastatin - decreases exposure

Etravirine is predicted to decrease the exposure to statins (simvastatin). Adjust dose.

Moderate Theoretical

Statins - decreases exposure

Etravirine slightly decreases the exposure to statins (atorvastatin). Monitor and adjust dose.

Moderate Study

Statins - increases exposure

Etravirine is predicted to increase the exposure to statins (fluvastatin). Adjust dose.

Moderate Theoretical

Unknown (15)

Antimalarials - decreases exposure

Etravirine decreases the exposure to antimalarials (artemether).

Unknown Study

Artemether - decreases exposure

Etravirine decreases the exposure to antimalarials (artemether).

Unknown Study

Avapritinib - decreases exposure

Etravirineispredictedtodecreasetheexposuretoavapritinib. Avoid.rTheoretical

Unknown Theoretical

Bedaquiline - decreases exposure

Etravirineispredictedtodecreasetheexposuretobedaquiline. Avoid.rTheoretical

Unknown Theoretical

Bosutinib - decreases exposure

Etravirineispredictedtodecreasetheexposuretobosutinib. Avoid.rTheoretical

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About this medicine

Etravirine is an antiviral medication used to treat HIV infection.

What it treats

  • HIV infection (human immunodeficiency virus)
  • AIDS (acquired immune deficiency syndrome)

How it works

It helps to control the amount of virus in the body, allowing the immune system to work better.

Who it's for

This medicine is for people living with HIV.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Etravirine

BNF-referenced

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in the treatment of human immunodeficiency virus type 1 (HIV-1) infection. It is indicated for adult and paediatric patients aged 2 years and older who are experienced in antiretroviral treatment. Etravirine is administered in combination with other antiretroviral drugs, including boosted protease inhibitors, to enhance therapeutic efficacy and reduce the viral load in patients with HIV-1.

Indications

  • HIV infection in antiretroviral treatment-experienced adults
  • HIV infection in antiretroviral treatment-experienced paediatric patients from 2 years of age

Dosage

Children: For paediatric patients aged 2 years and older, refer to the BNF for Children for specific dosing guidelines.

Adults: The recommended initial dose is 200 mg once daily for the first 14 days, followed by a maintenance dose of 200 mg twice daily, to be taken after food.

Mechanism of action

Etravirine exerts its effects via direct inhibition of the reverse transcriptase enzyme of HIV-1. It binds directly to reverse transcriptase, blocking both DNA-dependent and RNA-dependent polymerase activity, while sparing human DNA polymerase alpha, beta, and gamma from inhibition.

Pharmacodynamics

Clinical studies have demonstrated that Etravirine does not prolong QT intervals on electrocardiograms after 8 days of dosing, indicating a favorable cardiac safety profile.

Pharmacokinetics

Etravirine is well absorbed when taken orally, with food enhancing its bioavailability. It is extensively metabolized in the liver via cytochrome P450 enzymes, particularly CYP2C19, CYP2C9, and CYP3A4. The drug has a half-life of approximately 20 to 30 hours, allowing for twice-daily dosing. Etravirine is primarily excreted through feces, with only a small percentage eliminated unchanged in urine.

Contra-indications

  • Acute porphyrias

Adverse effects

  • Diarrhoea
  • Drowsiness
  • Dry mouth
  • Dyslipidaemia
  • Dyspnoea
  • Gastrointestinal discomfort
  • Headache
  • Hyperglycaemia
  • Hypersensitivity reactions
  • Hypertension
  • Memory loss
  • Myocardial infarction
  • Nausea
  • Peripheral neuropathy
  • Renal failure
  • Rash (usually in the second week)
  • Sleep disorders
  • Sweat changes
  • Thrombocytopenia
  • Vision blurred
  • Vomiting
  • Angina pectoris
  • Angioedema
  • Atrial fibrillation
  • Bronchospasm
  • Concentration impaired
  • Confusion
  • Gynaecomastia
  • Haematemesis
  • Hepatic disorders
  • Immune reconstitution inflammatory syndrome
  • Pancreatitis
  • Seizure
  • Syncope
  • Tremor
  • Vertigo
  • Osteonecrosis

Interactions

  • Etravirine + benzodiazepines: Severe (increases exposure)
  • Etravirine + diazepam: Severe (increases exposure)
  • Etravirine + mobocertinib: Severe (decreases exposure)
  • St John's Wort + etravirine: Severe (decreases exposure)
  • Etravirine + zanubrutinib: Severe (decreases exposure)
  • Etravirine + osimertinib: Moderate (decreases exposure)
  • Etravirine + phosphodiesterase type-5 inhibitors: Moderate (decreases exposure)
  • Etravirine + statins: Moderate (decreases or increases exposure, depending on the statin)

Precautions

  • Caution in elderly patients
  • Monitor liver function in patients with hepatic impairment
  • Caution in patients with CD4 cell counts greater than 250 cells/mm3
  • Caution in patients with severe renal failure

Pregnancy

Reports of neural tube defects when used

BNF 85 (British National Formulary) p.729 BNF for Children 2019-2020 p.451 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Etravirine

PubChem CID 193962

Molecular formula: C20H15BrN6O

Mechanism of action

Etravirine exerts its effects via direct inhibition of the reverse transcriptase enzyme of human immunodeficiency virus type 1 (HIV-1). It directly binds reverse transcriptase and consequently blocks DNA-dependent and RNA-dependent polymerase activity. Etravirine does not inhibit human DNA polymerase alpha, beta or gamma.

Pharmacodynamics

Clinical trials have shown no prolongation of QT intervals on electrocardiograms after 8 days of dosing.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.