Etravirine

Etravirine is an antiretroviral drug [see Microbiology (12.4) ] .

• Etravirine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14) ] Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older.ICD-10: B20

• None. None.contraindicated

Adult patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. ( 2.1 , 2.2 , 2.4 ) Pregnant patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. ( 2.2 ) Pediatric patients (2 years to less than 18 years of age and weighing at least 10 kg): dosage of etravirine is based on body weight and should not exceed the recommended adult dose. Etravirine tablets should be taken following a meal. ( 2.3 ) 2.1 Recommended Dosage in Adult Patients The recommended oral dosage of etravirine for adult patients is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. The type of food does not affect the exposure to etravirine [see Clinical Pharmacology (12.3) ] . 2.2 Recommended Dosage During Pregnancy The recommended oral dosage of etravirine for pregnant individuals is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal [see Use in Specific Populations (8.1) ] 2.3 Recommended Dosage in Pediatric Patients (2 Years to Less Than 18 Years of Age) The recommended dosage of etravirine for pediatric patients 2 years to less than 18 years of age and weighing at least 10 kg is based on body weight (see Table 1) not exceeding the recommended adult dosage. Etravirine should be taken orally, following a meal. The type of food does not affect the exposure to etravirine [see Clinical Pharmacology (12.3) ] .

Severe, potentially life threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, toxic epidermal necrolysis and erythema multiforme. Immediately discontinue treatment if severe hypersensitivity, severe rash or rash with systemic symptoms or liver transaminase elevations develops and monitor clinical status, including liver transaminases closely. ( 5.1 ) Monitor for immune reconstitution syndrome and fat redistribution. ( 5.3, 5.4 ) 5.1 Severe Skin and Hypersensitivity Reactions Severe, potentially life-threatening and fatal skin reactions have been reported. In clinical trials, these include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. In Phase 3 clinical trials, Grade 3 and 4 rashes were reported in 1.3% of subjects receiving etravirine compared to 0.2% of placebo subjects. A total of 2.2% of HIV-1-infected subjects receiving etravirine discontinued from Phase 3 trials due to rash [see Adverse Reactions (6.1 )] . Rash occurred most commonly during the first 6 weeks of therapy. The incidence of rash was higher in females [see Adverse Reactions (6.1) ] .

The following adverse reactions are described in greater detail in other sections: Severe skin and hypersensitivity reactions [see Warnings and Precautions (5.1) ] . Immune reconstitution syndrome [see Warnings and Precautions (5.3) ] . The most common adverse drug reactions of moderate to severe intensity (at least 2%) which occurred at a higher rate than placebo in adults are rash and peripheral neuropathy. ( 6.1 ) The most common adverse drug reactions in at least 2% of pediatric patients are rash and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Carnegie Pharmaceuticals, LLC at 1-732-783-7010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adults The safety assessment is based on all data from 1203 subjects in the Phase 3 placebo-controlled trials, TMC125-C206 and TMC125-C216, conducted in antiretroviral treatment-experienced HIV-1-infected adult subjects, 599 of whom received etravirine tablets (200 mg twice daily). In these pooled trials, the median exposure for subjects in the etravirine tablets arm and placebo arm was 52.3 and 51.0 weeks, respectively. Discontinuations due to adverse drug reactions (ADRs) were 5.2% in the etravirine tablets arm and 2.6% in the placebo arm.

Metabolism

The pharmacokinetic properties of etravirine tablets were determined in healthy adult subjects and in treatment-experienced HIV-1-infected adult and pediatric subjects. The systemic exposures (AUC) to etravirine were lower in HIV-1-infected subjects (Table 5) than in healthy subjects.

There is no specific antidote for overdose with etravirine tablets. Human experience of overdose with etravirine tablets is limited. The highest dose studied in healthy volunteers was 400 mg once daily. Treatment of overdose with etravirine tablets consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Because etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.

• Jan 18, 2008NDANDA022187Janssen R And D
• Jun 14, 2021ANDAANDA214196Amneal
• Apr 13, 2022ANDAANDA215402Carnegie
• Oct 2, 2025ANDAANDA219152Bionpharma

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Etravirine, Tablet, 100 mg (NDC 10147-0570-1)To be discontinued
  Sponsor: Janssen Research and Development
  Updated Apr 28, 2026
• Intelence, Tablet, 100 mg (NDC 59676-570-01)To be discontinued
  Sponsor: Janssen Research and Development
  Updated Apr 28, 2026

1. 1Pain2856.5%
2. 2Drug Interaction2826.4%
3. 3Drug Resistance2585.9%
4. 4Anxiety2475.6%
5. 5Emotional Distress2435.5%
6. 6Virologic Failure2335.3%
7. 7Anhedonia2195.0%
8. 8Death2064.7%
9. 9Treatment Failure2034.6%
10. 10Chronic Kidney Disease1924.4%
11. 11Lipodystrophy Acquired1754.0%
12. 12Renal Failure1653.8%
13. 13Anaemia1633.7%
14. 14Foetal Exposure During Pregnancy1633.7%
15. 15Drug Ineffective1573.6%

The 10 most recently updated of 88 ClinicalTrials.gov registrations naming Etravirine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
  Completed · Phase 3 · Interventional · 180 enrolled · Janssen Sciences Ireland UC
  NCT00980538updated 2026-06-09
• The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs
  Approved for marketing · Expanded access · Tibotec Pharmaceuticals, Ireland
  NCT00354627updated 2026-06-04
• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 133 enrolled · Gilead Sciences
  NCT02016924updated 2026-04-21
• Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
  Completed · Phase 3 · Interventional · 640 enrolled · ANRS, Emerging Infectious Diseases
  NCT03256422updated 2026-04-13
• Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL
  Completed · Phase 2 · Interventional · 170 enrolled · ANRS, Emerging Infectious Diseases
  NCT02212379updated 2026-04-03
• Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy
  Completed · Phase 3 · Interventional · 224 enrolled · University Hospital, Tours
  NCT02302547updated 2025-12-26
• Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
  Completed · Observational · 1,578 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00042289updated 2025-12-02
• Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses
  Not yet recruiting · Phase 2 · Interventional · 140 enrolled · ANRS, Emerging Infectious Diseases
  NCT06338826updated 2025-02-05
• A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants
  Completed · Phase 1 · Interventional · 32 enrolled · Janssen Research & Development, LLC
  NCT04208373updated 2025-02-03
• Switch From Etravirine to Doravirine as a Part of Antiretroviral Combination
  Completed · Observational · 109 enrolled · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
  NCT06155019updated 2025-01-10

Frequently asked questions

How does Etravirine work?

Etravirine is an antiretroviral drug [see Microbiology (12.4) ] .

What is Etravirine used for?

According to FDA labeling, Etravirine carries indications including: Etravirine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14) ] Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Etravirine?

Etravirine is classified as Non-nucleoside reverse transcriptase inhibitors, Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 2C9 Inhibitors, Cytochrome P450 3A Inducers, Non-Nucleoside Reverse Transcriptase Inhibitors, P-Glycoprotein Inhibitors, Decreased Reverse Transcription to DNA.

What are the brand names for Etravirine?

Etravirine is marketed under brand names including Intelence.

What are the contraindications for Etravirine?

Etravirine labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.