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Etravirine

Etravirine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection i.

Checked against the official label · Updated

Prescription medicine मुख संबंधी अलर्ट चालू

How to use Etravirine

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

यह किसके लिए है

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. (1)

How to take it and how often
  • Adult patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal
  • Pregnant patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal
  • 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
  • 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 ]
  • 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 ] 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 ] . …
Strengths it comes in

100 mg white to off-white, uncoated, oval shaped tablet, debossed “CP112” on one side and plain on other side. 200 mg white to off-white, uncoated, oval shaped tablet, debossed “CP113” on one side and plain on other side. Tablets: 100 mg, and 200 mg (3)

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • Administration Advise patients to take etravirine tablets following a meal twice a day on a regular dosing schedule, as missed doses can result in development of resistance
  • The type of food does not affect the exposure to etravirine
  • Inform patients not to take more or less than the prescribed dose of etravirine tablets or discontinue therapy with etravirine tablets without consulting their physician
  • Etravirine tablets must always be used in combination with other antiretroviral drugs [see Dosage and Administration ]. …
Talk to a doctor first if
  • None
  • None
Medicines it may not mix with

Co-administration of etravirine with other drugs can alter the concentrations of other drugs and other drugs may alter the concentrations of etravirine. The potential drug-drug interactions must be considered prior to and during therapy. ( 7 , 12.3 ) 7.1 Potential for Other Drugs to Affect Etravirine Tablets Etravirine is a substrate of CYP3A, CYP2C9, and CYP2C19. Therefore, co-administration of etravirine tablets with drugs that induce or inhibit CYP3A, CYP2C9, and CYP2C19 may alter the therapeutic effect or adverse reaction profile of etravirine tablets (see Table 4) [see Clinical Pharmacology (12.3) ]. …

Warnings

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. …

Possible side effects

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. …

If you take too much

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.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2024-03-05.

Brands around the world

Products with Etravirine as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

EtravirineETRAVIRINE 1 kg/kg · Granule · Amneal Pharmaceuticals Co. (I) Pvt. Ltd.
NDC 52493-200Label
EtravirineETRAVIRINE 1 kg/kg · Powder · Matrix Pharmacorp Private Limited
NDC 84206-0046Label
EtravirineETRAVIRINE 200 mg/1 · Tablet · Leading Pharma, LLC
NDC 69315-286Label
EtravirineETRAVIRINE 100 mg/1 · Tablet · Carnegie Pharmaceuticals LLC
NDC 80005-112Label
EtravirineETRAVIRINE 200 mg/1 · Tablet · Carnegie Pharmaceuticals LLC
NDC 80005-113Label

Nigeria (NAFDAC)

NAFDACIntelence 100 mg Tablet A4-8886

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Etravirine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, CanaU.S. FDA Class II
14 Nov 2014 · Attix Pharmaceuticals · TerminatedPenicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the poten

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Etravirine

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Etravirine

What is Etravirine used for?

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) (From the official U.S. FDA label.)

How do I take Etravirine?

Follow your prescription or the leaflet in your pack. The official label says: 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 …

Do I need a prescription for Etravirine?

Usually yes. Etravirine is a prescription medicine in most countries. Rules differ by country.

What brands contain Etravirine?

Etravirine is sold under names such as Intelence. Brand names differ between countries.

What are the side effects of Etravirine?

The official label lists: 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… Tell your doctor about any side effect that bothers you or does not go away.

What medicines interact with Etravirine?

Co-administration of etravirine with other drugs can alter the concentrations of other drugs and other drugs may alter the concentrations of etravirine. The potential drug-drug interactions must be considered prior to and during therapy. ( 7 , 12.3 ) 7.1 Potential for Other Drugs to Affect Etravirine Tablets Etravirine is a substrate of CYP3A, CYP2C9, and CYP2C19. Therefore, co… Use the free interaction checker before combining medicines.

What happens if I take too much Etravirine?

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 m… Get medical help right away.

How can I check that my Etravirine is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.