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Etravirine

Generic Name
Etravirine
Brand Names
Intelence
Drug Type
Small Molecule
Chemical Formula
C20H15BrN6O
CAS Number
269055-15-4
Unique Ingredient Identifier
0C50HW4FO1

Overview

Etravirine is an antiretroviral agent more specifically classified as a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI). Etraverine is used clinically for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. On January 18, 2007, the FDA granted accelerated approved for the use of etravirine 100mg tablets in the treatment of adult HIV-1 infection documented to be resistant to therapy with other NNRTIs and antiretroviral agents. On March 26, 2012, approval was extended for use in treatment-experienced pediatric patients 6 to 18 years of age, weighing at least 16 kg. Etravarine must always be used in combination with other antiretroviral drugs. Etravirine exerts its effects via direct inhibition of the reverse transcriptase enzyme of human immunodeficiency virus type 1 (HIV-1), and consequently blocks DNA-dependent and RNA-dependent polymerase activity. Etravirine does not inhibit human DNA polymerase alpha, beta or gamma. Common side effects of use include mild to moderate rash within the first 6 weeks of therapy, nausea, diarrhea and peripheral neuropathy. Patients are advised to immediately contact their healthcare provider if a rash develops. In 2009, postmarketing case reports of Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme, and other hypersensitivity reactions lead to a revision of etravirine's "Warnings and Precautions," as well as notification of health care providers. In 2013, reports of Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) in the setting of immune reconstitution, as well as more in depth information about the development of rashes in patients taking etravirine, lead to a modification of etravirine's monograph.

Background

Etravirine is an antiretroviral agent more specifically classified as a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI). Etraverine is used clinically for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. On January 18, 2007, the FDA granted accelerated approved for the use of etravirine 100mg tablets in the treatment of adult HIV-1 infection documented to be resistant to therapy with other NNRTIs and antiretroviral agents. On March 26, 2012, approval was extended for use in treatment-experienced pediatric patients 6 to 18 years of age, weighing at least 16 kg. Etravarine must always be used in combination with other antiretroviral drugs. Etravirine exerts its effects via direct inhibition of the reverse transcriptase enzyme of human immunodeficiency virus type 1 (HIV-1), and consequently blocks DNA-dependent and RNA-dependent polymerase activity. Etravirine does not inhibit human DNA polymerase alpha, beta or gamma. Common side effects of use include mild to moderate rash within the first 6 weeks of therapy, nausea, diarrhea and peripheral neuropathy. Patients are advised to immediately contact their healthcare provider if a rash develops. In 2009, postmarketing case reports of Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme, and other hypersensitivity reactions lead to a revision of etravirine's "Warnings and Precautions," as well as notification of health care providers. In 2013, reports of Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) in the setting of immune reconstitution, as well as more in depth information about the development of rashes in patients taking etravirine, lead to a modification of etravirine's monograph.

Indication

Etravirine is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment-experienced patients ≥2 years of age.

Associated Conditions

  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

FDA Approved Products

ETRAVIRINE
Manufacturer:Carnegie Pharmaceuticals LLC
Route:ORAL
Strength:100 mg in 1 1
Approved: 2024/03/05
NDC:80005-112
etravirine
Manufacturer:AvKARE
Route:ORAL
Strength:100 mg in 1 1
Approved: 2024/01/09
NDC:42291-473
ETRAVIRINE
Manufacturer:Leading Pharma, LLC
Route:ORAL
Strength:200 mg in 1 1
Approved: 2024/01/10
NDC:69315-286
Intelence
Manufacturer:Janssen Products LP
Route:ORAL
Strength:25 mg in 1 1
Approved: 2023/08/15
NDC:59676-572
etravirine
Manufacturer:Amneal Pharmaceuticals NY LLC
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/09/06
NDC:60219-1722

Singapore Approved Products

INTELENCE TABLET 200 MG
Manufacturer:Janssen Pharmaceutica NV (Spray Dried Powder), Janssen Cilag S.p.A
Form:TABLET
Strength:200mg/tablet
Online:Yes
Approved: 2014/04/03
Approval:SIN14535P

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