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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.

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2020/11/16
Phase 1
Completed
2020/02/17
Phase 2
Completed
IRCCS Eugenio Medea
2019/12/23
Phase 1
Completed
2016/06/29
Phase 1
Completed
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
2014/02/14
Phase 1
Completed
2013/06/13
Phase 1
Completed
Janssen Pharmaceutica N.V., Belgium
2012/07/16
Phase 4
Completed
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
2012/06/21
Not Applicable
Completed
2012/06/08
N/A
Completed
2012/01/05
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Leading Pharma, LLC
69315-286
ORAL
200 mg in 1 1
1/10/2024
Janssen Products LP
59676-571
ORAL
200 mg in 1 1
8/15/2023
Physicians Total Care, Inc.
54868-5864
ORAL
100 mg in 1 1
1/2/2013
AvKARE
42291-474
ORAL
200 mg in 1 1
1/9/2024
Physicians Total Care, Inc.
54868-6368
ORAL
200 mg in 1 1
1/2/2013
Leading Pharma, LLC
69315-285
ORAL
100 mg in 1 1
1/10/2024
AvKARE
42291-473
ORAL
100 mg in 1 1
1/9/2024
Amneal Pharmaceuticals NY LLC
69238-1720
ORAL
25 mg in 1 1
12/30/2023
Patriot Pharmaceuticals
10147-0570
ORAL
100 mg in 1 1
3/26/2025
Amneal Pharmaceuticals NY LLC
69238-1722
ORAL
200 mg in 1 1
12/30/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
8/28/2008

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
INTELENCE TABLET 200 MG
SIN14535P
TABLET
200mg/tablet
4/3/2014

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
INTELENCE etravirine 200 mg tablet bottle
176557
Medicine
A
8/22/2011
INTELENCE etravirine 100 mg tablet bottle
145797
Medicine
A
12/19/2008

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
INTELENCE
02396750
Tablet - Oral
25 MG
6/14/2013
INTELENCE
02306778
Tablet - Oral
100 MG
3/27/2008
INTELENCE
02375931
Tablet - Oral
200 MG
12/12/2011

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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