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 |
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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