ETRAVIRINE 200 mg Tablets

Next-Generation NNRTI – Non-Nucleoside Reverse Transcriptase Inhibitor

ATC Code: J05AG04 | Prescription Only | Second-Line or Salvage HIV Therapy

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Product Description:

Etravirine is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) used in the treatment of HIV-1 infection. Unlike older NNRTIs, it binds flexibly to reverse transcriptase and retains efficacy in the presence of several resistance mutations. It is primarily indicated for treatment-experienced patients with documented NNRTI resistance and is typically used in salvage or second-line regimens.

Etravirine is metabolized via CYP3A, CYP2C9, and CYP2C19, and may be co-administered with boosted protease inhibitors, integrase inhibitors, and NRTIs in multidrug-resistant HIV infection.

Available Presentation:

• Strength: 200 mg per tablet
• Formulation: Film-coated oral tablet
• Packaging: Bottle of 60 tablets (typically dosed as 200 mg twice daily)
• Route of Administration: Oral, after a meal
• Storage Conditions: Store below 30°C; protect from excessive moisture

Uses:

• Salvage therapy for patients with documented resistance to first-generation NNRTIs (efavirenz, nevirapine)
• Part of individualized regimens for treatment-experienced patients with multiclass resistance
• May be co-formulated with:
  • Boosted protease inhibitors (e.g., darunavir/ritonavir)
  • NRTI backbone or integrase inhibitors (e.g., dolutegravir) depending on resistance profile

Indications:

• HIV-1 infection in treatment-experienced adults and adolescents ≥6 years who have evidence of resistance to other NNRTIs
• Appropriate for use in:
  • Second-line or third-line ART regimens under WHO or national guidelines
  • Salvage therapy for multidrug-resistant HIV
  • Clinical protocols involving extensive genotypic resistance testing

Regulatory and Safety Profile:

• ATC Code: J05AG04
• Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
• Pregnancy Category: B – Limited human data; use only if clearly needed
• Common Adverse Effects: Rash, nausea, headache, peripheral neuropathy
• Serious Risks: Stevens-Johnson syndrome, hepatotoxicity, hypersensitivity reactions
• Contraindications: Known hypersensitivity to etravirine; coadministration with strong CYP3A inducers (e.g., carbamazepine, phenobarbital, rifampin)
• Monitoring Parameters: Liver function, skin reactions, lipid profile, adherence in complex regimens

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For inclusion in advanced HIV protocol formularies, resistance-guided salvage regimens, or institutional supply programs, contact info@panamfarma.com.