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etravirine (Rx)Brand and Other Names:Intelence

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 100mg
  • 200mg
more...

HIV Infection

Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents

200 mg PO q12hr

Administration

Take ONLY after a meal

If unable to swallow tablet whole, may disperse tablet(s) in 5 mL of water, stir dispersion well; may add more water or alternatively orange juice or milk; do not mix with grapefruit juice, warm liquids, or carbonated beverages

Drink dispersion immediately

Rinse glass several times with water, orange juice, or milk and completely swallow the rinse each time to ensure the entire dose is taken

Renal Impairment

No dosage adjustment required

Hepatic Impairment

Mild-to-moderate (Child-Pugh class A or B): No dosage adjustment required

Severe impairment (Child-Pugh class C): Not studied

Dosage Forms & Strengths

tablet

  • 25mg (scored)
  • 100mg
  • 200mg
more...

HIV Infection

Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents

<6 years

  • Safety and efficacy not established

>6 years

  • <16 kg: Safety and efficacy not established
  • 16 kg to <20 kg: 100 mg PO q12hr
  • 20 kg to <25 kg: 125 mg PO q12hr
  • 25 kg to <30 kg: 150 mg PO q12hr
  • 30 kg or greater: 200 mg PO q12hr

Administration

Take ONLY after a meal

If unable to swallow tablet whole, may disperse tablet(s) in 5 mL of water, stir dispersion well; may add more water or alternatively orange juice or milk; do not mix with grapefruit juice, warm liquids, or carbonated beverages

Drink dispersion immediately

Rinse glass several times with water, orange juice, or milk and completely swallow the rinse each time to ensure the entire dose is taken

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Interactions

Interaction Checker

etravirine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
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            Adverse Effects

            >10%

            Rash (16.9%)

            Nausea (13.9%)

            Increased LDL (13%)

            1-10%

            GI disorders (2.3-5.2%)

            Fatigue (3.3%)

            Peripheral neuropathy (4%)

            Increased creatinine (2%)

            Diarrhea (2%)

            <1%

            Stevens-Johnson syndrome

            Erythema multiforme

            Angina

            Angioedema

            Toxic epidermal necrolysis (including reports of fatalities)

            Hypersensitivity reactions (including cases of hepatic failure)

            Postmarketing Reports

            Immune system disorders: Severe hypersensitivity reactions including DRESS and cases of hepatic failure

            Musculoskeletal and connective tissue disorders: Rhabdomyolysis

            Skin and subcutaneous tissue disorders: Fatal cases of toxic epidermal necrolysis

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            Warnings

            Contraindications

            Coadministration with drugs (eg, CYP inducers) where significant decreases in etravirine plasma concentrations may occur, which may result in loss of virologic response and possible resistance and cross-resistance to other NNRTIs

            Cautions

            Hypersensitivity

            Risk of severe skin reactions, including Stevens-Johnson Syndrome, erythema multiforme, toxic epidermal necrolysis (sometimes accompanied by hepatic failure)

            Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction

            Discontinue if severe rash develops and initiate appropriate therapy

            Risk of immune reconstitution syndrome

            50% decrease in absorption when administered under fasting conditions: only take with meal

            Do not coadminister with other NNRTIs

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: It is not known whether etravirine is excreted in milk. It should not be administered to nursing mothers. The CDC advises HIV-infected women not to breast-feed to avoid postnatal transmission of HIV.

            Pregnancy Registry: Physicians are encouraged to enroll pregnant women exposed to etravirine by calling 1-800-258-4263.

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1

            Absorption

            Peak Plasma Time: 3-5 hr

            Distribution

            Protein Bound: 99.9%

            Metabolism

            Metabolized in liver by CYP3A4, CYP2C9, and CYP2C19

            Induces CYP3A4

            Inhibits CYP2C9 and CYP2C19

            Elimination

            Half-Life: 41 hr +/- 20 hr

            Excretion: Feces 93.7%; urine 1.2%

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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