Etravirine Dosage

Usual Adult Dose for HIV Infection

200 mg orally twice a day after a meal

Usual Pediatric Dose for HIV Infection

6 to less than 18 years:
16 kg to less than 20 kg: 100 mg orally twice a day after a meal
20 kg to less than 25 kg: 125 mg orally twice a day after a meal
25 kg to less than 30 kg: 150 mg orally twice a day after a meal
30 kg or more: 200 mg orally twice a day after a meal

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild or moderate hepatic impairment (Child-Pugh Class A or B): No adjustment recommended.
Severe hepatic impairment (Child-Pugh Class C): Data not available

Precautions

Severe, potentially life-threatening, and fatal skin reactions have occurred. Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver failure) have also been reported. Rash most commonly occurred within 6 weeks of treatment initiation. If signs or symptoms of skin reactions or hypersensitivity reactions develop, etravirine therapy should be discontinued at once, clinical status (including liver transaminases) should be monitored, and appropriate treatment should be started. Delay in discontinuing etravirine following the onset of severe rash may result in a life-threatening reaction.

Etravirine may potentially interact with many drugs resulting in altered plasma levels of the other drugs or of etravirine. Patients should be advised to report all concurrent medications they are taking, including nonprescription medications and nutritional/herbal supplements; especially St. John's wort.

Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

The potential for HIV cross-resistance among nonnucleoside reverse transcriptase inhibitors (NNRTI) exists but has not been fully explored. Cross-resistance to other NNRTIs is expected following virologic failure with an etravirine-containing regimen for the virologic failure isolates. Selection of antiretroviral agents for a patient's medication regimen should be done carefully.

Use in combination with other active antiretroviral agents will increase the likelihood of treatment response. Patients who have experienced virologic failure on an NNRTI-containing regimen should not use etravirine in combination with only nucleoside/nucleotide reverse transcriptase inhibitors.

Safety and efficacy have not been established in treatment-naive patients.

Special attention should be given to accurate dose selection, transcription of the medication order, dispensing information, and dosing instructions to reduce the risk of medication errors, overdosing, and underdosing.

Safety and efficacy have not been established in pediatric patients less than 6 years of age.

Dialysis

No adjustment recommended.

Other Comments

Etravirine should be taken after a meal. The type of food does not affect the exposure to etravirine.

The etravirine tablet(s) should be swallowed whole with a liquid (such as water). Patients unable to swallow the etravirine tablet(s) whole may disperse the tablet(s) in a glass of water. The following instructions are recommended:
1. Place the tablet(s) in 5 mL of water, or at least enough liquid to cover the medication.
2. Stir well until the water looks milky.
3. If desired, add more water or alternatively orange juice or milk; the tablet(s) should not be placed in orange juice or milk without first adding water. Grapefruit juice, warm beverages (greater than 40 degrees Celsius), and carbonated beverages should be avoided.
4. Drink it immediately.
5. The glass should be rinsed with water, orange juice, or milk several times and each rinse should be completely swallowed to ensure the entire dose is consumed.

Etravirine should always be used in combination with other antiretroviral agents.