Intelence Patient Counseling Information

Patients should be informed that INTELENCE is not a cure for HIV infection and that they may continue to develop opportunistic infections and other complications associated with HIV disease. Patients should be told that sustained decreases in plasma HIV RNA have been associated with a reduced risk of progression to AIDS and death. Patients should remain under the care of a physician while using INTELENCE.
Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
Patients should be advised to practice safe sex and to use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood. Patients should also be advised to never re-use or share needles or other injection equipment, or share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
Patients should be advised to take INTELENCE following a meal twice a day as prescribed. The type of food does not affect the exposure to etravirine.
Patients should be instructed to swallow the INTELENCE tablet(s) whole with a liquid such as water. Patients should be instructed not to chew the tablets. Patients who are unable to swallow the INTELENCE tablet(s) whole may disperse the tablet(s) in a glass of water. The patient should be instructed to do the following: Place the tablet(s) in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication.
Stir well until the water looks milky.
If desired, add more water or alternatively orange juice or milk (patients should not place the tablets in orange juice or milk without first adding water). The use of grapefruit juice or warm (greater than 40°C) or carbonated beverages should be avoided.
Drink it immediately.
Rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the patient takes the entire dose.
INTELENCE must always be used in combination with other antiretroviral drugs. Patients should not alter the dose of INTELENCE or discontinue therapy with INTELENCE without consulting their physician.
If the patient misses a dose of INTELENCE within 6 hours of the time it is usually taken, the patient should take INTELENCE following a meal as soon as possible, and then take the next dose of INTELENCE at the regularly scheduled time. If a patient misses a dose of INTELENCE by more than 6 hours of the time it is usually taken, the patient should not take the missed dose and simply resume the usual dosing schedule. Inform the patient that he or she should not take more or less than the prescribed dose of INTELENCE at any one time.
INTELENCE may interact with many drugs; therefore, patients should be advised to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John's wort.
Patients should be informed that severe and potentially life-threatening rash has been reported with INTELENCE. Rash has been reported most commonly in the first 6 weeks of therapy. Patients should be advised to immediately contact their healthcare provider if they develop rash. Instruct patients to immediately stop taking INTELENCE and seek medical attention if they develop a rash associated with any of the following symptoms as it may be a sign of a more serious reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis or severe hypersensitivity: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes, lips, mouth, breathing difficulty, and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on the right side below the ribs). Patients should understand that if severe rash occurs, they will be closely monitored, laboratory tests will be ordered and appropriate therapy will be initiated.
Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including INTELENCE, and that the cause and long-term health effects of these conditions are not known at this time.