The efficacy of INTELENCE for treatment-experienced pediatric subjects is based on two Phase 2 trials, TMC125-C213 and TMC125-C234/IMPAACT P1090.
Pediatric Subjects (6 Years to Less Than 18 Years of Age [TMC125-C213])
TMC125-C213, a single-arm, Phase 2 trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of INTELENCE enrolled 101 antiretroviral treatment-experienced HIV-1 infected pediatric subjects 6 years to less than 18 years of age and weighing at least 16 kg. Subjects eligible for this trial were on an antiretroviral regimen with confirmed plasma HIV-1 RNA of at least 500 copies/mL and viral susceptibility to INTELENCE at screening.
The median baseline plasma HIV-1 RNA was 3.9 log 10 copies/mL, and the median baseline CD4+ cell count was 385 × 10 6 cells/mm 3.
At Week 24, 52% of subjects had HIV-1 RNA less than 50 copies per mL. The proportion of subjects with HIV-1 RNA less than 400 copies/mL was 67%. The mean CD4+ cell count increase from baseline was 112 × 10 6 cells/mm 3.
Pediatric Subjects (2 Years to Less Than 6 Years of Age [TMC125-C234/IMPAACT P1090])
TMC125-C234/IMPAACT P1090 is a Phase 1/2 trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of INTELENCE in 20 antiretroviral treatment-experienced HIV-1 infected pediatric subjects 2 years to less than 6 years of age. The study enrolled subjects who had virologic failure on an antiretroviral treatment regimen after at least 8 weeks of treatment, or who had interrupted treatment for at least 4 weeks. Enrolled subjects had a history of virologic failure while on an antiretroviral regimen, with a confirmed HIV-1 RNA plasma viral load greater than 1,000 copies/mL and with no evidence of phenotypic resistance to etravirine at screening.
The median baseline plasma HIV-1 RNA was 4.4 log 10 copies/mL, the median baseline CD4+ cell count was 817.5 × 10 6 cells/mm 3 , and the median baseline CD4+ percentage was 28%.
Virologic response, defined as achieving plasma viral load less than 400 HIV-1 RNA copies/mL, was evaluated.
Study treatment included etravirine plus an optimized background regimen of antiretroviral drugs. In addition to etravirine, all 20 subjects received a ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs (n=14) and/or in combination with an integrase inhibitor (n=7).
At the time of the Week 24 analysis, seventeen subjects had completed at least 24 weeks of treatment or discontinued earlier. At Week 24, the proportion of subjects with less than 400 HIV-1 RNA copies/mL was 88% (15/17), and the proportion of subjects with less than 50 HIV-1 RNA copies/mL was 50% (7/14), for those with available data. The median change in plasma HIV-1 RNA from baseline to Week 24 was -2.14 log 10 copies/mL. The median CD4+ cell count increase and the median CD4+ percentage increase from baseline was 298 × 10 6 cells/mm 3 and 5%, respectively.
INTELENCE 25 mg tablets are supplied as white to off-white, oval, scored tablets containing 25 mg of etravirine. Each tablet is debossed with “TMC” on one side.
INTELENCE 100 mg tablets are supplied as white to off-white, oval tablets containing 100 mg of etravirine. Each tablet is debossed with “TMC125” on one side and “100” on the other side.
INTELENCE 200 mg tablets are supplied as white to off-white, biconvex, oblong tablets containing 200 mg of etravirine. Each tablet is debossed with “T200” on one side.
INTELENCE tablets are packaged in bottles in the following configuration:
- 25 mg tablets—bottles of 120 (NDC 59676-572-01). Each bottle contains 2 desiccant pouches.
- 100 mg tablets—bottles of 120 (NDC 59676-570-01). Each bottle contains 3 desiccant pouches.
- 200 mg tablets—bottles of 60 (NDC 59676-571-01). Each bottle contains 3 desiccant pouches.
Store INTELENCE tablets at 25°C (77°F); with excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Store in the original bottle. Keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant pouches.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients to take INTELENCE following a meal twice a day on a regular dosing schedule, as missed doses can result in development of resistance. The type of food does not affect the exposure to etravirine. Inform patients not to take more or less than the prescribed dose of INTELENCE or discontinue therapy with INTELENCE without consulting their physician. INTELENCE must always be used in combination with other antiretroviral drugs [see Dosage and Administration (2.4)].
Advise patients to swallow the INTELENCE tablet(s) whole with a liquid such as water. Instruct patients not to chew the tablets. Patients who are unable to swallow the INTELENCE tablet(s) whole may disperse the tablet(s) in 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,
- add approximately 15 mL (1 tablespoon) of liquid. Water may be used, but orange juice or milk may improve taste. Patients should not place the tablets in orange juice or milk without first adding water. The use of warm (temperature greater than 104°F [greater than 40°C]) or carbonated beverages should be avoided.
- drink the mixture immediately,
- rinse the glass several times with orange juice, milk or water and completely swallow the rinse each time to make sure the patient takes the entire dose.
Severe Skin Reactions
Inform patients 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. Advise patients 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 your skin or whites of your eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your 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 [see Warnings and Precautions (5.1)] .
INTELENCE may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John’s wort [see Warnings and Precautions (5.2)] .
Immune Reconstitution Syndrome
Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.3)].
Inform patients 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 [see Warnings and Precautions (5.4)] .
Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant individuals exposed to INTELENCE [see Use in Specific Populations (8.1)] .
Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (8.2)] .
Product of Belgium
Finished Product manufactured by:
Janssen Cilag S.p.A., Latina, Italy
Janssen Ortho LLC, Gurabo, PR 00778
Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 © 2008 Janssen Pharmaceutical Companies
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Revised July 2019|
PATIENT INFORMATION INTELENCE ® (in-tel-ence) (etravirine) tablets
Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with INTELENCE. For more information, see the section ” What should I tell my healthcare provider before taking INTELENCE?”
What is INTELENCE?
INTELENCE is a prescription medicine that is used to treat human immunodeficiency virus-1 (HIV-1) infection in combination with other HIV-1 medicines, in adults and children 2 years of age and older who have taken HIV-1 medicines in the past.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
INTELENCE is not recommended for use in children less than 2 years of age.
Before taking INTELENCE tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines may interact with INTELENCE. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take INTELENCE?
What are the possible side effects of INTELENCE?
INTELENCE can cause serious side effects including:
If you get a rash with any of the following symptoms, stop taking INTELENCE and call your healthcare provider or get medical help right away:
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Sometimes allergic reactions can affect body organs, such as your liver. Call your healthcare provider right away if you have any of the following signs or symptoms of liver problems:
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The most common side effects of INTELENCE in adults include rash as well as numbness, tingling or pain in the hands or feet.
The most common side effects of INTELENCE in children include rash and diarrhea.
These are not all the possible side effects of INTELENCE.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store INTELENCE?
Keep INTELENCE and all medicines out of the reach of children.
General information about the safe and effective use of INTELENCE
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INTELENCE for a condition for which it was not prescribed. Do not give INTELENCE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about INTELENCE that is written for health professionals.
What are the ingredients in INTELENCE?
Active ingredient: etravirine.
25 mg and 100 mg INTELENCE tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
200 mg INTELENCE tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose.
Product of Belgium Finished Product Manufactured by: Janssen Cilag S.p.A., Latina, IT Or Janssen Ortho LLC, Gurabo, PR 00778 Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 © 2008, 2018 Janssen Pharmaceutical Companies
For more information, call Janssen Products, LP at 1-800-526-7736.
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