Intelence
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Uses
INTELENCE®1, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
This indication is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.
The following points should be considered when initiating therapy with INTELENCE®:
- Treatment history and, when available, resistance testing, should guide the use of INTELENCE®.
- The use of other active antiretroviral agents with INTELENCE® is associated with an increased likelihood of treatment response.
- In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs [see Clinical Studies (14)].
- The risks and benefits of INTELENCE® have not been established in pediatric patients or in treatment-naïve adult patients.
- 1
- Registered trademark of Tibotec Pharmaceuticals
History
There is currently no drug history available for this drug.
Other Information
INTELENCE® (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1).
The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C20H15BrN6O and its molecular weight is 435.28. Etravirine has the following structural formula:
Etravirine is a white to slightly yellowish brown powder. Etravirine is practically insoluble in water over a wide pH range. It is very slightly soluble in propylene glycol and slightly soluble in ethanol. Etravirine is soluble in polyethylene glycol (PEG)400 and freely soluble in some organic solvents (e.g., N,N-dimethylformamide and tetrahydrofuran).
INTELENCE® is available as a white to off-white, oval tablet for oral administration containing 100 mg of etravirine. Each tablet contains the inactive ingredients hypromellose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and lactose monohydrate.
Sources
Intelence Manufacturers
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State Of Florida Doh Central Pharmacy
![Intelence (Etravirine) Tablet [State Of Florida Doh Central Pharmacy]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Intelence | State Of Florida Doh Central Pharmacy
The recommended oral dose of INTELENCE® tablets is 200 mg (two 100 mg tablets) taken twice daily following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine. Patients who are unable to swallow INTELENCE® tablets whole may disperse the tablets in a glass of water. Once dispersed, patients should stir the dispersion well and drink it immediately. The glass should be rinsed with water several times and each rinse completely swallowed to ensure the entire dose is consumed.
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Physicians Total Care, Inc.
Intelence | Physicians Total Care, Inc.
2.1 Adult PatientsThe recommended oral dose of INTELENCE® tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
2.2 Pediatric Patients (6 years to less than 18 years of age)The recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight (see table below) not exceeding the recommended adult dose. INTELENCE tablet(s) should be taken orally, following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
Recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age Weight
kilograms (kg) Dose greater than or equal to 16 kg to less than 20 kg 100 mg twice daily greater than or equal to 20 kg to less than 25 kg 125 mg twice daily greater than or equal to 25 kg to less than 30 kg 150 mg twice daily greater than or equal to 30 kg 200 mg twice dailyThe safety and efficacy of INTELENCE® have not been established in children less than 6 years of age [see Clinical Pharmacology (12.3)].
Healthcare professionals should pay special attention to the accurate dose selection of INTELENCE®, the transcription of the medication order, the dispensing information and the dosing instructions to minimize the risk of medication errors, overdosing, and underdosing.
2.3 Method of AdministrationPatients should be instructed to swallow the INTELENCE® tablet(s) whole with a liquid such as water. 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. -
Remedyrepack Inc.
Intelence | Remedyrepack Inc.
Adult patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. (2.1, 2.3) Pediatric patients (6 years to less than 18 years of age and weighing at least 16 kg): dosage of INTELENCE® is based on body weight and should not exceed the recommended adult dose. (2.2, 2.3) INTELENCE® tablets should be taken following a meal. (2.2, 2.3)The recommended oral dose of INTELENCE® tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
The recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight (see table below) not exceeding the recommended adult dose. INTELENCE tablet(s) should be taken orally, following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
Recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age Weight
kilograms (kg) Dose greater than or equal to 16 kg to less than 20 kg 100 mg twice daily greater than or equal to 20 kg to less than 25 kg 125 mg twice daily greater than or equal to 25 kg to less than 30 kg 150 mg twice daily greater than or equal to 30 kg 200 mg twice dailyThe safety and efficacy of INTELENCE® have not been established in children less than 6 years of age [see Clinical Pharmacology (12.3)].
Healthcare professionals should pay special attention to the accurate dose selection of INTELENCE®, the transcription of the medication order, the dispensing information and the dosing instructions to minimize the risk of medication errors, overdosing, and underdosing.
Patients should be instructed to swallow the INTELENCE® tablet(s) whole with a liquid such as water. 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. -
Janssen Products Lp
Intelence | Janssen Products Lp
2.1 Adult PatientsThe recommended oral dose of INTELENCE® tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
2.2 Pediatric Patients (6 years to less than 18 years of age)The recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight (see table below) not exceeding the recommended adult dose. INTELENCE® tablet(s) should be taken orally, following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
Recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age Weight
kilograms (kg) Dose greater than or equal to 16 kg to less than 20 kg 100 mg twice daily greater than or equal to 20 kg to less than 25 kg 125 mg twice daily greater than or equal to 25 kg to less than 30 kg 150 mg twice daily greater than or equal to 30 kg 200 mg twice dailyThe safety and efficacy of INTELENCE® have not been established in children less than 6 years of age [see Clinical Pharmacology (12.3)].
Healthcare professionals should pay special attention to the accurate dose selection of INTELENCE®, the transcription of the medication order, the dispensing information and the dosing instructions to minimize the risk of medication errors, overdosing, and underdosing.
2.3 Method of AdministrationPatients should be instructed to swallow the INTELENCE® tablet(s) whole with a liquid such as water. 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 (Etravirine) Tablet [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=73667241-b95a-49b0-9c51-a4289f20d5c2&name=5864.jpg)
![Intelence (Etravirine) Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ab4c9d4-c2fc-4e01-94f1-a280de33ab2a&name=MM2.jpg)
![Intelence (Etravirine) Tablet [Janssen Products Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6a9cbc29-9f15-4b24-8d86-206b82887f3d&name=intelence-02.jpg)
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