"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
INTELENCE®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
The indication for adult use 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 indication for pediatric use is based on 24-week analyses of a single-arm, Phase 2 trial in antiretroviral treatment-experienced pediatric subjects 6 years to less than 18 years of age [see Use in Specific Populations].
In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:
- Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance [see Microbiology and Clinical Studies].
- 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].
- The use of other active antiretroviral agents with INTELENCE® is associated with an increased likelihood of treatment response.
- The safety and efficacy of INTELENCE® have not been established in pediatric patients less than 6 years of age or in treatment-na´ve adult or pediatric patients.
DOSAGE AND ADMINISTRATION
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]. The type of food does not affect the exposure to etravirine.
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]. 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
|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 daily|
The safety and efficacy of INTELENCE® have not been established in children less than 6 years of age [see CLINICAL PHARMACOLOGY].
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.
Method Of Administration
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.
Dosage Forms And Strengths
INTELENCE® 25 mg Tablets
INTELENCE® 25 mg tablets are supplied as white to off-white, oval, scored tablets debossed with “TMC” on one side.
INTELENCE® 100 mg Tablets
INTELENCE® 100 mg tablets are supplied as white to off-white oval tablets debossed with “TMC125” on one side and “100” on the other side.
INTELENCE® 200 mg Tablets
INTELENCE® 200 mg tablets are supplied as white to off-white, biconvex, oblong tablets debossed with “T200” on one side.
Storage And Handling
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.
Product of Belgium Finished Product Manufactured by: Janssen Cilag S.p.A., Latina, IT Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560. Revised August 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/20/2015
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