Intelence (Page 8 of 9)

14.2 Treatment-Experienced Pediatric Subjects (2 Years to Less Than 18 Years of Age)

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 log10 copies/mL, and the median baseline CD4+ cell count was 385 × 106 cells/mm3.

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 × 106 cells/mm3.

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 log10 copies/mL, the median baseline CD4+ cell count was 817.5 × 106 cells/mm3 , 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 log10 copies/mL. The median CD4+ cell count increase and the median CD4+ percentage increase from baseline was 298 × 106 cells/mm3 and 5%, respectively.

16 HOW SUPPLIED/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.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Administration

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)].

Drug Interactions

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)].

Fat Redistribution

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)].

Pregnancy Registry

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)].

Lactation

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
Or
Janssen Ortho LLC, Gurabo, PR 00778

Manufactured for:
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.

What should I tell my healthcare provider before taking INTELENCE?

Before taking INTELENCE tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems, including hepatitis B or C.
  • are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant during treatment with INTELENCE.Pregnancy Registry: There is a pregnancy registry for people who take INTELENCE during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take INTELENCE.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • INTELENCE can pass to your baby in your breast milk.
    • Talk with your healthcare provider about the best way to feed your baby.

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.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with INTELENCE.
  • Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take INTELENCE with other medicines.

How should I take INTELENCE?

  • Stay under the care of your healthcare provider during treatment with INTELENCE.
  • Take INTELENCE tablets every day exactly as prescribed by your healthcare provider.
  • Your healthcare provider will tell you how many INTELENCE tablets to take and when to take them. Talk to your healthcare provider if you have questions about when to take INTELENCE.
  • Take INTELENCE 2 times each day.
  • If your child takes INTELENCE, your healthcare provider will prescribe the right dose based on your child’s weight.
  • Always take INTELENCE following a meal. Do not take INTELENCE on an empty stomach. INTELENCE may not work as well if you take it on an empty stomach.
  • Do not change your dose or stop taking INTELENCE without first talking with your healthcare provider.
  • Swallow INTELENCE tablets whole, with liquid, such as water. Do not chew the tablet(s).
  • If you are unable to swallow INTELENCE tablets whole, you may take your dose of INTELENCE as follows:Step 1: Measure approximately 5 mL (1 teaspoon) of water and pour into a cup.Step 2: Place the tablets in the cup containing 5 mL of water. If needed, add more water to cover the tablets. Do not put the tablets in other liquids. Step 3: Stir well until the water looks milky.Step 4: Add a small amount (approximately 15 mL or 1 tablespoon) of liquid. Water may be used but adding orange juice or milk rather than water may make it easier to take. Do not use warm (temperature more than 104°F or 40°C) or carbonated beverages.Step 5: Drink the mixture right away.Step 6: Add more orange juice, milk, or water to the cup to rinse the cup several times and completely swallow each time to make sure you take your entire dose of INTELENCE.
  • It is important that you do not miss or skip doses of INTELENCE during treatment.
  • When your supply of INTELENCE starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of INTELENCE. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
  • If you take too much INTELENCE, call your healthcare provider or go to the nearest emergency room right away.

What are the possible side effects of INTELENCE?

INTELENCE can cause serious side effects including:

  • Severe skin rash and allergic reactions. Skin rash is a common side effect of INTELENCE. The risk of getting a skin rash is higher in females. Rarely, rash can be severe and may lead to death. Severe skin rash with blisters or peeling skin, including the area around the mouth or eyes, may happen more frequently in children less than 18 years of age who take INTELENCE in combination with other HIV-1 medicines than in adults. Call your healthcare provider right away if a rash develops; severe cases may need to be treated in a hospital.

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:

  • fever
  • generally ill feeling
  • extreme tiredness
  • muscle or joint aches
  • blisters or sores in mouth
  • blisters or peeling of the skin
  • redness or swelling of the eyes
  • swelling of the mouth, lips, or face
  • problems breathing

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:

  • yellowing of your skin or whites of your eyes
  • dark or tea colored urine
  • pale colored stools (bowel movements)
  • nausea or vomiting
  • loss of appetite
  • pain, aching, or tenderness on the right side of your stomach area
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicines.
  • Changes in body fat can happen in people taking HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these problems are not known.

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?

  • Store INTELENCE tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep INTELENCE in the original bottle.
  • Keep the bottle tightly closed to protect INTELENCE from moisture.
  • The INTELENCE bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). The bottle of 25 mg tablets contains 2 desiccant packets. The bottles of 100 mg and 200 mg tablets contain 3 desiccant packets. Keep the desiccant packets in the bottle. Do not eat the desiccant packets.

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 BelgiumFinished Product Manufactured by:Janssen Cilag S.p.A., Latina, ITOrJanssen Ortho LLC, Gurabo, PR 00778Manufactured 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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