EDURANT (Page 8 of 9)

14.2 Virologically-Suppressed Adults Treated in Combination with Cabotegravir

The use of EDURANT in combination with VOCABRIA (cabotegravir) as an oral lead-in and in patients who miss planned injections with CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions was evaluated in two Phase 3 randomized, multicenter, active-controlled, parallel-arm, open-label, non-inferiority trials (Trial 201584: FLAIR [NCT02938520] and Trial 201585: ATLAS [NCT2951052]) in subjects who were virologically suppressed (HIV-1 RNA < 50 copies/mL). See full prescribing information for VOCABRIA and CABENUVA for additional information.

14.3 Treatment-Naïve Pediatric Subjects (12 to less than 18 years of age)

The pharmacokinetics, safety, tolerability and efficacy of EDURANT 25 mg once daily, in combination with an investigator-selected background regimen (BR) containing two NRTIs, was evaluated in trial TMC278-C213, a single-arm, open-label Phase 2 trial in antiretroviral treatment-naïve HIV-1 infected pediatric subjects 12 to less than 18 years of age and weighing at least 32 kg. Thirty six (36) subjects were enrolled in the trial to complete at least 48 weeks of treatment. The 36 subjects had a median age of 14.5 years (range: 12 to 17 years), and were 55.6% female, 88.9% Black and 11.1% Asian.

In the efficacy analysis, most subjects (75%; 28/36) had baseline HIV RNA <100,000 copies/mL. For these 28 subjects the median baseline plasma HIV-1 RNA was 44,250 (range: 2,060–92,600 copies/mL) and the median baseline CD4+ cell count was 445.5 cells/mm3 (range: 123 to 983 cells/mm3).

Among the subjects who had baseline HIV RNA ≤ 100,000, the proportion with HIV-1 RNA <50 copies/mL at Week 48 was 79% (22/28), versus 50.0% (4/8) in those with >100,000 copies/mL. The proportion of virologic failures among subjects with a baseline viral load ≤100,000 copies/mL was 21.4% (6/28), versus 37.5% (3/8) in those with >100,000 copies/mL. At Week 48, the mean increase in CD4+ cell count from baseline was 201.2 cells/mm3.

16 HOW SUPPLIED/STORAGE AND HANDLING

EDURANT (rilpivirine) tablets are supplied as white to off-white, film-coated, round, biconvex, 6.4 mm tablets. Each tablet contains 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of rilpivirine. Each tablet is debossed with “TMC” on one side and “25” on the other side.

EDURANT tablets are packaged in bottles in the following configuration: 25 mg tablets-bottles of 30 (NDC 59676-278-01).

Store EDURANT tablets in the original bottle in order to protect from light. Store EDURANT tablets at 25°C (77°F); with excursions permitted to 15°–30°C (59°–86°F) [see USP controlled room temperature].

17 PATIENT COUNSELING INFORMATION

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

Severe Skin and Hypersensitivity Reactions

Advise patients to immediately contact their healthcare provider if they develop a rash. Instruct patients to immediately stop taking EDURANT and seek medical attention if they develop a rash associated with any of the following symptoms as it may be a sign of more serious reactions such as DRESS severe hypersensitivity: fever, blisters, mucosal involvement, eye inflammation (conjunctivitis), severe allergic reaction causing a swelling of the face, eyes, lips, mouth, tongue or throat, which may lead to difficulty swallowing or breathing, and any signs and symptoms of liver problems as it may be a sign of a more serious reaction. Advise patients that if severe rash occurs, they will be closely monitored, laboratory tests will be performed and appropriate therapy will be initiated [see Warnings and Precautions (5.1)].

Hepatotoxicity

Inform patients that hepatotoxicity has been reported with EDURANT. Inform patients that laboratory monitoring for hepatotoxicity during therapy with EDURANT is recommended, especially for patients with underlying liver disease such as hepatitis B or C virus infection [see Warnings and Precautions (5.2)].

Depressive Disorders

Inform patients that depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) have been reported with EDURANT. Advise patients to seek immediate medical evaluation if they experience depressive symptoms [see Warnings and Precautions (5.3)].

Drug Interactions

EDURANT 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 Contraindications (4), Warnings and Precautions (5.4), and Drug Interactions (7)].

For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg once daily, taken with a meal. When rifabutin coadministration is stopped, the EDURANT dose should be decreased to 25 mg once daily, taken with a meal [see Dosage and Administration (2.3)].

Fat Redistribution

Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including EDURANT, and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.5)].

Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any signs or symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when EDURANT is started [see Warnings and Precautions (5.6)].

Administration Instruction

Advise patients to take EDURANT with a meal once a day as prescribed. A protein drink alone does not replace a meal. EDURANT must always be used in combination with other antiretroviral drugs. Advise patients not to alter the dose of EDURANT or discontinue therapy with EDURANT without consulting their physician. If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, advise the patient to take EDURANT with a meal as soon as possible and then take the next dose of EDURANT at the regularly scheduled time. If a patient misses a dose of EDURANT by more than 12 hours, advise the patient to not take the missed dose, but resume the usual dosing schedule. Inform the patient that he or she should not take more or less than the prescribed dose of EDURANT at any one time.

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EDURANT during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)].

EDURANT® is a registered trademark of Johnson & Johnson© Janssen Products, LP 2011

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 1/2021
PATIENT INFORMATIONEDURANT® (ee’ dur ant) (rilpivirine)tablets, for oral use
What is EDURANT?
EDURANT is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV-1) in people 12 years of age and older and who weigh at least 77 lbs (35 kg) who:
  • have never taken HIV medicines before, and
  • have an amount of HIV-1 in their blood (this is called ‘viral load’) that is no more than 100,000 copies/mL.
  • oral VOCABRIA (cabotegravir) for short term treatment of HIV-1 infection in adults when their healthcare provider determines that they meet certain requirements.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).If you take EDURANT in combination with oral VOCABRIA (cabotegravir), you should also read the Patient Information that comes with oral VOCABRIA (cabotegravir).It is not known if EDURANT is safe and effective in children less than 12 years of age or who weigh less than 77 lbs (35 kg).
Do not take EDURANT if you are taking any of the following medicines:
carbamazepine
phenobarbital
rifampin
dexamethasone (more than a single dose treatment)
esomeprazole
omeprazole
rabeprazole
oxcarbazepine
phenytoin
rifapentine
St. John’s wort (Hypericum perforatum)
lansoprazole
pantoprazole
Before taking EDURANT, tell your healthcare provider about all your medical conditions, including if you:
  • have ever had a severe skin rash or an allergic reaction to medicines that contain rilpivirine
  • have or had liver problems, including hepatitis B or C virus infection.
  • have kidney problems
  • have ever had a mental health problem.
  • are pregnant or plan to become pregnant. It is not known if EDURANT will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with EDURANT.Pregnancy Registry: There is a pregnancy registry for women who take EDURANT during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take EDURANT.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • It is not known if EDURANT passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during EDURANT treatment.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with EDURANT. Keep a list of your medicines to show 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 EDURANT.Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT with other medicines.
How should I take EDURANT?
  • Take EDURANT every day exactly as your healthcare provider tells you to.
  • Take EDURANT 1 time each day with a meal. A protein drink alone does not replace a meal.
  • Do not change your dose or stop taking EDURANT without first talking with your healthcare provider. Stay under the care of your healthcare provider during treatment with EDURANT.
  • Do not miss a dose of EDURANT.
  • If you take an H2 -receptor antagonist (famotidine, cimetidine, nizatidine, or ranitidine), you should take these medicines at least 12 hours before or at least 4 hours after you take EDURANT.
  • If you take antacids, or other products that contain aluminum, calcium carbonate, or magnesium hydroxide, you should take these medicines at least 2 hours before or at least 4 hours after you take EDURANT.
  • If you miss a dose of EDURANT within 12 hours of the time you usually take it, take your dose of EDURANT with a meal as soon as possible. Then, take your next dose of EDURANT at the regularly scheduled time. If you miss a dose of EDURANT by more than 12 hours of the time you usually take it, wait and then take the next dose of EDURANT at the regularly scheduled time.
  • Do not take more than your prescribed dose to make up for a missed dose.
  • If you take too much EDURANT, call your healthcare provider or go to the nearest hospital emergency room right away.
  • When your supply of EDURANT starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of EDURANT. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
  • When your healthcare provider prescribes use of EDURANT with oral VOCABRIA (cabotegravir):
    • Take EDURANT and oral VOCABRIA (cabotegravir) once a day at approximately the same time with a meal.
    • You will receive treatment with EDURANT tablets in combination with VOCABRIA tablets for one month (at least 28 days) before you receive the long-acting medicine called CABENUVA (cabotegravir; rilpivirine extended-release injectable suspensions) for the first time. This will allow your healthcare provider to assess how well you tolerate these medicines.
    • Your final dose of EDURANT and VOCABRIA tablets should be taken on the same day you receive your first CABENUVA injections.
What are the possible side effects of EDURANT?
EDURANT can cause serious side effects including:
  • Severe skin rash and allergic reactions. Call your healthcare provider right away if you develop a rash with EDURANT. In some cases, rash and allergic reaction may need to be treated in a hospital.Stop taking EDURANT and get medical help right away if you develop a rash with any of the following signs or symptoms:
    • fever
    • tiredness
    • difficulty breathing or swallowing
    • skin blisters
    • swelling of the face, lips, mouth, tongue, or throat
    • generally ill feeling
    • muscle or joint aches
    • blisters or mouth sores
    • redness or swelling of the eyes (conjunctivitis)
  • Liver Problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening changes in certain liver tests during treatment with EDURANT. Liver problems have also happened in people without a history of problems or other risk factors. Your healthcare provider may need to do tests to check your liver function before and during treatment with EDURANT. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:
    • your skin or the white part of your eyes turns yellow (jaundice)
    • light colored stools (bowel movements)
    • pain, aching, or tenderness on the right side of the stomach area
    • loss of appetite
    • dark or “tea colored” urine
    • nausea or vomiting
  • Depression or mood changes. Call your healthcare provider right away if you have any of the following symptoms:
    • feeling sad or hopeless
    • feeling anxious or restless
    • have thoughts of hurting yourself (suicide) or have tried to hurt yourself
  • Changes in body fat can happen in people who take HIV medicine. These changes may include 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.
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
The most common side effects of EDURANT include depression, headache, trouble sleeping (insomnia) and rash.These are not all the possible side effects with EDURANT.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 EDURANT?
  • Store EDURANT at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep EDURANT in the original bottle to protect from light.
Keep EDURANT and all medicines out of the reach of children.
General information about the safe and effective use of EDURANT
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EDURANT for a condition for which it was not prescribed. Do not give EDURANT to other people even if they have the same condition you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about EDURANT that is written for health professionals.
What are the ingredients in EDURANT?
Active ingredient: rilpivirine.
Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose. The tablet coating contains hypromellose 2910 6 mPa.s, lactose monohydrate, PEG 3000, titanium dioxide, and triacetin.
Manufactured by: Janssen-Cilag SpA, Latina, ItalyManufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560EDURANT® is a registered trademark of Johnson & Johnson© Janssen Products, LP 2011For more information go to www.EDURANT.com or call 1-800-526-7736

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.