Edurant 25mg film-coated tablets

  • Name:

    Edurant 25mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Rilpivirine Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/10/18

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Summary of Product Characteristics last updated on medicines.ie: 21/10/2019

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Janssen Sciences Ireland

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 21 October 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 March 2019 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.9     Overdose

 

There is no specific antidote for overdose with EDURANT. Human experience of overdose with rilpivirine is limited. Symptoms of overdose may include headache, nausea, dizziness and/or abnormal dreams. Treatment of overdose with rilpivirine consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. Administration of activated charcoal may be used to aid in removal of unabsorbed active substance.Further management should be as clinically indicated or as recommended by the national poisons centre, where available. Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.

Updated on 30 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change in co-marketing arrangement

Updated on 29 October 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use 

Immune reactivation syndrome

 

Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8). 

4.8     Undesirable effects

 Immune reconstitution inflammatory syndrome

In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).

Updated on 29 October 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use 

Immune reactivation syndrome 

Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).

 

Updated on 22 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 February 2018 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 6 - date of revision

Updated on 30 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 30 August 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

Pregnancy

Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely. Alternatively, switching to another ART regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).

 

 

4.4       Special warnings and precautions for use

Pregnancy

Edurant should be used during pregnancy only if the potential benefit justifies the potential risk. Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. In the phase 3 studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2). Alternatively, switching to another ART regimen could be considered.

 

4.6       Fertility, pregnancy and lactation

 

Pregnancy

There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine in pregnant women (see sections 4.4, 5.1 and 5.2). Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.

 

5.1          Pharmacodynamic properties

 

Pregnancy

Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum. The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks). The virologic response was generally preserved throughout the study: of the 12 subjects that completed the study, 10 subjects were suppressed at the end of the study; in the other 2 subjects an increase in viral load was observed only postpartum, for at least 1 subject due to suspected suboptimal adherence. No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available. Rilpivirine was well tolerated during pregnancy and postpartum. There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).

 

5.2          Pharmacokinetic properties

Pregnancy and Postpartum

The exposure to total rilpivirine after intake of rilpivirine 25 mg once daily as part of an antiretroviral regimen was lower during pregnancy (similar for the 2nd and 3rd trimester) compared with postpartum (see table 6). The decrease in unbound (ie, active) rilpivirine pharmacokinetic parameters during pregnancy compared to postpartum was less pronounced than for total rilpivirine.

 

In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intra-individual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 20%, 31% and 42% lower as compared to postpartum.

 

Table 6:          Pharmacokinetic Results of Total Rilpivirine After Administration of Rilpivirine 25 mg Once Daily as Part of an Antiretroviral Regimen, During the 2nd Trimester of Pregnancy, the 3rd Trimester of Pregnancy and Postpartum

Pharmacokinetics of total rilpivirine

(mean ± SD, tmax: median [range])

Postpartum

(6‑12 Weeks)

(n=11)

2nd Trimester

of pregnancy

(n=15)

3rd Trimester

of pregnancy

(n=13)

Cmin, ng/mL

84.0 ± 58.8

54.3 ± 25.8

52.9 ± 24.4

Cmax, ng/mL

167 ± 101

121 ± 45.9

123 ± 47.5

tmax, h

4.00 (2.03-25.08)

4.00 (1.00-9.00)

4.00 (2.00-24.93)

AUC24h, ng.h/mL

2714 ± 1535

1792 ± 711

1762 ± 662

 

 

Updated on 25 August 2017 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 18 August 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


4.5     Interaction with other medicinal products and other forms of interaction




Simeprevir*

simeprevir AUC ↔

simeprevir Cmin

simeprevir Cmax ↑ 10%

rilpivirine AUC ↔

rilpivirine Cmin ↑ 25%

rilpivirine Cmax

No dose adjustment is required.

Updated on 26 July 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 Renewal of marketing authorisation.

Removal of Black Triangle.

Changes mainly due to QRD and administrative

Updated on 25 July 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 2 February 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0Updates to Section 4.4 Special warnings and precautions for use$0$0 $0$0Fat redistribution$0$0Combinationantiretroviral therapy (CART) has been associated with redistribution of bodyfat (lipodystrophy) in HIV infected patients. The long‑term consequences ofthese events are currently unknown. Knowledge about the mechanism isincomplete. A connection between visceral lipomatosis and protease inhibitors(PIs) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs)has been hypothesised. A higher risk of lipodystrophy has been associated withindividual factors such as older age and with drug‑related factors such aslonger duration of antiretroviral treatment and associated metabolicdisturbances. Clinical examination should include evaluation for physical signsof fat redistribution (see section 4.8).$0$0 $0$0 4.8     Undesirable effects$0$0  $0$0Description of selected adverse reactions$0$0Lipodystrophy$0$0CART hasbeen associated with redistribution of body fat (lipodystrophy) in HIV infectedpatients, including loss of peripheral and facial subcutaneous fat, increasedintra‑abdominal and visceral fat, breast hypertrophy and dorsocervical fataccumulation (buffalo hump) (see section 4.4).$0

Updated on 1 February 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 24 November 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 24 November 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



4.1     Therapeutic indications

 

EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in antiretroviral treatment‑naïve adult patients 12 years of age and older with a viral load ≤ 100,000 HIV‑1 RNA copies/ml.

 

4.2     Posology and method of administration

 

Adults and adolescents (12 to less than 18 years of age)

The recommended dose of EDURANT is one 25 mg tablet taken once daily. EDURANT must be taken with a meal (see section 5.2).

 

Paediatric population

The safety and efficacy of EDURANT in children aged < 1812 years have not yet been established.

No data are available.

 

 

4.4     Special warnings and precautions for use

 

 

Virologic failure and development of resistance

 

 

Findings in adolescents (12 to less than 18 years of age) in trial C213 were generally in line with these data (for details see section 5.1).

 

Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.

 

4.5     Interaction with other medicinal products and other forms of interaction

 

Interaction table

Interaction studies have only been performed in adults.

 

4.8     Undesirable effects

 

Paediatric population (12 to less than 18 years of age)

The safety assessment is based on the week 48 analysis of the singlearm, open-label, Phase 2 trial, TMC278C213, in which 36 antiretroviral treatmentnaïve HIV1 infected adolescent patients weighing at least 32 kg received EDURANT (25 mg once daily) in combination with other antiretroviral agents (see section 5.1). The median duration of exposure for patients was 63.5 weeks. There were no patients who discontinued treatment due to ADRs. No new ADRs were identified compared to those seen in adults.

 

Most ADRs were Grade 1 or 2. The most common ADRs (all grades, greater than or equal to 10%) were headache (19.4%), depression (19.4%), somnolence (13.9%), and nausea (11.1%). No grade 34 laboratory abnormalities for AST/ALT or grade 34 ADRs of transaminase increased were reported.

 

The safety and efficacy of EDURANT in children aged < 1812 years have not yet been established. No data are available.

 

 

5.1     Pharmacodynamic properties

 

Paediatric population

The pharmacokinetics, safety, tolerability and efficacy of EDURANT 25 mg once daily, in combination with an investigator-selected BR containing two NRTIs, was evaluated in trial TMC278C213, a singlearm, openlabel Phase 2 trial in antiretroviral treatmentnaïve HIV1 infected adolescent subjects weighing at least 32 kg. This analysis included 36 patients who had completed at least 48 weeks of treatment or discontinued earlier.

 

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. The median baseline plasma HIV1 RNA was 4.8 log10 copies per mL, and the median baseline CD4+ cell count was 414 x 106 cells/l (range: 25 to 983 x 106 cells/l).

 

The proportion of subjects with HIV1 RNA < 50 copies/mL at week 48 (TLOVR) was 72.2% (26/36). The proportion of responders was higher in subjects with a baseline viral load ≤ 100,000 copies/mL (78.6%, 22/28) as compared to those with a baseline viral load > 100,000 copies/mL (50.0%, 4/8). The proportion of virological failures was 22.2% (8/36). The proportion of virologic failures was lower in subjects with a baseline viral load ≤ 100,000 copies/mL (17.9%, 5/28) as compared to those with a baseline viral load > 100,000 copies/mL (37.5%, 3/8). Rilpivirine resistance mutations were observed in 62.5% (5/8) of subjects with virological failure. In 4 of those 5 subjects, NRTI resistance was observed as well. One subject discontinued due to an adverse event and 1 subject discontinued due to reasons other than an adverse event or virological failure. At week 48, the mean increase in CD4+ cell count from baseline was 201.2 x 106 cells/l.

 

5.2     Pharmacokinetic properties

 

Additional information on special populations

Paediatric population (less than 18 years of age)

The pharmacokinetics of rilpivirine in antiretroviral treatmentnaïve HIV1 infected adolescent subjects receiving EDURANT 25 mg once daily were comparable to those in treatmentnaïve HIV1 infected adults receiving EDURANT 25 mg once daily. There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in trial C213 (33 to 93 kg), similar to what was observed in adults.

 

The pharmacokinetics of rilpivirine in paediatric patients less than 12 years of age are under investigation. Dosing recommendations for paediatric patients less than 12 years of age cannot be made due to insufficient data (see section 4.2).

 

 

 

 

Updated on 28 March 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 27 March 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4          Special warnings and precautions for use

 

While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.

Patients should be advised that current antiretroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood or sexual contact. Appropriate precautions should continue to be employed.

Updated on 22 January 2014 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 21 January 2014 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5

Rilpivirine inhibits the active renal tubular secretion of creatinine. Via the same mechanism exposure to metformin may be increased. Patients should be carefully monitored when initiating or stopping the concomitant administration of rilpivirine and metformin.Rilpivirine is an in vitro inhibitor of the transporter MATE2K with an IC50 of < 2.7 nM. The clinical implications of this finding are currently unknown.

Metformin*

850 mg single dose

metformin AUC ↔

metformin Cmin NA

metformin CmaxNot studied. It may not be excluded that rilpivirine will give rise to increased exposure of metformin.

 

(inhibition of the active renal secretion of metformin)

Careful patient monitoring is advised when starting or ending concomitant treatment.No dose adjustment is required.

Updated on 22 October 2013 PIL

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to how the medicine works
  • Change to date of revision
  • Addition of black triangle

Updated on 21 October 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 4.2 Add:

 

Dose adjustment

For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) taken once daily. When rifabutin co‑administration is stopped, the EDURANT dose should be decreased to 25 mg once daily (see section 4.5).

Section 4.3

Contraindications

; the antimycobacterials rifabutin  rifampicin, rifapentine
section 4.5
updated information in rifabutin interaction

section 4.8- standard ADR reporting text

Section 5.1

addition of:  Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut‑off (BCO) of the assay.

Updated on 11 June 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 10 June 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Implement class labeling relating to Immune Reconstitution Syndrome (IRS).

Updated on 21 March 2013 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Interactions with digoxin updated

Updated on 21 March 2013 PIL

Reasons for updating

  • Change to drug interactions

Updated on 7 January 2013 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of Y188L mutation

Updated on 9 November 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to improve clarity and readability
  • Improved electronic presentation

Updated on 8 November 2012 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Interaction details with raltegravir and telaprevir.
Inclusion of 96 weeks clinical data.

Updated on 1 May 2012 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 April 2012 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided