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Janssen-Cilag Ltd

50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG , UK
Telephone: +44 1494 567 567
Fax: +44 1494 567 568
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +353 1 800 709 122
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +353 1 620 2300
Medical Information Facsimile: +44 (0) 1494 567 445
Summary of Product Characteristics last updated on medicines.ie: 02/02/2016
SPC Intelence 100 mg tablets

When a pharmaceutical company changes an SPC or PIL, 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 02/02/2016 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   28-Jan-2016
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$0Fatredistribution$0$0Combination antiretroviral therapy (CART) has beenassociated with redistribution of body fat (lipodystrophy) in HIV infectedpatients. The long‑term consequences of these events are currently unknown.Knowledge about the mechanism is incomplete. A connection between viscerallipomatosis and protease inhibitors (PIs), and lipoatrophy and nucleosidereverse transcriptase inhibitors (NRTIs), has been hypothesised. A higher riskof lipodystrophy has been associated with individual factors such as older age,and with treatment related factors such as longer duration of antiretroviraltreatment and associated metabolic disturbances. Clinical examination shouldinclude evaluation for physical signs of fat redistribution (seesection 4.8).$0$0 $0$0Weight and metabolic parameters$0$0An increase in weight and in levels of blood lipidsand glucose may occur during antiretroviral therapy. Such changes may in partbe linked to disease control and life style. For lipids, there is in some casesevidence for a treatment effect, while for weight gain there is no strongevidence relating this to any particular treatment. For monitoring of bloodlipids and glucose reference is made to established HIV treatment guidelines.Lipid disorders should be managed as clinically appropriate.$0$0 $0$0 $0$0 $0$04.8     Undesirable effects$0$0 $0$0$0$0$0$0$0Skin and subcutaneous tissue disorders$0$0$0$0very common$0$0$0$0rash (10.0% vs 3.5%)$0$0$0$0$0$0common$0$0$0$0lipohypertrophy (1.0% vs 0.3%), nightsweats (1.0% vs 1.0%)$0$0$0$0$0$0uncommon$0$0$0$0swelling face (0.3% vs 0%), hyperhidrosis (0.5% vs 0.2%),prurigo (0.7% vs 0.5%), dry skin (0.3% vs 0.2%)$0$0$0$0$0$0$0 $0$0Additional ADRs of at least moderate intensity observed inother trials were acquired lipodystrophy, angioneuroticoedema, erythema multiforme and haemorrhagic stroke, each reported in no morethan 0.5% of patients. Stevens‑Johnson Syndrome (rare; < 0.1%) andtoxic epidermal necrolysis (very rare; < 0.01%) have been reportedduring clinical development with INTELENCE.$0$0 $0$0Description of selectedadverse reactions$0$0Lipodystrophy$0$0Combination antiretroviral therapy has beenassociated 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$0 $0$0 $0$0Metabolic parameters$0$0Weight and levels of blood lipids and glucose mayincrease during antiretroviral therapy (see section 4.4).$0
Updated on 27/10/2015 and displayed until 02/02/2016
Reasons for adding or 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-Sep-2015
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 and postpartum

Based on limited data available, no dose adjustment is required during pregnancy and postpartum (see section 5.2).

 

 

4.4     Special warnings and precautions for use

 

Pregnancy

Given the increased etravirine exposure during pregnancy, caution should be applied for those pregnant patients that require concomitant medications or have comorbidities that may further increase etravirine exposure.

 

 

4.9     Overdose

 

If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage.

 

5.1     Pharmacodynamic properties

 

Pregnancy and postpartum

INTELENCE (200 mg b.i.d.), evaluated in combination with other antiretroviral medicinal products in a study of 15 pregnant women during the second and third trimesters of pregnancy and postpartum, demonstrated that exposure to total etravirine was generally higher during pregnancy compared with postpartum, and less so for unbound etravirine exposure (see section 5.2). There were no new clinically relevant safety findings in the mothers or in the newborns in this trial.

 

5.2     Pharmacokinetic properties

 

Pregnancy and postpartum

Study TMC114HIV3015 evaluated etravirine 200 mg b.i.d. in combination with other antiretroviral medicinal products in a study of 15 pregnant women during the second and third trimesters of pregnancy and postpartum. The total etravirine exposure after intake of etravirine 200 mg b.i.d. as part of an antiretroviral regimen was generally higher during pregnancy compared with postpartum (see Table 9). The differences were less pronounced for unbound etravirine exposure.

In women receiving etravirine 200 mg b.i.d., higher mean values for Cmax, AUC12h and Cmin were observed during pregnancy compared to postpartum. During the 2nd and 3rd trimester of pregnancy mean values of these parameters were comparable.

 

 

Table 9: Pharmacokinetic results of total etravirine after administration of etravirine 200 mg b.i.d. as part of an antiretroviral regimen, during the 2nd trimester of pregnancy, the 3rd trimester of pregnancy, and postpartum.

Pharmacokinetics of etravirine (mean ± SD, median)

etravirine 200 mg b.i.d. postpartum

etravirine 200 mg b.i.d. 2nd trimester

etravirine 200 mg b.i.d. 3rd trimester

N

Cmin, ng/mL

10

269 ± 182

284

13

383 ± 210

346

10a

349 ± 103

371

Cmax, ng/mL

 

AUC12h, h*ng /mL

569 ± 261

528

5004 ± 2521

5246

774 ± 300

828

6617 ± 2766

6836

785 ± 238

694

6846 ± 1482

6028

a     n = 9 for AUC12h

 

Each subject served as her own control, and with an intra-individual comparison, the total etravirine Cmin, Cmax and AUC12h values were 1.2-, 1.4- and 1.4-fold higher, respectively, during the 2nd trimester of pregnancy as compared to postpartum, and 1.1-, 1.4- and 1.2-fold higher, respectively, based during the 3rd trimester of pregnancy as compared to postpartum.

 

 

Updated on 20/06/2014 and displayed until 27/10/2015
Reasons for adding or updating:
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   22-May-2014
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

Dolutegravir

50 mg once daily

 

 

 

Dolutegravir + darunavir/ritonavir

50 mg once daily + 600/100 mg twice daily

 

 

Dolutegravir + Lopinavir/ritonavir

50 mg once daily + 400/100 mg twice daily

 

dolutegravir

AUC ↓ 0.29 (0.26‑0.34)

Cmin ↓ 0.12 (0.09‑0.16)

Cmax ↓ 0.48 (0.43‑0.54)

etravirine

AUC ↔a

Cmina

Cmaxa

 

dolutegravir

AUC↓ 0.75 (0.69‑0.81)

Cmin ↓ 0.63 (0.52‑0.77)

Cmax ↓ 0.88 (0.78‑1.00)

etravirine

AUC ↔a

Cmina

Cmaxa

 

dolutegravir

AUC↔ 1.11(1.02‑1.20)

Cmin ↑ 1.28 (1.13‑1.45)

Cmax ↔ 1.07 (1.02‑1.13)

etravirine

AUC ↔a

Cmina

Cmaxa

Etravirine significantly reduced plasma concentrations of dolutegravir. The effect of etravirine on dolutegravir plasma concentrations was mitigated by co‑administration of darunavir/ritonavir or lopinavir/ritonavir, and is

expected to be mitigated by atazanavir/ritonavir.

 

INTELENCE should only be used with dolutegravir when co‑administered with atazanavir/ritonavir,

darunavir/ritonavir, or lopinavir/ritonavir. This combination can be used without dose adjustment.

 

 

Section 4.8

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

 

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

 

Ireland

IMB Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Updated on 27/03/2014 and displayed until 20/06/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Mar-2014
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 17/01/2014 and displayed until 27/03/2014
Reasons for adding or 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
Date of revision of text on the SPC:   08-Jan-2014
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 addition of

Boceprevir

Boceprevir 800 mg 3 times daily + etravirine 200 mg every 12 hours

boceprevir

AUC ↑ 1.10 (0.94‑1.28)

Cmax ↑ 1.10 (0.94‑1.29)

Cmin ↓ 0.88 (0.66‑1.17)

etravirine

AUC ↓ 0.77 (0.66‑0.91)

Cmax ↓ 0.76 (0.68‑0.85)

Cmin ↓ 0.71 (0.54‑0.95)

The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of the combination therapy with HIV antiretroviral medicines which also affect the pharmacokinetics of etravirine and/or boceprevir has not been directly assessed. Increased clinical and laboratory monitoring for HIV and HCV suppression is recommended.


Updated on 03/12/2013 and displayed until 17/01/2014
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   20-Nov-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Change to SPC removal of statement;

 

This medicinal product has been authorised under a so‑called ’conditional approval’ scheme.  This means that further evidence on this medicinal product is awaited. The European Medicines Agency will review new information on this medicinal product at least every year and this SPC will be updated as necessary.

Date of last renewal : 28 August 2013
Updated on 11/06/2013 and displayed until 03/12/2013
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   30-May-2013
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 20/03/2013 and displayed until 11/06/2013
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   06-Mar-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Paediatric indication
Interactions with telapervir, rilpivirine and antimalarials
Updated on 07/08/2012 and displayed until 20/03/2013
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Jul-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Renewal granted.
Updated on 30/03/2012 and displayed until 07/08/2012
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   19-Mar-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.6 updated with additional information.
Updated on 05/12/2011 and displayed until 30/03/2012
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   24-Nov-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


SmPC wording amended for clarity.
Updated on 08/09/2011 and displayed until 05/12/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Aug-2011
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 - Addition of interaction with Clopidogrel
Updated on 05/08/2011 and displayed until 08/09/2011
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 9
Date of latest renewal: 28 August 2010

Section 10
July 2011
Updated on 21/05/2010 and displayed until 05/08/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



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

Updated info regarding voriconazole and fluconazole DDI’s

Change to section 10 - Date of revision of the text

 Changed to April 2010

Updated on 23/12/2009 and displayed until 21/05/2010
Reasons for adding or 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
Date of revision of text on the SPC:   01-Nov-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to section 4.5 - Addition of further info regarding Lopinavir/ritonavir interaction.
Change to section 10 - Changed to Nov 2009.
Updated on 01/12/2009 and displayed until 23/12/2009
Reasons for adding or updating:
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Nov-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to section 4.4 - Addition of information re. severe hypersensitivity reactions, DRESS.
Change to section 4.5 - Addition of further info regarding rifabutin interaction.
Change to section 4.8 - Addition of information re. severe hypersensitivity reactions, DRESS.
Change to section 9 - Addition of date of latest renewal.
Change to section 10 - Changed to November 2009.
Updated on 13/05/2009 and displayed until 01/12/2009
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 5.3 - Preclinical safety data
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   23-Apr-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



4.8

Undesirable effects

Update with  pooled 48 week data from Phase III Clinical Trials

 

5.3

Preclinical Safety Data

Update with information form carcinogenicity studies

 

10.

DATE OF REVISION OF THE TEXT

 

Changed to April 2009

 

Updated on 30/10/2008 and displayed until 13/05/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Etravirine