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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

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Summary of Product Characteristics last updated on the eMC: 20/04/2012
SPC Prezista 75 mg, 150 mg, 400 mg, 600 mg film-coated tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 20/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   12-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Interaction with Boceprevir included.
Updated on 07/03/2012 and displayed until 20/04/2012
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   21-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Addition of Rilpivirine and Telaprevir interactions.
Updated on 08/08/2011 and displayed until 07/03/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8

In the 96 week analysis, the safety profile of PREZISTA/rtv 800/100 mg once daily in treatment‑naïve subjects was similar to that seen with PREZISTA/rtv 600/100 mg twice daily in treatment‑experienced subjects except for nausea which was observed more frequently in treatment‑naïve subjects. This was driven by mild intensity nausea. No new safety findings were identified in the 192 week analysis of the treatment‑naive subjects in which the mean treatment duration of PREZISTA/rtv 800/100 mg once daily was 162.5 weeks.


Section 5.1

Efficacy of PREZISTA 800 mg once daily co‑administered with 100 mg ritonavir once daily in ART‑naïve patients

The evidence of efficacy of PREZISTA/ritonavir 800/100 mg once daily is based on the analyses of 96192 week data from the randomised, controlled, open‑label Phase III trial ARTEMIS in antiretroviral treatment‑naïve HIV‑1 infected patients comparing PREZISTA/ritonavir 800/100 mg once daily with lopinavir/ritonavir 800/200 mg per day (given as a twice‑daily or as a once‑daily regimen). Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.

-----

 Non‑inferiority in virologic response to the PREZISTA/ritonavir treatment, defined as the percentage of patients with plasma HIV‑1 RNA level < 50 copies/ml, was demonstrated (at the pre‑defined 12% non‑inferiority margin) for both Intent‑To‑Treat (ITT) and On Protocol (OP) populations in the 48 week analysis. These results were confirmed in the analyses of data at 96 weeks of treatment in the ARTEMIS trial. These results were sustained up to 192 weeks of treatment in the ARTEMIS trial.

 

 
Updated on 10/06/2011 and displayed until 08/08/2011
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-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 4.5 - addition of Rosuvastatin
Change to section 10 - May 2011
Updated on 09/03/2011 and displayed until 10/06/2011
Reasons for adding or 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 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4 of the SmPC has been updated with relevant information following approval of the once-daily dosing regimen:

For ART‑experienced adults with no darunavir resistance associated mutations (DRV‑RAMs)* and who have plasma HIV‑1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l, a dose regimen of 800 mg once daily with ritonavir 100 mg once daily taken with food may be used .

Section 5 of the SmPC has been updated with the relevant clinical trial data:

ODIN is a Phase III, randomised, open‑label trial comparing PREZISTA/rtv 800/100 mg once daily versus PREZISTA/rtv 600/100 mg twice daily in ART‑experienced HIV‑1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV‑1 RNA > 1,000 copies/ml. Efficacy analysis is based on 48 weeks of treatment.
Updated on 09/12/2010 and displayed until 09/03/2011
Reasons for adding or updating:
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   29-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.3 Contra-indications

Addition of sildenafil when used for treatment of pulmonary hypertension.

Section 4.4 Special warnings

Warning added for life threatening/fatal drug interactions in patients treated with colchicine and strong inhibitors of CYP3A and Pgp.

Section 4.5 Interactions

Addition of information for sildenafil (when used for pulmonary hypertension), colchicine, bosentan, salmeterol.
Updated on 02/08/2010 and displayed until 09/12/2010
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Addition of contra-indication for alfuzosin to section 4.3.
Addition of statement regarding rifabutin dose reduction to section 4.5
A warning has been introduced in section 4.4 and 4.8 regarding potential for a higher than expected skin rash rate when raltegravir is co-administered with Prezista (in line with the Isentress label).
Date of revision changed to July 2010.
Updated on 23/06/2010 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change to joint SPC covering all presentations
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   02-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.4 - Special warnings and precautions for Use

Reformatting as per new SmPC guidance, and additional information regarding hepatotoxicity.

Change to section 4.8 - Undesirable Effects

Reformatting as per new SmPC guidance.

Change to section 10 - Date of revision of the text

Changed to 02.06.10

Change to joint SPC covering all presentations

 
Updated on 19/11/2009 and displayed until 23/06/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


4.5

Interaction with other medicinal products and other forms of interaction

Addition of buprenorphine/naloxone DDI

5.1

Pharmacodynamic properties

Addition of 96 week trial data (ARTEMIS & TITAN trials)

 

10.

DATE OF REVISION OF THE TEXT

 

 23.10.09

 
Updated on 31/07/2009 and displayed until 19/11/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  darunavir ethanolate