INTELENCE TABLET 100MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Etravirine

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Dosage:

100mg

Pharmaceutical form:

TABLET

Composition:

Etravirine 100mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Janssen Pharmaceutica N.V.

Authorization status:

ACTIVE

Authorization date:

2009-01-29

Patient Information leaflet

- 1 -

NAME OF THE MEDICINAL PRODUCT 
INTELENCE
TM
 100 mg tablets 
INTELENCE
TM
 200 mg tablets 

DOSAGE FORMS AND STRENGTHS 
100 mg tablet: Contains 100mg of etravirine. White to off-white, oval tablet, debossed with 
“T125” on one side and “100” on the other side. Contains 160mg lactose. 
200 mg  tablet:  Contains  200mg  of  etravirine.  White  to  off-white,  biconvex,  oblong  tablet

debossed with “T200” on one side 

For excipients, see ‘_List of Excipients’. _

CLINICAL INFORMATION 
INDICATIONS 
INTELENCE,  in  combination  with  other  antiretroviral  medicinal  products,  is  indicated  for 
the  treatment  of  human  immunodeficiency  virus  type  1  (HIV-1)  infection  in  antiretroviral 
treatment-experienced  adult  patients,  who  have  evidence  of  viral  replication  and  HIV-1 
strains  resistant  to  a  non-nucleoside  reverse  transcriptase  inhibitor  (NNRTI)  and  other 
antiretroviral agents.  
This  indication  is  based  on  week 48  analyses  from  2 randomised,  double-blind, 
placebo-controlled  trials  of  INTELENCE.  Both  studies  were  conducted  in  clinically 
advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.  
The following points should be considered when initiating therapy with INTELENCE: 
-

Treatment history,  and,  when available, resistance testing, should  guide the use of 
INTELENCE. 
-

The use of other active antiretroviral agents with INTELENCE is associated with an 
increased likelihood of treatment response. 
-

In  patients  who  have  experienced  virologic  failure  on  an  NNRTI-containing 
regimen,  do  not  use  INTELENCE  in  combination  with  only  N[t]RTIs  (see 
Pharmacodynamic Prope

Summary of Product characteristics

- 1 -
NAME OF THE MEDICINAL PRODUCT
INTELENCE
TM
100 mg tablets
INTELENCE
TM
200 mg tablets
DOSAGE FORMS AND STRENGTHS
100 mg tablet: Contains 100mg of etravirine. White to off-white, oval
tablet, debossed with
“T125” on one side and “100” on the other side. Contains 160mg
lactose.
200 mg tablet: Contains 200mg of etravirine. White to off-white,
biconvex, oblong tablet
debossed with “T200” on one side
For excipients, see ‘
_List of Excipients’. _
CLINICAL INFORMATION
INDICATIONS
INTELENCE
TM
, in combination with other antiretroviral medicinal products, is
indicated for
the treatment of human immunodeficiency virus type 1 (HIV-1) infection
in antiretroviral
treatment-experienced adult patients, who have evidence of viral
replication and HIV-1
strains resistant to a non-nucleoside reverse transcriptase inhibitor
(NNRTI) and other
antiretroviral agents.
This
indication
is
based
on
week 48
analyses
from
2 randomised,
double-blind,
placebo-controlled trials of
INTELENCE
TM
.
Both studies were conducted in
clinically
advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI)
treatment-experienced adults.
The following points should be considered when initiating therapy with
INTELENCE
TM
:
-
Treatment history, and, when available, resistance testing, should
guide the use of
INTELENCE
TM
.
-
The use of other active antiretroviral agents with INTELENCE
TM
is associated with
an increased likelihood of treatment response.
-
In
patients
who
have
experienced
virologic
failure
on
an
NNRTI-containing
regimen, do not use INTELENCE
TM
in combination with only N[t]RTIs (see
Pharmacodynamic Properties).
-
The risks and benefits of INTELENCE
TM
have not been established in pediatric
patients or in treatment naïve adult patients.
DOSAGE AND ADMINISTRATION
INTELENCE
TM
must always be given in combination with other antiretroviral
medicinal
products.
_ _
_ _
ADULTS
The recommended dose of INTELENCE
TM
is 200 mg (one 200mg tablet or two 100 mg
tablets) taken orally twice daily (b.i.d.), following a meal (see
_Pharmacokineti