Intelence

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Etravirine 100mg

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Etravirine 100 mg

Dosage:

100 mg

Pharmaceutical form:

Tablet

Composition:

Active: Etravirine 100mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose as a spray dried powder Lactose Magnesium stearate Microcrystalline cellulose

Units in package:

Bottle, plastic, HPDE x 120 tablets, 120 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Janssen Pharmaceutica NV

Therapeutic indications:

Etravirine, in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HPDE - 120 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2008-01-11

Patient Information leaflet

INTELENCE
®
(230406) ACMI
1
INTELENCE
® TABLETS
_etravirine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INTELENCE tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
INTELENCE against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN INTELENCE ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING INTELENCE.
You may need to read it again.
WHAT INTELENCE IS
USED FOR
INTELENCE is a medicine used for
the treatment of Human
Immunodeficiency Virus (HIV)
infection. It belongs to a group of
anti-HIV medicines called non-
nucleoside reverse transcriptase
inhibitors (NNRTIs). INTELENCE
works by reducing the amount of
HIV in your body. This will improve
your immune system and reduce the
risk of developing illnesses linked to
HIV infection.
INTELENCE is used to treat adults
who are infected by HIV and who
have used other anti-HIV medicines
before. INTELENCE can be used by
patients infected with HIV that is
resistant to other NNRTIs.
INTELENCE must be taken in
combination with other anti-HIV
medicines. Your doctor will discuss
with you which combination of
medicines is best for you.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INTELENCE
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
INTELENCE
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE INTELENCE:
•
if you are allergic
(hypersensitive) to etravirine, or
other ingredients of
INTELENCE. See Product
Description at the end of this
leaflet for a list of ingredients.
DO NOT TAKE INTELENCE:
•
if the packaging is torn or shows
signs of tampering.
•
if the expiry date (month and
year) printed on the pack has
passed. If you take
INTELENCE after the expiry
date it may not work.
DO NOT COMBINE INTELENCE WITH
ANY OF THE FOLLOWING MEDICINES:
•

Summary of Product characteristics

23.221121
1
INTELENCE (230406) ADS
INTELENCE
®
ETRAVIRINE
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
INTELENCE etravirine 100 mg tablets.
INTELENCE etravirine 200 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg tablet contains 100 mg of etravirine.
Each 200 mg tablet contains 200 mg of etravirine.
Etravirine
is
a
non-nucleoside
reverse
transcriptase
inhibitor
(NNRTI)
of
human
immunodeficiency virus type 1 (HIV-1).
Excipient with known effect:
Each 100 mg tablet contains 160 mg lactose.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Tablet
INTELENCE 100 mg tablet: white to off-white, oval tablet, debossed
with “T125” on one side and
“100” on the other side.
INTELENCE 200 mg tablet: white to off-white, biconvex, oblong tablet,
debossed with “T200” on
one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Etravirine, in combination with other antiretroviral agents is
indicated for the treatment of HIV-1
infection in antiretroviral treatment-experienced adults who have
evidence of viral replication and
resistance to non-nucleoside transcriptase inhibitors and other
antiretroviral agents.
This indication is based on 48-week analyses from 2 randomised,
double-blind, placebo controlled
trials of etravirine. Both studies were conducted in clinically
advanced, 3-class antiretroviral
(NNRTI, N(t)RTI, PI) treatment-experienced adults (see CLINICAL
TRIALS).
Treatment history of patients and genotypic testing should be
performed to guide the use of
etravirine.
4.2 DOSE AND METHOD OF ADMINISTRATION
INTELENCE must always be given in combination with other
antiretroviral medicinal products.
23.221121
2
INTELENCE (230406) ADS
ADULTS
:
The recommended oral dose of INTELENCE is 200 mg (one 200 mg tablet or
two 100 mg tablets)
taken orally twice daily (b.i.d.), following a meal (see SECTION 5.2).
Patients should be instructed to swallow the tablet(s) as a whole with
a liquid such as water.
Patients who are unable to swallow the INTELENCE tablet(s) whole may
disperse the ta