INCIVO

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Telaprevir

Available from:

Janssen-Cilag Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

Page 1 of 5 
INCIVO (120306) ACI 
INCIVO
®

_TELAPREVIR_

FILM-COATED TABLETS 
CONSUMER MEDICINE INFORMATION (CMI) 
WHAT IS IN THIS LEAFLET 
This leaflet answers some of the common questions 
about Incivo.  It does not contain all of the available 
information.  It does not take the place of talking to 
your doctor or pharmacist. 
IF YOU HAVE ANY CONCERNS ABOUT USING INCIVO, ASK 
YOUR DOCTOR OR PHARMACIST.  Your doctor and 
pharmacist have more information. 
KEEP THIS INFORMATION HANDY. You can refer to it later 
if you have any questions. 
Please also refer to Consumer Medicine Information 
documents of other medicines your doctor may have 
prescribed for use in combination with Incivo. Ask your 
doctor or pharmacist if you have any questions. 
WHAT INCIVO IS USED FOR 
Incivo belongs to a group of medicines called ‘NS3-4A 
protease inhibitors’. It is an inhibitor of the HCV NS3 4A 
protease, an enzyme that is essential for hepatitis C 
virus replication. 
Incivo is part of a treatment for chronic hepatitis C. It 
must be taken in combination with peginterferon alfa 
and ribavirin. This combination of medicines is used to 
treat adult patients (aged 18–65). 
Your doctor, however, may prescribe this medicine for 
another use.  ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED TO 
YOU. 
BEFORE YOU TAKE IT 
_WHEN YOU MUST NOT USE IT _
Do not use Incivo IF YOU KNOW YOU ARE ALLERGIC TO ANY 
OF ITS INGREDIENTS LISTED AT THE END OF THIS LEAFLET. 
Signs of allergy include skin rash, itching, shortness of 
breath, and/or swollen face. 
DO NOT USE IT AFTER THE EXPIRY DATE PRINTED ON THE 
PACK. 
If you use it after the expiry date has passed, it may not 
work as well. 
DO NOT USE IT IF THE PACKAGING IS TORN OR SHOWS 
SIGNS OF BEING TAMPERED WITH. 
DO N

Summary of Product characteristics

 
CCDS 121205 
Page 1 of 32 
INCIVO (130122) API 
INCIVO
® 
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Telaprevir 

The chemical name is (1_S_, 3a_R_,
6a_S_)-2-((_S_)-2-{(_S_)-2-Cyclohexyl-2-
[(pyrazine-2-carbonyl)-amino] 
-acetylamino}-3,3-dimethyl-butyryl)-octahydro-cyclopenta[c]pyrrole-1-carboxylic acid ((_S_)-1- 
cyclopropylaminooxalyl-butyl)-amide. 

O
N
O
N
H
O
N
N
H
N
O
H
N
H
N
O
O
(_S_)
(_S_)
(_S_)
(_S_)
(_S_)
(_R_)

Molecular Formula: C
36
H
53
N
7
O
6

CAS: 402957-28-2 

MW: 679.9 
DESCRIPTION

The active ingredient telaprevir is an inhibitor of the Hepatitis C
Virus (HCV) NS3 4A protease, an 
enzyme that is essential for HCV replication. Telaprevir drug
substance is a white to off-white 
powder with a solubility in water of 0.0047 mg/mL. The apparent log (P
1-octanol/aqueous solution
) values of 
telaprevir at room temperature (24 ± 3°C) are 3.96 (pH 1), 3.87 (pH
5), and 4.00 (pH 7). The high 
apparent partition coefficient is consistent with the low aqueous
solubility of the drug substance, 
and, hence, the hydrophobic nature of telaprevir. 

INCIVO is available as yellow, caplet-shaped, film-coated tablets of
approximately 20 mm in 
length, marked with “T375” on one side. The inactive ingredients
are hypromellose acetate 
succinate, sodium lauryl sulfate, calcium hydrogen
phosphate anhydrous, croscarmellose sodium, 
cellulose - microcrystalline, silicon dioxide, sodium stearyl
fumarate, polyvinyl alcohol, macrogol 
3350, talc - purified, titanium dioxide and iron oxide yellow. 
PHARMACOLOGY 
Pharmacotherapeutic group: Direct-acting antiviral. 

PHARMACODYNAMICS 
MECHANISM OF ACTION 
Telaprevir is an inhibitor of the HCV NS3 4A serine protease, which
is essential for viral replication. 

_Antiviral activity in cell culture _

In an HCV subtype 1b replicon assay, the telaprevir IC
50
 value against wild-type HCV was 354 nM, 
similar to a subtype 1a infectious virus assay IC
50
 value of280 nM. In biochemical e