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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
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제품 특성 요약
CCDS 121205
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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
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